COPD: Anaemia Is An Independent Risk Factor For Reduced Functional Capacity

Anaemia is a condition affecting patients who suffer from a variety of chronic illness. It has been found to be present in people with congestive heart failure, arthritis, cirrhosis of the liver, kidney failure and AIDS among others. Chronic obstructive pulmonary disease or COPD is also a chronic illness affecting adults. Although it is a disease of the lungs, it is also one that has important systemic consequences.


Because of the close relationship between oxygenation and haemoglobin (Hb) production and the fact that prior to the widespread use of oxygen to treat the hypoxia of severe COPD many patients had increased Hb (polycythaemia), it has been assumed that anaemia was a rare occurrence among these people.
However, as COPD is associated with inflammation it has become possible that the levels of Hb are abnormal in the patients as we see them today.



To answer that question, Claudia Cote (Dept of Medicine, Respiratory Disease Section, Bay Pines VAMC, Florida, USA) and her colleagues have investigated the prevalence and association of abnormal Hb with clinical outcomes.


Analysis of a prospective cohort of 683 stable COPD outpatients in a US Veterans Administration pulmonary clinic was performed.


The results show that anaemia is present in 116 (17%) and polycythaemia in 40 (6%) patients. While the only value that differs between polycythaemic and non-polycythaemic patients is mean Hb, anaemic patients have a significantly higher sensation of shortness of breath, lower capacity to exercise and shorter median survival (49 vs 74 months) than non-anaemic patients. Anaemia independently predicts dyspnoea and reduced exercise capacity.



The American team concludes that anaemia in COPD is an independent risk factor for reduced functional capacity. Polycythaemia prevalence is low and has no association with worsened outcomes. Further work is required to evaluate the effect of anaemia correction on outcomes in COPD.



"Haemoglobin level and its clinical impact in a cohort of patients with COPD"

European Respiratory Journal (ERJ)

News From The September Issue Of Chest

PEDIATRIC CHRONIC COUGH LINKED TO REFLUX AND ALLERGIES


New research shows that chronic cough in children is most often caused by gastroesophageal reflux
and allergies. Researchers from Tulane University in New Orleans, LA, evaluated 40 patients aged 5 to
12 years with chronic cough (> 8 weeks in duration) with no obvious cause. Each patient underwent
extensive multispecialty testing. Results showed that reflux was the single most commonly associated
factor of chronic cough by itself (27.5 percent), followed by allergy (22.5 percent). All patients
received treatment for their underlying conditions, and all responded to their respective treatments.
This study is published in the September issue of CHEST, the peer-reviewed journal of the American
College of Chest Physicians.



STATINS MAY BENEFIT PATIENTS WITH COPD



Statins have been shown to benefit patients with cardiovascular disease and high cholesterol, but now
research shows that statins may provide significant benefits for patients with chronic obstructive
pulmonary disease (COPD). Researchers from the University of British Columbia reviewed data from
nine studies that illustrated the beneficial effects of statins on patients with COPD. Further analysis
showed that each study provided at least one benefit to patients with COPD, including reduced
exacerbations (3 studies); reduction in the number of COPD-related intubations and time to COPDrelated
intubations (1 study); improved pulmonary function (1 study); improved exercise capacity (1
study); improved mortality (2 studies); and improved all-cause mortality (3 studies). Researchers
conclude that, although statins show promise for patients with COPD, additional research is needed.
The article is published in the September issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.



PATIENTS WITH INTERSTITIAL LUNG DISEASE NEED NOT AVOID AIR TRAVEL



Patients with interstitial lung disease (ILD) are often concerned about the occurrence of pneumothorax
(collapsed lung) or other life-threatening events during air travel. However, new research shows that,
even in ILD with a high prevalence of spontaneous pneumothorax, such as lymphangioleiomyomatosis
(LAM), there is a relatively low risk of these events occurring. Researchers from the National
Institutes of Health reviewed records and imaging studies of 449 patients with sarcoidosis, idiopathic
pulmonary fibrosis, and LAM, who made a total of 816 trips by airplane and 416 trips by land. Results
showed that the frequency of pneumothorax in patients with LAM was 2.9 percent in those who
traveled by airplane and 1.3 percent in those who traveled by ground transportation. No patients with
IPF or sarcoidosis had a new pneumothorax while traveling. Researchers conclude that, in patients
with LAM, the presence of pneumothorax associated with air travel may be related to the high
incidence of pneumothorax from the disease itself and not to travel. This article is published in the
September issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.

Chronic Obstructive Pulmonary Disease: Hospital Readmissions Could Be Reduced

Readmission of patients with chronic obstructive pulmonary disease (COPD) is a major problem within health systems. Each admission for exacerbation worsens the patient's quality of life and, at the same time, presents an economic challenge for the hospital centre. A study published in the European Respiratory Journal describes the usefulness of an integrated and coordinated intervention of primary health care and hospital health care. This work, which demonstrates the benefits of cooperation among several health care levels, has been led by Dr. Josep Roca and Mrs. Carme Hernandez, members of the IDIBAPS Physiopathological Mechanisms of the Respiratory Disease Group and of the Pneumology Unit of Hospital Cl?­nic.



This study includes 150 patients, 65 of which receive integrated health care. Results show that more than a half of these patients do not need readmission, whereas 67% of patients receiving conventional health care are readmitted in hospital. Previous studies assessing home health care did not obtain conclusive results. The main limitations were the lack of standardisation of the interventions and the lack of homogeneity of patients. In this new work, highly precise criteria for the inclusion of patients have been defined, and intervention protocols have been highly detailed. Protocols were not identical in both countries participating in the study, what reinforces the positive results obtained. Differences among both countries have permitted to conclude that a higher number of home health care appointments does not imply better results on the health of patients. The Belgian system implied more home care assistance than the Catalan system, but no differences were observed in the results. This works is presented as a conclusion of the European project CHRONIC, a pioneer European telemedicine research project started on January 2000 that closes with this publication.



The design of integrated health care of these initiatives makes health specialists much more accessible to patients, primarily thanks to an only telephonic switchboard for these patients. Furthermore, COPD patients receive an informative course on their disease, which gives them more autonomy. Results of this study are along the same line of those obtained with the Home Care Programme promoted by Hospital Clinic during the first trimester of 2006 aimed to patients with COPD and cardiac insufficiency. Patients included in this programme evolved from a 9-day admission to a 2-day admission. This programme, which emphasizes specialised nursing and medical cooperation, was initially supported by CATSalut, but now and until 31 December the project will be supported by Hospital Clinic. Home care health reflects the fructuous relationship between hospital care and research in Hospital Clinic, and could be a major tool of health management in several chronic diseases in the future. 60% of patients admitted in emergencies have a chronic pathology; therefore, the fact of giving assistance to these patients at the correct health care levels can be a decisive factor in third level hospitals, such as Hospital Clinic, in order not to collapse the centre.







Contact: Alex Argemi


IDIBAPS - Institut d'Investigacions Biomediques August Pi i Sunyer

Wrinkled Middle-Aged Smokers At Higher Risk Of COPD

If you are middle-aged, have lots of wrinkles and smoke, you are five times more likely to develop CPOD (chronic obstructive pulmonary disease) than middle-aged smokers who are not very wrinkly, says a study from the Royal Devon and Exeter Hospital, UK.


You can read the report in the journal Thorax. The scientists said that the heavy lines on a smoker's face could provide a good indication of COPD risk. They studied 149 people and concluded that genetic propensity to wrinkles seems to come with a higher susceptibility of developing COPD.


Millions of people around the world have COPD and have not been diagnosed. It is caused mainly by smoking. WHO predicts it will become the third leading cause of death in the world within the next 14 years.


The study looked at 149 people who smoke, or used to smoke. They were aged 45-70 and all came from the Cambridge, UK, area. 68 of them had COPD. 25 of them had very wrinkly faces, of which 21 had COPD. The researchers found that after taking into account the people's age and how long they had been smokers, those with wrinkly faces had five times the probability of having COPD compared to smokers who did not have wrinkly faces. Severe emphysema was also linked to wrinkly faces, said the researchers.


Team leader, Dr Bipen Patel, said "We think there is a genetic susceptibility to COPD. What this research shows is that those who are prone to COPD are also prone to wrinkles. If there is a gene for COPD susceptibility, it may also increase the chance of someone developing wrinkles." He added that wrinkles may become a risk indicator for COPD.


As early diagnosis is an essential part of effective COPD treatment, perhaps doctors should look out for middle-aged smoking patients who have wrinkly skin.

Air Travel and Lung Disease: Current Guidelines Are Inappropriate

For the first time, patients suffering from chronic obstructive pulmonary disease (COPD), were studied during a
commercial flight lasting almost six hours. Their blood oxygen content underwent a considerable reduction, more marked than
could have been predicted using the currently accepted guidelines. However, the oxygen reduction was generally well tolerated
by those subjects who, prior to departure, had a blood oxygen content equal to or greater than the recommended pre-flight
value.


A German team, whose study also appears in April's ERJ, conducted similar experiments on patients with cystic fibrosis. They
conclude that these patients can also travel on flights of several hours' duration without excessive risk.




What, in today's world, could be more commonplace than a plane trip lasting a few hours, whether for business or pleasure?
Yet, while such flights are unproblematic for most of us, they can be dangerous for people with certain conditions. This is
particularly true of lung disease sufferers, especially those with either chronic bronchitis (known to doctors as chronic
obstructive pulmonary disease or COPD) or cystic fibrosis. Under scrutiny, therefore, is the air pressure on board commercial
aircraft, whose passengers are subjected to a virtual altitude of 1,500 to 2,500 metres depending on the length of flight. At
such altitudes, the air contains some 30% less oxygen, a matter not to be taken lightly for patients whose blood oxygen level
is already precarious because of their respiratory condition.



For several years, doctors have been working on this issue and trying to develop recommendations, both on the minimum oxygen
level needed inside planes and on methods for identifying, in advance, patients who could encounter problems while flying.
These methods include respiratory capacity measurement and assessment of whether the subject can walk fifty metres without
getting excessively breathless. Measurement of arterial oxygen tension (PaO2) was also recommended: above a certain value, it
was deemed to indicate that the level would remain acceptable during the flight.



Real flight conditions



In fact, these various recommendations have created quite a lot of debate, especially since they partially contradict one
another.


So four Norwegian doctors decided to undertake a study in the conditions of a real flight. Their results can be seen in
April's issue of the ERJ, the scientific publication of the European Respiratory Society (ERS).


While most of the existing data came from experimental studies based either on inhalation of air with artificially reduced
oxygen levels or on time spent in a depressurised caisson, the Oslo team took an innovative approach and conducted a study on
board a real commercial flight.















