COPD World News Week of December 29, 2013

Total Smoking Bans Work Better Than Halfway Measures

San Diego, CA - Total smoking bans in homes and cities greatly increase the likelihood that smokers will cut back or quit, according to a new study. "When there's a total smoking ban in the home, we found that smokers are more likely to reduce tobacco consumption and attempt to quit than when they're allowed to smoke in some parts of the house," Dr. Wael Al-Delaimy, chief of the division of global health, department of family and preventive medicine, University of California, San Diego, said in a university news release. "The same held true when smokers report a total smoking ban in their city or town. Having both home and city bans on smoking appears to be even more effective," he added. The findings are from a survey of more than 1,700 current smokers in California. While total bans on smoking in homes and public places were associated with reduced smoking and quitting, partial bans were not. Total home bans were more effective in reducing smoking among women and people 65 and older, while total bans in cities significantly increased the chances that men would quit, but not women, according to the study published online Nov. 26 in the journal Preventive Medicine. The researchers also found that total home bans were more effective in homes without children. This may be because the bans in these homes are targeted specifically at quitting, rather than reducing children's exposure to secondhand smoke. The findings show the importance of smoking bans in homes and cities, according to Al-Delaimy. "California was the first state in the world to ban smoking in public places in 1994 and we are still finding the positive impact of that ban by changing the social norm and having more homes and cities banning smoking," he said.

For more information: http://www.nlm.nih.gov/medlineplus/news/fullstory_143780.html

COPD World News Week of December 22, 2013

Good news for New Brunswick COPD patients

Fredericton, NB - The New Brunswick government has added Seebri to the New Brunswick Prescription Drug Program formulary as a Special Authorization Benefit listing. The coverage became effective on December 19th. The drug will be covered if breathlessness symptoms persist after 2-3 months of short-acting bronchodilator therapy (i.e. salbutamol at a maximum dose of 8 puffs/day or ipratropium at maximum dose of 12 puffs/day). Seebri can be provided without a trial of short-acting agent if there is spirometric evidence of at least moderate to severe airflow obstruction (FEV1 < 60% and FEV1 /FVC ratio < 0.7) and significant symptoms (i.e. moderate to severe MRC score of 3-5). If spirometry cannot be obtained, reasons must be clearly explained and other evidence regarding severity of condition must be provided for consideration. Spirometry reports from any point in time will be accepted.
Seebri (glycopyrronium bromide) is a long-acting anticholinergic (LAAC) indicated for long-term, once-daily maintenance bronchodilator treatment in patients with chronic bronchitis and emphysema. As an inhaled, steroid-free COPD treatment, it is not indicated as a rescue medication for the relief of acute deterioration of COPD.
 

For more information: http://tinyurl.com/pk2zzzf

GSK's new LABA/LAMA for COPD approved in USA

Silver Spring, MD – The FDA approved umeclidinium/vilanterol (Anoro Ellipta) as the first fixed-dose combination of a long-acting beta agonist and a long-acting muscarinic antagonist (LABA/LAMA) onto the market. The once-daily dry-powder inhaler got an indication for long-term maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD). "The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD," Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research, noted in a statement. His office approved the drug in concordance with an advisory panel recommendation based on data showing improved lung function compared with placebo in trials across more than 2,400 COPD patients. Safety, though, had been a concern and the drug will carry a boxed warning that LABAs increase the risk of asthma-related death." The safety and efficacy of Anoro Ellipta in patients with asthma have not been established, and it is not approved for the treatment of asthma," the FDA statement cautioned. "Anoro Ellipta should not be used as a rescue therapy to treat acute bronchospasm (sudden breathing problems)."Other serious side effects associated with the drug include paradoxical bronchospasm, cardiovascular effects, acute narrow-angle glaucoma, and worsening of urinary retention. The most common adverse events reported were sore throat, sinus infection, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain, and chest pain. The drug is marketed by GlaxoSmithKline of Research Triangle, North Carolina.

For more information: http://tinyurl.com/ke4qqqw

COPD World News Week of December 15, 2013

Anti-Smoking Products Don't Cause Cardiovascular Harm

Ottawa, ON - The most widely used smoking cessation therapies did not appear to increase the risk for major adverse cardiovascular events, and one therapy -- the antidepressant bupropion (Wellbutrin, Zyban) -- actually showed a trend toward protecting against heart attack and stroke, a meta-analysis found. Use of nicotine replacement therapies (NRTs) was associated with a non-statistically-significant increase in major cardiovascular events (RR=1.38, 95% CI 0.58-3.26), Edward J. Mills, PhD, of the University of Ottawa in Ontario, Canada, and colleagues wrote in Circulation. Nicotine replacement therapies (NRTs) did increase the risk of minor heart symptoms, such as rapid heartbeat, but these symptoms occurred most often when people used the treatments while smoking, the researchers noted. The analysis, which included 63 trials involving 30,508 people, examined nicotine replacement gums, lozenges and patches; Pfizer's nicotine receptor partial agonist drug Chantix; and bupropion. Use of NRTs was associated with a significantly increased risk for all cardiovascular events compared with placebo, they found. However, sensitivity analysis revealed that the treatment effect among nicotine replacement therapy users was largely driven by low-level cardiovascular disease (CVD) events, including tachycardia and arrhythmia. These events most often occurred in studies with the longest follow-up periods. "Given the current findings of low risk of serious CVD events attributed to smoking cessation pharmacotherapies, combined with the well-established CVD and mortality risks of continued smoking, the benefits of use would seem to outweigh the risks: however, further study is needed, particularly investigation of the use of cessation medications with smokers hospitalized for ST-elevation MI [myocardial infarction]," the researchers wrote. Their search of 10 electronic databases revealed 63 smoking cessation randomized trials that included CVD outcomes, including 21 studies evaluating nicotine replacement therapies, 28 evaluating bupropion, and 18 evaluating varenicline. Most compared the drugs with placebo, but two compared bupropion to varenicline, three compared bupropion to nicotine replacement, and one evaluated varenicline versus nicotine replacement therapy. Pairwise comparison of all interventions with available head-to-head data showed no statistically significant evidence of harm for nicotine replacement therapy versus placebo. For all interventions, no major evidence of heterogeneity was seen, as I2 values were equal to or close to 0% at all times. For bupropion, the results suggested a direction of effect that was protective against major adverse cardiovascular events (MACE) for the entire study population. When the population was restricted to high-risk patients, the trend remained but confidence intervals became slightly wider. "Our study demonstrates that all three evaluated therapies were not harmful for MACE events," the researchers wrote. "Bupropion appears to have a protective effect, whereas varenicline was not significantly associated with harm." And while nicotine replacement was associated with an increase in CVD events, these events were largely benign, they added.

