COPD World News   Week of December 25, 2011

Tobacco firms 'misled' public about additives


San Francisco, CA - The tobacco industry is accused of misleading smokers over the safety of additives in cigarettes. Based on a new analysis of data used by the US cigarette manufacturer Philip Morris a decade ago, which found the additives were safe, University of California researchers claim the firm's research "obscured findings of toxicity".

The original study by Philip Morris, called Project Mix, resulted in the publication of four papers in a scientific journal that concluded there was "no evidence of substantial toxicity" associated with the additives studied. More than 300 additives are used in the manufacture of cigarettes to enhance their taste and make smoking smoother and more enjoyable.

The new study, by the Centre for Tobacco Control Research at the University of California, was based on the same data extracted from among 60 million documents released after litigation.
The researchers claim the original studies "cannot be taken at face value" and failed to reveal additives' dangers. When they conducted their own analysis examining the additives per cigarette – as specified in the original protocol for the Project Mix study but later changed – they found the level of 15 carcinogenic chemicals increased by an average of 20 per cent. They also discovered that, for what they call "unexplained reasons", Philip Morris had de-emphasised 19 of the 51 chemicals tested in the presentation of their results, including nine that were substantially increased in the smoke on a per cigarette basis.

Stanton Glantz, who led the new research published in the online journal Public Library of Science Medicine, said tobacco firms had spent decades preparing for the implementation of tougher regulation of their products, including the regulation of additives. The use of additives had worried the World Health Organisation, the US Food and Drug Administration and national regulatory bodies in the UK and around the world. Philip Morris had used the four papers published in Food and Chemical Toxicology in 2002 to defend their inclusion in cigarettes.

When millions of internal company documents from the tobacco industry were released it enabled Dr Glantz and colleagues to reanalyse the data. He said: "Putting additives in cigarettes increases the amount of fine particles and this is a bad thing because it increases the inflammatory response. "If you take [Philip Morris's] own data and interpret it correctly, you could use this data to ban these additives."

A Philip Morris spokesman said: "We believe that the points raised in this recent paper by Stanton Glantz and others do not invalidate the findings of the Project Mix studies. "All the Project Mix studies were reported alongside the actual data in four peer-reviewed scientific publications in 2002 and their way of calculation was discussed in one of the papers. "The studies were performed according to well-established principles and standard toxicological guidelines."

For more information:

http://www.worldhealthnews.harvard.edu/

COPD World News   Week of December 18, 2011

CT Can Detect COPD in Smokers


Amsterdam, Netherlands - Low-dose CT scans used in screening for lung cancer in heavy smokers might also help detect chronic obstructive pulmonary disease (COPD), a Dutch study found. 

Smoking-associated COPD is an underdiagnosed condition associated with considerable morbidity and mortality, which could be lessened with early smoking cessation. The recent finding that CT screening reduced mortality from lung cancer has prompted considerable interest, and Mets and colleagues hypothesized that screening could also be useful for diseases other than lung cancer

"Because smokers die not only from lung cancer but also from COPD and cardiovascular disease, the rationale for evaluating lung cancer screening CT scans for additional information may prove important," they wrote. Accordingly, they analyzed data from a cohort of 1,140 current or former male smokers who underwent both pulmonary function testing and inspiratory and expiratory CT scans.

On spirometry, COPD was defined as a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) of less than 70%. Obstruction was mild if FEV1 was at least 80%, moderate if between 50% and 80%, and severe if below 50% of predicted. The CT scans were used to quantify the degree of parenchymal loss and air trapping, with a radiation dose of 1.2 to 2 millisieverts.  Participants' mean age was 62.5 years, mean body mass index was 27.1, and the median number of smoking pack-years was 38.

A CT diagnosis of COPD was made for 274 participants, or 63% of those who were diagnosed using the reference standard of pulmonary function testing. There were 85 false positives. The diagnosis was made in 54% of those with mild obstruction, in 73% of patients with moderate obstruction, and in 100% of those whose obstruction was classified as severe. The predictive ability of the model was more accurate in symptomatic patients, who were likely to have more advanced pulmonary destruction.

If these findings can be validated in an independent cohort, using both an inspiratory and expiratory CT scan might aid in diagnostic accuracy with little additional radiation exposure or scan time, Mets and colleagues noted.

Strengths of the study, according to the investigators, included its relatively large population and the use of accepted densitometry measurements. Limitations included lack of a validation cohort, uncertain generalizability, possible differences in CT protocols, and absence of post-bronchodilator pulmonary function tests to exclude asthma.

For more information:

http://jama.ama-assn.org/content/306/16/1775.abstract

COPD World News   Week of December 11, 2011
                                 
BMA calls for smoking ban to include private motor vehicles

London, UK - The British Medical Association is calling on UK governments to introduce an extension to the current smoke-free legislation to include a ban on smoking in private vehicles.

Research compiled by the BMA shows that there is strong evidence that smoking in vehicles exposes non-smokers to very high levels of second-hand smoke. This is because of the restrictive internal environment in motor vehicles which exposes drivers and passengers to 23 times more toxins than a smoky bar.

Children and other vulnerable individuals, such as the elderly, are particularly at risk from these health dangers. Children are at particular risk from second-hand smoke in cars as they absorb more pollutants. A child’s immune system is also considerably under developed, compared to an adult’s, and lacks the necessary defenses to deal with the harms of second-hand smoke. The elderly are prone to respiratory problems so second-hand smoke is especially dangerous for them.

Vulnerable groups, including children, do not have the same choices as adults and may be unable to refuse to take a journey in a smoky vehicle. Dr Vivienne Nathanson, the BMA’s Director of Professional Activities, said today: “Every year in England there are over 80,000 deaths that are caused by smoking. This figure increases to a shocking six million worldwide. “But behind the stark statistics, doctors see the individual cases of ill-health and premature death caused by smoking and second-hand smoke. For this reason, doctors are committed to reducing the harm caused by tobacco.

“The UK made a huge step forward in the fight against tobacco by banning smoking in all enclosed public places but more can still be done.  We are calling on UK governments to take the bold and courageous step of banning smoking in private vehicles. The evidence for extending the smoke-free legislation is compelling. The current UK Government prefers voluntary measures or ‘nudging’ to bring about public health change but this stance has been shown to fail time and time again.”

The launch of the BMA’s briefing paper coincides with the second reading of Alex Cunningham’s Private Members’ Bill calling for a ban on smoking in private vehicles when children are present.

For more information:

http://www.bma.org.uk/health_promotion_ethics/tobacco/smokinginvehicles.jsp

COPD World News   Week of December 4, 2011
                                 
Genes May Make Quitting Tougher for Smokers

Atlanta, GA - Your particular DNA may explain why you can't break the habit, a new study suggests.  Despite decades of public health efforts aimed at snuffing out cigarette smoking, 20 percent of Americans still light up.