The researchers decided to assess the effects of oxygen-reduced air on 18 COPD patients during a flight from Oslo to Las
Palmas (five hours and forty minutes in duration) with the cabin pressure equivalent at cruising height to an average
altitude of 1,829 metres (6,000 feet).



"The experimental nature of the earlier studies made it impossible to incorporate the various stresses that travellers
encounter during their journey: the need to carry luggage, the often lengthy trek to the departure gate, the cramped
conditions in the plane, the dryness of the cabin air, turbulence and other factors", explains Aina Aker???, the article's main
author.


"But our work has been able to include all of these elements, and we have also studied the influence of hypoxia duration by
taking measurements twice during the flight", adds Ole Henning Skj???nsberg, Aker???'s colleague at the Department of Pulmonary
Medicine of Ullev???l University Hospital, Oslo.



Rigorous selection of subjects



The Norwegian researchers set themselves two goals: to measure various parameters during the flight and to compare the values
measured on the ground before the journey with those obtained in the air.


First, they measured the various dissolved gases and the oxygen saturation in the subjects' arterial blood, noting possible
clinical manifestations, such as when the subjects moved around the aircraft cabin.


These measurements were taken twice during the flight: approximately one hour after the plane reached cruising height, and
three hours later, following a light meal without alcohol.


Aker??? and her colleagues also looked at whether certain parameters connected with the respiratory volumes and blood gases
measured prior to departure could be correlated with the data registered in-flight, and, if so, whether they allowed
prediction of what would happen during the journey.


The 18 patients (five women and 13 men, aged 49 to 73) were recruited through a lung rehabilitation centre that organises
rehabilitation programmes in warmer climates specially designed for people with chronic bronchitis or emphysema.


An important detail: the subjects selected had not suffered an exacerbation for at least two months, and all but one used
bronchodilators. Additionally, to avoid any risk of misinterpretation, they had to be clear of any symptoms that could
suggest cardiac or neurological compromise, any lung disease other than their COPD and anaemia.



Risk of fatigue after five hours



"We had, of course, made sure that the rehabilitation centre had pronounced all of our subjects fit to fly without additional
oxygen", the authors explain, "and that they could all walk at least fifty metres without excessive breathlessness, which we
verified with a treadmill test."


After an hour at cruising height, the investigators found a considerable drop in blood oxygen pressure (averaging 20%),
while, quite logically, arterial oxygen saturation had decreased from 96???1% before departure to 90???4% in-flight. This held
true while subjects remained seated; moving around the cabin caused arterial oxygen saturation to fall even more, to
87???4%.



The Norwegian team also measured arterial carbon dioxide pressure and found it to fall slightly after the first hour of
flying, in parallel with a marked rise in heart rate.


"The reduction observed after four hours of flying constitutes in our view evidence of a compensatory hyperventilation
developed by subjects to maintain their arterial oxygen saturation", Skj???nsberg comments. "This could indicate that such
patients may be at risk of respiratory fatigue during longer flights."


Comparison of pre- and in-flight data revealed a number of correlations and confirmed that arterial oxygen pressure on the
ground can allow prediction of in-flight values. However, the Norwegian team's measurements show that the current guidelines
are inappropriate.


For example, the guidelines assume that arterial oxygen pressure will be adequate if, before departure, it exceeds a certain
level (9.3 kiloPascals), yet four patients meeting that criterion had an in-flight oxygen saturation of below 84%. Five
others who met the criterion complained of mild breathing difficulties during the flight - even though they remained seated -
and eight more experienced symptoms when moving around the cabin.


The Oslo researchers emphasise, though, that the rarefaction was well tolerated by most of the patients, and only one
presented severe breathlessness at rest, which was further exacerbated during movement around the cabin.



What about cystic fibrosis patients?



The same questions apply to patients with another very disabling lung disease, cystic fibrosis, who need or wish to travel by
air. The news is good for those patients too, according to another study also published in April's ERJ.



A team from Munich University, led by Rainald Fischer, examined lung function, arterial blood gases and respiratory symptoms
in 36 cystic fibrosis sufferers under simulated air travel conditions.


Following tests in Munich (approximately 500 metres above sea level), the patients were reviewed a fortnight later after
spending seven hours in a laboratory in the Bavarian Alps, at an altitude of 2,650 metres.



As with the COPD patients, arterial oxygen pressure fell significantly at the higher altitude. A third of the subjects were
found to have values below 6.6 kPa, which is the minimum value recommended by US and British guidelines for obstructive
pulmonary disease sufferers using commercial flights.


Likewise, the German team also found that the fall was greater during physical exertion (on an exercise bicycle), but only
one patient complained of feeling unwell during such exertion.
So the German team can conclude that cystic fibrosis patients with a ground PaO2 of more than 8 kPa are perfectly capable of
tolerating, for several hours, an altitude equivalent to that found in the cabin of a commercial aircraft. Nevertheless,
Fischer and colleagues suggest to include results of spirometry (e.g. FEV1) in future guidelines, in order to emphasise the
role of bronchial obstruction in a hypoxic environment.


Which means there is no automatic reason to forbid such patients the joys of far-flung adventures.



EUROPEAN RESPIRATORY JOURNAL (ERJ), Vol. 25, No 4

erj.ersjournals

Lungs Try To Repair Damaged Elastic Fibers

The lungs of patients suffering chronic obstructive pulmonary disease (COPD) attempt to repair damaged elastic fibers, a new finding that contradicts the conventional wisdom on the capabilities of the adult lung.


The study "Evidence for attempted regional elastic fiber repair in severe emphysema," was done by Jason Woods, Kristin Castillo, Alexander Patterson and Richard Pierce of Washington University, St. Louis, Mo.; Joel Cooper of the University of Pennsylvania, Philadelphia; and James Hogg of St. Paul's Hospital, Vancouver, British Columbia. The authors will be present their findings Nov. 3 at The American Physiological Society conference "Physiological Genomics and Proteomics of Lung Disease."


The researchers found that synthesis of elastin, a gene linked to elastic fiber growth, is increased in the moderately diseased tissue of COPD patients.
Elastic fibers allow the lung to expand and contract with breathing.


"We've found elastin synthesis to increase in the air sacs (alveoli) and airways of the lungs of patients suffering severe or end-stage COPD," Woods explained. "This shows that the lung may be attempting to repair itself."


The finding is important because it could pave the way to develop a drug to 'turn on' key genes to allow the lung to grow new alveoli, he said. Alveoli play a role in the exchange of oxygen and carbon dioxide between the lungs and the circulatory system.


A 2-year-old could do it


Very young children who suffer lung injuries increase elastin expression and produce new elastic fibers inside the alveoli, Woods said. Adults do not have that ability and that has led physiologists to conclude that the elastin gene must shut off after we reach a certain age, ending elastin fiber production.


Physiologists want to understand this process in the hope that it could be harnessed to repair the diseased adult lung. In particular, Woods and his colleagues looked at three genes associated with elastic fiber assembly:
Emilin-1, MFAP2 and elastin. They found the expression of elastin consistently increased in the diseased lungs they studied.


In a preliminary study, the researchers examined two diseased lungs removed from end-stage COPD patients undergoing lung transplants. COPD develops as a result of exposure to toxins such as cigarette smoke, resulting in inflammation to the small airways and destruction of elastic fibers within alveoli. The patients suffered from emphysema.


The team used hyperpolarized magnetic resonance imaging (MRI) to characterize the regions of the lung showing moderate emphysema and regions showing severe emphysema. They found that new elastin synthesis was initiated in moderately diseased specimens.


The researchers did a second study using 10 lungs from end-stage COPD patients who had undergone transplants. Again, they found the greatest amount of elastin gene expression in the moderately diseased areas of the lungs, Woods said. There was no variability in elastin levels within the control lungs.


Further, the team found that the increase in elastin expression occurred on the alveolar walls, the same area where elastin occurs during the lung's development in children. This shows the lung is attempting to repair the elastic fibers in end-stage emphysema, the authors concluded.


Funding


National Institutes of Health (Pierce) and the Barnes-Jewish Foundation
(Woods)


The American Physiological Society was founded in 1887 to foster basic and applied bioscience. The Bethesda, Maryland-based society has 10,500 members and publishes 14 peer-reviewed journals containing almost 4,000 articles annually.


APS provides a wide range of research, educational and career support and programming to further the contributions of physiology to understanding the mechanisms of diseased and healthy states. In 2004, APS received the Presidential Award for Excellence in Science, Mathematics and Engineering Mentoring.


American Physiological Society

Budesonide/formoterol Plus Tiotropium Improves The Quality Of Life Of Patients With Severe COPD

Preliminary results from a double-blind, randomised, multicentre trial among 660 patients with chronic obstructive pulmonary disease (COPD) show that budesonide/formoterol (Symbicort®: AstraZeneca) plus tiotropium (Spiriva™: Boehringer Ingelheim Limited) significantly improves disease control and patients' quality of life.1,2



The study known as CLIMB, compared 12 weeks treatment with budesonide/formoterol (400/12 mcg one inhalation twice-daily) plus tiotropium (18 ?µg one inhalation once daily) vs. tiotropium alone plus placebo.


"Combined inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) therapy with budesonide/formoterol (Symbicort®) is indicated for COPD patients with a forced expiratory volume in 1 second (FEV1) < 50% predicted normal and a history of repeated exacerbations",3 explained Professor Tobias Welte, the international coordinating investigator of the CLIMB study. "While budesonide/formoterol combination is commonly used together with tiotropium for the management of patients with severe COPD, CLIMB is the first study to evaluate the therapeutic effect of combining budesonide/formoterol with tiotropium. The results of the study confirmed that this triple therapy regimen has a key role to play in the management of patients with COPD," he continued.


CLIMB showed that tiotropium plus budesonide/formoterol combination versus tiotropium alone:


- reduced the rate of severe exacerbations by 62% (p







Full results of the CLIMB study are due to be published later in 2009.


Notes


An estimated 3.7 million people in the UK have COPD; COPD is the 5th biggest killer in the UK; around 30,000 people in the UK die from COPD each year, which is more than from bowel cancer, breast cancer or prostate cancer.6



References


1. Welte T, et al. Budesonide/formoterol added to tiotropium improves the management of COPD patients. American Thoracic Society International Conference, San Diego, USA, 15-20 May 2009; Abst 953775.


2. Welte T, et al. Budesonide/formoterol added to tiotropium is well tolerated and reduces the risk of severe exacerbations in COPD patients. American Thoracic Society International Conference, San Diego, USA, 15-20 May 2009; Abst 953763.


3. Symbicort 400/12® Summary of Product Characteristics, December 2008.


4. Miravitlles M et al. Patient's perception of exacerbations of COPD - The PERCEIVE study. Respir Med 2007; 101: 453-60.