For more information: http://tinyurl.com/kkmo43n

COPD World News Week of December 8, 2013

Quitting Smoking May Help Seniors' Hearts Sooner Than Thought


Birmingham, Alabama - Seniors who quit smoking cut their risk of death by heart disease much more quickly than previously thought, particularly if they were light-to-moderate smokers, a new study says. Past estimates held that it takes smokers about 15 years after they quit to lower their risk of heart attack, heart failure or stroke to that enjoyed by people who never smoked, said lead author Dr. Ali Ahmed, senior study researcher. Ahmed is a professor of cardiovascular disease at the University of Alabama at Birmingham's School of Medicine. But a new examination of 853 former smokers aged 65 and older found that many with a light-to-moderate smoking history can cut their risk in eight years or less, Ahmed said. "Even though they quit only eight years ago, because they smoked less they were able to become like never-smokers in half the time," Ahmed said, citing findings he is scheduled to present Wednesday at the American Heart Association's annual meeting in Dallas. Ahmed and his colleagues analyzed 13 years of medical information compiled by the U.S. National Heart, Lung, and Blood Institute to compare 853 people who had quit smoking 15 or fewer years ago with about 2,500 people who had never smoked. Half the smokers surveyed quit eight or fewer years before. The researchers defined light smokers as people who had smoked less than 32 "pack years." This adds up to 3.2 packs a day for 10 years, or less than one pack a day for 30 years. About 37 percent of the former smokers fell into this category. American Heart Association past president Dr. Gordon Tomaselli said that's a pretty generous definition of light smoking. "A pack a day for 32 years, that's not light," he said. Light-to-moderate smokers who more recently quit had just a 14 percent chance of dying from heart disease, heart attack or stroke, compared with a 22 percent chance for former heavy smokers. People who never smoked had a 17 percent chance of death due to heart health problems. These were somewhat surprising results, given the age of the patients and their smoking history, Tomaselli said. "The benefit was in a group we weren't sure would benefit as much as people who had smoked less or were younger," he said. However, both light and heavy smokers continued to have a higher risk of death from other causes, including cancer and emphysema, Ahmed said. Light smokers had a 29 percent chance of dying from a cause not related to their heart health, while heavy smokers had a 33 percent chance. Non-smokers had a 22 percent chance, the investigators found. "Yes, you get cardiovascular benefit [from quitting], but another part of your overall risk remains high even if you smoke at so-called light levels," Ahmed said. Overall risk of death was 39 percent for non-smokers, 43 percent for former light smokers and 55 percent for former heavy smokers in the study. Ahmed and Tomaselli said smokers should heavily weigh the heart benefits of quitting. Heart disease is the number-one cause of death in the United States, taking nearly 600,000 lives a year, according to the U.S. Centers for Disease Control and Prevention. "Cardiovascular disease is the biggest killer, and you can reduce that risk by smoking less and quitting early," Ahmed said. "Smoking is the single most preventable risk for heart disease." Tomaselli said this study gives doctors a leg up when seniors argue that they've been smoking for too long and it's too late for them to quit. "You can say to them with confidence that if you quit now, you can realize some benefits for cardiovascular health," Tomaselli said. "It's a reason even in older patients for doctors to be aggressive in recommending smoking cessation." Because this study was presented at a medical meeting, the data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.

For more information: http://www.nlm.nih.gov/medlineplus/news/fullstory_142709.html

COPD World News Week of December 1, 2013

Good news for Alberta COPD patients

Calgary, AB - Alberta patients suffering from chronic obstructive pulmonary disease (COPD) now have access to SEEBRI BREEZHALER (glycopyrronium bromide) 50 mcg with its listing on the Alberta Drug Benefit Listing. As well, Alberta began covering ONBREZ (indacaterol maleate) 75 mcg a long-acting once-daily maintenance bronchodilator for treatment in patients with chronic bronchitis and emphysema. Coverage for both drugs began December 1st.

