COPD World News    Week of December 26, 2010                                 

New COPD drug approved that reduces flare-ups or “lung attacks”

Oakville, ON, - Nycomed Canada Inc. announced that Daxas™ (roflumilast), a first in a new class of treatment, is now approved in Canada as an add-on therapy to bronchodilator treatment for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis in adult patients with a history of frequent flare-ups. 

Daxas is the first approved phosphodiesterase 4 (PDE4) inhibitor.  This treatment acts differently than bronchodilators which are first line treatment. It is designed to treat the underlying COPD-related inflammation, it does not directly impact everyday symptoms. A once daily tablet, Daxas works in addition to current COPD bronchodilator treatments by improving lung function and reducing flare-ups.  The drug will be available in Canadian pharmacies in January 2011. 

A flare-up or “lung attack”, is a worsening of COPD symptoms, including cough, excessive inflammation, increase in shortness of breath and mucus production, and can result in hospitalization.  It is a major cause of morbidity and mortality in the disease. Despite the fact that studies have shown that patients admitted for a “lung attack” are more likely to die in the 12 months following hospital admission than patients admitted for a heart attack, some doctors and patients may underestimate their impact. 

“Living with COPD, I understand how frightening and distressing a flare-up or lung attack can be. The coughing, breathlessness and the mucus can be so overpowering, that it feels like you are suffocating.  A really bad flare-up can land you in the hospital and the recovery can take a real toll on you and your body,” says Hank Knol, who has lived with COPD for eight years and has been hospitalized eight times for a “lung attack”.

Respiratory infections, such as the common cold and the flu, appear to be the main trigger for a “lung attack”.  “Lung attacks” are at their highest average annual levels during the Christmas period (also known as the “Christmas Peak”), because holiday social gatherings may be opportunistic for transmission of respiratory viruses.  While COPD “lung attacks” are at their highest during the holiday season, a person with COPD continues to be at-risk, especially during the winter, since respiratory infections are more frequent.

Prevention of “lung attacks” is therefore of fundamental importance for the well being of the COPD patient.  “COPD patients who suffer from chronic cough and sputum production, are at a higher risk of flare-ups or lung attacks,” says Dr. Alan Kaplan, a family physician and the director of the Family Physicians Airways Group of Canada. “Roflumilast gives physicians a new option in reducing flare-ups which often plunge patients into a downward spiral, in terms of their lung function and quality of life.”

“Treatment options which can improve lung function and reduce flare-ups may help these patients,” says Henry Roberts, who is a member of the executive committee of COPD Canada, a patient association focused on providing education and support to people living with COPD. “While we welcome the approval of Daxas, reimbursement of this medication in a timely manner is what will be equally important, so that the patients who can benefit from it, many of whom tend to be elderly, can have access to it.” 

For more information:

COPD World News    Week of December 19, 2010                                 

Second-hand smoke kills 600,000 a year: WHO study

London, UK - Around one in a hundred deaths worldwide is due to passive smoking, which kills an estimated 600,000 people a year, a new study by the World Health Organization (WHO) has found.

In the first study to assess the global impact of second-hand smoke, WHO experts found that children are more heavily exposed to second-hand smoke than any other age-group, and around 165,000 of them a year die because of it. "Two-thirds of these deaths occur in Africa and south Asia," the researchers, led by Annette Pruss-Ustun of the WHO in Geneva, wrote in their study.

Children's exposure to second-hand smoke is most likely to happen at home, and the double blow of infectious diseases and tobacco "seems to be a deadly combination for children in these regions," they said. Commenting on the findings in the Lancet journal, Heather Wipfli and Jonathan Samet from the University of Southern California said policymakers try to motivate families to stop smoking in the home. "In some countries, smoke free homes are becoming the norm, but far from universally," they wrote.

The WHO researchers looked at data from 192 countries for their study. To get comprehensive data from all 192, they had to go back to 2004. They used mathematical modeling to estimate deaths and the number of years lost of life in good health. Worldwide, 40 percent of children, 33 percent of non-smoking men and 35 percent non-smoking women were exposed to second-hand smoke in 2004, they found. This exposure was estimated to have caused 379,000 deaths from heart disease, 165,000 from lower respiratory infections, 36,900 from asthma and 21,400 from lung cancer. For the full impact of smoking, these deaths should be added to the estimated 5.1 million deaths a year attributable to active tobacco use, the researchers said.

While deaths due to passive smoking in children were skewed toward poor and middle-income countries, deaths in adults were spread across countries at all income levels. In Europe's high-income countries, only 71 child deaths occurred, while 35,388 deaths were in adults. Yet in the countries assessed in Africa, an estimated 43,375 deaths due to passive smoking were in children compared with 9,514 in adults.

Pruss-Ustun urged countries to enforce the WHO's Framework Convention on Tobacco Control, which includes higher tobacco taxes, plain packaging and advertising bans, among other steps. "Policy-makers should bear in mind that enforcing complete smoke-free laws will probably substantially reduce the number of deaths attributable to exposure to second-hand smoke within the first year of its implementation, with accompanying reduction in costs of illness in social and health systems," she wrote.

Only 7.4 percent of the world population currently lives in jurisdictions with comprehensive smoke-free laws, and those laws are not always robustly enforced. In places where smoke-free rules are adhered to, research shows that exposure to second hand smoke in high-risk places like bars and restaurants can be cut by 90 percent, and in general by 60 percent, the researchers said. Studies also show such laws help to reduce the number of cigarettes smoked by smokers and lead to higher success rates in those trying to quit.

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COPD World News    Week of December 12, 2010                                 

Autoimmunity Linked to COPD

Palma de Mallorca, Spain - The presence of circulating autoantibodies in patients with chronic obstructive pulmonary disease (COPD) suggests that the lung disorder may have an autoimmune component, according to a group of Spanish researchers.