5. 'Unleash the life within...' a patient's perspective of living with Chronic Obstructive Pulmonary Disease (COPD) Survey. Sponsored by AstraZeneca UK Ltd.


6. British Lung Foundation. Invisible Lives. Chronic Obstructive Pulmonary Disease (COPD) - finding the missing millions, November 2007.


Source
AstraZeneca


View drug information on Spiriva HandiHaler.

News From The Journal Chest, January

COMPRESSION DEVICES EFFECTIVE FOR RESTLESS LEGS SYNDROME


Pharmacotherapy for restless legs syndrome (RLS) may be ineffective or complicated by side effects. However, new research shows that pneumatic compression devices, which apply air pressure to the leg at regular intervals, may be an alternative therapy for RLS. Researchers from Walter Reed Army Medical Center in Washington, DC, conducted a prospective, randomized, double-blinded trial of 35 patients with RLS. Patients wore either a therapeutic or subtherapeutic (sham) device prior to the usual onset of RLS symptoms for a minimum of 1 hour daily. Therapeutic compression devices significantly improved all measured variables compared with shams, including the RLS severity score and Johns Hopkins restless legs severity scale score. All quality of life domains also were improved, including daytime function, sleep quality, and emotional well-being. Researchers conclude that pneumatic compression devices may be an effective nonpharmacologic therapy for RLS. This study is published in the January issue of the journal CHEST.



COPD ASSOCIATED WITH HIGHER DEPRESSION RATES THAN DIABETES


Chronic disease has been associated with higher rates of depression; however, new research shows that patients with chronic obstructive pulmonary disease (COPD) are nearly two times as likely to suffer from depression compared with patients with diabetes. Researchers from The Netherlands compared the health characteristics of 999 patients with COPD, 978 patients with diabetes, and 2,494 healthy control subjects. Results showed that patients with COPD were diagnosed almost twice as often with depression compared with diabetic patients and control subjects. Furthermore, the mean time to a first diagnosis of depression was 7.7 years for patients with COPD, 5.9 years for patients with diabetes, and 7.3 years for control subjects. Researchers speculate that the increased risk of depression is not the result of having a chronic disease in general but specific to COPD. This study is published in the January issue of the journal CHEST.



SURVIVAL CONTINUES TO IMPROVE FOR PATIENTS WITH HIV



New research finds that the survival rate for critically ill patients with HIV continues to improve. Researchers from the University of California, San Francisco, conducted a retrospective study of 281 adults who were HIV-infected and admitted to the ICU during a 5-year study period, with a total of 311 admissions. During the study period, respiratory failure remained the most common indication for ICU admissions (42 percent overall); however, the proportion of patients with respiratory failure decreased each year from 52 percent to 34 percent. Hospital survival rates also increased during the study period. Administration of antiretroviral therapy (ART) at admission was not associated with survival, although ART was associated with predictors that were associated with survival. This study is published in the January issue of the journal CHEST.

Noninvasive Ventilation: New Clinical Practice Guidelines

New clinical guidelines for use of noninvasive ventilation in critical care settings are published in CMAJ (Canadian Medical Association Journal).



The use of noninvasive positive-pressure ventilation and noninvasive continuous positive airway pressure by mask has increased significantly among acutely ill patients. A growing body of literature and variations in practice in recent years have necessitated the development of new clinical practical guidelines to help manage patients with acute respiratory distress or failure.



The guidelines were created by the Canadian Critical Care Trials Group/Canadian Critical Care Society Noninvasive Ventilation Guidelines Group. They address the use of noninvasive ventilation in the postoperative setting, in immunocompromised patients, in patients being weaned from conventional mechanical ventilation and in patients at high risk of respiratory failure after removal of breathing tube.



Noninvasive positive pressure ventilation should be the first choice in patients with chronic obstructive pulmonary disease (COPD) or cardiogenic pulmonary edema. It can be used postoperatively or in people with compromised immune systems.



"Implementation of these guidelines may require clinician education, additional health care personnel, organizational change or additional resources (equipment or beds with cardiopulmonary monitoring) to ensure safe and appropriate application of noninvasive positive-pressure ventilation and continuous positive airway pressure," writes Dr. Sean Keenan, Royal Columbian Hospital, with coauthors.



"Strategies for the implementation of these guidelines should be developed for each relevant clinician group (physicians in different clinical areas and with different levels of training and expertise, respiratory therapists and nurses)," they conclude.



In a related commentary, Dr. Andrew Bersten from Flinders Medical Centre in Adelaide, Australia, writes "many factors appear to influence the effective implementation of noninvasive ventilation. These factors include an experienced team of health care staff able to provide 24-hour service and detailed attention to mask interface and leaks, choice of equipment, ventilator settings, inspired oxygen levels, glottic function and clearance of secretions."



"For these guidelines to change clinical practice, they have to be supported by appropriate education, implementation and review. Helping clinicians know when and when not to use noninvasive ventilation is perhaps the most important role for these guidelines," he concludes.

News From The Annals Of Internal Medicine: Feb. 16, 2010

1. Early Release: Annals Readers Respond to USPSTF Mammography Guidelines



An editorial and a selection of reader responses to the November 17 article, "Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement," was published early online at annals on February 15.



2. Pipe and Cigar Smoking Strongly Associated with Decreased Lung Function, COPD



Pipe and cigar smoke may be more harmful than once thought. While some believe pipes and cigars are healthier than cigarettes, a major known cause of chronic obstructive pulmonary disease (COPD), a new study directly links pipe and cigar smoking to decreased lung function.



Researchers conducted a population-based study to determine whether pipe and cigar smoking was associated with elevated cotinine levels (the end product of tobacco, which can be detected in the urine), decrements in lung function, and increased odds of airflow obstruction. Among 3,528 participants, those who did not smoke cigarettes but did smoke pipes or cigars were more likely to have airflow obstruction than those who had never smoked.



While cotinine levels among current pipe and cigar smokers were lower than among current cigarette smokers, the relative differences in cotinine levels may reflect differences in nicotine absorption but not necessarily exposure to harmful products of tobacco smoke.



"Our study shows that pipe and cigar smoking is associated with decrements in lung function that are consistent with obstructive lung disease," said R. Graham Barr, MD, Dr.PH, Assistant Professor of Medicine and Assistant Professor of Epidemiology at Columbia Presbyterian and lead author of the study. "These findings, together with increased cotinine levels in current pipe and cigar smokers, suggest that long-term pipe and cigar smoking may damage the lungs and contribute to the development of COPD. Physicians should consider pipe and cigar smoking a risk factor for COPD and counsel their patients to quit."



In a related editorial, Michael B. Steinberg, MD, MPH, of the University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, stresses the importance of educating the public, and expresses concern for the rising rate of tobacco use in the United States.



"We are now witnessing the concerning trend of increased use of other tobacco products," Dr. Steinberg writes. "As changes in public health policy have made cigarette smoking less socially acceptable, a distinct set of characteristics are associated with cigar and pipe use, such as sophistication, affluence, education, and celebration. These images, largely fostered by the tobacco industry, perpetuate the idea that these products play a suitable role in our society."



3. Slight Risk Increase for Heart Attack Persists Six Years After HRT Use



Postmenopausal women who take estrogen plus progestin hormone therapy have a greater risk for coronary heart disease (CHD) during the first few years after starting hormone therapy. To determine how long this risk persists, researchers randomly assigned 16,608 postmenopausal women to either a daily hormone regimen (n = 8,506) or placebo (n = 8,102). The researchers found a possible increased risk for CHD in the first two years in women who started hormone therapy within 10 years after menopause. The increase risk persisted for up to six years after use. Investigators conclude that most women who are considering short-term estrogen plus progestin hormone therapy for the relief of menopausal symptoms should not expect protection against CHD, and may need to worry about a possible slightly increased risk for heart attacks.
















4. Superficial Venous Thrombosis Not So Superficial - Condition May Indicate More Serious Thromboembolic Risk



Superficial venous thrombosis (SVT) is a blood clot of the superficial vein of the limbs or chest. While the condition is painful and common, it is not considered life threatening. However, new evidence suggests that SVT can occur with deep venous thrombosis (DVT) or pulmonary embolism (venous thromboembolism), two more serious conditions. Researchers studied 844 consecutive patients with symptomatic SVT of the lower limbs that was at least 5 cm on compression ultrasonography. Of the patients studied, approximately 25 percent also had DVT and about 10 percent developed thromboembolic complications over the next three months. Researchers caution that symptomatic SVT of the lower limbs may be more serious than previously thought and may be a marker for more clinically significant thromboembolic risk. For patients presenting with symptomatic SVT, close follow up and evaluation through compression ultrasonography is suggested.



5. "Dead Fish" Odor May Cause Diabetics to Discontinue Treatment with Metformin



Metformin, an oral anti-diabetic drug, is considered the first line of treatment for type 2 diabetes. The drug is associated with few adverse effects, but gastrointestinal upset is common. While the gastrointestinal effects of metformin have been well documented, researchers uncovered one characteristic of the drug that had not been previously reported in medical literature - its strong and distinct fishy odor. After examining case files for two patients reporting a "dead fish" or "fishy" odor associated with the immediate release formulation of metformin, researchers searched medical literature for other documented cases. Although reaction to the odor of metformin had not been reported in medical literature, hundreds of postings to message boards on the Internet note the peculiar odor of the drug. In addition, an informal survey of pharmacists found that metformin was easily identified by its smell which was classified as "fishy" or "like old locker-room sweat socks." The researchers believe that the adverse reaction to metformin's odor may not be published because patients may report that the drug makes them nauseous, but they may not distinguish this as a visceral reaction to the smell of the medication. The authors recommend that physicians consider inquiring more closely about revulsion to the odor of the medication when patients stop taking it. Trial of a film-coated, extended release formulation may be a reasonable approach in such cases.

Advair Reduces Exacerbations In COPD Patients With A History Of Exacerbations

The use of Advair Diskus(R) 250/50 (fluticasone propionate and
salmeterol inhalation powder) demonstrated a 30% reduction in exacerbations
in patients with chronic obstructive pulmonary disease (COPD) who have a
history of exacerbations as compared with salmeterol alone, according to
new data presented today at the International Conference of the American
Thoracic Society meeting in Toronto.




COPD is a progressive, life-threatening lung disease that includes
chronic bronchitis, emphysema or both. Exacerbations are flare-ups or
episodes of worsening COPD symptoms that often require additional
treatment, such as antibiotics, oral corticosteroids and in some cases
hospitalization. Symptoms may include shortness of breath, or coughing up
excess mucus beyond normal day-to-day variations. Seventy-seven (77)
percent of patients with COPD report experiencing at least one exacerbation
within the past year.