For more information: http://www.health.alberta.ca/services/drug-benefit-list.html

High pneumonia incidence ups elderly COPD medical costs

Waltham, MA - Older individuals with chronic obstructive pulmonary disease (COPD) are almost six times more likely to develop pneumonia and eight times more likely to need hospital treatment than those without the disease, US researchers have found. This significantly increases the direct medical costs for up to 2 years after hospitalization, say Marian Ryan (Brandeis University, Waltham, Massachusetts) and colleagues and has implications for healthcare policy. “Acute exacerbations due to pneumonia that result in hospitalizations and re-admissions are the major contributors to the economic burden of COPD,” Ryan et al write in Plos One. They explain: “Although the incidence and cost of pneumonia in the elderly has been documented, less is know about the incidence and economic impact of pneumonia in elderly individuals with underlying COPD.” In their retrospective, longitudinal study of 1,565,638 individuals aged 65 years or older, the team found that the incidence of pneumonia was 167.6/1000 person-years in those with COPD and 29.5/1000 person-years in those without COPD (relative risk [RR]=5.7). And, the incidence of pneumonia requiring hospitalization was 54.2/1000 person-years compared with 7/1000 person-years for individuals with and without COPD (RR=7.7). The researchers also found that the risk for pneumonia and for hospitalization was increased in those who had concomitant congestive heart failure when compared with those without COPD. The team calculated that the direct medical cost of treating inpatient pneumonia from the time of hospitalization to 2 years afterwards was an extra US$28,638 (€21,160) for patients with COPD compared with those without COPD. The excess cost was highest in the first few months of hospitalization and totalled an additional $22,697 (€16,700) over the course of the first year and $5,941 (€4,380) over the course of the second year. “COPD and pneumonia are high cost conditions individually and concomitantly, pneumonia and COPD increase health care cost synergistically in the elderly,” Ryan et al state. They suggest that use of therapies specifically aimed at preventing pneumonia “may have a beneficial impact on health utilization and cost.”

For more information: http://tinyurl.com/prml4d4

COPD World News Week of November 24, 2013

Emerging tobacco products gaining popularity among youth

Atlanta, GA - Emerging tobacco products such as e-cigarettes and hookahs are quickly gaining popularity among middle- and high-school students, according to a report in this week’s Morbidity and Mortality Weekly Report. While use of these newer products increased, there was no significant decline in students’ cigarette smoking or overall tobacco use. Data from the 2012 National Youth Tobacco Survey (NYTS) show that recent electronic cigarette use rose among middle school students from 0.6 percent in 2011 to 1.1 percent in 2012 and among high school students from 1.5 percent to 2.8 percent. Hookah use among high school students rose from 4.1 percent to 5.4 percent from 2011 to 2012. The report notes that the increase in the use of electronic cigarettes and hookahs could be due to an increase in marketing, availability, and visibility of these tobacco products and the perception that they may be safer alternatives to cigarettes. Electronic cigarettes, hookahs, cigars and certain other new types of tobacco products are not currently subject to FDA regulation.  FDA has stated it intends to issue a proposed rule that would deem products meeting the statutory definition of a "tobacco product" to be subject to the Federal Food, Drug, and Cosmetic Act. Another area of concern in the report is the increase in cigar use among certain groups of middle and high school students.  During 2011-2012, cigar use increased dramatically among non-Hispanic black high school students from 11.7 percent to 16.7 percent, and has more than doubled since 2009. Further, cigar use among high school males in 2012 was 16.7 percent, similar to cigarette use among high school males (16.3 percent). “This report raises a red flag about newer tobacco products,” said CDC Director Tom Frieden, M.D., M.P.H. “Cigars and hookah tobacco are smoked tobacco – addictive and deadly. We need effective action to protect our kids from addiction to nicotine.” It is important to note that the cigars category includes little cigars, many of which look almost exactly like cigarettes but are more affordable to teens because they are taxed at lower rates and can be sold individually, rather than by the pack.  Little cigars also can be made with fruit and candy flavors that are banned from cigarettes. A CDC study published last month showed more than one in three (35.9 percent) middle and high school students who smoke cigars use flavored little cigars. “A large portion of kids who use tobacco are smoking products other than cigarettes, including cigars and hookahs, which are similarly dangerous,” said Tim McAfee, M.D., M.P.H., director of the CDC’s Office on Smoking and Health. “As we close in on the 50th anniversary of the first Surgeon General’s report on the dangers of smoking, we need to apply the same strategies that work to prevent and reduce cigarette use among our youth to these new and emerging products.”

For more information: http://www.cdc.gov/media/releases/2013/p1114-emerging-tobacco-products.html

COPD World News Week of November 17, 2013

Tobacco Myths Continue Half-Century After Landmark U.S. Report

Houston, TX - Dangerous myths about tobacco persist 50 years after the U.S. Surgeon General first warned Americans about the harm caused by smoking, experts say. The first Surgeon General's Report on smoking and health was released in January 1964. "Since 1964, smoking rates have dropped by more than half as a result of successful education, legislative and smoking cessation efforts. Still, lung cancer remains the number one cancer killer and the leading preventable cause of death in the United States," Dr. Lewis Foxhall, vice president for health policy at the University of Texas MD Anderson Cancer Center in Houston, said in a center news release. One of the biggest myths is that there's been a dramatic decline in the number of smokers. However, nearly 44 million (about one in five) Americans still smoke. "The current percentage of smokers is 19 percent. That's significantly lower than the 42 percent in 1965. However, the actual number of people smoking today is close to the same," Foxhall said. In 1965, about 50 million Americans smoked. "Because our population is much larger, it just seems like we have a lot fewer smokers," Foxhall said. Another myth is that infrequent, so-called "social" smoking is harmless. But any smoking is dangerous. "Science has not identified a safe level of smoking, and even a few cigarettes here and there can maintain addiction," David Wetter, chair of health disparities research at MD Anderson, said in the news release. "If you are a former smoker, data suggests that having just a single puff can send you back to smoking." Many people wrongly believe that smoking outdoors eliminates the dangers of secondhand smoke. However, there is no risk-free level of exposure to secondhand smoke and even brief exposure can cause harm. Families should ban smoking both in and around the home, Wetter said. Another myth is that e-cigarettes, cigars and hookahs are safe alternatives to cigarettes. They all contain nicotine, which is highly addictive. "The tobacco industry comes up with these new products to recruit new, younger smokers," Dr. Alexander Prokhorov, director of the Tobacco Outreach Education Program at MD Anderson, said in the news release. "And, they advertise them as less harmful than conventional cigarettes. But once a young person gets acquainted with nicotine, it's more likely he or she will try other tobacco products," he pointed out. Paul Cinciripini, professor and deputy chair of behavioral science and director of the Tobacco Treatment Program at MD Anderson, explained: "While e-cigarettes may contain less harmful substances than combustible tobacco, they're presently unregulated so quality control over the nicotine content and other components is left to the manufacturer." So, he added, "At this time, it's far too early to tell whether or not e-cigarettes can be used effectively as a smoking cessation device." In the United States alone, over 200,000 people are diagnosed with lung cancer and about 150,000 people die from the disease each year, and it is estimated that smoking contributes to nearly 90 percent of those lung cancer deaths. In addition, 30 percent of all cancer deaths have been linked to smoking.