A study conducted among more than 300 patients hospitalized for a first exacerbation of COPD found that 34% had high levels of antinuclear antibodies (ANA) a prevalence 11 times higher than seen in a separate control group, said Belén Núñez, MD, of the Hospital Universitari Son Dureta in Palma de Mallorca, and colleagues. In addition, 26% of the COPD patients had anti-tissue (AT) antibodies -- which appear to be related to lung impairment -- a number 4.5 times more common than in the controls, Núñez and co-authors reported online in the American Journal of Respiratory and Critical Care Medicine. An enhanced and persistent inflammatory response to the inhalation of particles and gas, mostly tobacco smoking, is considered a key pathogenic mechanism of chronic obstructive pulmonary disease," the researchers explained.

Autoimmune disease typically results from an immune system attack on otherwise healthy tissues. Recent evidence has suggested that an inflammatory response to particulates, gas and tobacco, is characterized by antibodies directed against the pulmonary epithelium and lung matrix. However, ANA and AT antibodies -- markers usually associated with autoimmune diseases -- had not previously been explored in COPD, the investigators pointed out.

To examine a possible autoimmune contribution, the researchers enrolled 328 COPD patients, measured their antibody levels, and compared those levels with disease activity. Along with the COPD patients, the researchers also enrolled 67 otherwise healthy volunteers (around half of whom were smokers) to serve as controls. The study participants' mean age was about 67 and most were men. Among those whose COPD was rated "severe" or "very severe," 30% to 48% were current smokers.

The researchers acknowledged that they could only speculate about the potential mechanisms linking COPD with autoimmunity, noting that the presence of these autoantibodies could either indicate a chronic immune response or could be causally related to disease pathogenesis. However, they found it of particular interest that more than 90% of the patients who were AT positive had antibodies directed at smooth muscle. "This may be relevant for airway remodeling in COPD because airway smooth muscle cells can synthesize extracellular matrix proteins, down-regulate matrix metalloproteinases, and up-regulate their tissue inhibitors," they wrote.

The study had limitations, including the small numbers of women included and the possibility that the exclusion of patients who had had previous multiple hospitalizations may have created a bias against identifying associations between COPD and autoimmunity. They concluded that a "substantial percentage" of patients with COPD have these autoantibodies, which supports the concept that autoimmunity may be a contributing factor in COPD.

For more information:

COPD World News    Week of December 5, 2010                                 

Canada Wanes on Cigarette Smoking

Puente del Este, Paraguay - The participants at a major international conference on tobacco control in Uruguay this week will receive a pamphlet from the Canadian Cancer Society that says Canada is losing its status as a world leader in smoking cessation.  The pamphlet, titled Cigarette Package Health Warnings: International Status Report, comes two months after the federal government told the provinces it has abandoned a six-year project to update Canadian cigarette packages with new and more graphic photos.

It will be distributed at a meeting of the 172 parties who have signed the World Health Organization’s Framework Convention on Tobacco Control that is taking place all this week in Puente del Este. “Package warnings are very important and Canada was the first country to acquire picture warnings [in 2001] and now we’re falling behind,” said Rob Cunningham, a senior policy analyst with the Canadian Cancer Society.

“We want Canada to regain international leadership. Whereas Canada used to have the biggest warnings in the world, it has now fallen to 15th, tied with 18 other countries and territories.” Even small countries like Uruguay and Mauritius require bigger warning labels than Canada does on tobacco package. “By documenting that other countries are leap-frogging over Canada, we hope that that provides impetus to Health Canada to announce its own warnings,” said Mr. Cunningham.

An editorial published last week by the Canadian Medical Association Journal harshly criticized the government for its decision not to update the package warning, saying it was a “senseless” and “ill-conceived” policy change, and even questioned whether it was a result of the government bowing to pressure from the tobacco industry.

The government says it remains committed to reducing youth smoking, helping Canadians to quit smoking, and addressing the pressing issue of contraband tobacco. “Health Canada continues to examine the renewal of health warning messages on tobacco packaging but is not ready to move forward at this time,” said Jenny Van Alstyne, a spokeswoman for Health Minister Leona Aglukkaq.

The department continues to review available research, including international best practices, on health warning messages, said Ms. Van Alstyne. “As well, the impact and possible effectiveness of any new messages on the smoking behaviour of Canadians needs to be determined before new messages are considered.”

Health Canada had been reviewing the warnings for tobacco products for several years and was considering new labels that would have been larger and, in many cases, much more graphic than the originals until the project was suddenly halted earlier this year. One of the most powerful new labels that received a strong reaction in Health Canada focus groups was the image of Barb Tarbox, one of Canada’s best-known anti-tobacco advocates, emaciated and dying from smoking-related illnesses.

The U.S. Food and Drug Administration started a consultation last week around a number of proposed warnings that could appear on updated U.S. cigarette packages. One of them featured Ms. Tarbox. “Wouldn’t it be ironic if the Americans end up having Barb Tarbox on cigarette packages before Canada does?” asked Mr. Cunningham.

The fact that Canadian cigarette packages have not been changed for 10 years is frustrating, said Mr. Cunningham. There is extensive proof that the graphic pictures on cigarette packages play a role in getting smokers to quit, he said. “A picture says a thousand words and, if you can see that picture of Barb Tarbox, that brings to life what lung cancer is really like. It has a lot more emotional impact than just what text can say,” he said. “And if it didn’t work, the tobacco companies wouldn’t lobby against it.”

For more information:

COPD World News    Week of November 28, 2010                                 

Mortality Benefit Seen With CT Halts Lung Cancer Screening Trial

New York, NY - A 20% reduction in lung cancer deaths with low-dose helical CT scans has led researchers to call a halt to the large randomized controlled trial testing the screening method against chest x-ray, the National Cancer Institute announced. These early results from the long-awaited National Lung Screening Trial (NLST) are the first to find a benefit for lung cancer screening in a randomized, controlled study.

The trial, begun in August 2002, enrolled more than 53,000 current and former heavy smokers ages 55 to 74 who were assigned to receive three annual screens with either low-dose helical CT or standard chest x-ray.  All participants had a history of at least 30 pack-years, and were either current or former smokers without signs, symptoms, or a history of lung cancer. As of Oct. 20, 2010, the researchers saw a total of 354 deaths from lung cancer in the CT group, compared with 442 in the chest x-ray group. That amounts to a 20.3% reduction in lung cancer mortality, a finding that the study's independent data and safety monitoring board decided was statistically significant enough to halt the trial and declare a benefit.

