Archive - COPD World News     Week of December 24, 2006

The Respiratory Year in Review

PHILADELPHIA -- Asthma mortality rates are declining worldwide, largely due to increased use of inhaled corticosteroids to manage the disease. That was the conclusion of an international group of researchers, who presented data on world trends.

Despite the decline in mortality reported at the 2006 annual meeting of American College of Asthma, Allergy & Immunology, asthma still accounts for one of every 250 deaths worldwide, many of which could have been prevented with better medical care.

One element that may presage better care in poorer areas is the advent of generic corticosteroids. The FDA approved the first this year - a generic version of Flonase (fluticasone propionate) - and more are in the pipeline, a Chicago researcher said, noting the price difference for a one-month supply was substantial.

Corticosteroids remain the gold standard for treating asthma, despite options such as Intal (sodium cromoglycate), according to a review published by the Cochrane Collaboration. Intal, a non-steroidal inhaler, can be used, the review said, but the corticosteroids let adults and children breathe easier. The finding supported the consensus in the medical community.

On the other hand, two randomized trials this year showed that pre-emptive use of corticosteroids in childhood does not prevent the later development of asthma. In some kids, the drugs controlled persistent or severe wheezing - thought to be a precursor to later asthma - but researchers on both trials said there was no evidence they prevented the disease. And, given that the drugs are not risk-free, they cautioned that children under the age of two should be given corticosteroids carefully.

The antibiotic Ketek (telithromycin) improved recovery from an acute asthma attack by three days, reduced symptoms, and improved hospital-based lung function measurements, researchers in London said. However, the drug, a member of a new class of antibiotics, had no effect on peak expiratory flow.

Smoking and asthma don't go together - or at least they shouldn't. But when smokers with asthma quit, they get an immediate bang for the buck - an improvement in lung function by 15.2% within six weeks. In fact, even after a week off cigarettes, there was a noticeable improvement in lung function, according to researchers in Glasgow.

Chronic obstructive pulmonary disease (COPD) is the only disease in the top 10 that's on the rise, and it's not coming cheap. Healthcare costs associated with COPD are expected to top $800 billion over the next 20 years, reported investigators at the annual meeting of the American Thoracic Society. Although smoking rates are falling, the researchers said, associated pathology, such as COPD, takes years to develop and will continue to rise.

But even now, when costs are relatively low, patients with asthma and COPD get only half the care that they should, according to a national sample reported in the journal CHEST. Overall, study participants received only 55.2% of recommended care for COPD and asthma patients received 53.5% of recommended care.

Even standard COPD care can be improved, as researchers found when they investigated the combination of Flovent (fluticasone propionate) and Serevent (salmeterol) in a single formulation. The combination of the drugs - usually used alone --- increased survival, quality of life, and lung function. Compared with placebo, the combination resulted in a 17.5% relative risk reduction in all-cause mortality over three years.

And finally, British researchers have found that middle-age smokers with heavily wrinkled faces are five times more likely to develop COPD than smooth-faced smokers. Exactly why remains unclear, although the researchers think both wrinkles and COPD may be a function of some underlying susceptibility, triggered by tobacco.

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COPD World News     Week of December 17, 2006

Rhinoviruses Fatal to Lung Transplant Recipients

GENEVA, Switzerland,  -- A common cold virus can be deadly for lung-transplant recipients, reported researchers here. Two of 11 recipients infected with human rhinoviruses developed progressive respiratory and graft dysfunction leading to their deaths, reported Laurent Kaiser, M.D., of the University Hospital of Geneva, and colleagues.

The findings flout conventional wisdom holding that human rhinoviruses only infect the upper respiratory tract, the investigators wrote in the second December issue of the American Journal of Respiratory and Critical Care Medicine.  "The report by Dr. Kaiser and colleagues ends once and for all the argument that rhinovirus cannot infect the lower airways," wrote Marc B. Hershenson, M.D., of the University of Michigan in Ann Arbor, and Sebastian L. Johnston, M.D., Ph.D., of the National Heart and Lung Institute at Imperial College in London, in an accompanying editorial.

Dr. Kaiser and colleagues looked at the occurrence of chronic rhinovirus infection in 69 lung transplant recipients at two centers.

Their index case was a patient in whom rhinovirus was isolated repeatedly over a period of several weeks. The investigators and determined that the patient had a chronic infection with a single rhinovirus isolate. They then looked at an additional 68 patients for the incidence and effects of chronic rhinoviral infections in an ongoing prospective study.

All lung transplant recipients who underwent bronchoalveolar lavage for various diagnostic and therapeutic reasons were screened for the presence of 13 different respiratory viruses with reverse transcription-polymerase chain reaction, and for three atypical bacteria (Mycoplasma pneumoniae, Chlamydophila pneumoniae, and Legionella pneumophila).

The viruses included rhinovirus, influenza A and B, parainfluenza 1-3, respiratory syncytial virus A and B, enterovirus, human metapneumovirus, and coronaviruses OC43, 229E, and NL63.

The investigators followed patients over 19 months, using molecular analysis to screen for the 13 different respiratory viruses.

They found that three of the patients with lung graft dysfunction had rhinovirus identified by RT-PCR in both the upper and lower airways over 12 months. In two of the cases, rhinoviruses were repeatedly isolated in culture, and genetic sequence analysis confirmed that the infections were caused by persistent strains. In the index patient, the presence of rhinovirus was detected in the lower respiratory parenchyma by transbronchial biopsy.

Among all of the 69 lung transplant recipients, rhinoviral infections were documented in bronchoalveolar lavage specimens from 11 patients (including the index patient). Three presented with a persistent infection, and two of these patients died with graft dysfunction. The remaining eight patients had transient infections.

The authors concluded that lung transplant recipients should be monitored from signs of chronic rhinoviral infections.  "In lung transplant recipients with severe immunosuppression, clinical rhinovirus infection needs to be considered," said Dr. Kaiser. "This point might have substantial implications in terms of diagnostic procedures, clinical management, and anti-viral use, if available."

In their editorial, Dr. Hershenson and Dr. Johnston pointed to recent evidence suggesting that rhinoviruses may evoke inflammatory responses in lung cells independent of viral replication, although replication would be most likely need to induce a large response.

"However, until the present report, which includes positive bronchoalveolar cultures and lung immunochemistry, incontrovertible evidence of rhinoviral replication in the lung in the setting of spontaneous infection has been lacking," they wrote. "This report informs our understanding of the mechanisms underlying rhinovirus-induced exacerbations of asthma and COPD."

"These exciting new data raise the possibility that patients with asthma and other patients with chronic airway disease are unusually susceptible to rhinovirus infection leading to increased rates of exacerbation," they continued. "These results may also help explained the increased susceptibility of children to rhinovirus infections. Further studies on susceptibility to rhinovirus infection in the population are now required."

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COPD World News            Week of December 10, 2006

New drug to treat respiratory disorder

Ireland - A new treatment to tackle a major respiratory disease which claims 2,000 lives a year in the state, will be launched  December 6, 2006

Around 110,000 people in the State suffer with the respiratory condition Chronic Obstructive Pulmonary Disease which is an irreversible health problem mainly caused by smoking. Ireland has one of the highest death rates from COPD in Europe and it estimated it is responsible for 2,000 deaths in the Republic each year.

The drug, Erdotin, has been available for over 10 years in 31 other countries, but is the first treatment of its type to be launched in Ireland in 25 years.

The disease leads to the debilitating symptoms of breathlessness and coughing which grow progressively worse over time. Patients also experience up to three exacerbations or flare-ups of the disease each year where the severity of the cough and the breathlessness worsens.  Erdotin reduces the severity of the cough by lowering the amount of mucus produced by sufferers of COPD.

Dr Kevin Gruffydd-Jones, GP and Committee Member of the General Practice Airways Group (GPIAG), said: "Exacerbations have a major impact on the quality of life of patients and can be life-threatening, often requiring hospitalisation. Early and aggressive treatment is essential. Any new treatment that improves the resolution of exacerbations is to be welcomed."

The standard treatment for flare-ups of the disease involve steroids and bronchodilators to control breathlessness and antibiotics.  The producers of Erdotin, which, said it is intended as an add-on medicine which can be used alongside standard therapies for a 10-day period.

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Editors Note: The product is not available in Canada or the USA - Following is more info on the product and manufacturer - Edmond Pharma

Erdosteine is a NCE developed entirely by Edmond Pharma, from initial laboratory synthesis to international patenting and registration.  Erdosteine is used in the treatment of acute and chronic bronchitis based on unique mechanism of action:

- muco-modulatory activity
- antibacterial activity
- anti-inflammatory activity
- antioxidant activity

… which enables Erdosteine to affect many steps in the vicious circle that characterises the development of COPD.

Erdosteine is marketed in Europe, South America and Asia by leading pharmaceutical companies, with a significant market share. The manufacturing of its original API Erdosteine is the core activity of the Edmond Pharma chemical plant. The plant has been recently enlarged in order to satisfy the increase of the world-wide demand.