While anti-smoking campaigns are credited with slicing cigarette use drastically over the past 40 years -- from 42 percent of all Americans in 1965 to just under 20 percent in 2010 -- the number of people who haven't been able to nix their nicotine habit has flatlined in recent years, according to the U.S. Centers for Disease Control and Prevention.

Two out of three adults who smoke want to quit, a CDC report out earlier this month said, and more than half (52 percent) had attempted to quit in the past year.

The authors of the new study, released online in advance of publication in an upcoming print issue of Demography, say new tactics may be needed to help the remaining smokers. "Federal and social policies may be somewhat less effective now because maybe the composition of those at risk [those who smoke] has changed," said study co-author Fred Pampel, a professor of sociology at the University of Colorado at Boulder and a research associate at the Institute of Behavioral Science there. Those who can quit easily have probably done so, the authors said. Study lead author Jason Boardman, an associate professor of sociology, said anti-smoking messages, higher taxes and restrictions on smoking have made a difference. "But for hard-core smokers, there may be something else going on," he said. That "something else" is likely genetics, he added.

The researchers drew this conclusion after analyzing the smoking habits between 1960 and 1980 of nearly 600 pairs of twins who answered an extensive health questionnaire -- 363 were identical sets of twins and 233 were fraternal twins. Identical twins come from the same fertilized egg before it splits into two embryos and they share the same genes or DNA, while fraternal twins come from two separately fertilized egg cells and only share some genetic similarities. In the identical twin group, 65 percent of both individuals quit within a two-year period of each other, while only 55 percent of the fraternal twins quit within that same stretch of time. "The logic here is that the identical twins share genes, so if they act alike it probably reflects a genetic component," said Pampel. The new research adds to a growing body of literature suggesting there is probably a substantial genetic influence when it comes to nicotine addiction, said Dr. Aditi Satti, an assistant professor of medicine and director of the smoking cessation program at Temple University Hospital in Philadelphia.

For more information:

http://www.nlm.nih.gov/medlineplus/news/fullstory_119279.html

COPD World News   Week of November 27, 2011
                                 
Steroids work for COPD attacks in critically ill

Getafe, Spain - Corticosteroids ease acute exacerbations of chronic obstructive pulmonary disease in the intensive care unit, a randomized trial suggested. In critically ill COPD patients on mechanical ventilation, systemic corticosteroids cut the median duration of ventilatory support from four days to three and tended to reduce intensive care unit (ICU) stays as well, Andrés Esteban, MD, PhD, of the Hospital de Getafe, Spain, and colleagues found.

Corticosteroid treatment also reduced the need to transition patients from noninvasive to invasive ventilation as a rescue measure (0% versus 37% without corticosteroids), the group reported in the Nov. 28 issue of the Archives of Internal Medicine.These advantages would certainly be clinically significant and lead to substantial financial savings, according to an accompanying invited commentary by Andrew F. Shorr, MD, MPH, and Chee M. Chan, MD, MPH, both of Washington Hospital Center and Georgetown University in Washington, D.C.

Systemic corticosteroids have been proven to help with acute exacerbations in clinical trials before, but always excluded critically ill patients.The magnitude of effect appeared similar in Esteban's critically ill population to that seen in trials with COPD exacerbation patients not on mechanical ventilation, the researchers noted.Proof that the drugs work in critically ill COPD patients is important, though unlikely to change practice much because intensivists had already been widely extrapolating the evidence from non-critically ill populations, Shorr and Chan noted.

They pointed to the low enrollment in the trial -- only 25% of planned, due largely to the fact that many potential subjects already had been exposed to steroids -- and questioned whether there truly was equipoise to withhold systemic corticosteroids as part of the trial.

The researchers cautioned that the low sample size made the study underpowered to detect uncommon risks -- such as neuropathy resulting in difficulty weaning from ventilation -- or to find a significant impact on ICU stay.But they also noted that the results may be generalizable even to patients excluded from the trial -- largely those with prior systemic corticosteroid treatment -- because demographics, severity of illness, and mortality rates were similar to those of the patients included in the trial.

For more information:

http://www.medpagetoday.com/Pulmonology/SmokingCOPD


COPD World News   Week of November 20, 2011
                                 
The best ways to quit smoking


Silver Spring, Maryland - Experts here have agreed that a two-pronged strategy is the best bet for success. "The U.S. Public Health Service has twice done very extensive reviews of all the evidence, and [best] is a combination of counseling/advice, by pharmacists, physicians or quitlines, plus medicine," said Thomas Glynn, director of cancer science and trends and of international cancer control for the American Cancer Society.

A lot has changed since 1976, Glynn noted. "People could smoke on airplanes and in restaurants; the person sitting next to you in the movie theater could be smoking. Two of every five people smoked; now it's one of five." Another difference: "Now, there are a number of ways that people can succeed, [including] seven medications approved by the FDA [U.S. Food and Drug Administration]," he said.

Still, many Americans resist medications or counseling, and rely on personal willpower to get them through nicotine withdrawal. "Cold turkey, sheer willpower; the best data is that about 5 percent of people succeed," said Dr. Norman Edelman, chief medical officer at the American Lung Association. "People who smoke 10 cigarettes a day, light smokers, if they want to try quitting on their own, that's fine," said Gary Giovino, chair of the department of community health and health behavior at the University at Buffalo, State University of New York. For heavy smokers, he recommends starting with nicotine replacement therapy.

Smoking-cessation medications come "in three buckets: nicotine replacement, Wellbutrin/Zyban (bupropion) and Chantix (varenicline)," said Dr. Nancy Rigotti, director of the tobacco research and treatment unit at Massachusetts General Hospital in Boston. "They all work. It's better to take one than none." Nicotine patches give users a steady dose of nicotine through the skin and come in 16- or 24-hour varieties, by prescription or over-the-counter.  Fast-acting forms of nicotine replacement therapy are lozenges and gum, available over-the-counter, and prescription inhalers and nasal sprays. "You use the patch to get constant coverage and use the other forms to get over cravings, as supplements," Rigotti said. In its 2008 recommendations, the U.S. Agency for Healthcare Research and Quality advised clinicians to consider nicotine patches in combination with Wellbutrin or Zyban for smokers unable to quit with a single type of medication.

Wellbutrin, Zyban and Chantix all carry black box warnings about the increased possibility of suicidal thoughts, although Chantix has come under the most scrutiny for this potential side effect. "The fear is of big changes in behavior," Giovino said. "The question is, does it happen more often with Chantix or if you stop smoking with a nicotine replacement drug?" "If people want something based on a prescription, they should discuss it with their doctor," Giovino said.