Harold Varmus, MD, director of the National Cancer Institute, said that a validated approach that can reduce lung cancer mortality "by even 20% has the potential to spare very significant numbers of people from the ravages of this disease."  But he cautioned that the findings "should in no way distract us from continued efforts to curtail the use of tobacco, which will remain the major causative factor for lung cancer and several other diseases."

The early results also showed that all-cause mortality was 7% lower in the CT screening group. In 2006, the I-ELCAP trial, led by Claudia Henschke, MD, PhD, of Weill Cornell Medical Center in New York, found that screening could prevent 80% of deaths from lung cancer in an at-risk population. But researchers were quick to point out that study's lack of control group and its inability to find a reduction in mortality. Henschke's study was also controversial because it had been funded with undisclosed tobacco industry money. 

A subsequent study in 2007 found that low-dose helical CT diagnosed three times as many lung cancers as predicted and resulted in 10 times as many operations, but did not decrease mortality or advanced stage cancers. It also did not include a control arm.

For more information:

COPD World News    Week of November 21, 2010                                 

Air Pollution Ups Risk of Chronic Lung Disease

Copenhagen , Denmark - A new study from Denmark says long-term exposure to low levels of air pollution could increase the risk of developing severe chronic obstructive pulmonary disease (COPD). Previous research has found a link between high levels of air pollution and exacerbation of COPD, but this study connects long-term air pollution exposure to the development or progression of the lung disease, according to the researchers.

"Our findings have significance on a number of levels --- patients, primary care physicians, pulmonologists and public health officials should take note," lead researcher Zorana Andersen, a post-doctoral fellow at the Institute of Cancer Epidemiology of the Danish Cancer Society in Copenhagen, said in a news release.

Andersen and colleagues analyzed data to compare air pollution exposure and COPD incidence among more than 52,000 people, ages 50 to 64, who lived in Copenhagen and Aarhus (the two largest cities in Denmark). They found a "significant" association between long-term exposure to low levels of air pollution and COPD, even after they accounted for smoking status and other factors that affect COPD risk. The association was strongest for people with diabetes and asthma and was slightly stronger for men, obese people, and those who ate less than 240 grams (about 8 ounces) of fruit per day.

"These results are in agreement with those of other cross-sectional studies on COPD and air pollution and longitudinal studies of air pollution and lung function. [They] strengthen the conclusion that air pollution is a causal agent in development of COPD," Andersen said. The study appears online ahead of print in the American Journal of Respiratory and Critical Care Medicine

For more information:

COPD World News    Week of November 14, 2010                                 

Medicaid Lagging on Tobacco Cessation Coverage

Berkeley, CA - States may be falling short on tobacco-cessation programs for Medicaid enrollees, the CDC warned in a report. Although 92% of states covered some form of tobacco-dependence treatment, only eight states covered all recommended medications along with at least one form of counseling for all enrollees in 2009, Sara B. McMenamin, PhD, of the University of California Berkeley, and colleagues found in collaboration with the CDC.  Still, this represents an improvement over 2007, with increased coverage in 12 states, they reported.

Penny-conscious states may be pound-foolish, it was pointed out. Tobacco-dependence treatments are one of the few clinical preventive services shown to reduce costs.  Medicaid covers a population with nearly twice the smoking rate of adults in the general population (37% versus 21%). Smoking-related medical costs eat up approximately 11% of Medicaid spending.

The federal government advocated in its Healthy People 2010 goals for Medicaid programs to cover all FDA-approved medications and counseling for tobacco cessation. To see how the states were doing on that goal, McMenamin's group surveyed Medicaid programs in all 50 states and the District of Columbia for 2009.

A total of 47 states offered coverage of tobacco-dependence treatments for at least some enrollees, including 38 that covered at least one such treatment for all enrollees without differences between fee-for-service and managed care organization plan.

As part of the recently-enacted Affordable Care Act, the federal government will bump up assistance to the states by an entire percentage point for expenditures on counseling and FDA-approved treatments for tobacco dependence when they are offered without cost-sharing.

The study may have been limited by lack of documentation to verify coverage policies in a few cases, it was cautioned. Moreover, some managed care organizations offered Medicaid enrollees coverage for tobacco dependence not required by the contracts with state Medicaid programs, which might have led to under-reporting of coverage among these enrollees in the report.

For more information:

COPD World News    Week of November 7, 2010                                 

Poor Diet May Make COPD Worse, Study Finds

Vancouver, BC - A new study has found that antioxidant deficiency is tied to lower lung function, especially for men Certain vitamin deficiencies may lead to decreased lung function in people with chronic obstructive pulmonary disorder, which includes emphysema and chronic bronchitis, says a new study.

For the study, 20 COPD patients (13 women, seven men) completed a questionnaire to assess their dietary intake of vitamins A, C, D, E and selenium, all of which contain cell-protecting antioxidants. A diet low in antioxidants, as compared to national dietary intake requirements, was common among the patients.  The percentages of deficiencies were: 25 percent (selenium), 45 percent (vitamin C), 90 percent (vitamin E), 55 percent (vitamin A), and 70 percent (vitamin D). The researchers then measured the maximum amount of air the patients could exhale with force. All the patients with a selenium-deficient diet had decreased lung function. Among patients deficient in vitamins C, A, and D, only men had decreased lung function.

"Our study, along with other research, suggests that strategies for dietary modification and supplementation should be considered in patients with COPD," Dr. M. Salman Khan of Akron City Hospital, Ohio, said in an ACCP news release. "Further studies are needed to clarify the role gender has on the loss of lung function in COPD and the impact of antioxidant nutrient intake," Khan said. Khan added that antioxidants might also benefit people with severe asthma. "

We would guess that the role of antioxidant nutrients in a well-controlled asthma patient would be less than that seen in patients with COPD," Khan said. "However, in patients with severe asthma with poorly controlled symptoms and frequent, recurring exacerbations, antioxidant nutrient intake may indeed play an important role in the preservation of lung function." COPD is the fourth leading cause of death in America, with 119,000 deaths annually, according to the ACCP.

The study was presented on November 2nd at the annual meeting of the American College of Chest Physicians (ACCP) in Vancouver, Canada and was released by the American College of Chest Physicians.