Cost of selling ban on smoking will burn a hole in healthcare budgets

London, England - The cost of advertising to prepare the public and businesses for the new anti-smoking laws will top £12 million between now and next July, making it one of the most expensive public health campaigns ever.

The ban on smoking in public places comes into force on 1 July, as first revealed in The Observer last month, and ministers intend to embark on a Hollywood-style shock TV campaign. But the costs may be questioned at a time when many hospital trusts are having to make difficult decisions about spending. It emerged yesterday that the biggest trust in England, Leeds Teaching Hospitals, is having to save nearly £50m over two years by cutting jobs and closing services.

Spending in other public health areas, such as the campaign to promote safer sex, is also likely to be hit. Some £50m had been earmarked over the next three years to warn 18-to-24-year-olds of the dangers of sexual infection, but that budget is likely to be greatly reduced. Spending on anti-drink messages totalled only £40,000 last year, to the dismay of doctors who called for much stronger warnings about the dangers of alcohol.

The £12m earmarked for anti-smoking messages, however, has been sanctioned by ministers, who are known to be concerned that much of the hospitality industry is still opposed to the 1 July ban, which will see all smoking banned in pubs, clubs, workplaces, private venues and any 'substantially enclosed public space'. Business leaders have warned that this last definition is vague and that they need a clearer idea of what will be allowed.

PR firm Fishburn Hedges and a digital agency, Profero, have joined an 'anti-smoking' campaign team that includes the advertising agency Golley Slater to win over doubters. An anti-smoking website will be set up to provide information on the ban. Its main purpose is to ensure that businesses, individuals and stakeholders are aware of the new legislation and how it may affect them.

The hard-hitting TV ads are directed by Barry Ackroyd, who worked on United 93, the film about the downed 9/11 flight, and will be streamed on the new website. The ads are filmed in a cafe and pub and show how other people's smoke can end up in the lungs of anyone sitting in the same room.

Fishburn Hedges has been briefed to target businesses and the pub and hospitality trade, which is known to be concerned about the system of fines for landlords found flouting the ban and also fears problems with noise and litter caused by people smoking outside premises.

The Observer understands that some £2m will be spent in Wales on a campaign between now and 2 April, when the ban comes into force there, and the rest of the £12m will be spent in England between now and next July.

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COPD World News            Week of December 3, 2006

New Smoking-Cessation Drug

The latest data available on the newest drug marketed to aid smoking cessation, varenicline, show that the drug is safe and effective, in both the short and long term for smokers trying to quit, according to the results of two phase 2 studies. The studies, by the US Varenicline Study Group in cooperation with researchers from the pharmaceutical company that developed and markets varenicline, Pfizer, are published in the August 14/28 issue of the Archives of Internal Medicine.[1,2]

Varenicline (varenicline tartrate) is a partial agonist that selectively and specifically targets the nicotinic alpha-4/beta-2 receptor and acts by simultaneously blocking these nicotine receptors and stimulating dopamine. Oral varenicline has an agonist effect on dopamine release that amounts to about 30% to 60% of that with nicotine, which would appear to be enough to block craving and withdrawal without producing dependence or creating a competitive antagonist effect on nicotine.

In addition to the phase 2 data, the results of phase 3 randomized clinical trials by the same team of researchers were published simultaneously in JAMA in July.[3-5] They showed that 12 weeks of treatment with varenicline was significantly more efficacious than placebo for smoking cessation at all time points and significantly more efficacious than bupropion at the end of treatment and at 24 weeks[3] and 52 weeks.[4] In smokers who had stopped smoking for 7 days at the end of varenicline treatment, a further 12 weeks of varenicline significantly reduced relapse compared with placebo for up to 1 year thereafter.[5] An accompanying editorial said that although the studies demonstrated the efficacy of varenicline, there were concerns about the adverse-effect profile of the drug, particularly nausea, which occurred in almost 30% of the participants.[6]

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COPD World News            Week of November 26, 2006

COPD A Crucial Women's Health Issue

TORONTO (CP) - Almost half a million Canadian women struggle with chronic obstructive pulmonary disease, yet screening for early detection of this often deadly condition is unacceptably low, says a report by the Canadian Lung Association.

Calling COPD a "crucial women's health issue,"  the report released Wednesday shows that more than 425,000 Canadian  women aged 35 and olderwere diagnosed last year with the breathing disease, which kills morethan 4,300 each year. "Canadians need to recognize that the face of COPD has truly changed and we will be seeing more and more women living with and dying from this disease," Dr. Anna Day, head of the Gender Asthma and COPD Program at Women's College Hospital in Toronto, said in a release.

COPD, which includes lung-destroying emphysema and chronic bronchial inflammation, can lead to severe shortness of breath. The disease affects almost five per cent of Canadian women and almost four per cent of men.

Although research suggests that occupational and environmental pollution may contribute to COPD, smoking is the primary cause. (Forty-five per cent of Canadians report having been smokers at one time, including 20 per cent who currently use tobacco.)

While mammography, pap smear and bone density testing have become standard practice in women's health care, the report says the amount of screening for COPD using spirometry - a simple breathing test - is "unacceptably low" and should become part of routine testing for those at risk. Yet in 2002, just one in five women who were potential candidates for COPD were sent for a spirometry test, the report says. "We need to keep up the pressure to raise awareness of this terrible disease and advocate for all people with COPD, especially women," said Nora Sobolov, president and CEO of the Lung Association. "We can't continue to be polite about COPD."

Research has shown that smoking seems to affect women's respiratory systems more than men's, noted Dr. Denis O'Donnell, a professor of medicine at Queen's University in Kingston, Ont. "Perhaps due to smaller lung capacity, airways and ventilatory muscle mass, women report worse symptoms for similar severity of COPD." And, because women tend to use a higher fraction of lung capacity, they often experience increased effort and shortness of breath in the presence of COPD, says the Lung Association, noting that for women, breathlessness is the No. 1 reason for restricting physical activity.

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Retinoids, derivatives of vitamin A, are being examined as a potential method for regenerating damaged lung tissue in patients with emphysema. In the “Feasibility of Retinoids for the Treatment of Emphysema” (FORTE) study, researchers from six institutions in the United States enrolled 148 subjects with moderate-to-severe chronic obstructive pulmonary disease (COPD) with a primary component of emphysema. Patients received all-trans retinoic acid (ATRA) at either a low or high dose, 13-cis retinoic acid (13-cRA), or placebo for 6 months followed by a 3-month crossover period.

At the end of 6 months, no treatment was associated with an overall improvement in pulmonary function, CT density mask score, or health-related quality of life (HRQL). However, time- and dose-dependent changes in diffusing capacity, CT density mask score, and HRQL were observed in patients that achieved the highest blood levels of ATRA.

These preliminary results do not support the clinical use of retinoids at this time, but warrant further development and investigation of this new approach. This study appears in the November issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.

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Flu Season Creeps in Slowly and Quietly

ATLANTA,  -- The seasonal flu season is here, but tell that to the viruses. The quixotic little pathogens haven't yet flexed their muscles in earnest, according to the CDC.

Still, one never knows with flu viruses, so the CDC has designated next week as National Influenza Vaccination Week to emphasize the importance of getting a flu shot. So far, CDC surveillance shows, only two states -- Alabama and North Carolina -- are reporting regional flu activity, while four others are reporting so-called local activity. The remaining states are reporting sporadic or no flu, according to the CDC's weekly flu report.

"What that map tells you is that it's early in the season," said Joseph Bresee, M.D., chief of the epidemiology and prevention branch of the influenza division of the CDC. But anything can happen over the next few months, he said. "The mantra is if you've seen one flu season, you've seen one flu season," Dr. Bresee said. Both in its timing and in where it occurs, "influenza is very variable."

A few pediatric cases of flu cropped up in the New Orleans area last month, but "we're not seeing a lot of activity in the adult world," said Sandy Kemmerly, M.D., an infectious diseases specialist with the Ochsner Medical Center there.  "In general, we have a later flu season than the rest of the country," Dr. Kemmerly said, but this year the southeast -- Florida, Louisiana, and Mississippi, as well as Alabama and North Carolina -- has an early lead, while the northeast states and the rest of the nation haven't seen much activity.

The west and south of North Carolina have seen some outbreaks, said Keith Kaye, M.D., of Duke. "There's a pretty steady flow of cases in certain parts of the state," he said. "We don't have hot activity in Durham, but we know that we will have soon."

The typical flu season peaks in January or February, he said, but it's possible -- and has happened -- for there to be a spike in cases in November, followed by a more normal peak later.   One hint that a November spike may happen in that many of flu strains that have been isolated so far are influenza B, the less common variant. "We might see a spike of B influenza now, and then I wouldn't be surprised to see the more typical A strains later in the winter," he said.