Even with outside help, willpower still comes into play in breaking long-held habits and battling sharp cravings. Giovino suggested the "'six Ds': delay, drink water, distract yourself, discuss with someone, deep breath and, finally, don't debate. People who do best are those who decide smoking is no longer an option."

For more information:

http://www.nlm.nih.gov/medlineplus/news/fullstory_118793.html

COPD World News   Week of November 13, 2011
                                 
COPD Exacerbation Not Linked to Low Vitamin D Levels


Minneapolis, MN - Because low levels of Vitamin D are common in people who have COPD, and people with severe COPD are at the highest risk for COPD exacerbation, researchers once believed that low Vitamin D levels were associated with a higher risk of COPD exacerbation. After a recent, North American study, this hypothesis has now been tossed aside.

The cohort study, consisting of 973 COPD patients, found that low levels of Vitamin D were NOT associated with COPD exacerbation in patients with severe COPD.  Ken M. Kunisaki, M.D., of the Minneapolis Veterans Affairs Medical Center said this about the study: "Vitamin D insufficiency and deficiency are common in patients with COPD, and patients with severe COPD are at the highest risk for exacerbations, so we hypothesized that low vitamin D levels might increase the risk of acute exacerbation of COPD (AECOPD). Our negative results are in contrast with earlier studies in which lower vitamin D levels were associated with higher rates of respiratory infections in adults and more frequent asthma exacerbations in children."

Dr. Kunisaki further concluded: "Contrary to what we expected, baseline vitamin D levels were not related to the risk of subsequent AECOPDs in this large group of COPD patients at high risk of AECOPD.  Vitamin D supplementation is unlikely to have an effect on AECOPD risk in these patients."

Vitamin D is necessary for absorption and metabolism of calcium and phosphorus. People who get adequate amounts of sunshine don't really need to take Vitamin D supplements. However, for people with COPD who spend a lot of time indoors, low Vitamin D levels are quite common. COPD patients may therefore benefit from Vitamin D supplementation.

A simple blood test will tell you whether your Vitamin D levels are within normal limits. If low, you may want to talk to your doctor about adding Vitamin D supplements to your diet.

For more information:

http://copd.about.com/b/2011/11/12/copd-exacerbation-not-linked-to-low-vitamin-d-levels.htm?nl=1

COPD World News   Week of November 6, 2011
                                 
Return to smoking after heart attack ups death risk


Rome - After a heart attack, quitting smoking may offer a patient more benefits than any medication, but Italian researchers say the flipside is that resuming smoking after leaving the hospital can raise the same patient's risk of dying as much as five-fold.

On average, people who started smoking again after being hospitalized for acute coronary syndrome (ACS), crushing chest pain that often signals a heart attack, were more than three times as likely to die within a year as people who successfully quit in a study led by Dr. Furio Colivicchi of San Filippo Neri Hospital in Rome. 

"Relapse is a major risk factor for long term survival," said Dr. David Katz, associate professor of internal medicine at University of Iowa Carver College of Medicine in Iowa City. Quitting smoking has a similar lifesaving effect for ACS patients as taking recommended drugs to lower blood pressure or cholesterol, added Katz, who was not involved in the new study.

To gauge the effects of resuming smoking after a heart "event," and to see how many people are likely to relapse, Colivicchi and his colleagues tracked 1294 patients who reported being regular smokers before they were hospitalized with ACS. All the participants had ceased smoking while in the hospital and declared themselves motivated to continue abstaining once they were released. Patients received a few brief smoking-cessation counseling sessions while in the hospital, but no further counseling, nicotine replacement or other smoking-cessation help was provided after they left the hospital.

The researchers interviewed patients about their smoking status at one, six, and 12 months after their release from the hospital and found that a total of 813 (63 percent) had relapsed by the end of the first year. About half had begun smoking again within 20 days of leaving the hospital. Within a year, 97 patients died, with 81 of those deaths attributed to cardiovascular causes, according to findings published in the American Journal of Cardiology.

A recent study from Harvard Medical School suggested that a comprehensive anti-smoking counseling program for heart attack patients could save thousands of lives at a relatively low cost. These findings, along with the results of the Italian study, said Rigotti, suggest that hospitals and insurers should work together to implement comprehensive anti-smoking programs to continue to help patients after they leave the hospital.

For more information:

http://bit.ly/nbuaPz

COPD World News   Week of October 30, 2011
                                 
CT Can Detect COPD in Smokers


Amsterdam, Netherlands - Low-dose CT scans used in screening for lung cancer in heavy smokers might also help detect chronic obstructive pulmonary disease (COPD), a Dutch study found. 

Smoking-associated COPD is an underdiagnosed condition associated with considerable morbidity and mortality, which could be lessened with early smoking cessation. The recent finding that CT screening reduced mortality from lung cancer has prompted considerable interest, and Mets and colleagues hypothesized that screening could also be useful for diseases other than lung cancer

"Because smokers die not only from lung cancer but also from COPD and cardiovascular disease, the rationale for evaluating lung cancer screening CT scans for additional information may prove important," they wrote. Accordingly, they analyzed data from a cohort of 1,140 current or former male smokers who underwent both pulmonary function testing and inspiratory and expiratory CT scans.

On spirometry, COPD was defined as a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) of less than 70%. Obstruction was mild if FEV1 was at least 80%, moderate if between 50% and 80%, and severe if below 50% of predicted. The CT scans were used to quantify the degree of parenchymal loss and air trapping, with a radiation dose of 1.2 to 2 millisieverts.  Participants' mean age was 62.5 years, mean body mass index was 27.1, and the median number of smoking pack-years was 38.

A CT diagnosis of COPD was made for 274 participants, or 63% of those who were diagnosed using the reference standard of pulmonary function testing. There were 85 false positives. The diagnosis was made in 54% of those with mild obstruction, in 73% of patients with moderate obstruction, and in 100% of those whose obstruction was classified as severe. The predictive ability of the model was more accurate in symptomatic patients, who were likely to have more advanced pulmonary destruction.

If these findings can be validated in an independent cohort, using both an inspiratory and expiratory CT scan might aid in diagnostic accuracy with little additional radiation exposure or scan time, Mets and colleagues noted.

Strengths of the study, according to the investigators, included its relatively large population and the use of accepted densitometry measurements. Limitations included lack of a validation cohort, uncertain generalizability, possible differences in CT protocols, and absence of post-bronchodilator pulmonary function tests to exclude asthma.