For more information:

COPD World News    Week of October 31, 2010                                 

Once-a-Day Beta Agonist Works in COPD

Vancouver, BC - A novel once-daily beta-2 agonist appears as effective against chronic obstructive pulmonary disease as once-daily anticholinergic treatment, researchers found. Indacaterol matched tiotropium (Spiriva) for lung function at trough levels of the drug just before redosing, Leonard Jay Dunn, MD, of Clinical Research of West Florida in Clearwater, Fla., and colleagues reported at the CHEST meeting.

The experimental inhaled drug also appeared to hold some advantages for dyspnea symptoms and for the need for rescue albuterol in the industry-sponsored trial. All currently available drugs in the beta-2 agonist class require twice-daily dosing, so indacaterol could give an advantage for medication adherence, Dunn predicted, noting that studies have shown it as effective as others in the class.

"In COPD patients, it [nonadherence] affects their daily life a lot more and it can also lead to emergency room visits, exacerbations, and hospitalizations," he said. "So keeping these patients well-controlled actually is extremely important not only for our patients but for the healthcare system.

"To explore the issue further, the researchers compared indacaterol to the only FDA-approved long-acting bronchodilator, tiotropium, in a 12-week double-blind study. The researchers randomized 1,593 patients with predominantly mild-to-moderate COPD to receive once-daily treatment with indacaterol (150 µg) or tiotropium (18 µg). Patients averaged a mean disease duration of 7.0 years. About half had a current or prior smoking habit.

After 12 weeks of treatment, indacaterol-treated patients were 49% more likely to have had a clinically-important improvement in dyspnea symptoms indicated by a change of at least one point on the Transition Dyspnea Index (TDI) total score.  Although both drugs were effective by spirometry, indacaterol held the advantage for clinical outcomes as a maintenance bronchodilator, according to Dunn's group. A dverse event rates came out fairly even for the two drugs at 39.7% overall for the novel beta-2 agonist versus 37.2% with the anticholinergic.  Serious adverse events tended to be less common with indacaterol (2.8% versus 3.8%), but no statistical comparisons were made for individual side effects.

Indacaterol is approved for use in Europe and was submitted for regulatory consideration before the FDA in 2008, but has yet to gain U.S. approval pending further data requested by the agency. For more information.  The drug is not available in Canada at this time.

For more information:

COPD World News    Week of October 24, 2010                                 

Air Pollution Ups Risk of Chronic Lung Disease: Study

Copenhagen , Denmark - A new study from Denmark says long-term exposure to low levels of air pollution could increase the risk of developing severe chronic obstructive pulmonary disease. Previous research has found a link between high levels of air pollution and exacerbation of COPD, but this study connects long-term air pollution exposure to the development or progression of the lung disease, according to the researchers.

"Our findings have significance on a number of levels --- patients, primary care physicians, pulmonologists and public health officials should take note," lead researcher Zorana Andersen, a post-doctoral fellow at the Institute of Cancer Epidemiology of the Danish Cancer Society in Copenhagen, said in an American Thoracic Society news release.

Andersen and colleagues analyzed data to compare air pollution exposure and COPD incidence among more than 52,000 people, ages 50 to 64, who lived in Copenhagen and Aarhus (the two largest cities in Denmark). They found a "significant" association between long-term exposure to low levels of air pollution and COPD, even after they accounted for smoking status and other factors that affect COPD risk. The association was strongest for people with diabetes and asthma and was slightly stronger for men, obese people, and those who ate less than 240 grams (about 8 ounces) of fruit per day.

"These results are in agreement with those of other cross-sectional studies on COPD and air pollution and longitudinal studies of air pollution and lung function. They strengthen the conclusion that air pollution is a causal agent in development of COPD," Andersen said.

The study appears online ahead of print in the American Journal of Respiratory and Critical Care Medicine.
For more information:

COPD World News    Week of October 17, 2010                                 

FDA Panel Hears About Menthol in Cigarettes

Silver Spring, MD - Tobacco companies believed that adding menthol to cigarettes made them easier for young people to smoke and sought eagerly to capitalize on it, according to testimony before the FDA's advisory committee on tobacco products. But, the panel also heard that there is little evidence indicating that menthol in cigarettes encourages an earlier start to smoking or that the additive has health risks of its own.

The agency's Tobacco Products Scientific Advisory Committee has a March 2011 deadline to submit a report on menthol cigarettes to help the FDA decide whether it should regulate the products more tightly or ban them entirely.  Last year, the agency outlawed cigarettes with fruit and herbal flavors. but exempted menthol from the order.  When that ban was announced, the FDA cited surveys showing that young people believed that flavorings make smoking more appealing and safer. Tobacco company documents presented at the committee meeting showed that the industry's own research indicated the same is true for menthol.

At the panel's request, two researchers from the University of California San Francisco (UCSF) reviewed documents contained in the Legacy Tobacco Documents Library, a trove of more than 11 million individual documents obtained mostly through litigation and managed by the university. Stacey Anderson, PhD, presented memo after memo indicating that cigarette makers believed that menthol cigarettes were more attractive to novice smokers - in one case, calling them "good starter products." Consumer surveys sponsored by the industry indicated that smokers who preferred the menthol products perceived them as "mild" or "light" compared with regular cigarettes. Anderson also showed memos and advertisements indicating that companies preferentially targeted African - Americans, the Asian market, and young people - especially young women, described as "female students and office girls" in one memo from the mid-1980s. Billboards and print ads for menthol brands such as Newport often portrayed groups of happy, active young people, she noted.  Most of these points were also confirmed in presentations by FDA staff who reviewed published scientific studies and surveys.  For example, they noted that ads for menthol cigarettes were especially common in publications aimed at young people.  Also, these products were disproportionately advertised on billboards, which tend to be located in low-income neighborhoods.

James Dillard, a representative of Altria, parent company of cigarette maker Phillip Morris, told the panel during the meeting's public comment portion that his company has changed its marketing of mentholated products considerably since the time period when the memos were written.  He said the company disagrees that menthol makes tobacco smoke easier to inhale. 