The randomized study of 797 patients was a replicate study which found
that after a year of treatment, patients treated with Advair Diskus 250/50
had a 30% reduction in the rate of annual exacerbations compared to
salmeterol (p








About Advair in COPD



Advair Diskus 250/50 is indicated for the maintenance treatment of
airflow obstruction in patients with COPD, including chronic bronchitis
and/or emphysema. Advair Diskus 250/50 is also indicated to reduce
exacerbations in patients with a history of exacerbations. Advair Diskus
250/50 is the only approved strength for COPD because an efficacy advantage
of the higher strength Advair Diskus 500/50 over Advair Diskus 250/50 has
not been demonstrated.



Patients should only take one inhalation of Advair twice a day. People
with COPD taking Advair may have a higher chance of pneumonia. Patients
should call their doctor if they notice any of the following symptoms:
change in amount or color of sputum, fever, chills, increased cough, or
increased breathing problems. Advair may increase the risk of osteoporosis
and some eye problems (cataracts or glaucoma). Patients should have regular
eye exams. Thrush in the mouth and throat may occur. Patients should tell
their doctor if they have a heart condition or high blood pressure before
taking Advair. Do not use Advair with long-acting beta2-agonists for any
reason. Advair does not replace fast-acting inhalers for sudden symptoms.



For more information about Advair please visit gsk.



About GlaxoSmithKline (NYSE: GSK)



GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies. GlaxoSmithKline is committed to
improving the quality of human life by enabling people to do more, feel
better and live longer. For company information visit gsk.


GlaxoSmithKline

gsk

Pharmacists Reduce Hospital Visits For Respiratory Patients

Patients with chronic obstructive pulmonary disease (COPD) experience 55%
fewer hospital admissions and 50% less visits to accident and emergency
departments when clinical pharmacists intervene in their care, research
launched at the British Pharmaceutical Conference (BPC) in Manchester has
shown.


Six months into a year-long study on a pharmacy-led disease and medicine
management programme in patients with COPD (an umbrella term for serious
respiratory diseases like emphysema), pharmacy researchers in Belfast have
shown that the involvement of a clinical pharmacist improves patients'
health-related quality of life and results in greater cost-effectiveness for
the NHS.


Patients in the study group reported 81% adherence to medication regimes,
compared to only 60% in the control group.


The study maintained a strong focus on self-management because COPD
patients may benefit from the early intervention that comes from following
self-management plans(1),(2), which may prevent a crisis and possibly the
need for hospital admission.


Lead researcher, Maher Al-khdour, said: "This ongoing study indicates
that a management programme led by clinical pharmacists can improve
adherence, reduce the need for hospital care in patients with moderate to
severe COPD and improve their quality of life."


Through a separate study investigating inhaler treatments for patients
with asthma and COPD, John Moores University pharmacy researchers in
Liverpool found that switching inhaler medicines could result in NHS savings
of ??5,100 a year. Two similar and equally effective inhalers are available -
the newer Symbicort inhaler is not as well-known or prescribed as often as
the Seratide inhaler, but is much cheaper.


Head researcher, Lewis Brien, said: "This study indicates considerable
progress in the management of these chronic respiratory diseases. It also
highlights the fact that more detailed clinical interventions can result in
both health and cost benefits - a demonstration of the value and expertise of
pharmacists."


About Chronic Obstructive Pulmonary Disease (COPD)


COPD is an umbrella term covering a range of conditions including chronic
bronchitis and emphysema. It is a long term condition that leads to damaged
airways, causing them to become narrow, making it harder for air to get in
and out of the lungs. There is no cure for COPD, but it can be managed
through drug therapy.


The World Health Organisation estimates suggest that COPD will become the
third leading cause of death, world-wide, by 2030:
who.int/gard/news_events/World_Health_Statistics_2008/en/















About Asthma


Asthma affects the airways of the lungs (
nhsdirect.nhs.uk/glossary/#Lung ) (the bronchi) which causes the
airways to become inflamed and swollen. The bronchi are small tubes that
carry air in and out of the lungs. In asthmatics, bronchi are more sensitive
than normal and certain substances, or triggers, can irritate them.


Common triggers include house dust mites, animal fur, pollen, tobacco
smoke, cold air, and chest infections. When the bronchi are irritated, they
become narrow and the muscles around them tighten, which can increase the
production of sticky mucus, or phlegm. This makes it difficult to breathe,
and causes wheezing (nhsdirect.nhs.uk/glossary/#Wheezing),
coughing, and a feeling of tightness in the chest.


The United Kingdom has one of the highest incidences of asthma in the
world(3). Over 5 million people suffer from the condition(4), which causes
around 2000 deaths annually; approximately 90% of which are avoidable(3).


Despite better health care and medical advances, asthma is the only
disease in the UK still increasing in prevalence. In England, the mortality
rate from respiratory diseases is almost double the average for Europe(5).


About the British Pharmaceutical Conference 2008 (BPC)


BPC 2008: Pharmacy in the 21st Century: Adding years to life and life to
years. In 2008, as the NHS marks its 60th anniversary year, BPC will examine
how pharmacy and the pharmaceutical services are helping to add years to life
and life to the year of the UK population. The profession of pharmacy plays
an important role in meeting the healthcare challenges associated with the
UK's ageing population.



How can pharmacists contribute to caring for the population as well as
ensuring quality of life? Increasingly, scientists and practitioners have to
consider the cost implications of this conundrum, and the evidence base for
all interventions is becoming of paramount importance: BPC 2008 will debate
these issues and open up discussion on them.



bpc2008



The main sponsors of BPC 2008 are: Boots The Chemists (Lead Sponsor),
AstraZeneca (Associate Sponsor and BPC-PJ Careers Forum Platinum Sponsor),
Pharmacists' Defence Association (PDA) (Associate Sponsor) and GSK (BPC-PJ
Careers Forum Platinum Sponsor).



Research released at BPC is published in the International Journal of Pharmacy Practice (IJPP).



References


(1) Bourbeau J, et al. Reduction of hospital utilization in
patients with chronic obstructive pulmonary disease: a disease specific
self-management intervention. Arch Intern. Med. 2003; 163, 585 -591.


(2) Lorig KR, et al. Evidence suggesting that a chronic disease
self-management program can improve health status while reducing
hospitalization: a randomized trial. Medical care. 1999; 37, 5-14.


(3) Asthma UK. "Where do we stand? Asthma in the UK today" December
2004. p3 - 10.


(4) Prescribing Review. Drugs used in asthma and COPD. Prescription
Pricing Division. May 2007.


(5) It takes your breath away: The Impact of Chronic Obstructive
Pulmonary Disease. CMO Annual Report 2004. Pages 21 and 23.

British Pharmaceutical Conference

Walsall And Hull Launch Mainstream Deployments Of Telehealth For People With COPD And Congestive Heart Failure, Using Tunstall Genesis Monitors, UK

Walsall and Hull have announced the launch of large mainstream deployments of telehealth to monitor people with chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF) in their own homes.


Both Primary Care Trusts are using Genesis monitors from leading telehealth and telecare specialist Tunstall to ensure best use of healthcare resources, reduce COPD and CHF related hospital admissions, support independent living and deliver an improved quality of life for patients.


COPD kills 30,000 people every year in England and Wales alone, making it the fifth biggest killer, and the cost to the NHS of treating COPD is high, at ??818 million per annum.


The cost to Walsall PCT for each patient admitted to Accident and Emergency can be as high as ??2,300, and it is hoped that the telehealth solutions from Tunstall will prevent hundreds of avoidable admissions. Previous research has shown that use of Genesis monitors can reduce the need for hospitalisation by over 50% and for emergency care visits by nearly two thirds.


Tony Diaram, Project Manager at Walsall Metropolitan Borough Council said: "This telehealth project will give patients truly person-centred care, helping them to manage their condition and avoid the constant cycle of hospitalisation. Tunstall Genesis units support greater independence and encourage better self-management of COPD, especially within hard-to-reach communities."


The telehealth programme being run by Hull PCT uses Tunstall Genesis units to let people monitor their weight and blood pressure, enabling daily accurate monitoring without needing the person to visit their GP. Patients' stress levels, which are a contributing factor to the condition, are also reduced, as it keeps them in a comfortable and familiar environment.


Clare Brown, Locality Manager for Hull City council's Community Care services and Telecare Project Lead commented: "Previously, during acute phases of CHF, we would often have to hospitalise patients for long periods to simply monitor their condition, when they were in fact well enough to be at home.


"The Tunstall Genesis monitors allow us to track a patient's condition closely while they remain in their home, which is proven to help their well-being, yet we can still react quickly if their condition worsens. It truly is a win-win situation for both patients and PCT."

tunstall.co.uk

Beta-Blockers May Be Associated With Benefits In Patients With Lung Disease

Patients with chronic obstructive pulmonary disease (COPD) may have fewer respiratory flare-ups and longer survival if they take beta-blocker medications, according to a report in the May 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.



By the year 2020, COPD-a diagnosis that includes emphysema and chronic bronchitis-is expected to become the third leading cause of death in the Western world, according to background information in the article. Patients with the condition are also prone to develop and die from cardiovascular diseases. Medications known as beta-blockers, used to treat high blood pressure and heart rhythm disorders, are known to improve the survival of patients with cardiovascular disease. However, clinicians avoid use of beta-blockers in patients with COPD because of concerns about adverse effects on the lungs.



Frans H. Rutten, M.D., Ph.D., of University Medical Center Utrecht, the Netherlands, studied data from electronic medical records of 2,230 patients (average age 64.8) with COPD who visited 23 general medical practices between 1996 and 2006. Of these, 560 had COPD at the start of the study and 1,670 developed it during the study period; 665 used beta-blockers and 1,565 did not.



During an average of 7.2 years of follow-up, 686 patients (30.8 percent) died, including 27.2 percent of those who used a beta-blocker compared with 32.3 percent of those who did not use a beta-blocker. In addition, 1,055 patients (47.3 percent) had at least one exacerbation of COPD, including 42.7 percent of those who had used a beta blocker and 49.3 percent of those who did not use a beta-blocker.



Among the subgroup of 1,229 patients without overt cardiovascular disease, 520 (42.3 percent) experienced at least one exacerbation of COPD and 241 (19.6 percent) died. These outcomes were both less likely among the 239 patients (19.4 percent) who used beta-blockers.



"To our knowledge, this is the first observational study that shows that long-term treatment with beta-blockers may improve survival and reduce the risk of an exacerbation of COPD in the broad spectrum of patients with a diagnosis of COPD, including those who have COPD with but, importantly, also without overt cardiovascular comorbidities," the authors write.