For more information:

http://jama.ama-assn.org/content/306/16/1775.abstract

COPD World News   Week of October 23, 2011
                                 
Smoking's Effect on Lungs Similar to Cystic Fibrosis

Chapel Hill, NC - Smoking seems to have a similar effect on the lungs as cystic fibrosis, a life-threatening genetic disease affecting the lungs and other organs, a new study reveals.

Researchers found that like cystic fibrosis, smoking leads to the production of sticky mucus that causes dry cough and infections. They concluded that cystic fibrosis treatments could potentially be used to treat smoking-related diseases -- and vice versa.

Cystic fibrosis interferes with the movement of salt and water in the cells lining the lungs, trapping bacteria in thick mucus, resulting in potentially fatal infections. The researchers said that smoking has a similar effect, resulting in mucus that causes several health problems, including dry cough, chronic bronchitis and chronic obstructive pulmonary disease.

"We hope this study will highlight the importance of airway hydration in terms of lung health and that it will help provide a road map for the development of novel therapies for the treatment of smoking-related lung disease," Robert Tarran, a researcher at the Cystic Fibrosis/Pulmonary Research and Treatment Center at the University of North Carolina at Chapel Hill, said in a Federation of American Societies for Experimental Biology (FASEB) news release.

For more information:

http://www.nlm.nih.gov/medlineplus/news/fullstory_117682.html

COPD World News   Week of October 16, 2011
                                 
Higher risk of death for underweight COPD patients

Amsterdam, Netherlands - Chronic obstructive pulmonary disease patients who are underweight are at greater risk of dying from the illness, a new study has found.

In a study by researchers at Uppsala University in Sweden, 552 patients were assessed. Information was collected using questionnaires to review patients age, education, smoking status and level of care. They also looked at information on lung function and history of comorbidities.

The results showed that heart disease, hypertension and being underweight were all associated with higher mortality in COPD patients. People who were underweight were 1.7-times more likely to die than people with a normal body weight. Additionally, people with heart disease or cardiac failure were 1.9-times more likely to die than people with COPD alone. The results were found even when taking into account age, sex, lung function and smoking. The findings have important implications for health practitioners in both primary and secondary care settings.

The World Health Organization predicts that COPD will become the third leading cause of death worldwide by 2030. A number of co-morbid conditions often exist with COPD, including cardiovascular disease, muscle wasting, type-2 diabetes and asthma. Dr Bjorn Stallberg, from Uppsala University in Sweden, said: "As the population is aging, people are more likely to suffer from more than one condition at the any given time. It will be important for clinicians to recognise other symptoms outside of their specialist area to ensure patients are receiving all the necessary treatment." 

For more information:

http://www.erscongress2011.org/mediacentre/news-releases/item/324-underweight-copd-patients-at-higher-risk-of-death.html

COPD World News   Week of October 9, 2011
                                 
FDA Okays CFC-Free Spray to Treat COPD

Washington, DC - The FDA has approved a combination of ipratropium bromide and albuterol sulfate (Combivent Respimat) inhalation spray for treatment of chronic obstructive pulmonary disease (COPD).

The treatment is a non-aerosol form of the existing Combivent Inhalation Aerosol, which is being phased out due to restrictions placed on products that produce chlorofluorocarbons as a result of the Montreal Protocol on Substances that deplete the ozone layer,  an FDA statement said. The new form of the COPD combination drug uses a slow-moving mist rather than a propellant-based delivery. It also requires a single inhalation-per-dose and contains a dose indicator that shows the remaining amount of medication in the inhaler, a statement from Boehringer Ingelheim said.
The drug is indicated for patients with COPD on a regular aerosol bronchodilator who present with continued evidence of bronchospasm and require a second bronchodilator, the statement added.

Efficacy of the slow-moving mist was established in a 12-week clinical trial that found the drug was clinically comparable with Combivent MDI aerosol. The combination product -- whether spray or aerosol -- is contraindicated in patients hypersensitive to the drug or its components and to atropine or atropine derivatives. In addition, drug treatment can cause a potentially life-threatening paradoxical bronchospasm.

Other adverse events include elevated pulse rate, blood pressure, and related symptoms; myocardial ischemia; electrocardiogram changes; urinary retention; hypokalemia; bronchitis; upper respiratory tract infection; headache; dyspnea; cough; pain; respiratory disorder; sinusitis; pharyngitis; nausea; and nasopharyngitis. Patients with convulsive disorders, hyperthyroidism, or diabetes mellitus, and those with sensitivity to sympathomimetic amines should consult a healthcare professional before using the drug due to the presence of albuterol sulfate.

For more information:

http://www.medpagetoday.com/Pulmonology/SmokingCOPD/28973

COPD World News   Week of October 2, 2011
                                 
Lung disease puts many black patients back in hospital

Baltimore, Maryland - Among U.S. patients aged 40 and older with chronic obstructive pulmonary disease (COPD), blacks have the highest rate of hospital readmission, a new report reveals.

In 2008, COPD patient hospital readmissions within 30 days were 30 percent higher among blacks than Hispanics or Asians and Pacific Islanders, and about 9 percent higher than among whites, according to an analysis of data from State Inpatient Databases for 15 states, including: Arkansas, California, Florida, Hawaii, Louisiana, Massachusetts, Missouri, Nebraska, New Hampshire, New York, South Carolina, Tennessee, Utah, Virginia and Washington.

Overall, in 2008, about 7 percent of COPD patients were readmitted within 30 days principally for COPD, and 21 percent were readmitted for any type of health problem ("all-cause readmission"), according to the Sept. 14 News and Numbers summary from the U.S. Agency for Healthcare Research and Quality.

The 190,700 initial hospital admissions to treat COPD cost an average of $7,100 each. The average cost for readmission principally for COPD was $8,400 per stay (18 percent higher than for the initial stay) and $11,100 for all-cause readmission (50 percent higher), the investigators reported.

Re-admissions were 22 percent higher among patients in the poorest communities than among patients in high-income areas, and 13 percent higher among men than women, the report indicated.

For more information:

http://www.nlm.nih.gov/medlineplus/news/fullstory_116745.html

COPD World News   Week of September 25, 2011
                                 
Commonly prescribed antibiotic reduces acute COPD attacks

Baltimore, Maryland - Adding a common antibiotic to the usual daily treatment regimen for chronic obstructive pulmonary disease (COPD) can reduce the occurrence of acute exacerbations and improve quality of life, reports new results from a clinical trial funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.  "Acute exacerbations account for a significant part of COPD's health burden," said Susan B. Shurin, M.D., acting director of the NHLBI. "These promising results with azithromycin may help us reduce that burden and improve the lives of patients at risk."

COPD exacerbations are sudden onsets of worsened cough, wheeze, and labored breathing which are typically induced by bacterial and/or viral infection. Azithromycin is already prescribed for a wide variety of bacterial infections including pneumonia and strep throat. Previous research suggested that this antibiotic might work for COPD exacerbations, but this study was the first to enroll a large number of COPD patients and treat exacerbations with this drug over a long time.