For more information:

COPD World News    Week of October 10, 2010                                 

Earlier diagnosis and earlier treatment of COPD in primary care

Aberdeen, Scotland - According to researchers here, chronic obstructive pulmonary disease (COPD) is a progressive disease that usually begins many years before a diagnosis is made.

The need for an early and confirmed diagnosis of COPD is increasingly appreciated by primary care physicians in whose hands the ability to make improvements in early diagnosis largely rests. Case-finding of patients with symptoms of lifestyle limitation is probably the most practical way to achieve early diagnosis.

Evidence suggests a burden of early COPD on afflicted people and their families.  Early encouragement of smoking cessation, in conjunction with management of symptoms and treating activity limitation and exacerbations by appropriate non-pharmacologic and pharmacologic management at the earliest possible stage, could positively affect the impact and progression of the disease.

For more information:

COPD World News    Week of October 3, 2010                                 

Lung Valves Have Some Benefits for Emphysema

Pittsburgh, PA - Patients with advanced emphysema received modest improvements in lung function and exercise tolerance after implantation of an endobronchial valve aimed at reducing pulmonary hyperinflation, a randomized trial showed. 

Compared with optimal medical therapy alone, patients who also received a valve had a 6.8% relative improvement in forced expiratory volume, according to Frank Sciurba, MD, of the University of Pittsburgh, and colleagues. The valve recipients also extended their six-minute walk distance by 5.8% compared with the controls, the researchers reported in the New England Journal of Medicine.  But the benefits were accompanied by an increase in pneumonia, chronic obstructive pulmonary disease exacerbations, and hemoptysis.

In an accompanying editorial, Antonio Anzueto, MD, of the University of Texas Health Science Center at San Antonio, noted that the use of medical therapy was not standardized during the study, which hampered interpretation of the findings.  Without such standardization, "it is impossible to fully understand the benefits and potential complications of new treatments," he wrote. "In my opinion, it is premature to recommend the routine use of endobronchial valves in patients with COPD."

For more information:

COPD World News    Week of September 26, 2010                                 

Co-morbidities of COPD in primary care

Groningen, Netherlands - A study recently published in the Primary Care Respiratory journal looked at the frequency of co-morbidities in relation to COPD and the resultant treatment consequences.

In the Western world, chronic obstructive pulmonary disease (COPD) is predominantly caused by long-term smoking, which results in pulmonary inflammation that is often associated with systemic inflammation. A number of co-morbid conditions, such as cardiovascular disease, muscle wasting, type 2 diabetes and asthma, may coexist with COPD; these and other co-morbidities not directly related to COPD are major causes of excess morbidity and mortality.

The researchers concluded that co-morbidities are frequent, but often remain undiagnosed in the COPD patient. In order to provide the best possible care for people with COPD, the physician should be aware of all potential co-morbidities that may arise, and the critical role that effective management of these co-morbidities can play in improving patient outcomes.

They recommend an increased awareness of the potential co-morbidities of COPD, although potentially adding to the general practitioner’s work burden, may provide insights into this difficult disease state and possibly improve each individual’s prospects for effective management.

For more information:

COPD World News    Week of September 19, 2010                                 

Smoking Ban Linked to Drop in Kids' Hospitalization

Glascow, Scotland - Children's hospital admissions for asthma plummeted after passage of a law banning smoking in all enclosed public places and workplaces, a Scottish study found.

Before the Smoking, Health and Social Care (Scotland) Act was implemented in 2006, asthma admissions had increased at a mean annual rate of 5.2%, according to Daniel Mackay, PhD, of the University of Glasgow, and colleagues.  But after the law was enacted, rates of admission fell by 18.2% per year, the researchers reported in the New England Journal of Medicine.

The legislation was "extremely successful" in its primary aim, which was the reduction of exposure to tobacco smoke in places such as bars, with a pronounced reduction in respiratory ailments among exposed workers.  To see if children -- who would not be subject to workplace exposure -- also benefited, Mackay and colleagues analyzed data on all 21,415 hospital admissions for asthma that occurred in Scotland between January 2000 and October 2009.  The analysis was restricted to children younger than 15 at the time of admission. The net reduction in hospital admissions was 13% per year, the researchers reported. 

Reductions in admissions were seen in both preschool and school-age children, which fell by 18.4% and 20.8%, respectively.  Before the smoking ban went into effect, there had been concern that environmental exposure among children would increase if adults who could no longer smoke outside the home would smoke more at home. This did not happen, however, and the legislation actually was followed by increases in voluntary restrictions on household smoking. Smoking among children themselves also decreased, from 5% among 13-year-old boys in 2004 to 3% in 2007.

Strengths of the study were the inclusion of data from all areas of Scotland, with consistent results throughout.  The authors concluded that the effects of smoking prohibitions can extend to populations other than those directly targeted.

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COPD World News    Week of September 12, 2010                                 

Room Air Matches Oxygen for Dyspnea Relief

Durham, NC - Oxygen therapy isn't any better than regular room air to ease refractory dyspnea at the end of life, a multinational trial showed. Morning and evening breathlessness scores didn't improve any more with palliative oxygen than with room air delivered by a similar concentrator and cannula (Amy P. Abernethy, MD, of Duke University Medical Center, and colleagues found.

Most improvements in dyspnea in the clinical trial occurred early, typically within the first 24 to 72 hours, with both gases, they reported. "So if a person isn't feeling like they've had benefit after three days, it's okay to stop," Abernethy said in an interview. "Maybe this is not the right solution for many of our patients."

The clinical trial included a group of terminal patients who didn't clearly require oxygen therapy. Their blood oxygen levels hadn't fallen into the hypoxic danger zone that clinical guidelines define as a partial pressure of oxygen in arterial blood. However, clinical practice is a different matter, Abernethy's group noted.

Palliative oxygen is often prescribed as a standard of care regardless of blood oxygen level at the end of life out of compassion or at the request of the patient or family despite lack of evidence for benefit. But there are good reasons to change that practice, Irene J. Higginson, BMedSci, BMBS, PhD, of King's College London, wrote in a commentary that accompanied the Lancet paper. "Today's results suggest that, because oxygen provision can often provide a further barrier for patients as well as incurring health-care costs, its use in nonhypoxic patients should be avoided, unless there is very good reason otherwise," she wrote.