For more information: http://www.nlm.nih.gov/medlineplus/news/fullstory_142527.html

COPD World News Week of November 10, 2013

Yoga May Be Good for COPD

Chicago, IL - With its focus on breathing exercises, yoga may improve some of the symptoms of chronic pulmonary obstructive disease (COPD) along with boosting quality of life, researchers said here. In a small study of patients in India, 12 weeks of twice weekly yoga classes improved several measurements of dyspnea and living quality, Randeep Guleria, MD, of All India Institute of Medical Sciences in New Delhi, and colleagues reported at the CHEST meeting. "Yoga is a simple, cost-effective method that improves dyspnea and quality of life in COPD," Guleria said during the presentation. Zachary Morris, MD, of Henry Ford Hospital in Detroit, who moderated the session at which the findings were presented, agreed that yoga may fill an unmet need, given a known lack of success for standard pulmonary rehabilitation programs. "I was skeptical until I heard this talk, but it actually makes a lot of sense," Morris said. "Pulmonary rehabilitation failure rates are so high because patients go home, feel fine, and don't do [their exercises]. But this is something they can continue to do, and that they want to do at home." Indeed, Guleria said patients were told they only needed to do yoga twice per week at home, but ended up doing it much more often. To assess whether yoga could have an impact on COPD, the researchers enrolled 29 patients (25 men, four women) with a mean age 56. They were taught several yoga techniques, including physical postures, breathing techniques, and meditation and relaxation techniques. For the first 4 weeks of the study, patients came to the hospital for hour-long yoga sessions twice a week. Then for the next 8 weeks, patients were told to do their yoga exercises at home, and only came to the hospital for one class every other week. The researchers measured several parameters of COPD at baseline and at 12 weeks, including lung function, dyspnea severity, quality of life, and inflammation. Over the 3 months of the study, they found significant improvement in dyspnea severity, for all the ways it was measured. However, there were no significant improvements on pulmonary function tests or on inflammatory markers, including interleukin-6 (IL-6), IL-8, and TNF-alpha. But Guleria noted that there was a trend toward improvement in C-reactive protein levels, although it wasn't significant. Guleria said the benefits likely have to do with the fact that "yoga is a way of life and meditation improves general spiritual well-being." Also, it focuses on breathing, which could effectively be looked at as respiratory exercises and "could help as far as [lung] muscle function is concerned." It's also a "more acceptable" physical activity to many patients, compared with something more rigorous or routine as walking on a treadmill, Guleria said. He added that his team is now doing another study to compare their COPD patient yoga program with standard pulmonary rehabilitation. "It will be interesting to see whether in 6 months yoga drops off as does pulmonary rehabilitation," Morris said.

For more information: http://tinyurl.com/l6hxymy

COPD World News Week of November 3, 2013

Health Canada approves new treatment for COPD patients

Mississauga, ON – Health Canada has approved Tudorza™ Genuair™ (aclidinium bromide) as a long-term maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, giving the 750,000 Canadians living with this serious lung disease a new treatment proven to improve breathlessness, lung function, and health-related quality of life. Tudorza Genuair is an effective, inhaled, long-acting muscarinic receptor antagonist (LAMA), administered via a new multi-dose dry powder inhaler, for the maintenance treatment of patients with COPD. The Genuair inhaler is a device that is designed with unique features that make it easy for patients to use. “COPD is a complex condition to manage, and despite the numerous treatment options available, there remain significant unmet needs in helping patients control their symptoms,” says Dr. Ronald Grossman, Respirologist, Credit Valley Hospital and Professor of Medicine at University of Toronto. “The Health Canada approval of Tudorza Genuair is exciting as it provides physicians with a unique option that offers sustained treatment throughout the entire day, reducing the frequency of night-time and early morning symptoms and ultimately offering patients a better quality of life. Genuair is also a novel inhalation device with unique features that may help reduce patient-related dosing errors and ensure proper delivery of medication.” Tudorza Genuair 400 mcg is recommended twice daily, once in the morning and once in the evening. This has proven effective in providing full 24-hour symptom control. The treatment was developed by Almirall and is being co-promoted in Canada with Forest Laboratories Canada Inc. “We are very proud to bring Tudorza Genuair to COPD patients in Canada,” says Ed Dybka, General Manager, Almirall Canada. “Canadian patients not only have a new treatment option with proven results in managing COPD symptoms, but we’re excited about the innovation behind the Genuair inhaler, and believe its ease of use will help patients take their medication correctly and experience improved outcomes.”