Eighty percent of the study participants were already taking other medications normally used to manage COPD, including inhaled steroids and long-acting bronchodilators. "This study suggests that azithromycinís benefits extend beyond those of other therapies," noted James Kiley, Ph.D., director of the NHLBI's Division of Lung Diseases.  Kiley added that more research is needed to determine the long-term effects of azithromycin treatment and to identify which group of patients would benefit the most. Side effects of azithromycin during the study were minimal.

For more information:

http://www.nhlbi.nih.gov

COPD World News   Week of September 18, 2011
                                 
COPD Risk Outpaces Host of Other Diseases

Toronto, ON - The lifetime risk that someone will develop chronic obstructive pulmonary disease (COPD) is about one in four -- higher than the risk for many cancers and cardiovascular diseases, researchers reported.

In a large Canadian population, the incidence of physician-diagnosed COPD over a 14-year period was 27.6%, according to Andrea Gershon, MD, and colleagues at the Institute for Clinical Evaluative Sciences in Toronto. Over the same period in the same population, that was about twice the lifetime risk of congestive heart failure and three to four times the risk of breast and prostate cancer, they reported in the Sept. 10 issue of The Lancet. The findings "draw attention to the huge burden of COPD on society and can be used to educate the public about the need for attention and resources to combat the disease," they concluded.

Gershon and colleagues noted that COPD is "one of the most deadly, prevalent, and costly chronic diseases" but there have been no comprehensive estimates of the risk of the disease in the general public. To fill the gap, they turned to administrative health databases in the province of Ontario, where the population of more than 13 million people has universal health insurance for all medically necessary services. Using those data, they conducted a retrospective longitudinal cohort study of all people over the age of 35 and free of COPD in 1996. That group was followed for up to 14 years for three possible outcomes: diagnosis of COPD by a physician, death, or turning 80.

In parallel, the researchers looked at the incidence of several other conditions, including physician-diagnosed heart attack, asthma, diabetes, congestive heart failure, lung cancer, colorectal cancer, breast cancer, and prostate cancer.

They found: 579,466 people developed physician-diagnosed COPD. Overall incidence was 5.9 cases per 1,000 person-years. Lifetime risk of physician-diagnosed COPD 29.7% in men and 25.6% in women. Only diabetes and asthma had higher lifetime risks than COPD. Risk of COPD was about double that of congestive heart failure, at 29.7% versus 16.6% in men and 25.6% versus 11.5% in women. Risk of COPD was more than double the risk of acute MI, 29.7% versus 10.7% in men and 25.6% versus 4.46% in women. In women, lifetime risk of breast cancer was 7.6% compared with the 25.6% risk of COPD. In men, lifetime risk of prostate cancer was 9.3%, compared with the 29.7% risk of  COPD.

The researchers cautioned that they used an administrative database to identify those with incident COPD, and the case definition of physician-diagnosed COPD might have meant some people without the disease were included. They also noted that spirometry data were not included for all people in the dataset, so that they could only estimate the risk of physician-diagnosed COPD, rather than the risk of spirometry-confirmed disease.

For more information:

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60990-2/abstract

COPD World News   Week of September 11, 2011
                                 
COPD Stent Fails Clinical Test

London, UK - Patients with severe emphysema derived no significant benefits from a less invasive alternative to surgical lung-volume reduction, investigators in a randomized trial reported.

Airway bypass failed to improve lung function or dyspnea as compared with a sham procedure, despite successful release of trapped air in emphysematous lung tissue. The composite six-month endpoints for efficacy and safety were met in 14.4% of patients randomized to active treatment and 11.2% of those in the sham group, as reported online in The Lancet.

"Findings of the EASE [Exhale Airway Stents for Emphysema] trial showed that at day one, airway bypass released trapped gas from hyperinflated regions, thereby improving pulmonary function," Pallav L. Shah, MD, of the Imperial College in London, and co-authors wrote in their discussion.
"However, durability was limited by pulmonary function tests and subjective, functional, and post-hoc CT measures.  Outcomes for sham control and airway bypass were similar at months three, six, and 12."

Surgical lung-volume reduction has demonstrated ability to improve breathing and reduce dyspnea in patients with severe emphysema. However, the surgery causes substantial morbidity. Recently, the less invasive procedure airway bypass has shown potential to reduce lung volume by eliminating trapped air in emphysematous tissues. Performed by broncoscopy, airway bypass involves surgical creation of passages in bronchial airways, followed by placement of paclitaxel-coated stents to maintain passages' patency.

"Although our findings showed safety and transient improvements, no sustainable benefit was recorded with airway bypass in patients with severe homogeneous emphysema," the authors wrote in conclusion.  An accompanying commentary said the negative results of the study should not deter continued investigation of novel therapies for emphysema. "Technical development in this area should continue, with the aim of prolonging the patency of airway stents, wrote Walter Weder, MD, and Erich Russi, MD, of the University of Zurich in Switzerland. "In future trials, selection of patients needs to be done carefully so that the chances of producing a persistent therapeutic effect are high.

"For progress to be made, detailed analysis of the EASE trial will be needed, to identify responding populations and to improve procedural methods. Only then will this type of procedure enrich our therapeutic arsenal for treatment of advanced pulmonary emphysema."

For more information:

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)61050-7/abstract

COPD World News   Week of September 4, 2011
                                 
Risk for COPD Higher Than Thought

Toronto, ON - Canadian researchers found that one out of every four people 35 and older is likely to develop COPD, which they called "one of the most deadly, prevalent and costly chronic diseases." COPD includes emphysema and chronic bronchitis, and the overall risk for developing it surpasses that of heart failure as well as breast and prostate cancer.

"Our novel findings draw attention to the huge burden of COPD on society... and can be used to combat the disease [and] justify the continuation of smoking cessation programs," the study's authors wrote in a news release from The Lancet, which published the results in a special European Respiratory Society issue.

The researchers, from the Institute for Clinical Evaluative Sciences in Toronto, used health data on 13 million people ranging in age from 35 to 80 years old to determine the lifetime risk of developing the condition. Over the course of 14 years, 579,466 cases of COPD were diagnosed.

The research found that the average 35-year-old woman is more than three times as likely to get COPD than breast cancer during her lifetime, and the average 35-year-old man is at more than three times greater risk for COPD than prostate cancer.

The study also pointed out that males, people living in rural areas or those with lower socioeconomic status have a greater risk of developing COPD over their lifetimes. Meanwhile, a separate study in the same journal issue revealed that airway bypass, an experimental and minimally-invasive procedure, does not alleviate the symptoms of severe emphysema, which causes the destruction and hyperinflation of the lungs, making it difficult for people to breathe and perform daily activities such as eating, bathing, and walking.