"Whether beta-blockers can also cause beneficial pulmonary [lung] activity and therefore are truly 'cardiopulmonary' drugs remains to be proved," the authors write. Randomized controlled trials to assess the use of beta-blockers in patients with COPD are necessary, they conclude.



Arch Intern Med. 2010;170[10]:880-887.



Source
Archives of Internal Medicine

Perforomist Inhalation Solution Data Presented At American Thoracic Society Conference

Data from two presentations highlighting the use of Perforomist® (formoterol fumarate) Inhalation Solution in moderate to severe chronic obstructive pulmonary disease (COPD) patients were featured at the International Conference of the American Thoracic Society in San Diego. In one analysis, use of Perforomist Inhalation Solution, when added to maintenance tiotropium, resulted in improved pulmonary function, dyspnea (shortness of breath) and rescue medication use versus treatment with tiotropium alone. In a second study, patient satisfaction increased in those treated with Perforomist Inhalation Solution twice daily compared with ipratropium/albuterol metered-dose inhaler (MDI) four times daily.



Perforomist Inhalation Solution was approved in 2007 by the U.S. Food and Drug Administration (FDA) for long-term, twice-daily maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema. It is the only FDA-approved nebulized formoterol fumarate.



"These results are significant because they validate the benefits and satisfaction when using Perforomist," said Carolyn Myers, Ph.D., President of Mylan's specialty division, which includes Dey, L.P. "We continue our dedication to further research surrounding illnesses such as COPD, and are pleased that patients can benefit from our treatments."



Studies Find Improvements in Pulmonary Function, Dyspnea, and Rescue Medication Use



A pooled analysis of two similar studies evaluated the efficacy and safety of adding Perforomist Inhalation Solution to maintenance tiotropium in patients with moderate to severe COPD versus treatment with tiotropium alone.



This data analysis assessed a combined total of 285 subjects with moderate to very severe COPD. When combining Perforomist Inhalation Solution with maintenance tiotropium in such patients, significant improvements in pulmonary function, dyspnea and rescue medication use were seen over tiotropium treatment alone, without any additional safety or tolerability issues.



Efficacy was measured by serial spirometry, transitional dyspnea index (TDI), rescue albuterol use and the St. George's Respiratory Questionnaire (SGRQ).



The primary efficacy endpoint was standardized absolute FEV1 AUC0-3. At Week 6 the primary efficacy endpoint was significantly improved by 192 mL compared with placebo/tiotropium (1.54 versus 1.37 L, p







Overall, 31 percent of Perforomist Inhalation Solution/tiotropium-treated subjects experienced adverse events versus 46 percent of the placebo/tiotropium-treated subjects. COPD exacerbations were the most common adverse events, and occurred in over twice as many placebo/tiotropium-treated subjects as Perforomist Inhalation Solution/tiotropium-treated subjects. The most frequent adverse events following COPD exacerbations were acute bronchitis and upper respiratory tract infections.



"COPD patients in this analysis saw improvement in several areas when adding Perforomist Inhalation Solution to their tiotropium treatment," said Davida J. White Pettaway, M.D., Senior Manager, Medical and Scientific Affairs, Dey, L.P. "Having replicate data from two well-controlled, double-blind studies will provide physicians with valuable information as they consider treatment options for patients with moderate to severe COPD."



Results Suggest Increased Treatment Satisfaction with Twice Daily Perforomist Inhalation Solution Compared with Ipratropium/Albuterol MDI Four Times Daily



In a separate poster presentation, results were presented from a post-hoc analysis conducted to assess the effects of age, gender and COPD severity on patient responses to Perforomist Inhalation Solution and ipratropium/albuterol MDI.



"Nebulized Formoterol Improved Efficacy and Increased Patient Satisfaction Compared with Ipratropium/Albuterol MDI," led by E. Rand Sutherland, M.D., M.P.H., National Jewish Health, Denver, Colo., was a multicenter, randomized, open-label, crossover study of 109 patients with moderate to severe COPD. Perforomist Inhalation Solution was shown to provide superior morning bronchodilation and increased patient satisfaction versus ipratropium/albuterol MDI in older, male and more severe patients with COPD.



Efficacy was assessed by spirometry, TDI and a treatment preference/satisfaction survey. Subgroups with a significant difference in pre-treatment FEV1 on Day 14 favoring Perforomist Inhalation Solution were older, (?‰?65 years), severe to very severe COPD (

Few People Realize Persistent Cough Is A Key Symptom Of Lung Cancer

A new survey timed to coincide with Lung Cancer Awareness Month found that only a small minority of people in the UK
realize that a persistent cough is a key symptom of lung cancer.


In a bid to raise awareness of early symptoms of lung cancer as the season for flus and colds sets in, people are urged to seek help
if they find themselves unable to shake off a persistent cough: it could be a sign of something more serious.


A Royal Pharmaceutical Society/YouGov survey of over 2,000 adults in the UK found that only 33 per cent of people questioned
identified a cough as a warning sign or symptom of lung cancer, while as few as a further 11 per cent specifically mentioned a
"persistent cough", which is a key symptom.


In the UK, lung cancer is the second most common cancer in men, after prostate cancer, and also the second most common in
women, after breast cancer. It accounts for more than 1 in 5 cancer deaths, that is more than 35,200 people a year or 95 people
a day.


Worldwide, lung cancer is the most common cancer: in 2008 it is estimated that 1.6 million new cases were diagnosed and 1.38
million people died of the disease.


However, early detection of lung cancer can save lives, says Graham Phillips, who is a community pharmacist and Board member
of the Royal Pharmaceutical Society.


"When symptoms are present and recognised at an early stage, treatment is much more likely to be successful," he added, which
is why the Society is trying to get people to realize the importance of getting a persistent cough checked out.


When people get a cough that won't clear up, they tend to buy cough medicines, or even iron tablets if they also find themselves
feeling tired and low in energy.


Phillips urges people to talk to their pharmacist if they find themselves doing this.


"We can discuss your symptoms with you and help you understand you may have an underlying problem that needs checking out
with your GP," he explained in a press statement.


Phillips said pharmacists have an important role to play in helping to spot the early signs of lung cancer and other serious lung
problems.


This role appears to be welcome by the public too, because nearly 4 out 5 people surveyed said they would like their local
pharmacists to talk to them if they were showing any signs of lung cancer before they had noticed them, and over 9 out of 10
acknowledged that catching the disease in the early stages is important to ensure treatment is effective.


Phillips said whatever the time of year, if you have symptoms of cold or flu that won't go away, such as a persistent cough, chest infection, or keep losing your voice, or you feel breathless, tired and lacking in energy, then instead of reaching for the over-the-counter remedy, you should ask your pharmacist's advice.

The key signs of lung cancer

A cough that does not clear and persists for more than three weeks.
A long-standing cough that gets worse or changes.
Persistent or repeated chest infections.
Persistent and unexplained breathlessness.
Coughing up blood, or blood in the phlegm.
Feeling tired or lacking in energy for no apparent reason.
Unexplained and persistent weight loss.
Persistent pain in the chest and/or shoulder.
Persistent and unexplained hoarseness or loss of voice.
Unexplained swelling of the face or neck.

Lung Cancer Top 5 Myths

Myth: coughing up blood is usually the earliest sign of lung cancer.

Fact: the first symptoms of lung cancer are often a persistent cough or persistent breathlessness.

Myth: if you smoke there is no point in giving up because the damage is already done.

Fact: as soon as you quit you are already starting to reduce your risk of developing lung cancer and other serious health
problems like stroke or heart attack, and giving up before you hit middle age avoids most of the risk of smoking-related lung
cancer.

Myth: lung cancer is predominantly a male disease.

Fact: while this may have true in the 1950s, when there was only 1 female case of lung cancer for every 6 male cases,
nowadays the ratio is 3 cases of lung cancer in women to every 4 cases in men.

Myth: lung cancer is a death sentence.

Fact: over three quarters of lung cancer cases are diagnosed at an advanced stage: when it is found early, the treatment is
40 times more likely to be successful.

Myth: only smokers get lung cancer.

Fact: 1 in 10 cases of lung cancer are not linked to smoking.

The Roy Castle Lung Cancer Foundation is working with the Royal Pharmaceutical Society to promote lung cancer awareness.
The Foundation's Medical Director, Dr Jesme Fox, said:















"Pharmacy staff can play a key role in the fight against lung cancer and we hope this campaign will help to increase early
detection of the disease as this can save lives."


While most medical professionals would agree that a persistent cough should be checked out, many would say that other
problems were more likely to be the cause, not necessarily cancer.


One of these is Chronic Obstructive Pulmonary Disease (COPD), a progressive, irreversible lung disease that kills about 30,000
people a year in the UK: more than breast, bowel or prostate cancer.


COPD is an umbrella term for a number of conditions, including chronic bronchitis and emphysema.


Every year the British Lung Foundation focuses its campaigning around World COPD Day, which this year was on 17
November.


Their chief executive, Dame Helena Shovelton, told the BBC that while a persistent cough can be an early sign of lung cancer, it
can also be a sign of COPD.


She said their research shows that 28 per cent of smokers would class their cough as just a "smoker's cough", and that nearly 3.5
million people in the UK are at high risk of developing COPD and similar lung conditions.


"We would urge anyone with symptoms such as nasty cough, wheezy chest or breathlessness to ask their GP for a lung function
test or to take our online breath test," said Shovelton.


-- Take the
BLF Breath Test

Different Dosing, Administration Of Corticosteroids For Severe COPD Shows Comparable Outcomes

In contrast to clinical guidelines, new research finds that the vast majority of patients hospitalized for severe symptoms of chronic obstructive pulmonary disease (COPD) were initially treated with higher doses of corticosteroids administered intravenously, with analysis indicating that these patients had outcomes comparable to patients who received the recommended and lower-cost, less-invasive treatment of low doses of steroids administered orally, according to a study in the June 16 issue of JAMA.



COPD is the fourth leading cause of death in the United States, affects more than 6 percent of adults in the U.S., and accounts for $32 billion in direct health care costs. "In 2006, there were approximately 600,000 hospital admissions for acute exacerbation COPD, making this 1 of the 10 leading causes of hospitalization nationwide," the authors write. "Systemic corticosteroids are beneficial for patients hospitalized with acute exacerbation of COPD; however, their optimal dose and route of administration are uncertain."



Peter K. Lindenauer, M.D., M.Sc., of Baystate Medical Center, Springfield, Mass., and colleagues investigated the use of corticosteroids among patients hospitalized for acute exacerbation of COPD at 414 U.S. hospitals in 2006 and 2007. The researchers compared the outcomes of those initially treated with low doses of steroids administered orally to those initially administered steroids at higher doses intravenously during the first 2 hospital days. Among the outcomes the researchers analyzed included a composite measure of treatment failure, defined as the initiation of mechanical ventilation after the second hospital day, inpatient mor-tality, or readmission for acute exacerbation of COPD within 30 days of discharge.