For more information:  www.almirall.com
 
Bronchodilator Combo Works Best for COPD

Chicago, IL - Combining bronchodilators formoterol (Foradil Aerolizer) and aclidinium (Tudorza Pressair) in a single twice-daily inhaler was better than either drug alone in chronic obstructive pulmonary disease (COPD), a randomized trial showed. The combination of the long-acting beta2 agonist and long-acting muscarinic antagonist (LABA/LAMA) had a significantly stronger impact on lung function measured by forced expiratory volume in 1 s (FEV1) both at peak and trough time points compared with the single agent inhalers and compared with placebo. The safety profile came out similar to either drug alone and to placebo, Anthony D'Urzo, MD, of the University of Toronto, and colleagues reported in the AUGMENT trial here at the CHEST meeting. "For patients with moderate-to-severe COPD, a fixed-dose combination of two agents with different mechanisms of action is often recommended for improved bronchodilation, patient compliance, and cost-effectiveness," D'Urzo noted at the late-breaking clinical trial session. A variety of other fixed-dose combination inhalers are in development for COPD, noted Charles Powell, MD, chief of pulmonary, critical care, and sleep medicine at Mount Sinai Hospital in New York City. "I think we can look for multiple drugs that combine LABA and LAMA medications into single device being introduced into clinical practice," Powell said in an interview. "As of today, there are none yet available in the United States but I believe we can look forward to seeing multiple drugs with multiple actions available, these could include even a triplet of a LABA, LAMA, and a long-acting corticosteroid. I believe that's the future." A once-daily LABA/LAMA combination of glycopyrronium/indacaterol showed promising results in cutting COPD exacerbations compared with either single agent in the SPARK trial last month. While a single dose of a single inhaler would be convenient, some patients might benefit more from a twice-daily regimen, commented late-breaking session co-chair Andrew Berman, MD, director of pulmonology at Rutgers New Jersey Medical School in Newark. "When you deliver that second dose at the 12-hour point, when they get an additional boost from the drug, some of our patients who are brittle really do benefit from that," he said. "This group of patients is usually using rescue inhalers periodically through the day, so a twice per day drug is not really one that is inconvenient."

For more information: http://tinyurl.com/ml7lzud

COPD World News Week of October 27, 2013

Viral infection and specialized lung cells linked to COPD

St. Louis, MO - Investigators at Washington University School of Medicine in St. Louis have described another link in the chain of events that connect acute viral infections to the development of chronic obstructive pulmonary disease (COPD). Their discovery points to a new therapeutic target for COPD, an extremely common disease of the lower airways that is seen in chronic bronchitis and emphysema. It is well established that smoke exposure is a major risk factor for COPD, but in this new research, investigators show that the cells that line the airways also can respond to viruses in a way that leads to long-term lung inflammation and mucus production that are typical of COPD. The research, featured on the cover of the September issue of the Journal of Clinical Investigation, reconciles the discrepancy between the transient nature of most viral infections and the relatively permanent nature of chronic inflammatory diseases such as COPD. Michael J. Holtzman, MD, the Selma and Herman Seldin Professor of Medicine at Washington University, has devoted much of his career to understanding the connections between environmental agents and development of chronic lung disease. Five years ago, he and his colleagues reported that a signaling molecule called interleukin-13 (IL-13) was the key driver of excess production of chronic airway mucus after viral infection. Since then, they have pursued the basis for IL-13 production and its usefulness as a marker and a target for more precise therapeutic intervention in COPD and related diseases such as asthma. The team traced the source of IL-13 to the immune cells of the innate immune system that had not previously been described as part of COPD. But until now, they didn’t know how this type of immune response could be perpetuated to cause such a long-term disease like COPD. “The innate immune response is conventionally viewed as built for short- rather than long-term activation,” said Holtzman. “So the type of pathway that we identified was thought to be activated for only short periods of time. However, we found that it could be persistently activated after viral infection and became even more active with time.” The new research identifies another signaling molecule that plays a key role in this phenomenon. “We reasoned that events upstream from IL-13 production might be involved in keeping the immune response active,” said the study's lead author, Derek Byers, PhD, MD, assistant professor of medicine. “When we checked for candidates, we focused our efforts on the types of molecules that are associated with controlling the immune response and especially the production of IL-13.” One of these candidates, a signaling molecule called IL-33, was strongly linked to production of IL-13 in a mouse model of chronic obstructive lung disease that developed after viral infection. In fact, delivery of IL-33 directly to the airway in these animals was also enough to cause production of IL-13 and accumulation of mucus in the lungs. Working further in this experimental model, co-lead author Jennifer Alexander-Brett, MD, PhD, a postdoctoral fellow, traced the source of the upstream signaling molecule IL-33 to a specialized set of cells within the epithelial layer that lines the airways of the lung. These IL-33-producing epithelial cells were found to possess the characteristics of progenitor cells — meaning that these cells, like stem cells, had the ability to self-renew and to execute a program that gave rise to a complete airway. “To translate our findings from the mouse model to humans, we used whole lungs removed from patients undergoing lung transplantation for very severe COPD,” said Alexander-Brett. Analysis of these human tissue samples also pointed to epithelial cells with progenitor properties as the source of IL-33. “From this work, we now know that a respiratory viral infection leads to an increase in lung epithelial progenitor cells that are programmed for increased production of IL-33,” said Holtzman. “We also provided the initial evidence that an additional stress or danger, such as smoking or pollution or even another infection, could cause these cells to release IL-33, which then stimulates immune cells to produce IL-13 and in turn the airway mucus typical of COPD and related respiratory diseases. It’s also possible that smoke exposure predisposes individuals to the development of these cells and, in turn, the susceptibility to exacerbation and progression of this type of disease.” He noted that it is reasonable to think that monitoring the IL-33 to IL-13 pathway will allow physicians to identify which patients would benefit from strategies to interrupt this cascade and prevent an otherwise progressive and devastating respiratory disease. "This work suggests that previous viral infections of the lung may worsen COPD by stimulating a particular type of lung cell that overactivates the immune system,” noted James P. Kiley, PhD, director of the Division of Lung Diseases at the National Heart, Lung, and Blood Institute, of the National Institutes of Health (NIH). "Additional research on these cells and their products may lead to new ways to diagnose and treat COPD."

