четверг, 29 сентября 2011 г.

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.

понедельник, 26 сентября 2011 г.

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.






пятница, 23 сентября 2011 г.

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.


вторник, 20 сентября 2011 г.

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.


суббота, 17 сентября 2011 г.

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

среда, 14 сентября 2011 г.

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

воскресенье, 11 сентября 2011 г.

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

четверг, 8 сентября 2011 г.

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

понедельник, 5 сентября 2011 г.

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 (

пятница, 2 сентября 2011 г.

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