Of 79,985 patients, 73,765 patients (92 percent) were initially treated with higher doses of steroids administered intravenously, while 6,220 (8 percent) began low doses of steroids given orally. A total of 1.4 percent of patients initially treated with intravenous steroids died during the hospitalization and 10.9 percent experienced the composite treatment failure outcome, whereas 1.0 percent of orally treated patients died during the hospitalization and 10.3 percent experienced the composite outcome. A total of 1,356 patients (22 percent) initially treated with low-dose oral steroids were later switched to intravenous therapy.



The researchers found that in analysis that adjusted for various factors including patient, hospital, and physician characteristics, the risk of treatment failure among patients given low doses of steroids orally was not significantly different from those treated with high-dose steroids intravenously. Also, patients treated with low doses of steroids administered orally had shorter lengths of hospital stay and lower costs.



"In this large observational study, we found that, in sharp contrast to the recommendations contained in leading clinical guidelines, the vast majority of patients hospitalized for acute exacerbation of COPD were initially treated with high doses of corticosteroids administered intravenously. This practice does not appear to be associated with any measurable clinical benefit and at the same time exposes patients to the risks and inconvenience of an intravenous line, potentially unnecessarily high doses of steroids, greater hospital costs, and longer lengths of stay," the authors write.



"In light of the greater risks and higher costs associated with high-dose intravenous treatment, opportunities may exist to improve care by promoting greater use of low-dose steroids given orally. Given the large numbers of patients hospitalized with COPD each year in the United States, a clinical trial comparing these 2 approaches to management would be valuable."


JAMA .
2010;303[23]:2359-2367.


Source
Journal of the American Medical Association

Forest Labs Get FDA COPD Risk Treatment Approval

Approximately 12 million people in the United States are currently diagnosed with chronic obstructive pulmonary disorder (COPD), and an additional 12 million are likely to have the disease and not know. This week Daliresp (roflumilast) was approved by the US Food and Drug Administration (FDA) as a treatment to reduce the risk of disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.


COPD is caused by noxious particles or gas, most commonly from tobacco smoking, which triggers an abnormal inflammatory response in the lung. The inflammatory response in the larger airways is known as chronic bronchitis, which is diagnosed clinically when people regularly cough up sputum. In the alveoli, the inflammatory response causes destruction of the tissues of the lung, a process known as emphysema. The natural course of COPD is characterized by occasional sudden worsening of symptoms called acute exacerbations, most of which are caused by infections or air pollution.


The World Health Organization (WHO) predicts that total deaths from COPD could increase by more than 30% in the next 10 years unless urgent action is taken to reduce the underlying risk factors, especially smoking. Approximately half of COPD patients treated by a physician with controller medications have severe COPD. Of the patients diagnosed with severe COPD, almost three quarters, or 2.8 million, have chronic bronchitis.


COPD is projected to be the fourth leading cause of death worldwide by 2030 (an increase from sixth in 2009) due to an increase in smoking rates and demographic changes in many countries. COPD is the fourth leading cause of death in the U.S. and the economic burden of COPD in the U.S. in 2007 was $42.6 billion in health care costs and lost productivity.


COPD remains a significant area of unmet medical need. It is a progressive and irreversible lung disease resulting in difficulty in breathing. The disease is characterized by severe episodes of worsening, called exacerbations or lung attacks.


Forest expects Daliresp to be available to wholesalers in the second calendar quarter of 2011.


Guido Oelkers, Executive Vice President, Commercial Operations at Nycomed, Forest's parent, said:


"Nycomed is very pleased with the US approval of Daliresp by the FDA. With Forest we have an ideal partner, who is absolutely committed to make this innovative treatment available in the United States for the many patients suffering from severe COPD. The approval of Daliresp offers clinicians and patients a much needed new treatment option alongside existing inhaled therapies."



Roflumilast has been approved in the European Union and Canada in 2010 and it is marketed under the brand name Daxas. In February 2011 it received marketing authorisation from the Brazilian National Health Surveillance Agency (ANVISA). Daxas has been launched in several countries already, as for example Germany, Denmark, Sweden, UK, Canada and Spain. It is scheduled to be launched in other markets in 2011.


Professor Stephen Rennard, M.D., University of Nebraska Medical Center and clinical trial investigator continues:


"The introduction of Daliresp as an additional treatment option to reduce the risk of COPD exacerbations is an important development for patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Reducing the risk of COPD exacerbations is an important goal of COPD treatment."

Patients dislike hospital admission more than worsening symptoms in exacerbations of COPD

Exacerbations of COPD - an acute worsening of symptoms, often triggered by a respiratory infection, requiring medical intervention and often hospitalisation - are extremely distressing for patients with this condition and their families.
But what features of exacerbations do patients with COPD consider most important and most distressing?



In this study, undertaken by John Haughney (University of Aberdeen, UK) and his European colleagues, 125 patients from five countries with recurring exacerbations of COPD were interviewed face-to-face. This study was the first of its kind to use discrete-choice modelling in COPD.


Discrete-choice modelling is a powerful tool, which, through forcing choice, allows measurement of the relative importance of different features of a scenario, in this case exacerbations of COPD. It has been used widely in commercial situations and a number of studies have now been reported in the medical literature.



Contrary to a popularly held belief that symptom control is the main aim of treatment, the authors report that the feature that most patients with COPD desire at the time of an exacerbation is not to be housebound, and, in particular, not to be admitted to hospital.


These features ranked as more important than relief of breathlessness, cough and speed of recovery.



The authors conclude that clinicians should focus their efforts on minimising the frequency and severity of exacerbations; the relief of symptoms, such as breathlessness and cough, is not enough.



The European Respiratory Journal is the peer-reviewed scientific publication of the European Respiratory Society (more than 7,000 specialists in lung diseases and respiratory medicine in Europe, the United States and Australia).

European Respiratory Journal

Children With Severe Asthma At Increased Risk Of Developing COPD

Children with severe asthma have more than 30 times the risk of developing adult chronic obstructive lung disease (COPD) as adults compared to children without asthma, according to a prospective longitudinal cohort study from the Royal Children's Hospital in Melbourne.


The results will be presented at the ATS 2010 International Conference in New Orleans.


"There is important epidemiological evidence to suggest that events in childhood that influence lung growth constitute a significant risk for COPD," explained lead author, Andrew Tai, MBBS, FRACP. "The aim of this study was to describe the association between the pattern of childhood asthma and the risk of developing adult COPD in a longitudinal cohort."


Subjects of the Melbourne Asthma Study were recruited at the age of seven, from a 1957 birth cohort and were assessed regularly until the age of 50. At recruitment, subjects were classified as having no history of wheeze, intermittent asthma (such as viral-induced wheezing), persistent asthma (in the absence of illness), or severe asthma. Of the surviving members of the original group, 197 answered a detailed questionnaire and underwent lung function testing for the current study.


Subjects who were classified as having severe asthma in childhood had an adjusted risk of COPD of 31.9 times that of children without asthma. Interestingly, children with mild asthma were not at increased risk of developing adult obstructive lung disease.


"At this stage, children with mild asthma are those who have symptoms of wheeze which are triggered primarily by respiratory infections. A majority [of children with mild asthma] remit by adolescence or adulthood," explained Dr. Tai. "However, children with more severe asthma features tend to have predisposing risk factors (like atopy) and continue to have symptoms of wheeze well into adult life."


"It is important to emphasize that the lung function decline in this group is not increased compared to those with mild or no asthma, as has been raised in some other studies," Dr. Tai continued. "However, lung function in children with severe asthma are reduced in childhood years and decline in adult life to levels consistent with adult obstructive lung disease. Fundamentally, we believe that this severe asthma group start with a lesser baseline lung function and gradually deteriorate to the levels consistent with a diagnosis of COPD. At this stage, there is no data on when airway remodeling occurs in children and hence, its impact on lung function, but there is an emerging relationship between childhood severe asthma and adult obstructive lung disease."


Importantly, this study was performed on a group of children recruited in the 1960s when anti-inflammatory treatment was not available. Studies to date suggest that anti-inflammatory medications do not alter the natural progression of mild childhood asthma, but there are no studies performed in those children with severe asthma.


"There should be greater emphasis on the surveillance and treatment of children with asthma, therefore potentially preventing the development of adult obstructive lung disease," said Dr. Tai.


Researchers still do not fully understand the mechanisms that link severe childhood asthma with adult COPD, but these findings suggest that appropriate treatment strategies (and surveillance) should be instigated early in life to potentially minimize future risk.


"Early treatment to prevent airway remodeling in childhood may reduce the incidence of this long-term complication of childhood asthma," concluded Dr. Tai.


"Currently, there are more than 30 birth cohort studies of varying duration being conducted around the world. In particular, the long-term follow-up of the Tucson birth cohort into young adulthood has shown trends similar to our findings of airway obstruction originating from early life. Clearly, more research to understand the mechanisms and timing of changes within the airway wall, inflammation and function needs to be conducted, applying preferably non-invasive methods in determining potential contributing factors."


"Pediatric Origins of Adult Chronic Obstructive Pulmonary Disease (COPD): Childhood Asthma" (Session A95, Sunday, May 16, 1:30-4:00 p.m., CC-Room 295-296 (Second Level), Morial Convention Center; Abstract 2206)


Source
American Thoracic Society (ATS)

Closed Circuit Breathing Device Could Transform The Lives Of Patients With Chronic Obstructive Pulmonary Disease

A UNIQUE partnership between Smiths Medical, part of the FTSE 100
technology business Smiths Group, and University College London (UCL)
has resulted in the development of a breakthrough clinical device that
could transform the lives of patients with COPD across the world. COPD
will be the third leading cause of death worldwide by 2030, according to
the World Health Organisation (WHO).



The new technology is based on a closed circuit oxygen device invented
over 50 years ago by the British rocket scientist Tom Bourdillon, who
hoped that it would help take him to the top of the world.



Three days before Edmund Hillary and Tenzing Norgay made the first
ascent of Mount Everest in 1953, Bourdillon nearly got there first with
the help of his ground-breaking invention. When he and his climbing
partner Charles Evans, a British brain surgeon, set out on the first
ever summit attempt they were breathing pure oxygen from the device. It
helped them climb higher than any man had ever been before and at speeds
that have rarely been matched since.



The two men were just 90 metres from the summit when Evans' device
malfunctioned dashing their hopes of becoming the most celebrated
mountaineers in the world. Three days later Hillary and Norgay claimed
that honour using open circuit oxygen devices.



Bourdillon believed that closed circuit oxygen was more efficient and
effective than open circuit because a closed circuit efficiently
recycles exhaled oxygen, which would be lost to the atmosphere in an
open circuit.