For more information: https://news.wustl.edu/news/Pages/25661.aspx

COPD World News Week of October 20, 2013

EU to ban menthol cigarettes and make tobacco pack health warnings bigger

Brussels, Belgium - Not wanting to rush into things European MEPs voted to outlaw menthol from 2022, nine years from now, but rejected a proposal to regulate electronic cigarettes as medicine. Health warnings covering nearly two-thirds of cigarette packs and a ban on menthol cigarettes across the EU have come a step nearer following a vote in the European parliament. Menthol and other flavours will be banned from 2022, but in a blow to the UK government MEPs decided on Tuesday that most electronic cigarettes, increasingly popular as alternatives to tobacco products, need not be regulated in the same way as medicines. Health officials and the e-cigarette industry in Britain are seeking to clarify what this means – for instance, whether companies in the fast-expanding market face the same bans on sponsorship and promotion at sports events as tobacco firms. The Department of Health would not comment on the advertising issue until officials had studied the MEPs' decisions. But in a statement the DoH said: "We are very pleased to see the move towards tougher action on tobacco, with Europe-wide controls banning flavoured cigarettes and the introduction of stricter rules on front-of-pack health warnings. "However, we are disappointed with the decision to reject the proposal to regulate nicotine-containing products, including e-cigarettes, as medicines. We believe these products need to be regulated as medicines and will continue to make this point during further negotiations. "Figures out today show smoking levels in England are at their lowest since records began – 19.5 per cent – but we are determined to further reduce rates of smoking and believe this important step today will help." The UK e-cigarette industry, which broadly welcomed the parliament's vote, said it was already in talks with the Advertising Standards Authority but added that it would not be "sensible, proportionate, reasonable or useful" to ban all advertising. MEPs decided e-cigarettes should only be regulated as medical products if manufacturers claimed they could cure or prevent smoking tobacco – a decision criticized by the government's main medicines regulator.

For more information: http://tinyurl.com/ln5r47y

COPD World News Week of October 13, 2013

Smoking even deadlier than previously thought

Sydney, Australia -Two-thirds of smokers' deaths linked to their habit and smoking cuts 10 years from lifespan, comprehensive study shows. The risk of death is doubled even among those smoking an average of 10 cigarettes a day, the researchers say. An Australian study has shown that smoking is even more deadly than previously thought, cutting 10 years off the average smoker’s life. A study of more than 200,000 Australians shows the habit is directly linked to two-thirds of deaths in current smokers, much higher than previous international estimates of 50%. The four-year analysis of health records in the Sax Institute's  45 and Up Study shows even moderate smoking is a major killer. "We all know that smoking is bad for your health. But until now we haven't had direct large-scale evidence from Australia about just how bad it is," says study leader, professor Emily Banks, the scientific director of the 45 and Up study. "We've been relying on evidence from other countries." The study, supported by the National Heart Foundation in collaboration with Cancer Council NSW, shows risk increases with the number of cigarettes smoked a day. The risk of death is doubled even among those smoking an average of 10 cigarettes a day, says study co-author, associate professor Freddy Sitas, from Cancer Council NSW. The good news, says Banks, is that stopping smoking at any age reduces the risk. Smoking is the largest single preventable cause of death in Australia and kills 15,000 people a year, says the National Heart Foundation's Dr Rob Grenfell, who worked on the study. "People need to realize that smoking is a dangerous activity," he said. "There's no safe level of smoking and there's no such thing as social smoking."

For more information: http://tinyurl.com/p5vmytj

COPD World News Week of October 6, 2013

New COPD drugs approved for coverage

Winnipeg, MB - Good news for COPD patients in Manitoba, BC and the Yukon. Onbrez, a long acting bronchodilator, has been approved for coverage in Manitoba and is now listed on that province’s formulary. Seebri Breezhaler, also a once-per-day bronchodilator, has been approved for coverage in the Yukon and BC.