The key to keeping the flu season innocuous is vaccination, and this year there is no shortage of vaccine, Dr. Kemmerly said. "For the first time in many years, we have an adequate supply of vaccine," she said, although some practitioners may still be having trouble getting it.  In fact, according to the CDC, 83 million doses of vaccine had been manufactured and shipped by Nov. 10, and more than 100 million doses are expected to be available this flu season. On the other hand, without the sense of urgency that a shortage creates, Dr. Kemmerly said, the public may be feeling complacent. "We're not having people clamoring at our doors," she said. She and Dr. Kaye said the key goal for doctors and their institutions is to persuade as many people as possible to get their shots. "Keep poking that vaccine," Dr. Kemmerly said

The CDC is urging health-care professionals to target what it calls the high-risk groups -- children between the ages of six months and five years, those older than 65, pregnant women, and those with underlying health disorders that may make them vulnerable to the flu. The idea of the special flu shot week is to "raise the visibility of influenza vaccination so we do a better job of getting the vaccine into people who need it," the CDC's Dr. Bresee said. On the other hand, Dr. Kaye said, everybody else can also benefit, unless they're allergic to eggs or have previously had a hyper-sensitivity reaction to a flu vaccine. He added it's important for doctors to counter the "huge misconception" that the vaccine can cause the flu. While the key form of prophylaxis is vaccination, some people turn to Tamiflu (oseltamivir), which can be used to prevent or lessen the effect of an influenza infection.

The FDA last week warned that the drug has been associated with cases of abnormal behavior among children and required that a warning be placed on the drug's label.
Also, the drug's maker, Roche, sent out a Dear Doctor letter outlining the changes, which arose after more than 100 new cases of delirium, hallucinations, and other unusual psychiatric behaviors were reported in children treated with the drug, mostly in Japan, where it is widely used.

Between 2001 and 2005, Tamiflu was prescribed 24.5 million times in Japan, compared with just 6.5 million in the United States, according to the FDA.
The new warning is "not front-page news," Dr. Kemmerly said, if only because doctors know that Tamiflu chemical cousins -- Symmetrel (amantadine) and Flumadine (rimantadine) -- also have central nervous system effects. "It's not that huge of a surprise," she said. "I don't think that it will affect anyone's prescribing habits."

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New research shows that patients who are HIV positive may be at an increased risk for developing chronic obstructive pulmonary disease (COPD).

Researchers from Yale University School of Medicine investigated the prevalence of COPD among 1,014 HIV-positive and 713 HIV-negative men enrolled in the Veterans Aging Cohort 5 Site Study. Results showed that the prevalence of COPD was 10 percent in HIV-positive and 9 percent in HIV-negative patients, as reported by ICD-9 codes, and 15 percent and 12 percent respectively, as indicated by patient self-report. However, after adjusting for age, race/ethnicity, pack-years of smoking, and injection drug use and alcohol abuse, HIV infection was an independent risk factor for COPD, with HIV-infected patients 50 to 60 percent more likely to have COPD than HIV-negative subjects.

This study appears in the November issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.

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COPD World News            Week of November 19, 2006

Researchers check if lungs are self-healing

BETHESDA, Md., (UPI) -- Researchers from several U.S. universities found evidence that lungs of patients with chronic obstructive pulmonary disease attempt to repair themselves.

The researchers found an increased synthesis of elastin, a gene linked to elastic fiber growth, in moderately diseased tissue of COPD patients, the American Physiological Society said in a news release. Elastic fibers allow the lung to expand and contract while breathing.

The finding is important because it could lead to the development of a drug that stimulates genes to grow new alveoli, air sacs that assist in the exchange of oxygen and carbon dioxide between the lungs and the circulatory system, said the Bethesda, Md.-based organization.

In their preliminary study, the researchers examined diseased lungs removed from end-stage COPD patients who underwent lung transplants, the society said. COPD develops after exposure to toxins such as cigarette smoke resulting in inflammation to the small airways and the destruction of elastic fibers within alveoli.

The team used magnetic resonance imaging to distinguish between moderately and severely affected areas of the lungs, the physiological society said. It found that new elastin synthesis had begun in moderately diseased regions.

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COPD World News            Week of November 12, 2006

Cold and flu season can be deadly for people with COPD

Sore throat, muscle aches or a cough: for many of us, these are the uncomfortable but hardly life-threatening symptoms of the winter cold and flu season. For the 714,000 Canadians with Chronic Obstructive Pulmonary Disease (COPD), these seemingly minor infections can trigger dangerous flare-ups of COPD symptoms, creating shortness of breath so severe that it can require a lengthy hospital stay, cause permanent damage to the lungs, and lead to death.

COPD is a serious and disabling respiratory disease that causes the airways of the lungs to become obstructed or blocked, making it hard for the body to take in oxygen. Infections like colds and the flu can lead to flare-ups or a rapid worsening of COPD symptoms. This generally results in lengthy hospital stays and a drastic reduction of the amount of activity the person can do comfortably.

"With the cold and flu season upon us, it's vital for Canadians to know how devastating a cold or flu can be for the many people with COPD," says Mary Layton, founder of COPD Canada and a COPD patient. "COPD is a serious and disabling disease to live with, and catching a simple cold can cause COPD symptoms to spiral dangerously out of control."

People with COPD should do their best to avoid catching a cold or the flu. This is especially important for elderly people. Prevention methods include getting a flu shot, staying away from ill friends and family, taking medications as prescribed and contacting a doctor immediately when cold or flu symptoms appear. Cold weather is a major trigger for flare-ups - a loosely draped scarf placed over the nose and mouth will warm and humidify the air before it is breathed in.

"I make sure I get a flu shot every year and encourage all my friends and family to help protect me by doing the same, as well as by staying away if they're sick," says Layton. "I see my doctor regularly, take my medications as prescribed, and get checked out as soon as I think I may have a cold or the flu. Flare-ups and trips to the hospital are not only alarming, but I know they can worsen my COPD permanently."

Patients should have a plan for what to do if they experience a flare-up. COPD Canada suggests that all people living with COPD develop a written plan of action with their physician. If they experience a flare-up, the plan helps quickly determine the best response - a doctor's visit, an emergency room visit, or other action.

For more information on staying healthy with COPD during cold and flu season, contact:  COPD Canada at:

Smoking May Increase Risk of Cognitive Impairment After Coronary Bypass

CHICAGO, -- Smokers-current and past-are twice as likely to suffer cognitive impairment following coronary artery bypass graft surgery as never-smokers, a researcher reported here.

In a single-center study of bypass patients, those who had a positive smoking history had an odds ratio of 2.04 (95% confidence interval 1.11-3.74, P=0.022), said James P. Slater, M.D., of the Morristown (N.J.) Memorial Hospital/Gagnon Heart Hospital at the American Heart Association meeting here. A typical case, he said, was a 71-year-old woman who had stopped smoking 20 years before surgery. Three weeks after surgery, she told Dr. Slater that the operation "made me dumber."

As Dr. Slater related, the patient was an avid fan of the New York Times crossword puzzles. The easiest of these appears regularly in the Monday paper and the puzzles increase in difficulty throughout the week, with the Sunday puzzle considered the most difficult. Before surgery, the patient has worked the puzzles every day, but after surgery she said she couldn't solve puzzles beyond Thursday. Dr. Slater, who discussed his findings at a press conference, hypothesized that smoking may cause damage to the vasculature in the brain.

The study lumped all smoking history together "with no differentiation between current smokers and past smokers." The stress of surgery, "combined with old injury may explain the cognitive impairment," he said.

The 240 patients were a subset of patients enrolled in a trial of a cerebral oximetry monitoring device, he said. All patients had surgery using the cardiopulmonary bypass, he said, adding that this is "not an on-pump, off-pump issue." Cognitive testing was conducted before surgery, and again during the first three months following surgery.

A number of studies have suggested that cognitive impairment after bypass surgery is usually temporary, with patients returning to baseline cognitive scores by 12 months. Asked whether these patients had a similar improvement, Dr. Slater said that follow-up has not yet been done, "but I expect that these patients will also improve." But Dr. Slater added that early cognitive impairment is also "predictive of late impairment, so these patients may have a continued risk." Robert O. Bonow, M.D., a professor of cardiology at Northwestern Feinberg School of Medicine in Chicago, said that long-term data are needed to truly assess the smoking risk. "But it is pretty clear that this is more reason not to smoke," he said.

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Flu Shot Ups Relative Risk of Guillain-Barré

TORONTO,  -- A flu shot appears to increase the relative risk of Guillain-Barré syndrome by 45%, according to researchers here But because the occurrence of the syndrome is so rare, the increased relative risk does not appear to translate into increased hospital admissions, said David Juurlink, M.D., Ph.D., of Sunnybrook and Women's College Health Sciences Center.