The results of the study may not be generalizable to the sickest patients in palliative care (the study included only outpatients) or those eligible for long-term oxygen therapy due to hypoxia or conditions for which it is indicated, the researchers cautioned. Nor did the study assess breathlessness during or after movement, which may deserve further exploration, Higginson added.

For more information:

COPD World News    Week of September 5, 2010                                 

Medicare to Cover Smoking Cessation

Washington, DC - Good news for seniors who want to quit smoking. Medicare will now cover tobacco cessation counseling, the Department of Health and Human Services announced. The new coverage was mandated by the Affordable Care Act (ACA), which contains a number of measures that focus on preventing diseases before they occur, such as paying for cancer screenings, and annual no-cost wellness checkups.

"For too long, many tobacco users with Medicare coverage were denied access to evidence-based tobacco cessation counseling," HHS Secretary Kathleen Sebelius said in a statement announcing the new benefit. "Most Medicare beneficiaries want to quit their tobacco use. Now, older adults and other Medicare beneficiaries can get the help they need to successfully overcome tobacco dependence."

Of the 46 million Americans who smoke, about 4.5 million are Medicare beneficiaries over age 65, and another million receive Medicare benefits because of a disability, according to HHS. Previously, Medicare only covered smoking cessation counseling if a recipient had already been diagnosed with a tobacco-related disease or showed symptoms of such a disease.

All Medicare beneficiaries already have access to smoking cessation prescription medication through Medicare's prescription drug program, Part D. Under the new coverage, which applies to Medicare Part A and Part B, any Medicare beneficiary who smokes will be able to receive counseling from a "qualified physician or other Medicare-recognized practitioner" who can help them quit smoking. The benefit will cover up to two separate tobacco cessation attempts per year -- and each stint in stop-smoking counseling can include up to four sessions.

"Giving older Americans and persons with disabilities who rely on Medicare the coverage they need for counseling treatments that can aid them in quitting will have a positive impact on their health and quality of life," said CMS Administrator Don Berwick, MD, in a prepared statement. "As a result, all Medicare beneficiaries now have more help to avoid the painful, and often deadly, consequences of tobacco use."

HHS will issue guidance in the next few months on a Medicaid provision in the ACA that requires states to help pregnant women quit smoking.

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COPD World News    Week of August 29, 2010                                 

New test may help detect lung cancer early

De Soto, Kansas - A new blood test, called Early CDT-Lung, provided by OncImmune, aids in the early detection of lung cancer and has the potential to replace the need for invasive diagnostic procedures.

This is an important new option, because occasionally, nodules develop in lungs, and it needs to be determined whether or not they are cancerous. Although the majority of the nodules people develop are non-cancerous, and the list of causes of those nodules long,  those with COPD can be at a much greater risk of developing lung cancer than people without COPD.

Standard PET and CAT scans might initially indicate nodules, but they might not be able to accurately determine the nature of a nodule.  Ordinarily, the next step is usually an invasive procedure such as a needle biopsy or perhaps a bronchoscopy.  Needle biopsies, however, are often risky or contraindicated for those with damaged lungs.  When needle biopsies are considered too problematic, a "wait and see" attitude is adapted to see what happens to the nodules over time to determine whether or not they behave or grow like cancers.

This new simple blood test can assist in assessing the risk of the nodule being cancerous. The CDT-Lung test looks for "markers" to identify cancer.  These "markers" indicate the presence of specific molecules, called antigens. The antigens they are looking for are produced by tumors, suggesting, therefore, that cancer is present.

The manufacturer's web site, explains the accuracy and proper use of this test. It has limitations. For example, it can't be used on people with a history of cancer.

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COPD World News    Week of August 22, 2010                                 

U.S. Clears MERCK Lung Drug Dulera

Silver Spring, MD - Merck & Co Inc's new two-in-one respiratory drug Dulera has been approved by the U.S. Food and Drug Administration, the U.S. company said confirming an earlier Reuters report. But Britain's *SkyePharma Plc (SKP.L) said it was no longer hopeful of a U.S. green light for its rival combination treatment Flutiform.

The new product combines the dual action of an inhaled corticosteroid and a long-acting beta agonist (LABA) to improve lung function in asthma sufferers. That makes Dulera a rival for GlaxoSmithKline Plc's (GSK.L) market-leading Advair and AstraZeneca Plc's (AZN.L) Symbicort, both of which act in a similar way.

Recently the FDA has taken a critical look at LABA drugs, drawing up new warnings earlier this month for the inhaled treatments. Some analysts said the issues over LABA safety may have delayed the FDA's decision on Dulera, which had initially been expected by April.  In the end, however, the agency gave approval for the medicine and disclosed the move in an update on its website before Merck issued a press release.

Merck said it expected Dulera to be available in retail pharmacies across the United States by the end of July 2010. The drug is also being developed as a treatment for COPD. SkyePharma, meanwhile, saw its stock end 18 percent lower after announcing that the FDA had set tougher than expected demands for approving Flutiform, which could prove insurmountable.  "The company is working with its advisors to review all of the options available to it with a view to determining whether there is a viable way forward for Flutiform in the United States," it said.

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COPD World News    Week of August 15, 2010                                 

No Benefit Seen for Lung Disease Drug

Copenhagen, Denmark - Intravenous augmentation therapy for people with the inherited disorder alpha-1 antitrypsin deficiency is costly, risky, and has no clinical benefit, according to a systematic review. 

 Based on the data, culled from  two randomized placebo-controlled trials, intravenous augmentation with the missing substance "cannot be recommended," argued Peter Gotzsche, MD, and Helle Krogh Johansen, MD, both of the Nordic Cochrane Centre at Copenhagen's Rigshospitalet. The crucial question, they said online in the Cochrane Database of Systematic Reviews, is whether the therapy decreases the risk of death from the deficiency, which leads to shortness of breath, reduced ability to exercise, and wheezing and is especially hazardous in smokers. However, neither of the two published studies reported whether augmentation therapy affected mortality, they noted.