For more information: http://www.gov.mb.ca/health/mdbif/bulletin74.pdf
or: http://www.health.gov.bc.ca/pharmacare/newsletter/news13-007.pdf

Smokers Have Higher Complication Risk After Colon Surgery

Rochester, NY - Smoking increases the risk of complications and death following colorectal surgery, a new study says. The study is based on an analysis of data from 47,000 patients in the United States who had major, non-emergency colorectal surgery. Researchers from the University of Rochester Medical Center in New York found that smoking raised the risk of complications such as pneumonia and other infections by about 30 percent. "Anecdotally, we know that many patients don't take the opportunity to quit or join a smoking cessation program before surgery," study lead author Dr. Fergal Fleming, an assistant professor in the department of surgery, said in a university news release. "We want to find out what motivates patients, how can we make them a major player in their own care, and how can we as physicians do a better job of explaining issues like this to patients," Fleming explained. The study, published in the journal Annals of Surgery, looked at 26,000 patients who had surgery for colorectal cancer, 14,000 operated on because of diverticular disease (small, inflamed pockets that form along the colon wall), and 7,000 who had surgery for inflammatory bowel disease. Twenty percent of the patients were current smokers, 19 percent were former smokers and the rest had never smoked. After taking age, body fat, alcohol use and other health conditions into account, the researchers concluded that current smokers still had an estimated 30 percent higher risk of dying or developing complications following colorectal surgery compared to those who never smoked. Current smokers, who were younger than ex-smokers and never-smokers, had the highest rates of pneumonia and infection, were more likely to require additional surgery and had much longer hospital stays, the researchers said. They also found the rates of all complications and the risk of death were significantly higher in patients who smoked two packs a day for more than 30 years.

For more information: http://www.nlm.nih.gov/medlineplus/news/fullstory_141073.html

COPD World News Week of September 29, 2013

Third-Hand Smoke Impacts Kids' Breathing

Barcelona, Spain - Residue that remains on the skin, clothes, and furniture of smokers, even if they do their smoking out of the house -- still impacts children's breathing, researchers reported here. The risk of respiratory tract infections in children from infancy to 13 years of age more than doubled in households in which parents smoked cigarettes but claimed to smoke only outside, said Edward Dompeling, MD, professor of pediatric lung diseases at Maastricht University Medical Center in the Netherlands. There was also a more than doubling of the incidence of recent wheezing in homes where third-hand smoke was reported, Dompeling and colleagues reported at the annual meeting of the European Respiratory Society. They also found more cases of children who ever wheezed and asthma in these homes, but those increases did not reach statistical significance. "Our findings suggest that interventions aimed at preventing second-hand smoke exposure in children may consider also including strategies and education to prevent third-hand smoke exposure in children," reported Dompeling. The information about third-hand smoke came in the form of responses to questionnaires in which parents addressed 91 items, including smoking behavior, environmental tobacco exposure among children, and the respiratory health of the child. The questionnaire was sent to 10,000 families in the South-Limburg area of the Netherlands, and 1,899 families responded.
He noted 68% of the respondents were from highly educated families, and about 56% of their children were 6 years of age or younger; 54% were boys.
The researchers also found:
36% of families reported respiratory tract infections among their children in the past 12 months
28% reported that their children had ever experienced wheezing
13% reported recent wheezing
12% reported asthma in their children
Dompeling said that 21% of the children experienced second-hand smoke exposure, including 3% who were exposed in utero. About 5% of the children experienced third-hand smoke, which he described as tobacco residue that remains on the skin after a person smokes a cigarette. That residue may be transferred to furniture or clothing that is then contacted by the child. When people think about harm caused by tobacco they are generally aware of smoking and second-hand smoke. Only recently are we finding that third-hand smoke as well can cause problems."

For more information: http://tinyurl.com/ksqyy2a

COPD World News Week of September 22, 2013

US advisory panel recommends new COPD Drug

Washington, DC - A federal advisory panel recommended approval of GlaxoSmithKline's new drug to treat chronic obstructive pulmonary disease (COPD), and suggested the company be required to conduct further safety studies afterwards. The panel of expert advisers to the U.S. Food and Drug Administration voted 11-2 to approve the inhalant drug, Anoro, to help improve lung function in people with the disorder often associated with smoking. Anoro is a combination of vilanterol, which is designed to open the airways, and umeclidinium, which works to improve lung function. GSK is developing the product with partner Theravance Inc. The FDA is not required to follow the advice of its advisory panels but typically does so. A decision is expected by December 18. A large part of the panel's discussion centered on the drug's safety profile. Dr. James Stoller, chair of the Education Institute at the Cleveland Clinic, said the data left him with a "non-specific sense of unease" and he voted against the drug. Even some of those who voted in favor of the drug did so with hesitation. Dr. David Jacoby, professor of medicine at Oregon Health and Science University, said he was "very borderline" on his decision and continues to have "serious concerns" about whether the drug will prove safe when used outside the confines of a clinical trial. "I strongly support warnings in the labeling and a post-marketing study," he said.

For more information: http://tinyurl.com/q2rvzc4

COPD World News Week of September 15, 2013

Good news for Ontario COPD patients as new drug covered by OPDP

Dorval, PQ – Ontario patients suffering from chronic obstructive pulmonary disease (COPD) now have access to SEEBRI BREEZHALER (glycopyrronium bromide) 50 mcg with its listing as a General Benefit on the Ontario Drug Benefit (ODB) Formulary. The drug is available in pharmacies province-wide. Glycopyrronium bromide is a long-acting anticholinergic (LAAC) indicated for long-term, once-daily maintenance bronchodilator treatment in patients with chronic bronchitis and emphysema. As an inhaled, steroid-free COPD treatment, it is not indicated for the relief of acute deterioration of COPD. The Ontario government recognized the therapeutic value of Seebri leading to its inclusion on the list of recommended drugs reimbursed by the Ontario Public Drug Program. Other provinces are also providing access to this new treatment