While people getting a flu shot should be told of the increased risk, "the decision to recommend vaccination against influenza should primarily be guided by evidence of its benefit," Dr. Juurlink and colleagues concluded in the Nov. 13 issue of Archives of Internal Medicine.

The link between flu vaccination and Guillain-Barré has been a subject of controversy since 1976, when the U.S. National Influenza Immunization Program against so-called Swine Flu was halted early, partly because of reports of Guillain-Barré among recipients of the vaccine. Since then, some studies have suggested an adjusted relative risk increase of about 70%, while other studies have seen no association, the researchers noted.

Dr. Juurlink and colleagues took advantage of individual-level data in the province of Ontario to conduct two related studies -- a self-matched case series analysis of the temporal link between vaccination and Guillain-Barré, and a time-series look at Guillain-Barré hospital admissions before and after the start of a universal flu vaccination program.

The advantage of the self-matched case series approach, Dr. Juurlink and colleagues said, is that it allows patients to serve as their own controls, avoiding many confounding factors. In this study, the researcher identified 269 patients from April 1, 1993, through March 31, 2004 who were diagnosed with Guillain-Barré within 43 weeks of a vaccination in October or November.

The researchers assumed that a Guillain-Barré hospital admission within seven days of the vaccination was not linked to the shot, that admission during the next six weeks (dubbed the "risk interval") might be linked, and that admission after the risk interval (the "control interval") was not associated. Compared with the control interval, the relative incidence of hospitalization because of Guillain-Barré during the risk interval was 1.45 (with a 95% confidence interval from 1.05 to 1.99), which was statistically significant at P=0.02, Dr. Juurlink and colleagues found.

In 2000, the province of Ontario began a program of providing free flu vaccination to all residents older than six months, a program that produced a marked increase in the proportion of residents who were vaccinated. From June 1, 1991, through March 31, 2004, the researchers identified 2,173 incident hospital admissions because of Guillain-Barré -- about 170 new cases a year and approximately 14 cases per million person-years in the province.

The rate of admissions did not change after the introduction of the universal flu shot program, Dr. Juurlink and colleagues found. "Our results must be interpreted carefully," the researchers cautioned, because the increased relative risk corresponds to a very low absolute risk of Guillain-Barré. "Furthermore, the lack of association on a population health level is consistent with the prevalent impression that influenza vaccine is only one of many potential causes" of the syndrome, they said.

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COPD World News            Week of November 5, 2006

Cutting Drug Dose by Enhancing Nebulizers in COPD Seen Safe and Thrifty

SALT LAKE CITY,  Upgrading nebulizers to deliver less medicine less often saved staff time and overall costs for treating patients hospitalized with chronic obstructive pulmonary disease, researchers here reported.

The changes to a newer drug and a reduction in its dose did not compromise patients' health or safety, according to a poster presentation at CHEST 2006, the meeting of the American College of Chest Physicians.

First, the clinicians at Crouse Hospital in Syracuse, N.Y., replaced albuterol with Xopenex (levalbuterol) because patients were having breakthrough bouts of shortness of breath even when albuterol was delivered six times a day. Next, the clinicians and therapists dropped the individual dose of Xopenex from 3 mL, to 1.5 mL, and finally to 1 mL. They found that by using Xopenex at 1 mL every eight hours at the same frequency and switching to a more efficient nebulizer, they could reduce the amount of time it took to deliver each dose, the overall cost of medication and supplies, as well as hourly therapist costs.

The nebulizer change involved a switch from the standard small-volume nebulizer to the speedier AeroEclipse Breath Actuated Nebulizer (BAN), which permitted more efficient drug delivery. "When you work at a non-profit community hospital, you are always looking for ways of delivering good medicine for less cost," said Robert Pikarsky, BSRT, administrative director for respiratory services at Crouse Hospital. "We found that by using the faster AeroEclipse nebulizer we can deliver Xopenex more efficiently," he said.

Instead of delivering the standard 3 mL dose of Xopenex, respiratory therapists, under a hospital-arranged study protocol, poured the drug into 1 mL doses that were then delivered to patients in 1 mL treatments. As with the 3 mL dose, the 1 mL doses were given every eight hours.
However, it takes just 2.67 minutes to deliver the 1 mL dose compared with 8.33 minutes to deliver the 3 mL dose. The 5.66-minute saving per treatment translate into many hours when therapists and clinicians have to deliver more than 30,000 doses a year, Pikarsky said.
Doctors moved away from albuterol in favor of Xopenex, he said, because patients were having breakthrough bouts of shortness of breath even when albuterol was being delivered six times a day.

With albuterol, breakthroughs occurred 13.7 times for every 100 treatment days. With Xopenex given in any protocol, breakthroughs were cut by more than half. Delivered via the standard mask, given in the standard dose with the AeroEclipse device, or even given in the lower dose with the AeroEclipse device, breakthrough bouts occurred only 4.91 to 7.18 times in 100 treatment days, differences that were not statistically significant.

"The difference from my standpoint," said Stephen Alkins, M.D., a pulmonary specialist in Syracuse whose patients are at Crouse Hospital, "was that I wasn't getting those emergency calls at home that my patients needed additional treatment. This new nebulizer even with the lower dose appears to do the job," he added.

Pikarsky said that in the two-month trial of the system, the hospital respiratory therapists and nurses were able to save 99 hours of time, a labor savings of about $3,000.

On an annual basis, switching from the 3 mL treatment to the 1 mL treatment would save $54,693 in labor costs, although that advantage would be offset by an increase of $10,851 to use the more efficient nebulizer, leaving a yearly net savings of $43,842. The pharmacy costs did not change. "Basically that would save up to one job position, but practically that means that one person would be free to perform other duties at the hospital where staffing is always tight," Pikarsky said. He also noted that the study was performed using hospital staff and funds and was not paid for by the pharmaceutical industry or the manufacturer of the device.

"This was a two-month trial," cautioned Donald Tashkin, M.D, of the University of California, Los Angeles, who commented as he reviewed the poster presentation. "We need to see if in practice the efficiency demonstrated in the trial can be carried forward. We also have to be sure that the reduction in medicine does not affect outcomes."

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COPD World News            Week of October 29, 2006

Smoking-Cessation Efforts in the U.S. Stumble

ATLANTA -  Just as many adult Americans smoked cigarettes in 2005 as did in 2004, a troubling stalemate in the nation's efforts to reduce tobacco use, the CDC reported.  The agency said that in 2005 approximately 20.9% of U.S. adults were current cigarette smokers, the same percentage as in 2004. It cited "lagging progress" compared with the decline in the preceding eight years. 
The statistics mirror a lack of decline in smoking among adolescents since 2002, according to the report in the Oct. 27 issue of Morbidity and Mortality Weekly Report.

The lack of a decrease in cigarette smoking among adults is a setback in efforts to meet the Healthy People 2010 objectives in all the states and U.S. territories, according to the CDC. Those 2010 goals include reducing cigarette smoking to 12%, cigar smoking to 1.2%, smokeless tobacco use to 0.4%, and increasing cessation attempts among adults to 75%.

In addition to the 45.1 million (20.9%) current smokers in 2005, an estimated 2.2% of U.S. adults were current cigar smokers, 2.3% used smokeless tobacco, and 42.5% of current cigarette smokers had stopped smoking for at least one day in the preceding 12 months because they were trying to quit.

The responses to the 2005 National Health Interview Survey, the source of these data, came from interviews given to a nationally representative sample of 31,428 persons from the non-institutionalized U.S. civilian population age 18 or older. The survey also included responses to the other forms of smoking.

The 2005 findings included the following:
Of the estimated 45.1 million (20.9%) smokers, 80.8% smoked every day, and 19.2% smoked some days. Current cigarette smoking was higher among men (23.9%) than among women (18.1%). Adults, ages 18 to 24 years (24.4%) and 25 to 44 years (24.1%) had the highest smoking rates. Among racial/ethnic groups, American Indians and Alaska natives had the highest prevalence (32%), while Asians (13.3%) and Hispanics (16.2%) had the lowest rates.

Prevalence remained high among adults who had earned a General Education Development diploma (43.2%) and those with nine to 11 years of education. However, prevalence generally decreased with increasing education.  The prevalence of current smoking was higher among those adults living below the poverty level (29.9%) than among those at or above the poverty level (20.6%).  Certain populations had already surpassed the 2010 target of 12%. These included Hispanic and Asian women, women and men with undergraduate or graduate degrees, and men or women ages 65 years or older.

Among current cigarette smokers, an estimated 42.5% had stopped smoking for at least one day during the preceding 12 months because they were trying to quit. Among these estimated 91.8 million persons who had smoked at least 100 cigarettes during their lifetime, 50.8% did not currently smoke. The prevalence of current cigar smoking was 2.2% and the current use of smokeless tobacco was 2.3%, both higher among men than women.