His research was forgotten for 50 years but now Smiths Medical and UCL
have developed Bourdillon's idea into a breakthrough medical device that
could help patients with COPD, which is a disease of the lungs in which
the airways become narrowed leading to a limitation of the flow of air
to and from the lungs, causing shortness of breath.



"We are hoping that this new technology will transform the lives of
people living with COPD by allowing them to breathe more easily,
exercise and ultimately reduce their dependence on oxygen. It is
incredible to think that this breakthrough device is based on a British
invention designed to help the first mountaineers reach the top of the
world," said Dr Jeremy Russell, head of research and development at
Smiths Medical International.



Bourdillon's research was rediscovered by Jeremy Windsor and Roger
McMorrow, mountaineering scientists at the UCL Centre for Altitude,
Space and Extreme Environment Medicine (CASE), who had the idea to
redevelop it into a modern breathing circuit for climbers.



"Bourdillon recognized that the problem on Everest was low levels of
oxygen and if you solved the problem of delivering oxygen you would
effectively reduce the height of the mountain to sea level," said Dr
McMorrow. "No-one knows exactly why his device failed but when I tested
my prototype on Cho Oyu in the Himalayas 2005 it also failed. In my case
the soda lime CO2 absorber malfunctioned and it is possible Bourdillon
had the same problem although another theory is that it was a frozen
valve. A recently invented CO2 absorber called ExtendAir solved the
problem on my circuit."
















Dr McMorrow, when a Smiths Medical Research Fellow at UCL, showed his
mountaineering prototype to Dr Russell at Smiths Medical, which has a
long-standing partnership with UCL that includes collaboration on
research in the field of respiratory medicine. The two scientists
quickly realized that the prototype for mountaineers had the potential
to evolve into a ground-breaking device for COPD patients as well as for
other patients weaning from oxygen in hospital and those on home oxygen.



Last year the device was successfully tested on Mount Everest at the
Smiths Medical High Altitude Laboratory at Namche Bazaar, Nepal at
3,400m, (11,154 ft) as part of the Caudwell Xtreme Everest Study (CXE),
a medical research project conducted by CASE. Smiths Medical is now
optimizing and miniaturizing the prototype for patients.



Exercise is important for COPD patients but existing oxygen systems mean
it is often not possible. The size of current open circuit systems mean
that patients are often confined to their hospital beds or treated at
home with large cylinders that severely restrict their mobility.
Portable open circuit systems are not able to deliver high enough
volumes of oxygen for long enough to permit exercise. In an open circuit
system the faster a person breathes the more they dilute the oxygen with
ordinary air. This means that if a patient dependent on oxygen starts to
exercise their oxygen levels actually drop as their breathing grows
faster.



Dr Russell added: "The new system is portable and should deliver a very
high concentration of oxygen for a sustained period of time. It should
help keep oxygen levels constant no matter how fast or slow a patient is
breathing."



Previously, portable closed circuits have been used by Special Forces
frogmen (because there are no bubbles), mine rescue workers,
firefighters and in bioterrorism suits.



George Band, who was the youngest member of the 1953 Everest expedition,
said: "I remember how passionate Tom was about his closed circuit device
and how disappointed he and Charles were not to make it to the summit.
I'm sure Tom would have been really thrilled that his research on the
closed-circuit oxygen equipment did not go to waste and could help
people suffering from respiratory problems today."



Professor Monty Mythen, Smiths Medical Professor of Anaesthesia at UCL
and Director of Research and Development at UCL Hospitals said: "This
project is a fantastic example of the success that comes from scientists
in industry working closely with clinicians and university academics for
patient benefit. Smiths Medical in collaboration with UCL and NHS
Partners makes a formidable team and I am delighted that the Caudwell
Xtreme Everest expedition is beginning to reap rewards for patients."



COPD


COPD stands for chronic obstructive pulmonary disease. This is a term
used for a number of conditions including chronic bronchitis and
emphysema. COPD leads to damaged airways in the lungs, causing them to
become narrower and making it harder for air to get in and out of the
lungs. The word 'chronic' means that the problem is long-term. The WHO
predicts it will be the third leading cause of death worldwide by 2030.



Smiths Medical


Smiths Medical is a leading supplier of high-quality medical devices and
products for global markets. It designs and manufactures specialist
medical devices in three key areas: Safety Devices, Vital Care and
Medication Delivery. Smiths Medical's customers include hospitals,
alternate care such as home care, and other healthcare providers
worldwide. Smiths Medical is part of the global technology business
Smiths Group, a world leader in the practical application of advanced
technologies. Smiths is a global technology company listed on the London
Stock Exchange. For further information, visit smiths-medical




Smiths Group


Smiths is a global technology company listed on the London Stock
Exchange. A world leader in the practical application of advanced
technologies, Smiths Group delivers products and services for the threat
& contraband detection, medical devices, energy and communications
markets worldwide. Our products and services make the world safer,
healthier and more productive. Smiths Group employs more than 20,000
people in over 50 countries. For more information visit smiths



Caudwell Xtreme Everest (CXE)


Caudwell Xtreme Everest is a research project coordinated by the UCL
Centre for Altitude, Space and Extreme (CASE) environment medicine -
doctors and scientists studying human systems stretched to breaking
point in extreme environments to increase our understanding of
critically ill patients. The goal is to place a research team on the
summit of Mount Everest in 2007 and make the first ever measurement of
the level of oxygen in human blood at this altitude. This is the
centrepiece of an extensive programme of research into hypoxia (low
oxygen levels) and human performance at extreme altitude aimed at
improving the care of the critically ill and other patients where
hypoxia is a fundamental problem. The Caudwell Xtreme Everest
expedition is being sponsored by John Caudwell, a businessman and
founder of The Caudwell Charity. Scientific studies in the run-up to
the expedition have been supported by a research grant from medical
gases specialist BOC Medical.

Caudwell Xtreme Everest

Kamada Completes Enrollment In Its Phase II Bronchiectasis Trial With Inhaled AAT

Kamada (TASE:KMDA), a biopharmaceutical company engaged in the development, production and marketing of specialty life-saving biotherapeutics, announced recently that it has completed patient enrollment in its Phase II clinical trial evaluating treatment of bronchiectasis patients with inhaled Alpha-1 Antitrypsin (AAT) delivered by the investigational eFlow® nebulizer system (PARI Pharma GmbH).



Chief Executive Officer of Kamada, David Tsur, said, "We are very pleased with the progress of this study and look forward to its upcoming completion. We believe that Kamada's AAT delivered by PARI's eFlow® has the potential to become a novel treatment for bronchiectasis. Kamada is committed to the development of inhaled AAT to treat bronchiectasis and to proceed with its ongoing clinical efforts in Alpha 1 Antitrypsin Deficiency and Cystic Fibrosis."



About the study



A total of 21 patients with brochiectasis were enrolled and randomized into this , double-blind, placebo controlled Phase II study. The purpose of the trial is to investigate safety and efficacy of inhaled AAT in this patient population.



About Kamada's Inhaled AAT



Kamada's AAT product has the advantages of a high purity preparation combined with a liquid, ready to use, presentation that does not include stabilizers or preservatives. Efficacy trends towards reduction in lung inflammation were also shown recently by inhaled AAT in a phase II cystic fibrosis study sided to a high safety profile for the given study period.



Kamada's inhaled AAT, which is delivered via an optimized Investigational eFlow Nebulizer System (PARI Pharma GmbH), has received Orphan Drug Designation from the US FDA for the bronchiectasis indication.



About Bronchiectasis



Bronchiectasis is an abnormal stretching and enlarging of the airways. Bronchiectasis patients usually suffer from recurrent, severe episodes of bronchitis, chronic cough and sputum production. According to the US COPD foundation approximately 600,000 individuals suffer from bronchiectasis worldwide, with an estimated 100,000 people in the US alone (excluding cystic fibrosis patients).



About PARI Pharma and the Investigational eFlow® Nebulizer System



Kamada's Inhaled AAT is delivered by the Investigational eFlow Nebulizer System (PARI Pharma GmbH). The Investigational eFlow Nebulizer System uses eFlow Technology to enable extremely efficient aerosolization of liquid medications via a vibrating, perforated membrane that includes thousands of small holes that produce the aerosol mist. Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its silent mode of operation, small size (it fits in the palm of your hand), light weight, and battery use, eFlow Technology reduces the burden of taking daily, inhaled treatments. The Investigational eFlow Nebulizer System and eFlow Technology are proprietary to PARI Pharma and can be optimized to specific drug formulations.



PARI Pharma focuses on the development of aerosol delivery devices and therapies. Based on PARI's 100-year history working with aerosols, PARI Pharma develops treatments for pulmonary and nasal administration optimized with advanced delivery technologies, such as eFlow technology. Online at PariPharma.



About Kamada



Kamada is a public biopharmaceutical company (kamada) developing, producing and marketing a line of specialty life-saving biopharmaceuticals using its proprietary chromatographic purification technologies. Several of these specialty therapeutics are currently undergoing advanced clinical trials.

Budesonide Added To Formoterol And/or Short Acting Beta 2 Agonist Lowers Mortality Risk For Severe COPD Patients

Important new data from the analysis of combined data from the two pivotal Symbicort(R) studies, announced today at the 5th International Multidisciplinary Conference on Chronic Obstructive Pulmonary Disease (COPD5), reveals that budesonide added to formoterol (Symbicort (R)) and/or terbutaline significantly reduces mortality in severe COPD over one year, compared to the bronchodilators formoterol and/or terbutaline alone.



Today's results show fewer deaths in the Symbicort / budesonide group compared with the bronchodilator group (p=0.036), with an associated hazard ratio of 0.564 (p=0.039). This represents a 44% reduction in all-cause mortality over one year for patients treated with Symbicort / budesonide1 .



"Previous findings have shown the beneficial effects of combination budesonide and formoterol, i.e. Symbicort, therapy in significantly reducing COPD exacerbations", explained Professor Peter Calverley, Aintree Chest Centre, University of Liverpool. "Today's presentation further demonstrates the link between COPD exacerbations and an increased risk of mortality, reinforcing the importance of reducing these events, as indicated by COPD guidelines".



The re-analysis comprised data from 1834 patients with severe COPD evenly distributed between the two treatment groups, i.e. budesonide added to bronchodilators compared to bronchodilators alone.



The survival benefits in this analysis also appear to corroborate the findings in the three year prospective TORCH (TOwards a Revolution in COPD health) study2, presented at the American Thoracic Society Congress in 2006, which has reported a 17% reduction in mortality for fluticasone/salmeterol compared with placebo.