Alpha-1 antitrypsin deficiency is an inherited disorder that can cause either lung or liver disease; the genotype associated with the most severe cases affects about one in 1,600 to 5,000 people. The therapeutic approach is to supply the missing substance, a protease inhibitor, intravenously. But the infusion therapy is extremely costly, the researchers noted -- about $150,000 a year per patient in the U.S. and has well-known risks, including dyspnea, deterioration of serious heart failure, and serious allergic reactions.

"The effects (of treatment) appear contradictory and of uncertain clinical significance," they wrote. But from a clinical point of view, there's no evidence of benefit for what is an expensive therapy, so it cannot be recommended. Any future studies should not use surrogate markers of clinical efficacy, but should be large enough to see if the therapy has an effect on mortality, the reviewers added.

Both the American Thoracic Society and European Respiratory Society have guidelines that promote alpha-1 antitrypsin replacement, the reviewers noted. "Both societies recommend augmentation therapy for patients with breathing problems related to alpha-1 antitrypsin deficiency. In our opinion, these recommendations are not reasonable," they said

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COPD World News    Week of August 8, 2010                                 

Patient survival varies significantly after lung transplantation

Rochester, MN - The volume of procedures done by a transplant center explained only 15% of the variation in patient survival among the nation's lung transplantation centers, according to a major study.

An analysis of more than 15,000 lung transplants found that five-year survival ranged from 30% to 61.1% among the more than 60 U.S. centers performing lung transplants that were included in the study.  While higher procedure volume had a significant association with patient survival after lung transplant, there were also significant survival variations.  "This study suggests that true variability exists in the quality of care provided across lung transplantation centers," Gabriel Thabut, MD, PhD, of the Mayo Clinic in Rochester, Minn., and coauthors wrote in conclusion.

"There is a great need to explore practices at high-performing centers with the goal of exporting beneficial practices to lower-performing centers.  If such efforts do not equalize outcomes for lung transplant recipients, consideration might be given to further regionalizing the lung transplantation system in the United States."

Reasons for the variability in outcome have yet to be determined, but "disentangling these multiple potential explanations" could identify ways to improve care and the lung allocation process. Toward that end, Thabut and coauthors analyzed data from the United Network for Organ Sharing registry and identified 15,642 lung transplant procedures performed from 1987 to 2009 at 61 U.S. centers still active as of 2008.  Overall survival at one month, one year, three years, and five years was 93.4%, 79.7%, 63%, and 49.5%, respectively.

Characteristics of donors, recipients, and surgical techniques varied markedly across the 61 centers. After adjusting for center volume, the authors found that significant variability persisted, which they could not trace to specific factors. However, they found some clues. For example, center performance was substantially more heterogeneous during the first year after transplantation than later on, suggesting variability in centers' peri-operative and early post-operative practices.

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COPD World News    Week of August 1, 2010                                 

Wood Smoke Risky in COPD

Albuquerque, N.M. - Exposure to wood smoke may increase the risk of chronic obstructive pulmonary disease,particularly among current smokers, researchers have found.

Breathing in wood smoke, either through home heating, cooking, or ambient outdoor pollution, was associated with a two-fold increased risk of airflow obstruction, according to Yohannes Tesfaigzi, PhD, of Lovelace Respiratory Research Institute in Albuquerque, N.M., and colleagues. They reported their findings in the American Journal of Respiratory and Critical Care Medicine.

"Because exposure to wood smoke appears to increase the risk of reducing lung function, cigarette smokers should try to avoid heating their homes or cooking with wood stoves and try to avoid environments where wood smoke is likely, for example, neighborhoods where wood smoke is common," Tesfaigzi said in a statement.  Wood smoke-associated chronic obstructive pulmonary disease (COPD) is common among women in developing countries, but hasn't been adequately described in developed countries, the researchers said.  So to determine whether wood smoke exposure was a risk factor for COPD among smokers in the U.S., the researchers conducted a cross-sectional study of 1,827 patients from the Lovelace Smokers' Cohort, which is predominantly female and maintains records of wood smoke exposure.  About 28% of the cohort reported such exposure.

The researchers found that breathing wood smoke was independently associated with greater odds of respiratory disease, particularly among current smokers, non-Hispanic whites, and men. Self-reported exposure was independently associated with a significant risk of low percent predicted forced expiratory volume. It was also associated with a higher prevalence of airflow obstruction and chronic bronchitis. The associations were significantly stronger among current cigarette smokers, non-Hispanic whites, and men, the researchers said.

"Future studies may show that it would be appropriate to screen patients for lung cancer if these exposures to wood smoke were present for prolonged periods. "The study was limited because it may not be generalizable, the authors wrote.  Still, the researchers called for additional studies on associations between wood smoke and COPD in cigarette smokers - "with particular emphasis on understanding the characteristics and dose-response relationship of wood smoke exposure."

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COPD World News    Week of July 25, 2010                                 

Ancestry May Affect Lung Function Tests

San Francisco, CA - The lung function tests used to diagnose conditions like asthma may need to be adjusted to account for differences in patients' genetic ancestry, a new study suggests. Now, physicians adjust the test results to account for factors like age, sex, race and weight, but not for mixed ancestry.

The study, published in the New England Journal of Medicine, indicates more adjustments may be necessary because many people have mixed ancestry, which influences the test results. "People throughout the world have a richer genetic heritage than can be captured by our current definitions of race," said study senior author Dr. Esteban G. Burchard in a journal news release.

"When we force patients into an individual box, such as 'African-American' or 'Caucasian,' we're missing a lot of genetic information," added Burchard, director of the University of California, San Francisco's Center for Genes, Environment and Health. In the study, which looked at data from more than 3,000 patients, the researchers found that genetic ancestry significantly affects performance on the lung function tests.

The breathing tests can detect signs of illness like asthma and chronic obstructive pulmonary disease.
Test results can also help doctors make decisions about disability claims and eligibility for lung transplants. "Taking genetic ancestry into account could result in more appropriate treatment for patients," said study lead author Dr. Rajesh Kumar, an associate professor at Northwestern University Feinberg School of Medicine, in the release.  In an interview, Mayo Clinic pulmonologist Dr. Paul D. Scanlon said the study findings offer "a step forward in our understanding."