Discussing factors that might have affected the 2004-2005 findings, the MMWR editors cited smaller annual increases in the retail price of cigarettes and a 26.5% reduction in funding for comprehensive state programs in tobacco control and prevention during the year.  Additionally, they said, tobacco-industry advertising and promotional expenditures, primarily focused on price-discounting strategies, more than doubled from $6.7 billion in 1998 to $15.1 billion in 2003.

Effective interventions have been identified for decreasing smoking initiation and increasing cessation, but they have not been implemented adequately, the CDC authors wrote.  Recommended interventions included increases in the unit price for tobacco, mass media campaigns combined with other interventions, and community mobilization campaigns to restrict access of minors to tobacco products, along with stronger retail sales laws and retailer education.

The study authors also advised reducing out-of-pocket costs to smokers for effective cessation therapies and the use of multicomponent interventions (patient education, counseling, or nicotine replacement therapies) that also include phone quit-lines and health-care provider reminder systems.

The findings in the report are subject to certain study limitations, the authors noted, including the use of self-reports for smoking, and the fact that the questionnaire was administered in English and Spanish only, which may have resulted in imprecise estimates for certain racial and ethnic populations. Finally, the small samples for certain populations (Alaska Natives and American Indians) produced single-year estimates with large confidence intervals. 

"The lack of progress in reducing tobacco use and increasing cessation attempts among adults underscores the need for increasing measures to establish sustained, comprehensive evidence-based tobacco control programs that address both initiation and cessation," authors wrote.  "Full implementation of these programs at CDC-recommended levels of funding would accelerate progress toward meeting the 2010 objectives and decreasing the health burden and economic impact of tobacco-related disease," the report concluded.

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GERD Symptoms Increase the Rate of COPD Exacerbations 

The rate of chronic obstructive pulmonary disease (COPD) exacerbations in patients with gastroesophageal reflux (GERD) symptoms is twice as high as in those without GERD symptoms, according to the results of a cross-sectional survey published in the October issue of Chest.

"Microaspiration of gastric contents and/or vagal irritation from GER [gastroesophageal reflux] may constitute airway irritants and thus represent a potential pathogenic mechanism for acute exacerbations of COPD," write Ivan E. Rascon-Aguilar, MD, from the University of Florida Health Science Center in Jacksonville, and colleagues. "The impact of gastroesophageal reflux disease (GERD) on exacerbations of COPD has never been evaluated. The aims of this investigation were to determine the prevalence of gastroesophageal reflux (GER) symptoms in COPD patients and the effect of GER on the rate of exacerbations of COPD per year."

For this questionnaire-based, cross-sectional survey, 86 patients with an established diagnosis of COPD were recruited from outpatient pulmonary clinics and interviewed in person or by telephone. Patients with respiratory disorders other than COPD, known esophageal disease, active peptic ulcer disease, Zollinger-Ellison syndrome, mastocytosis, scleroderma, and current alcohol abuse were excluded. Clinically significant reflux was defined as weekly episodes of heartburn and/or acid regurgitation. Other endpoints were frequency and type of COPD exacerbations.

Mean patient age was 67.5 years, 55% were men, and 37% reported GERD symptoms. The mean forced expiratory volume in 1 second (FEV1) percentage of predicted was similar in patients with or without GERD, but the rate of COPD exacerbations was twice as high in patients with GERD symptoms as in those without GERD symptoms (3.2 per year vs 1.6 per year; P = .02).

"The presence of GER symptoms appears to be associated with increased exacerbations of COPD," the authors write. "We also conclude that COPD patients with weekly GER symptoms and COPD are twice as likely to be hospitalized, have an ED [emergency department] visit, or unscheduled clinic visit when compared with COPD patients with less frequent GER symptoms."

Study limitations include inability to conclude whether the use of antireflux therapy was protective against exacerbations, inability to establish a cause-and-effect association from the cross-sectional data, possible recall bias, and limited sample size.  "The findings of this study suggest a possible modifiable risk factor in exacerbations of COPD," the authors conclude. "The implications of this link may not only be of clinical significance but also of economic significance, considering the cost of a single hospitalization, and taking into account that in the year 2000 there were 726,000 hospitalizations, 1.5 million ED visits, and 8 million office visits all due to exacerbations of COPD."

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COPD World News            Week of October 22, 2006

Statins May Retard Lung Deterioration in Smokers

SALT LAKE CITY, -- Smokers and ex-smokers treated with statins for cardiovascular disease had less of a decline in lung function than comparable non-statin patients, researchers reported here.

In a retrospective review of 303 ex-smokers and 182 current smokers, about half in each group taking statins, smokers and ex-smokers not taking statins had an average decline in forced expiratory volume in one second (FEV1) of 88 ml/year of air, found Walid G. Younis, M.D., of the University of Oklahoma in Oklahoma City. But patients who were taking statins had an average decline of only 12 ml/year, he said at CHEST 2006, the meeting of the American College of Chest Physicians.

After age 30, lung function normally declines at the rate of 30 ml/year on the FEV1 test, he noted. The difference between 12 ml and 30 ml was not significant, whereas the difference between 12 ml and 88 ml was highly significant (P<0.0001).
This beneficial effect of statin use remained significant irrespective of whether the patient had obstructive, or restrictive disease, or whether the patient continued or stopped smoking.

Dr. Younis characterized the finding as compelling because smoking cessation has been the only therapy shown to slow smoking-induced lung damage. "Our study is the first to show that statins may decrease the decline in lung function in smokers and former smokers, and, therefore, prevent millions from developing debilitating diseases that could eventually lead to death," said Dr. Younis. Therefore, further study is needed to corroborate this finding.

Most patients in the study were taking Zocor (simvastatin) for prevention of coronary artery disease. All but 67 of the patients included in the study had some type of lung disease. The average patient was about 66 years of age and had been taking statins for about 2.7 years.

The data emerged from a review of medical records of 485 patients at the Veterans Affairs Medical Center in Oklahoma City in 2005. All patients had had at least two pulmonary function tests performed at least six months apart. Patients diagnosed with asthma as well as those who had never smoked were excluded from the study.

Dr. Younis and colleagues also compared rates of admission to the emergency department. They found that patients taking statins who had obstructive lung disease (as diagnosed through lung performance tests) had a 35% reduced risk of required emergency department visits or subsequent hospitalization (P=0.02).

The reasons why statins may reduce lung injury are not known. However, Diane Stover, M.D., of Memorial Sloan Kettering Cancer Center in New York, commented, "We have found that chronic obstructive pulmonary disease involves inflammatory processes. It is possible that statins, which have anti-inflammatory properties, have an impact on these processes in the lungs as well as elsewhere in the body."

Dr. Younis cautioned that taking statins doesn't mean that patients can continue to smoke with impunity. "We saw no difference in lung cancer or mortality between the patients who smoked and were on statins or not on statins," he said.

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Sepracor Inc. a research-based pharmaceutical company, reported that the FDA has approved its New Drug Application for BROVANA Inhalation Solution 15 micrograms as a long-term, twice-daily, maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema. BROVANA is for use by nebulization only.

The Massachusetts based company said that BROVANA is the first long-acting beta2-agonist to be approved as an inhalation solution for use with a nebulizer, a machine
that converts liquid medication into a fine mist that is inhaled through a mouthpiece or mask. Sepracor noted that it would its sales force would carry out promotional activities in hospitals and to primary care physicians and pulmonologists who treat COPD patients with a focus on introducing the drug in the second quarter of 2007.

Sepracor completed more than 100 preclinical and 16 clinical studies of BROVANA. In the Phase III studies, patients treated with BROVANA showed considerable improvement in FEV1, a measure of lung function, than placebo. BROVANA 15 mcg twice daily significantly improved bronchodilation compared to placebo over the 12 hours after dosing.


Acid reflux atop COPD is associated with twice as many COPD exacerbations per year compared with patients without acid reflux. Reflux patients also appeared to have more severe COPD exacerbations, reported Kenneth J. Vega, M.D., of the University of Florida here, and colleagues, in the October issue of Chest.

An acute COPD exacerbation was defined as worsening difficulty breathing, increasing volume of sputum, or purulent sputum in conjunction with physician-initiated use of corticosteroids or antibiotics, hospitalization, or emergency department visit during the previous year.
Participants in the study with gastroesophageal reflux disease symptoms had 3.2 exacerbations per year compared with 1.6 per year among those without reflux symptoms. This was despite similar lung capacity between groups and use of anti-reflux medications by most GERD patients. According to previous studies, COPD patients have an average of 2.4 to three acute exacerbations per year.

Compared with COPD patients without GERD, exacerbations in patients with weekly reflux symptoms required significantly more:

 a.. Hospitalizations per year
 b.. Emergency room visits per year
 c.. Unscheduled clinic visits per year
 d.. Antibiotic use per year

They (researchers) said the study supports GERD as a possible modifiable risk factor in exacerbations of COPD.