Even though earlier studies had shown the airway bypass reduced lung inflation and shortness of breath one day after the procedure, the latest analysis of 315 patients followed for one year found no such positive effects after one month or at six months post-procedure. In addition, the patients received no more benefit than the control group patients who underwent a sham procedure.

The London researchers on the trial, known as EASE (Exhale Airway Stents for Emphysema), said that the disappointing results were due to a combination of factors, including mucus blockages.

For more information:

http://www.nlm.nih.gov/medlineplus/news/fullstory_116272.html

COPD World News   Week of August 28, 2011
                                 
U.S. Smoking Rates Dropping Slowly

Washington, DC - Smoking prevalence in the U.S. has fallen over the last five years, but not at  a consistent rate, CDC researchers said.

The percentage of adults who smoke  fell from 20.9% in 2005 to 19.3% in 2010, a 1.6% drop that  amounts to about three million fewer smokers than there would have been with no decline, Brian King, PhD, of the CDC, and colleagues reported.  But that means about one in five adults -- some 45 million Americans -- still smoke. As well, the amount and direction of change has not been consistent year-to-year. For instance, there was a slight drop from 2006 to 2007, but not from 2007 to 2008, they wrote. "It's been much slower than the rate of decline in the previous five years," Thomas Frieden, MD, MPH, director of the CDC, said.

King and colleagues noted that if current trends continue, smoking prevalence among adults in the U.S. will fall to 17% in 2020, but that's far short of the Healthy People 2020 goal of 12% or less. They said the modest reduction seen between 2005 and 2010 is likely attributable to the proliferation of smoke-free environments, greater awareness of the dangers of smoking, and increased cigarette prices. Still, Frieden called for greater funding of highly effective state tobacco cessation programs.

The tobacco industry spends almost $10 billion per year on advertising and promotion, and 72% of these dollars are spent on discounts to offset the costs of tobacco taxation and other policies, they added. Frieden said companies have also made their products more addictive, by enabling greater and faster delivery of nicotine to the bloodstream, which may present future challenges in smoking cessation.

The report was limited by self-reported data, and because neither survey assessed institutionalized patients or people in the military, which could limit its generalizability. King and colleagues also noted that BRFSS data didn't include adults who had cellphones only. Previous research has shown that wireless-only users are more likely to smoke. Low response rates in the surveys may also increase the potential for bias, they said. The researchers concluded that "enhanced efforts are needed to accelerate the decline in cigarette smoking among adults.

For more information:

http://news.yahoo.com/cdc-reports-adult-smoking-rate-slowly-declining-leaders-174610776.html

COPD World News   Week of August 21, 2011
                                 
Long-Term Antibiotic Use May Lessen COPD Flare-Ups

Denver, CO - Taking a daily dose of the antibiotic azithromycin may help prevent life-threatening complications of chronic obstructive pulmonary disease (COPD), researchers say. These complications are commonly referred to as acute exacerbations, and they can cause frequent doctor visits and hospitalizations.

Although numerous medications are available to help prevent exacerbations, some people still experience several flare-ups a year. For people with this more serious form of COPD, a new study found that taking azithromycin daily helped to reduce exacerbations.

People on the antibiotic had an average of 1.48 exacerbations over a year, compared with 1.83 exacerbations for people who received usual care for COPD. "We tested whether adding azithromycin to standard therapy would decrease COPD exacerbations, and it did. It was associated with some side effects, but we thought the side effects were limited and the potential benefits for patients with COPD -- in our opinion -- outweighed the potential risks," said the study's lead author, Dr. Richard Albert, chief of medicine at Denver Health, and a professor of medicine at the University of Colorado. 

Symptoms of an exacerbation -- which often accompany a bacterial or viral infection -- may include worsening cough, wheezing and difficulty breathing. People with more frequent exacerbations have an increased risk of death and experience a more rapid decline in lung function and quality of life, according to background information in the study.

Azithromycin, is known to cause irregular heartbeats in some people. Some hearing loss has also been associated with use of this drug, and people with existing hearing impairments were excluded from the study.

Researchers don't know exactly how azithromycin reduced exacerbations, but said it has antibiotic and anti-inflammatory properties, both of which could be helpful in COPD.  "This is not for all COPD patients; the group of patients we selected were predisposed to having multiple acute exacerbations. This shouldn't be used for everyone," he noted. "In this study, the exclusion criteria were very selective, and physicians have to be very careful to follow this exclusion criteria," said Dr. Arunabh Talwar, director of advanced lung diseases at North Shore-LIJ Health System in New Hyde Park, N.Y. "Physicians have to ask themselves, 'Does my patient have any cardiac conditions that can impact the use of azithromycin,'" he advised.

Said Dr. Kevin Grady, director of pulmonary and critical care services at St. John Hospital and Medical Center in Detroit, "This study clearly shows a decrease in exacerbations, and that's what we're looking for. We want to keep a patient out of trouble as long as possible because there's higher mortality with frequent exacerbations. The addition of azithromycin therapy makes great sense for the right patient."

For more information:

http://www.nlm.nih.gov/medlineplus/news/fullstory_115741.html

COPD World News   Week of August 14, 2011
                                 
Cigarette smoking implicated in half of bladder cancers in women

Baltimore, Maryland - A recent National Institute of Health study confirms that the risk of developing bladder cancer is higher than previously estimated and that the risk in women is now comparable to that of men.

According to a new study by scientists from the National Cancer Institute (NCI), data indicate that smoking is responsible for about half of female bladder cancer cases – similar to the proportion found in men in current and previous studies.  The increase in the proportion of smoking-attributable bladder cancer cases among women may be a result of the increased prevalence of smoking by women. The majority of the earlier studies were conducted at time periods or in geographic regions where smoking was much less common among women.

“Current smokers in our study had a fourfold excess risk of developing bladder cancer, compared to a threefold excess risk in previous studies.  The stronger association between smoking and bladder cancer is possibly due to changes in cigarette composition or smoking habits over the years,” said study author Neal Freedman, Ph.D in NCI’s Division of Cancer Epidemiology and Genetics (DCEG).

Incidence rates of bladder cancer in the United States have been relatively stable over the past 30 years, despite the fact that smoking rates have decreased overall. The higher risk, as compared to studies reported in the mid-to-late 1990s, may explain why bladder cancer rates haven’t declined.  Although there have been reductions in the concentrations of tar and nicotine in cigarette smoke, there have been apparent increases in the concentrations of certain carcinogens associated with bladder cancer.