Blacks generally score lower on the tests than whites, added Scanlon, who wrote a commentary accompanying the new study. If test results aren't adjusted to account for this fact, patients may be wrongly diagnosed with lung disease because their test results appear too low. Right now, the tests are a "very crude tool" because the benchmarks aren't designed to account for someone of mixed race like President Obama, he said.

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COPD World News     Week of July 18, 2010

Diabetes Seems to Up Risks for Lung Disease Patients

New South Wales, NZ - A new study reports that longer hospital stays and more deaths heve been noted in those with COPD plus high blood sugar.

People with diabetes who are hospitalized for sudden worsening of symptoms of chronic obstructive pulmonary disease have longer hospital stays and are more likely to die than COPD patients without diabetes, a new study has found. This might be because impairment of their immune response due to high blood sugar may result in more severe infections, explained the researchers at Liverpool Hospital in Australia.

The investigators reviewed the records of COPD patients admitted with a sudden worsening of symptoms (acute exacerbations) during 2007. The average length of stay for patients with diabetes was 7.8 days, which was 10.3 percent longer than the average stay of 6.5 days for patients without diabetes.  Among hospitalized patients, the death rate for COPD patients with diabetes was 8 percent, compared with 4 percent for those without diabetes, according to the report published in the June issue of the journal Respirology.

"Taken together with other studies, our study shows that diabetes was an adverse prognostic factor in COPD patients. We believe that better control of diabetes in patients with COPD could improve outcomes; in particular, reducing length of hospital stays and risk of death," study leader Dr. Ali Parappil, of the Liverpool Hospital's respiratory medicine department, said in a news release from the journal's publisher.

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COPD World News     Week of July 11, 2010

Plain packs for cigarettes turn off teens

Auckland , NZ - Wiping virtually all branding off cigarette and tobacco packets could prove crucial in turning teenagers off smoking, a New Zealand study indicates.  Australia is the first country to announce a plan to force tobacco into plain packaging with large pictorial health warnings - a move the industry says it will fight.

From 2012, the only remnant of branding would be the name of the product, in uniform print. Gone would be the colours and attractive pictures. "I think it would be hugely powerful for young people," Auckland University researcher Judith McCool said last night. "The pack is the last bastion of tobacco industry promotion.

"Dr McCool co-supervised master's degree research by Lisa Webb in which 80 students aged 14 or 15 from six Auckland schools were interviewed about their attitudes to smoking, smokers, tobacco packaging and plain packets. The Heart Foundation-funded study found the teenagers considered the plain packets they were shown to be dull, but said they enhanced the impact of the graphic health warnings. "These perceptions were transferred to the act of cigarette smoking as an unattractive or uncool behaviour," the researchers said. The teenagers thought plain packaging would remove the "purpose" of smoking. It then became simply a "bad habit" rather than a cool and rebellious behaviour".

Many submitters to the Maori affairs select committee's tobacco inquiry have urged the MPs to recommend the Government impose plain packaging on the industry among a range of new tobacco control policies. Otago University marketing expert Professor Janet Hoek said plain packaging "would be a very powerful measure to decrease the attractiveness of smoking."

"When you ask young smokers, a lot say they thought smoking was cool. A lot also regret it when they become addicted. Ninety per cent of adult smokers regret it."

The Auckland study found that although the present graphic warnings - some of which show body parts diseased from smoking - were designed to prompt adult smokers to quit, they also led teenagers to view smokers as undesirable, prompting descriptions like "addicted", "lacking in common sense" and "social outcasts".  But, the teenagers were confused by the health messages appearing on brightly coloured packets alongside brand imagery, and the researchers said this blunted the effect of the warnings.

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COPD World News     Week of July 4, 2010

Pulmonary rehabilitation effective for both obese and slim COPD patients

New Orleans, LA - Obese patients with chronic obstructive pulmonary disease stand to gain as much from pulmonary rehabilitation as their slimmer counterparts, even though as a group they have a lower exercise capacity, according to new research from the University Hospitals of Leicester in the UK.

"Like the healthy population, the prevalence of obesity is increasing in those with COPD," said Neil Greening, M.B.B.S, M.R.C.P., who led the study. "There is evidence that obesity may lower exercise capacity but at the same time appears to confer a survival advantage, which is known as the obesity paradox. Pulmonary rehabilitation is effective in improving exercise capacity and health status in COPD but it is unclear whether these benefits accrue in patients with extreme obesity. We wanted to compare the outcomes of a pulmonary rehabilitation program in patients with obesity of varying severity and normal weight subjects."

The results of their study was reported at the ATS 2010 International Conference in New Orleans.  To compare the effects of pulmonary rehabilitation between obese and non-obese patients, Dr. Greening and colleagues recruited patients with clinical and spirometric COPD and classified them according to their level of obesity, from normal weight (BMI 21-25kg/m2) to extreme obesity (BMI >40 kg/m2). The patients underwent pulmonary rehabilitation at a single center in the UK.

The improvements in their exercise performance and endurance, as well as their health status (chronic respiratory questionnaire) and baseline characteristics were assessed. "We found that obese people with COPD are more disabled in terms of exercise capacity, despite having less severe airflow obstruction (the measure used to quantify severity of COPD). However, they do just as well with rehab including those with extreme obesity," said Dr. Greening. "There is no difference between obesity subgroups in the proportion of patients achieving a clinically significant improvement in the incremental shuttle walk test."

This is the first study to look at PR in extreme obesity. While the researchers expected to find that some improvement would be seen after the pulmonary rehabilitation program, they were surprised to see no difference in training effects between normal weight and extremely obese patients. "Patients with COPD, irrespective of body mass, improve following a pulmonary rehabilitation program. Therefore extremely obese patients with COPD should still be considered for enrolment," said Dr. Greening, adding that although there are no weight limits for pulmonary rehabilitation programs, there is likely some discrimination by medical staff who may emphasize weight loss over exercise.

"We are planning a study to look at the underlying mechanisms of skeletal muscle dysfunction and obesity in COPD," said Dr. Greening. "Rather than a larger multi-centre study looking at epidemiology, we are trying to understand why obesity affects patients with COPD in the way it does.

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