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At least one in four smokers will develop COPD, finds a long-term study published in Thorax. For the study, 8,000 residents of Copenhagen were monitored for 25 years. More than 5,000 people were smokers and more than 1,200 were former smokers.

On the study's onset, all participants had no respiratory problems, and their lung function was checked regularly throughout the study period. Lungs of almost all the male nonsmokers continued to work well, as did the lungs of six of 10 of smokers. Similarly, nine out of 10 female nonsmokers still had healthy lungs at the end of the monitoring period, but this was only true of seven out of 10 of the smokers.

Persistent smokers were six times more likely to develop COPD than nonsmokers. One in four of them developed stage 2 or higher COPD. Of the 2,900 deaths recorded over the 25 years, 109 were directly attributable to COPD. Virtually all the deaths were in people who had been active smokers at the start of the study. Only two nonsmokers died of the disease. The researchers concluded this study points to COPD's risk being higher than previously thought.

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COPD World News            Week of October 15, 2006

Scots bar staff health 'improved' after smoking ban

The health of Scotland's bar staff has improved dramatically since the introduction of a smoking ban, a medical study has found.

Researchers at Dundee University found significant health improvements in the first two months after the March ban. The results have led to calls for the UK Government to speed the introduction of a similar ban south of the border. But smokers' rights group Forest said the link between passive smoking and ill health had not been proven.

The team from the university's asthma and allergy research group began testing bar workers in and around Dundee in February, a month before the ban came into force.

Using a series of indicators, they established symptoms attributable to passive smoking, measuring lung function and inflammation in the bloodstream.

Testing volunteers a month later and then again in May, the researchers were not only able to back up anecdotal evidence of a general feeling of wellbeing but scientifically establish significant improvements in people's health.

Daniel Menzies, from the research group, said that in the two months following the introduction of the ban, the number who showed smoke-related symptoms fell from more than 80% to fewer than half.

The team also recorded reductions in levels of nicotine in the bloodstream and breathing tests showed improvement in lung function of as much as 10%.

Shelagh Matthews, an asthmatic who works as the bar manager at Dundee city centre pub The Phoenix, said she had used her inhaler less frequently since the ban. "The smoke was something that definitely did have an effect, though perhaps we didn't realise how much of an effect until it was gone," she said. "I do actually feel the difference."

Neil Rafferty, from the Freedom Organisation for the Right to Enjoy Smoking Tobacco (Forest), questioned the medical basis for the research.

Mr Rafferty said it diverted attention from the issue of people's right to choose under a system of smoking and non-smoking venues.  He said: "Many people who work in pubs are smokers, many of whom like to have a cigarette during their shift and many of whom aren't really concerned about the issue of passive smoking. "The science on passive smoking is still very inconclusive, the anti-smoking lobby are still making exaggerated claims about passive smoking, meanwhile people are being denied choice."

Following the results of the study, which have been published in the Journal of the American Medical Association, the British Heart Foundation called on Prime Minister Tony Blair to name a precise date for the introduction of an English ban. Chief executive Peter Hollins said: "This study provides compelling evidence that making workplaces smoke free can have a significant and speedy impact on people's health."

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Blocker Helps Women Stop Smoking

CHICAGO, -- The opiate blocker Depade (naltrexone), when added to behavioral therapy and nicotine patches, can help women quit smoking, researchers here found. But men gained no benefit.

In an ongoing clinical trial, Depade plus other smoking-cessation tools increased the quit rate among women by nearly 50%, and reduced the typical weight gain during the first month after quitting, reported Andrea King, Ph.D., of the University of Chicago, and colleagues, in the October issue of Nicotine & Tobacco Research.

"Women have historically had less success than men in giving up cigarettes.  In this small study, naltrexone seems to have closed that gap" said Dr. King.

Depade has a long track record as an aid in controlling opiate addictions and in reducing relapse rates among alcoholics, but studies of the agent's ability to curb nicotine craving have been mixed. The drug may also work only in certain subgroups, the authors noted.

The research was supported by the National Institute on Alcohol Abuse and Alcoholism and the National Cancer Institute.

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COPD World News            Week of October 8, 2006

Smoking Ban Snuffs Heart Attack Hospital Admissions

TURIN, Italy  -- In the five months after a tough smoking ban was enacted, hospital admissions for acute myocardial infarction dropped by 11% in the Piedmont region in northern Italy.

Moreover, most of the reduction, as much as 90% of it, seemed attributable to a decline in passive smoking, Francesco Barone-Adesi, M.D., of the University of Turin, and colleagues, reported online today in the European Heart Journal.

"We estimated that the observed reduction in active smoking after the introduction of the ban could account for a 0.7% decrease in admissions for acute MI during the study period, suggesting that most of the observed effect (11%) might be due to the reduction of passive smoking," they wrote. The Italian government banned smoking in all indoor public places beginning Jan. 10, 2005.

The investigators compared the rate of hospital admissions for October to December 2004 (just before the ban) with the admission rate from February to June 2005 (just after the ban). Both time periods were also compared with the corresponding time periods 12 months earlier and were checked again against acute MI admission rates for the February to June time period in 2001, 2002, and 2003, in order to determine whether a long-term trend was present.

When men and women of all ages were considered, there was no apparent change in the acute MI admission rate during the ban period, but when the data were analyzed by age, the relative risk for acute MI admission was 0.89 compared with the rate during the same period a year earlier (95% CI 0.81-0.98).

Moreover, the age specific analysis found that admission rates had dropped for both men and women younger than 60 but the greatest decrease was for women who had a 25% decline in the risk of admission for acute MI (RR=0.75, 95% CI 0.58-0.96). Notably, no decrease was seen before the ban (comparison of October-December 2004 with October-December 2003), they wrote. There was, however, no evidence of a decrease in admissions for people ages 60 or older. The authors said the relative risks among people younger than 60 were homogeneous before the ban, but they diverged after the ban (P=0.003; P=0.04 for men and P=0.01 for women), suggesting that the ban modified admission rates for acute myocardial infarction only among those younger than age.

The authors said the drop in admissions was similar to benefit reported by researchers who studied health effects of a smoking ban in Helena, Mont. During a six-month long smoking ban in that city, there was a decline in hospital admissions for acute MI.

Dr. Barone-Adesi said the smoking ban in Italy not only reduced exposure to passive smoke, but also changed the smoking habits of active smokers who needed to seek an outside smoking area in order to light up. Both factors, he said, probably contributed to the observed decline.

In an editorial Peter W. Radke, M.D., and Heribert Schunkert, M.D., of Universitätsklinikum Schleswig-Holstein in Lübeck, Germany, noted that the study is limited because it may be biased by confounding data such as seasonal variations and the inability to precisely measure the effect size. Moreover, Drs. Radke and Schunkert said the lack of an effect among older patients was puzzling. They also pointed out that "the size of the effect among active compared with passive smokers remains rather speculative and is not supported by hard data." Nonetheless, they said the findings have important public health implications because it "confirms and extends recent observations following regulatory changes" in the U.S.

Dr. Barone-Adesi and colleagues concluded that despite the study's limitations, "our findings suggest that smoking regulations may have important short-tem effects on health." The long-term impact on cardiovascular disease and cancer will "have to be evaluated in the years to come."

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Reduced Smoking Called Key to Male Drop in Cancer

ATLANTA, -- Smoking cessation accounts for about 40% of the decrease in cancer deaths seen among U.S. men since 1991, according to a report by American Cancer Society researchers. From 1991 to 2003, reductions in tobacco smoking have prevented at least 146,000 cancer deaths among men, reported epidemiologists Michael Thun, M.D., and Ahmedin Jemal, Ph.D., in the October issue of Tobacco Control.

The decrease in lung cancer and overall cancer mortality among men began approximately 30 years after the downturn in the smoking rate of U.S. men, the investigators pointed out. But no decrease in lung cancer mortality has yet occurred among U.S. women, who began regular smoking some 20 to 30 years after men and have been slower to give it up, the epidemiologists said.

From 1991, when the cancer death rate peaked, to 2003, the overall age-adjusted cancer death rate in the U.S. dropped by 16.1% in men and by 8.4% in women. During the same period, the lung-cancer death rate (a proxy for the total impact of cigarette smoking on all cancer mortality) decreased by 20% in men but increased by 9.6% in women, the researchers reported.

Overall, the researchers reported that on the basis of the absolute change in death rates, the decrease in lung cancer death rates in men accounted for 40% of the decrease in their overall cancer death rates.

In contrast, none of the 8.4% decrease in the all-cancer death rate for women was accounted for by lung cancer. In fact, lung-cancer deaths went in the opposite direction (9.6% increase) of their overall death rates. The decrease in overall cancer mortality in women would have been larger had there not been an increase in lung cancer mortality, the investigators said.