In the current study, they found that former smokers were twice as likely to develop bladder cancer as never smokers, and current smokers were four times more likely than those who never smoked.  As with many other smoking-related cancers, smoking cessation was associated with reduced bladder cancer risk.

Participants who had been smoke-free for at least 10 years had a lower incidence of bladder cancer compared to those who quit for shorter periods of time or who still smoked. In 2011, approximately 69,250 people will be diagnosed with bladder cancer in the United States, and 14,990 will die from the disease.

For more information:

http://www.nih.gov/news/health/aug2011/nci-16.htm

COPD World News    Week of August 7, 2011
                                 

Physician Groups Issue New COPD Guidelines

Philadelphia, PA - Patients with more severe COPD are best managed with inhaled monotherapy of either long-acting beta agonists or anticholinergics, according to a new guideline from several physician organizations. These patients can also be given combination therapy that includes inhaled corticosteroids, although there is less evidence for this recommendation.

This information is according to a combined statement from the American College of Physicians (ACP), the American College of Chest Physicians, the American Thoracic Society, and the European Respiratory Society.  But screening for the disease in asymptomatic patients, even if they're in an at-risk population such as smokers, is unnecessary, Amir Qaseem, MD, PhD, director of clinical policy at ACP, and colleagues wrote in their guideline on diagnosing and treating COPD, published in the Annals of Internal Medicine. The recommendations are an update to a 2007 guideline from the ACP, with the researchers reviewing studies published between that year and 2009 to create the new guidance.

Overall, they made seven recommendations addressing diagnosis and treatment, noting that the guideline doesn't cover smoking cessation, surgical options, palliative care, end-of-life care, or nocturnal ventilation. In terms of diagnosis, the researchers recommend using spirometry to diagnose airflow obstruction in patients with respiratory symptoms, which is especially beneficial for those with dyspnea. This information, however, doesn't appear to influence the likelihood of quitting smoking or staying off tobacco, they said.

Spirometry shouldn't be used to screen for airflow obstruction in patients without respiratory symptoms, even at-risk patients such as smokers, they said. This could lead to unnecessary testing, increased costs, and unnecessary disease labeling. As well, they warned, there are no known preventive effects of treatment. Both of these are strong recommendations backed by moderate quality evidence, they added.

In terms of treatment, the researchers said there's moderate evidence for their strong recommendation for using inhaled bronchodilators, including long-acting beta agonists and anticholinergics, in symptomatic patients with an FEV1 less than 60% of the predicted value. There is weaker evidence of benefit for these drugs in patients with an FEV1 between 60% and 80% of predicted value, they warned, though they still "suggested" treatment of this population with these medications. They noted that these recommendations don't pertain to the occasional use of short-acting bronchodilators.

Qaseem and colleagues also strongly recommended monotherapy with either long-acting beta agonists or anticholinergics in patients with an FEV1 of 60% predicted volume or less. Physicians should base their choice on patient preference, cost, and adverse effects, they said.

The moderate-quality evidence, on which this recommendation is based, shows that monotherapy is beneficial in reducing exacerbations and improving quality of life, but it's unclear whether it can improve mortality, hospitalizations, and dyspnea, the researchers said. Corticosteroids can also reduce exacerbations, but there are lingering concerns about their side effect profile, and are thus "not a preferred monotherapy," they wrote.

They also "suggested" that physicians use combination inhaled therapies in this population, with any of the three previous therapies, although they noted that studies have been inconsistent in terms of exacerbation reduction, mortality, and adverse event risk. The most-studied combination to date is long-acting beta agonists plus corticosteroids, they said. However, it's unclear when to use combination therapy instead of monotherapy, they warned.

For more information:

www.acponline.org/pressroom/copd.htm


COPD World News    Week of July 31, 2011                                 

Corticosteroid Use Increases Fracture Risk in COPD Patients

Baltimore, MD - Patients with chronic obstructive pulmonary disease (COPD) who use inhaled corticosteroids to improve breathing for more than six months have a 27 percent increased risk of bone fractures, new Johns Hopkins-led research suggests. Because the research subjects were mostly men age 60 and older, the findings raise perhaps more troubling questions about the medication's effects on women with COPD, a group already at a significantly higher risk than men for fractures.

"There are millions of COPD patients who use long-term inhaled corticosteroids in the United States and millions more across the world," says Sonal Singh, M.D., M.P.H., an assistant professor of general internal medicine at the Johns Hopkins University School of Medicine and the senior author of the study published online in the journal Thorax. "The number of people who are getting fractures because of these medications is quite large."

The inhaled corticosteroids evaluated were fluticasone, sold in combination with salmeterol as Advair, and budesonide, sold in combination with formoterol as Symbicort. Although applied through the mouth, the body absorbs corticosteroids, which have long been linked to a decline in bone density.

Patients with COPD, the researchers note, are already at a high risk of osteoporosis and fractures, which may stem from nutritional deficiencies or previous corticosteroid use. At larger doses, adverse effects of inhaled corticosteroids may come close to that of oral steroids, which are well known to increase bone loss and decrease bone formation.

Singh says he would like the U.S. Food and Drug Administration to look into the issues discovered in this research by his team and his colleagues from the University of East Anglia in the United Kingdom and the University of Louisville in the United States.

Although many asthma patients also take inhaled corticosteroids, Singh says his research does not apply to that mostly younger cohort since they were not included in the study. Singh says he is most concerned about those who were not the focus of this study: women. "It was surprising to find an increased risk of fractures in this study where two-thirds of the participants were men over the age of 60," Singh says. "It really makes us wonder what is happening to women with COPD who use inhalers, because older women are already at a much higher fracture risk than men."

This study was supported by the National Institutes of Health's National Center for Research Resources and the NIH's Roadmap for Medical Research.

For more information:

http://www.sciencedaily.com/releases/2011/06/110623161946.htm

COPD World News    Week of July 24, 2011                                 

Secondhand Smoke Linked to Hearing Loss in Teens

Worchester, MA - Children exposed to secondhand smoke may need to be screened for auditory problems, researchers here say. 

Exposure to secondhand smoke could affect hearing development in children and increase their risk of hearing loss during adolescence, a new study indicates. These findings may warrant screenings for hearing loss among children exposed to secondhand smoke, the researchers warned.

Roughly 60 percent of children in the United States are exposed to secondhand smoke, reported the study's authors. These children are at greater risk for certain health problems, from respiratory infections to behavioral difficulties and otitis media (acute ear infection). Babies whose mothers smoked when pregnant are also at greater risk for low birthweight and other problems. "Secondhand smoke may also have the potential to have an impact on auditory development," something that has significant implications for U.S. public health, the researchers wrote.