The retrospective pooled analysis also showed that health-related quality of life (HRQL) - as measured by the St. Georges Respiratory Questionnaire (SGRQ), an independently validated tool for measuring quality of life in COPD - was the strongest predictor of mortality in COPD, over and above any other reported predictor (e.g. lung function, breathlessness, Body Mass Index and age), equating to better quality of life leading to lower risk of premature death3. Using the SGRQ, a change of four points is defined as clinically meaningful, equating to a patient being able to walk up a flight of stairs without stopping or to being able to sleep without disruption from coughing. The data presented today suggests that SGRQ scores may have a role in identifying patients at increased risk of mortality over 1 year.



"Previous studies have demonstrated that budesonide/ formoterol is a very effective treatment in preventing COPD exacerbations, leading to clinically important improvements in health-related quality of life", explained Professor Paul Jones, St George's Hospital Medical School, London "Today's data are important, suggesting as it does that a combination of budesonide and formoterol may provide a tangible survival benefit as well as improving the patients quality of life".



The pooled-analysis, presented today at COPD5, is based upon the data from two 1-year prospective Symbicort studies in COPD (Calverley et al. 4 and Szafranski et al5), both published in the European Respiratory Journal in 2003.



"Randomised, controlled trials are the best way of determining whether therapy is effective in COPD. However, re-analysis of pooled data from comparable clinical trials, as we did in this case, can provide new and potentially important clinical insights", Professor Calverley concluded.



References:
1 Peter Calverley, Paul Jones, Thomas Larsson, Stefan Peterson. Preventing mortality in COPD: The value of inhaled budesonide added to bronchodilators. Abstract scheduled for presentation at COPD5, Birmingham, UK, 28 June 2006

2 TORCH Study Group. The TORCH (TOwards a Revolution in COPD health) survival study protocol Eur Respir J 2004;24:206-210

3 Paul Jones, Peter Calverley, Thomas Larsson, Stefan Peterson. SGRQ scores may help identify COPD patients at increased risk of death in 1 year. Abstract scheduled for presentation at COPD5, Birmingham, UK, 28 June 2006

4 Calverley PM, Boonsawat Z, Zhong N, Peterson S and Olsson H. Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease. Eur Resp J 2003; 22; 912-919.

5 Szafranski W, Cukier A, Ramirez A, Menga G, Sansores R, Nahabedian S, Peterson S, Olsson H. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Resp J 2003; 21: 74-81.


astrazeneca

Clinical Trial Data On The Safety And Efficacy Of Concomitant Formoterol Fumarate/ Tiotropium Treatment For COPD

Data presented at
CHEST 2007, the annual scientific assembly of the American College of Chest
Physicians (ACCP), demonstrate concomitant use of nebulized formoterol
fumarate and tiotropium provided improved bronchodilation over tiotropium
monotherapy and was well-tolerated in this clinical study. The only
commercially available version of nebulized formoterol fumarate is
Perforomist(TM) Inhalation Solution, which is indicated for long-term,
twice-daily maintenance treatment of bronchoconstriction for emphysema and
chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease
(COPD).


Formoterol fumarate is a rapid and long-acting beta2-agonist (LABA)
that has been previously available in the U.S. in a dry powder formulation
and has twenty years of worldwide experience. Perforomist(TM) Inhalation
Solution is the first and only FDA-approved nebulized form of this
molecule. Nebulizers convert liquid medication into a mist that patients
inhale through a mouthpiece or face mask.



Results presented were from "Safety and Efficacy of Concomitant
Treatment with Nebulized Formoterol and Tiotropium in COPD," a randomized,
placebo-controlled Phase IIIb trial. The trial demonstrated that
concomitant therapy with twice-daily nebulized formoterol fumarate (FFIS)
and once-daily tiotropium provided patients with statistically significant
and clinically relevant improvements in bronchodilation over treatment with
tiotropium alone. In this six-week study, patients receiving concomitant
therapy with nebulized FFIS and tiotropium experienced fewer adverse events
or COPD exacerbations than patients receiving placebo or tiotropium
monotherapy.



According to Donald P. Tashkin, MD, FACP, FCCP, Professor of Medicine,
David Geffen School of Medicine at the University of California at Los
Angeles and the lead clinical investigator, "For the patients in this
study, adjunctive use of nebulized formoterol fumarate and tiotropium
showed statistically significant improvements in lung function by improving
bronchodilation over use of tiotropium alone. For physicians,
Perforomist(TM) Inhalation Solution and commonly prescribed long-acting
anticholinergics such as tiotropium offers a new and valuable treatment
option for COPD patients with moderate to severe manifestations of the
disease."



Christy Taylor, Chief Operating Officer at Dey, L.P., commented, "At
DEY, we specialize in developing effective new treatments for serious and
complex respiratory diseases, and it is gratifying that the newest addition
to our franchise, Perforomist(TM) Inhalation Solution, offers physicians
additional prescribing flexibility. For over a decade, Dey, L.P. has been
the U.S. leader in sales of nebulized respiratory medication. We thank Dr.
Tashkin and the other members of the research team for their assessment of
how Perforomist(TM) Inhalation Solution may be used concomitantly with
tiotropium for improved clinical effect for COPD patients."
















For those attending CHEST 2007, the presentation is available as follows:



Poster viewing: Session ID 902 -- COPD Treatment II



Wednesday, October 24, 2007, 12:30 -- 2:00 PM



Convention Center, Exhibit Hall, McCormick Place, Lakeside Center, Chicago.



Poster # 251: Safety and Efficacy of Concomitant Treatment with Nebulized



Formoterol and Tiotropium in COPD



The research presented at CHEST 2007 was supported through grants
provided by Dey, L.P., which developed and markets Perforomist(TM)
Inhalation Solution. Dey, L.P. is a subsidiary of Mylan Inc. (NYSE: MYL).



About Perforomist(TM) Inhalation Solution



Indication



Perforomist(TM) Inhalation Solution is indicated for the long-term,
twice-daily (morning and evening) administration in the maintenance
treatment of bronchoconstriction in patients with chronic obstructive
pulmonary disease (COPD) including chronic bronchitis and emphysema.



Important Safety Information



Perforomist(TM) Inhalation Solution belongs to a class of medications
known as long-acting beta2-adrenergic agonists (LABAs). LABAs may increase
the risk of asthma-related death. Data from a large placebo-controlled US
study comparing the safety of another LABA (salmeterol) or placebo added to
usual asthma therapy showed an increase in asthma-related deaths in
patients receiving salmeterol. This finding with salmeterol may apply to
formoterol (a LABA), the active ingredient in Perforomist(TM) Inhalation
Solution.



Perforomist(TM) Inhalation Solution should not be used in patients with
acutely deteriorating COPD or to treat acute symptoms. Acute symptoms
should be treated with fast-acting rescue inhalers. Perforomist(TM)
Inhalation Solution should not be used with other medications containing
LABAs. Do not use more than one nebule twice daily. Perforomist(TM)
Inhalation Solution should be used with caution in patients with
cardiovascular disorders. Perforomist(TM) Inhalation Solution is not a
substitute for inhaled or oral corticosteroids. The safety and efficacy of
Perforomist(TM) Inhalation Solution in asthma has not been established.



In COPD clinical trials, the most common adverse events reported with
Perforomist(TM) Inhalation Solution were diarrhea, nausea, nasopharyngitis,
dry mouth, vomiting, dizziness, and insomnia.



About COPD



COPD refers to a number of chronic lung disorders in which the airways
to the lungs become narrowed and breathing becomes increasingly difficult.
The most common forms of COPD are chronic bronchitis and emphysema, and
many patients suffer from a combination of the two diseases.



COPD is the fourth leading cause of death in America, behind heart
disease, cancer and stroke. Twelve million Americans have been diagnosed
with COPD and at least another 12 million have symptoms but are not
diagnosed. COPD is not well understood or recognized -- most Americans have
not heard of it, not even those who may be living with the condition. The
most common cause of COPD is cigarette smoking, which is responsible for an
estimated 80 to 90 percent of COPD cases. Estimates of the total incidence
of COPD in America range from 24 to 30 million.



About Nebulization



Of the three types of devices used to deliver bronchodilators --
nebulizers, metered-dose inhalers, and dry powder inhalers -- nebulizers
require no special technique or coordination, as the medication is
converted into a fine mist that the patient inhales through a mouthpiece or
face-mask while breathing naturally. Because nebulization is an easy,
effective, and thorough method of delivering medicine directly into the
lungs, many COPD patients ask for it, particularly as their symptoms
worsen.



With Perforomist(TM) Inhalation Solution, nebulization may become a
more widely used treatment option for many COPD patients at earlier
treatment stages who could benefit from twice-daily maintenance dosing of a
nebulized LABA such as Perforomist(TM) Inhalation Solution. For example,
this new COPD treatment may be a valuable clinical option for many patients
who are not adequately controlled with short-acting bronchodilators.



About Dey, L.P.



Dey, L.P., a subsidiary of Mylan Inc. (NYSE: MYL), is a specialty
pharmaceutical company focused on the development, manufacturing and
marketing of prescription drug products for the treatment of respiratory
diseases, respiratory-related allergies, and emergency care medicine. As
the U.S. leader in sales of nebulized respiratory medication, Dey, L.P.
puts patients first through its development of innovative and affordable
therapies. The Web sites for Dey, L.P. include dey,
accuneb, curosurfusa, cyanokit, duoneb, epipen and perforomist.



Perforomist is a trademark of Dey, L.P.



About Mylan



Mylan Inc. is one of the world's leading quality generic and specialty
pharmaceutical companies. The Company offers one of the industry's broadest
and highest quality product portfolios, a robust product pipeline and a
global commercial footprint through operations in more than 90 countries.
Through its controlling interest in Matrix Laboratories Limited, Mylan has
direct access to one of the largest active pharmaceutical ingredient (API)
manufacturers in the world. Dey L.P., Mylan's fully integrated specialty
business, provides the Company with innovative and diversified
opportunities in the respiratory and allergy therapeutic areas.



For more information about Mylan, please visit mylan



This press release includes statements that constitute "forward-looking
statements," including with regard to the concomitant use of nebulized
formoterol fumarate and tiotropium and its effects. These statements are
made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Because such statements inherently involve
risks and uncertainties, actual future results may differ materially from
those expressed or implied by such forward-looking statements. Factors that
could cause or contribute to such differences include, but are not limited
to: the risk that the adjunctive use may not ultimately prove to be as
successful as anticipated; the impact of the competitive COPD environment;
and the other risks detailed in the Company's Form 10-Q for the quarter
ended June 30, 2007 and its other periodic filings with the Securities and
Exchange Commission. The Company undertakes no obligation to update these
statements for revisions or changes after the date of this release.


Dey, L.P.

dey