Explaining the use of lung-cancer deaths as a proxy in this study, Drs. Thun and Jemal noted that although active smoking causes a long list of other cancers, lung cancer deaths make up 80% of all smoking-attributable cancer deaths in the U.S. Cigarette smoking, they said, accounts for a larger fraction of lung cancer deaths in men (88%) and women (72%) than any other smoking-related cancer except laryngeal cancer.

Discussing their methodology, the researchers wrote that while it seemed prudent to base the estimates only on observed data and only during the period when cancer deaths actually decreased, this approach greatly underestimated the full impact of reduction in smoking on cancer death rates over the preceding three decades.

A second method was to take into account what might have happened to cancer death rates over the last half century had cigarette smoking not been discouraged. Projecting the increase in lung cancer death rates that would have occurred with increases at the previous rates, they found that without the drop in smoking that began in the 1960s, there would essentially be no decrease in cancer death rates today.

Furthermore, they said, the predicted lung cancer death rates would have increased from 1991 in both sexes, and the increase would have been sufficient to cancel out nearly all of the decrease in overall cancer mortality from 1991 to 2003. This scenario, although hypothetical, they said "provides an alternative, and perhaps more realistic view of what the actual benefits of past reductions in smoking have been with respect to cancer mortality."

In a third approach, the researchers considered the number of cancer deaths avoided, rather than the reduction in death rates, and concluded that about 146,000 lung cancer deaths were prevented or postponed by the decrease in the age-specific lung-cancer death rates in men between 1991 and 2003.

Even though this method considered only the observed change in lung cancer rates during this period, it illustrates that a large number of deaths from lung cancer were avoided because of the decrease in the lung cancer death rates in men during this period.

In turn, Drs. Thun and Jemal said, these findings reflect the reduction in cigarette smoking that occurred because of anti-smoking and other tobacco-control measures implemented since the 1950s.

The researchers mentioned several caveats regarding these estimates. Restricting analyses to lung cancer may underestimate the contribution of smoking reduction by up to 20%. Offsetting this underestimate, at least partly, they said, is the fact that they ignored other risk factors, such as exposure to carcinogens in occupational settings that have also changed since the 1950s. Despite these limitations, the researchers said they believe that the true contribution of smoking reduction is within the range of these estimates.

"The payoff from past investment in tobacco control has only just begun," Drs.Thun and Jemal wrote. "The aging of birth cohorts with lower smoking initiation rates and the anticipated future decrease in lung cancer mortality in women will help to sustain progress." What is necessary, they added, "is that sustained progress in tobacco control is essential if we are to continue to make progress against cancer."

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Environmental Tobacco Smoke (ETS) Exacerbates Allergic Airway

There has been a troubling increase in the prevalence of allergic airway diseases over the last years. There have been a number of possible explanations for this observation, none of which has emerged as the most likely culprit. The increase in the prevalence of allergic disease may also be the result of a combination of factors. Explanations proposed for this trend include exposure to indoor and outdoor pollution, dietary factors, childhood infections, allergen levels (such as dog, cat, and dust mite), and other factors.

This randomized, placebo-controlled, crossover study used 19 nonsmoking volunteers with ragweed allergy who underwent nasal lavage followed by controlled exposure to either environmental tobacco smoke (ETS) or clean air in a challenge chamber. The subjects randomly received immediate nasal challenge with either ragweed allergen or placebo. They then performed nasal lavage at 10 minutes, 24 hours, and 4 and 7 days after the exposure. Immunoglobulin E (IgE), cytokines, and histamine were then measured. Subsequent challenges were spaced at least 6 weeks after the first challenge.

The authors found that ETS promoted the production of IgE in nasal lavage fluid. Four days following the exposure to ETS and ragweed, IgE levels were on average 16.6-fold higher in those exposed to ETS/ragweed compared with those exposed to plain air and ragweed. The ETS/ragweed combination also promoted a TH2 cytokine milieu compared with the air/ragweed combination. The authors concluded that this study provides the first experimental evidence that secondhand smoke can exacerbate allergic responses in humans concomitantly exposed to allergens.

Secondhand cigarette smoke amplifies the response to inhaled allergen in this setting, and presumably in other settings as well. Of particular concern is the fact that the allergic antibody, IgE, is over 16-fold higher in nasal lavage fluid despite only 2 hours of exposure a full 4 days earlier. The implications of this findings on the risk of allergic response amplification are significant, particularly for those who work around secondhand smoke for 8 or more hours a day.

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Microbial Flora Restored After Smokers Quit

SAN FRANCISCO (Reuters Health) - "Interfering bacteria" in the nasopharynx - the aerobic and anaerobic bacteria that prevent colonization of pathogenic bacteria -- are restored to normal levels after smokers quit, researchers reported here at the 4th Interscience Conference on Antimicrobial Agents and Chemotherapy.

"These findings illustrate for the first time that the high number of pathogens and the low number of interfering organisms found in the nasopharynx of smokers reverse to normal levels after complete cessation of smoking," researchers from Georgetown University in Washington, DC, said Wednesday.

Nasopharyngeal cultures were taken from 20 smokers before they quit smoking and again 12 to 15 months after they stopped, according to Drs. Alan E. Gober and Itzhak Brook.

At baseline, they identified 11 pathogens from 9 subjects, which was reduced to 2 pathogens in 2 subjects about 1 year after the subjects stopped smoking (p < 0.0.5).

Bacterial interference occurred against four potential pathogens: Streptococcus pneumoniae, Hemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes. The researchers also observed interference between two anaerobic species, Prevotella and peptostreptococcus, and two aerobic bacteria, alpha and non-hemolytic streptococci species.

Overall, 35 instances of interference, by 14 normal flora isolates against 4 potential pathogens were isolated at baseline. This increased to 116 instances of bacterial interference by 42 normal isolates 1 year after the subjects quit smoking (p < 0.01).

These findings provide evidence that colonization of potential pathogens is reduced and normal flora is restored after individuals quit smoking, which in turn lowers their risk of respiratory infections, the investigators conclude.

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Nicotine Replacement Helps COPD Patients to Quit Smoking

NEW YORK (Reuters Health) - Nicotine replacement therapy enables a significant number of patients with chronic obstructive pulmonary disease (COPD) to stop smoking, according to a report in the August issue of Chest.

"Nicotine replacement therapy works in COPD," Dr. Philip Tnnesen from Gentofte Hospital, Hellerup, Denmark, told Reuters Health. "And nicotine replacement therapy works in smokers of fewer than 10 cigarettes per day. I believe this is the first study ever to show this."

Dr. Tnnesen and colleagues compared the efficacy of nicotine replacement combined with high- or low-behavioral support for smoking cessation in 370 patients with COPD who smoked a mean of 19.6 cigarettes daily.

The use of sublingual nicotine tablets was associated with an approximate doubling of abstinence rates compared with placebo at 6 (23% versus 10%) and 12 months (17% versus 10%) respectively, the authors report. However, the intensity of behavioral support did not significantly influence the outcomes.

"The good thing from our design is that both the interventions used seem to be effective," Dr. Tnnesen said. "So it's up to local decision what program to follow." Neither nicotine replacement nor behavioral support significantly influenced smoking reduction among patients who continued to smoke after 6 or 12 months, the results indicate.

Smoking cessation was associated with a significant increase in FEV1, the investigators say, whereas FEV1 remained stable among those who reduced their smoking but deteriorated among those who continued smoking at their baseline rate. Adverse events occurred at similar rates in the nicotine and placebo groups and in the high- and low-behavioral support groups, the researchers note.

"We must get our COPD patients to quit smoking," Dr. Tnnesen said. "In the European Respiratory Society we will soon publish guidelines about smoking cessation in respiratory patients and here we underline that smoking cessation should be an integral part of therapy for patients who smoke with respiratory disease."  Chest 2006;130:334-342.

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COPD World News            Week of October 1, 2006

Women with COPD receiving long-term oxygen more likely to die

Saõ Paulo, Brazil — Women with chronic obstructive pulmonary disease (COPD) receiving long-term oxygen therapy (LTOT) are more likely to die than their male counterparts, according to the results of a 7-year, prospective cohort study reported in the September 1 issue of the American Journal of Respiratory and Critical Care Medicine.

"COPD is a leading cause of death worldwide," write Maria-Christina L. Machado, MD, from the State Public Hospital of Saõ Paulo, Brazil, and colleagues. "The prevalence of COPD is rising among women and is approaching that of men, but it is not known if sex affects survival."

Of 435 outpatients with COPD referred for LTOT at 2 respiratory clinics in Saõ Paulo, Brazil, 184 were women and 251 were men. The investigators collected baseline data at enrollment into oxygen therapy, when patients were clinically stable, and they examined the effect of sex on survival using Kaplan-Meier survival curves. Cox proportional hazards models were used to control for potential confounders.