In the study, they questioned 1,533 teens about their health status and family medical history, exposure to secondhand smoke and their knowledge of whether or not they had a hearing problem. The teens were also given physicals, which included blood testing for cotinine (a byproduct of nicotine exposure) and hearing tests. Teens who had been exposed to secondhand smoke had higher rates of low- and high-frequency hearing loss than their peers who were not exposed, researchers found.

The study noted that judging by cotinine levels, the severity of the hearing loss depended on how much exposure they had had. The study pointed out, however, more than 80 percent of the teens suffering from hearing loss didn't even realize they had a problem.

The findings were published in the July issue of the Archives of Otolaryngology,
Head and Neck Surgery.  Since teenagers are not screened for hearing loss in the absence of risk factors for the condition, the researchers argued teens that have been exposed to secondhand smoke should be more closely monitored for hearing impairment. The study added that teens should also be educated about risk factors for hearing loss, such as noise exposure and secondhand smoke.

For more information:

http://www.nlm.nih.gov/medlineplus/news/fullstory_114399.html

COPD World News    Week of July 17, 2011                                 

No Headway Against COPD, Which Now Affects Women More

Atlanta, GA - Between 1998 and 2009 there was no significant decline in cases of the often deadly ailment known as chronic obstructive pulmonary disease (COPD), and the burden of the disease has shifted from men to women, a new report finds.

By 2009, 11.8 million Americans aged 18 and over suffered from the progressive respiratory illness -- about 1 in every 20 adults, according to the report from the U.S. Centers for Disease Control and Prevention. Just over 6 percent of women now have COPD, the study found, compared to just over 4 percent of men.

"COPD is now the third leading cause of death, behind heart disease and cancer," said lead author Dr. Lara J. Akinbami, a medical officer in the Office of Analysis and Epidemiology at the CDC's National Center for Health Statistics.  COPD "has replaced stroke, which was the third leading cause of death," she said. "That is mainly because stroke has dramatically declined."

The new report also finds COPD disproportionately affecting the poor and smokers. The latter finding is not surprising, since smoking is a prime risk factor for COPD.  Most COPD is caused by chronic exposure to lung irritants such as cigarette smoke, but it can also be caused by long-term exposure to other environmental toxins. The relative increase of COPD among women is largely due to more women taking up smoking in the 1970s and 1980s, Akinbami believes.  These women are only now entering a time when the symptoms of COPD start to appear.

Akinbami hopes that with fewer people smoking today vs. decades past, there will be fewer cases of COPD in the future. In that sense, COPD largely is a preventable condition, she said. In addition to smoking, other environmental risk factors include exposure to toxic fumes at work. There is also a genetic component that can raise the risk, Akinbami said. In addition, the CDC report noted that diet and recurrent infections may play a role.

The CDC team also found strong ethnic and geographical disparities in COPD. For example, COPD was more common among Puerto Ricans and whites than among blacks and Mexican Americans. COPD was also more common among adults living below the poverty level (8.3 percent) than among those whose income is at least 200 percent above the poverty level (4.3 percent). And there were big differences region-to-region. The rate of COPD was almost twice as high in the East South Central states (7.5 percent) vs. the Pacific states (3.9 percent), according to the report. COPD is a progressive and incurable disease.

However, progress has been made in treating the symptoms of the disease, which can at least improve a patient's quality of life. This report found that the rate of hospitalizations for COPD fell among both men and women during the study period, the CDC noted. However, the death rate from COPD dropped only for men.

For more information:

http://www.nlm.nih.gov/medlineplus/news/fullstory_113774.html

COPD World News    Week of July 10, 2011                                 

New COPD drug wins US approval

Washington, DC - A new beta2-adrenergic agonist drug, indacaterol inhalation powder (Arcapta Neohaler), has won FDA approval as long-term maintenance therapy for chronic obstructive pulmonary disease, the agency announced. A product of Novartis, the drug was tested in six clinical trials with a total of nearly 5,500 current or former smokers 40 and older.

An FDA advisory committee voted 13-4 in March to recommend that the drug be approved, although only at the 75-mcg dosage. The panel recommended against approval of a 150-mcg dose, citing a lack of clear evidence that the higher dose was any more effective or that it was as safe as the lower dose. Following the committee's recommendation, the FDA approved only the 75-mcg dose. This was the second try by Novartis to win FDA approval for indacaterol. The agency had rejected the company's first application in 2009, which had sought approval for doses as high as 300 mcg.

Novartis conducted additional clinical studies at the 75- and 150-mcg doses to satisfy the FDA's concerns. The agency emphasized that the drug is not to be used to treat acute exacerbations. It also should not be used by people with asthma unless they are also taking long-term controller medications such as inhaled corticosteroids. Indacaterol will carry the same black-box warning as other long-acting beta agonists about increased risk of asthma-related death.

Side effects seen most commonly in the drug's clinical studies included runny nose, cough, sore throat, headache, and nausea, the FDA said.

For more information:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm261649.htm


COPD World News    Week of July 3, 2011                                 

Smoking Tied to Worse Prostate Ca Survival


Boston, MA - Men who are smokers when they receive a prostate cancer diagnosis have significantly worse survival and a greater risk of biochemical recurrence, researchers found.

During a two-decade study, Stacey Kenfield, ScD, of the Harvard School of Public Health in Boston, and colleagues compared men who had quit smoking for 10 or more years or who had quit for fewer than 10 years but smoked less than 20 pack-years had prostate cancer mortality risks similar to those of men who had never smoked.  They noted that the outcomes are not likely explained by differences in screening behaviors, as analyses adjusted for PSA screening history yielded similar estimates.

The link between smoking and prostate cancer progression, which has been suggested by previous studies, is biologically plausible, Kenfield and her colleagues stated. Possible mechanisms include tumor promotion through the carcinogens in tobacco smoke, increased plasma levels of testosterone in smokers, epigenetic effects, and nicotine-induced angiogenesis, capillary growth, and tumor growth and proliferation.

A 2004 report from the U.S. Surgeon General concluded it was probable that smoking contributes to a higher prostate cancer mortality rate, but few studies have examined the relationship directly. To investigate the link, Kenfield and her colleagues looked at data from the Health Professionals Follow-Up Study, a prospective observational cohort study started in 1986. For the current analysis, they included 5,366 men who were cancer-free at baseline and were diagnosed with prostate cancer between the start of the study and 2006. During the study, there were 1,630 deaths, 32% from prostate cancer, 26% from cardiovascular disease, and the rest from other causes. There were also 878 biochemical recurrences. The rate of prostate cancer-specific death was significantly greater in men who reported being smokers at the time of diagnosis than in those who had never smoked. The rates for former smokers fell in between.

For more information:

http://www.medpagetoday.com