Unadjusted analyses revealed a nonsignificant trend toward increased mortality for women (hazard ratio [HR], 1.28; 95% confidence interval [CI], 0.98 - 1.68; P = .07). After adjustment for potential confounders (age, pack-years smoked, PaO2, forced expiratory volume in 1 second [FEV1], body mass index), women were at a higher risk for death than were men (HR, 1.54; 95% CI, 1.15 - 2.07; P = .004). Other independent predictors of mortality were lower PaO2 (P < .001) and lower body mass index (P < .05).

"Among patients with COPD on LTOT, women were more likely to die than men," the authors write. "Men and women exhibited similar survival rates during the initial follow-up period; differences in survival became more apparent only after approximately 3 years of follow-up."

Study limitations include lack of data on adherence to LTOT or smoking status during the follow-up period and few participants with follow-up times greater than 48 months.

"Our results suggest that, when properly adjusted for potential confounding factors, women with severe COPD using LTOT have a greater risk of death than do men," the authors conclude. "It is not clear why this is the case; we recommend additional studies that address the role of inflammation, bronchial hyperresponsiveness, oxidative stress, and other variables that may influence women's lower survival rate."

One of the authors has disclosed relevant financial relationships with GlaxoSmithKline, ALTANA, Schering Plough, Merck, AstraZeneca, Boehringer Ingelheim, Pfizer, Novartis, and Cheesy.

In an accompanying editorial, David M. Mannino, MD, from the University of Kentucky Medical Center in Lexington discusses other potential study limitations. These include inability to determine whether the decision-making processes to have patients receive oxygen therapy were similar between men and women, whether a similar proportion of men and women dropped out or died within 6 months, and whether treatment adherence was different between men and women.

"Whether this observation holds true in other cohorts with differing severity of COPD is yet to be determined," Dr. Mannino writes. "Careful analysis from both clinical data and observational trials will shed more light on this important question and, it is hoped, provide guidance for how to better intervene in the care of our patients with COPD."

Dr. Mannino has disclosed serving on the advisory board for Boehringer Ingelheim, GlaxoSmithKline, and Ortho Biotech as well as on the speakers' bureau for Boehringer Ingelheim, Pfizer, GlaxoSmithKline, and Dey and receiving research grants from GlaxoSmithKline and Pfizer.  Am J Respir Crit Care Med. 2006;174:488-489, 524-529.

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Health Canada Advises Consumers Not To Use Dietary Supplement Due To Potential Health Risks

OTTAWA - Health Canada is advising consumers not to use Salt Spring Herbals Sleep Well Dietary Supplement because a sample analyzed by Health Canada has been found to contain the undeclared drug estazolam, a sedative that can be habit-forming when used for as little as a few months. Consumers already taking this product should consult with a health care professional before they stop taking the capsules, since symptoms of withdrawal are possible. A recall has been initiated by the Canadian distributor.

Salt Spring Herbals Sleep Well Dietary Supplement capsules are advertised as a herbal natural health product to relieve insomnia and restless leg syndrome. The most common side-effects associated with the use of products containing estazolam are dizziness and drowsiness. More serious side-effects include loss of memory, hallucinations, confusion and depression.

Drugs in the same class (benzodiazepine) as estazolam can only be prescribed by a physician. Estazolam should not be used by people with an allergy to other benzodiazepines (such as Valium, Restoril and Ativan), or those affected by the neuromuscular disorder myasthenia gravis or sleep apnea. Estazolam should be used with caution by pregnant women, the elderly, and those with a history of substance abuse.

Consumers who have purchased Salt Spring Herbals Sleep Well Dietary Supplement capsules should return the product to the place of purchase. To date, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.

This product has been found on the Canadian market but is not authorized for sale in Canada. The Canadian distributor, Salt Spring Herbals in British Columbia, is recalling the product based on preliminary findings with one package, and Health Canada is conducting additional tests to determine the source of the undeclared drug. Health Canada will update this advisory as more information becomes available.

Health Canada also advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find Salt Spring Herbals Sleep Well Dietary Supplement for sale in Canada. 

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Youth smoking rates continue to decline

OTTAWA, - The number of Canadian youth trying tobacco products has continued to fall, Health Canada's 2004-2005 Youth Smoking Survey has found.

"The survey results show fewer young people in grades five to nine are trying and using tobacco products," said Minister Clement. "This research is evidence that progress is being made in discouraging youth from taking up smoking, which is one of the goals of the Federal Tobacco Control Strategy."

In 2004-05, only 21 per cent of youth in grades five through nine had tried any type of tobacco product. This represents a 50 per cent reduction over a 10-year period from the rate in 1994.

The Youth Smoking Survey is a monitoring tool for Health Canada. It is intended to provide the department, its partners and stakeholders, and the Canadian public, with important information related to tobacco use, including estimates of smoking prevalence, for Canadian youth in grades five to nine.

For 2004-05, a national survey of more than 29,000 Canadian students in grades five to nine was conducted to monitor changes in smoking status and to provide information related to tobacco use in Canada. It is generally recognized that this is the population most at risk for trying tobacco products.

The implementation of the 2004-05 YSS was the result of a successful capacity building project funded by Health Canada through a contribution agreement between Health Canada, the University of Waterloo and its partners in a pan Canadian consortium of tobacco control researchers. Based on the success of this project, Health Canada has continued its collaboration with the University of Waterloo and the pan Canadian consortium of tobacco control researchers to conduct the 2006-07 YSS during the upcoming school year.

It is expected that the 2006-07 YSS will expand to include grades 5-12, with an estimated 100,000 students expected to participate making this the largest school based survey in Canada.

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Long-standing anger and hostility compromise lung function and hasten the natural decline in lung power that is a normal part of aging, reveals research published in Thorax.

The authors base their findings on a study of 670 men, taking part in the long term US Normative Aging Study. Their ages ranged from 45 to 86, but the average age was 62. Their levels of hostility were measured in 1986, using a validated scoring system. The average hostility score was around 18.5, but ranged from 7 to 37. After this initial assessment, the men were monitored for an average of eight years, during which their lung function was measured on three separate occasions.

The men's lung function at the start of the study varied according to their initial levels of hostility. It was significantly poorer among those men deemed to exhibit high levels of anger and hostility compared with those who exhibited medium to low levels. But it was also worse at each examination throughout the period of study.

Although the impact was lessened, the association held true even after taking account of factors likely to influence the findings, such as smoking and educational attainment. Higher levels of hostility were also associated with a faster rate of the natural decline in lung function that occurs with aging. Each point increase in hostility score was associated with a loss of FEV1 -- the volume of air that can be forced out of the lungs in one second, and a measure of lung power -- of 9 ml a year compared with men whose hostility levels were lower.

The authors point out that hostility and anger have been associated with cardiovascular disease, death, and asthma, and that previous research has suggested that changes in mood can have short term effects on the lungs. Anger and hostility will alter neurological and hormonal processes, which in turn may disturb immune system activity, producing chronic inflammation, suggest the authors.

An accompanying editorial comments that the physiological components of anger and stress overlap, and stress is well known to affect the immune system.

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COPD World News            Week of September 24, 2006


Boehringer-Ingelheim has developed a novel device to deliver respiratory medicines, a step that it hopes will represent a significant advancement upon traditional inhaler technologies. The reformulation of the best-selling asthma/COPD drug Spiriva in the Respimat may well be the key to differentiating Spiriva from similar drugs coming on the market from 2011.

Boehringer-Ingelheim (BI) recently presented a study on Respimat at the 16th Annual Congress of the European Respiratory Society in Munich. The Respimat is a new device that delivers medication in a soft and slow-moving mist with a high fine particle fraction, allowing the active compound to penetrate deep into the lungs. The mist formulation also decreases deposition in the mouth and throat compared to traditional MDI devices, resulting in fewer oropharyngeal side effects.

The Respimat is currently in development for BI's most important respiratory product Spiriva (tiotropium bromide). Importantly, the data presented in Munich showed that patients with asthma and chronic obstructive pulmonary disease (COPD) are highly satisfied with the novel Respimat Soft Mist Inhaler (SMI).

The Respimat technology is currently used in BI's Berodual (ipratropium bromide/fenoterol hydrobromide) which was launched in January 2004 on the German market. A 12 week study evaluating the satisfaction of patients using the Berodual Respimat concluded that most patients (74%) rated the treatment with the Respimat as better or much better than their previous Berodual inhaler.

This real-life validation of the new technology provides a good platform from which to reformulate BI's COPD-blockbuster Spiriva in the Respimat inhaler. Phase III trials for Spiriva in this device were successfully completed and BI is currently preparing the filing documents, according to the company's 2005 Annual Report.

Currently Spiriva is the only once-daily long-acting anticholinergic (LAMA) on the market with sales of $950 million in 2005, which is forecasted to grow to $1.9 billion by 2015.  Spiriva's only disadvantage is its current inhaler device - the Handihaler which is said to be too complicated, especially for elderly patients. Several companies have once-daily LAMAs in their pipeline, but none is expected to be launched before 2011. That year will mark the end to Spiriva's monopoly.

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