For more information:
http://tinyurl.com/nhnzv44

E-cigarettes and nicotine patches shows comparable success

Barcelona, Spain - First trial to compare e-cigarettes with nicotine patches shows comparable success in helping smokers to quit. The first ever trial to compare e-cigarettes with nicotine patches has found that both methods result in comparable success in quitting, with roughly similar proportions of smokers who used either method remaining abstinent from smoking for six months after a 13 week course of patches or e-cigarettes. The study, presented at the European Respiratory Society (ERS) Annual Congress in Barcelona, Spain and published in The Lancet, is only the second controlled trial to be published which evaluates e-cigarettes, and is the first ever trial to assess whether e-cigarettes are more or less effective than an established smoking cessation aid, nicotine patches, in helping smokers to quit. Led by Associate Professor Chris Bullen, Director of the National Institute for Health Innovation at The University of Auckland in New Zealand, a team of researchers recruited 657 smokers to the trial through adverts in local newspapers. Study participants were all people who wanted to quit smoking, and were divided into three groups: just under 300 (292) received 13 weeks' supply of commercially available e-cigarettes, each of which contained around 16mg nicotine. The same number (292) received 13 weeks' supply of nicotine patches, and a smaller number of participants (73) received placebo e-cigarettes, which contained no nicotine. Over 13 weeks of using the cessation aids, and 3 months further follow-up, participants underwent testing to establish whether they had managed to remain abstinent from cigarettes. At the end of the six-month study period, around one in twenty study participants (overall, 5.7%) had managed to remain completely abstinent from smoking. While the proportion of participants who successfully quit was highest in the e-cigarettes group (7.3%, compared to 5.8% for those in the nicotine patches group, and 4.1% in the placebo e-cigarettes group), these differences were not statistically significant. The results suggest that e-cigarettes are comparable to nicotine patches in helping people to quit for at least six months. Additionally, the results found no statistically significant difference in any adverse changes to health reported by participants in the e-cigarettes and the nicotine patches group. Among those who had not managed to quit after six months, cigarette consumption was markedly reduced in the nicotine e-cigarettes group, compared to the patches and placebo groups; well over half (57%) of the participants in the e-cigarettes group had reduced their daily consumption of cigarettes by at least half after six months, compared to just over two fifths (41%) of the patches group. In both of the nicotine and placebo e-cigarettes groups, a third of participants were still using the devices after six months, compared to under one in ten (8%) of those in the patches group. When asked whether they would recommend their allocated product to a friend one month after finishing the course, around 9 out of 10 participants in both the e-cigarettes and the placebo groups said they would, compared to just over half (56%) in the patches group; these proportions were little changed after six months. Professor Bullen said: "Our study establishes a critical benchmark for e-cigarette performance compared to nicotine patches and placebo e-cigarettes, but there is still so much that is unknown about the effectiveness and long-term effects of e-cigarettes. Given the increasing popularity of these devices in many countries, and the accompanying regulatory uncertainty and inconsistency, larger, longer-term trials are urgently needed to establish whether these devices might be able to fulfil their potential as effective and popular smoking cessation aids." European Respiratory Society President, Professor Francesco Blasi, said: "The introduction of e-cigarettes on the market has caused some debate amongst healthcare professionals. Our position is clear: we need more research on the positive or negative effects of these products. "This study has taken us one step closer to understanding the effectiveness of these devices as a quitting aid, but we still need long-term independent clinical trials and behavioural studies. It is also essential that research focuses on the safety of these devices, as this is still an area that is lacking data and the results of this study suggest many people are enthusiastic about the use of the devices. Until this strong scientific evidence exists, policymakers who are deciding how to regulate the devices should proceed with caution."

For more information: http://tinyurl.com/o2t9rzb

COPD World News Week of September 8, 2013

Novartis presents new data at ERS congress on investigational COPD drug

Dorval, QC - Novartis announced new analyses of data for investigational QVA149 (indacaterol 85 mcg/glycopyrronium 43 mcg delivered dose, equivalent to 110 mcg/50 mcg metered dose per capsule), which showed clinically significant improvements in lung function, shortness of breath and health-related quality of life for chronic obstructive pulmonary disease (COPD) patients versus those comparators evaluated in the study. These data were part of 39 respiratory abstracts presented at the European Respiratory Society (ERS) Annual Congress in Barcelona, Spain. First results from a pooled analysis of 4,891 COPD patients in the IGNITE clinical trial program (SHINE, ILLUMINATE and SPARK studies) showed that investigational QVA149 provided rapid and sustained improvements in lung function, and significantly reduced shortness of breath, evaluated against comparator treatments widely used as current standards of care evaluated in the study. These improvements were maintained throughout the duration of the trials. "These new trial results for investigational QVA149 are good news for my COPD patients who struggle each day with a disease that causes disabling breathlessness as they attempt simple everyday tasks," says Dr. Kenneth Chapman, Director, Asthma & Airway Centre of the University Health Network. "A new treatment option improving lung function and relieving breathlessness around the clock with just one inhalation will be a welcome advance." "COPD is known to affect an estimated 210 million people worldwide3 and is projected to be the third leading cause of death by 20204. Many patients find COPD symptoms really tough to cope with - even if they're already taking treatment," said Tim Wright, Global Head of Development, Novartis. "Novartis is pleased that these new analyses further support the efficacy of dual therapy, which has the potential to make a real difference to peoples' lives." Currently being assessed in a clinical trial program involving over 10,000 patients5-15, investigational QVA149 is a fixed-dose combination (FDC) of two bronchodilators, ONBREZ* BREEZHALER* (indacaterol maleate), a long-acting beta2-adrenergic agonist (LABA) and SEEBRI* BREEZHALER* (glycopyrronium bromide), a long-acting anticholinergic (LAAC). Both are currently used by healthcare professionals as individual therapies to treat COPD.

For more information: http://www.novartis.ca 

COPD World News Week of September 1, 2013

Women Smokers Face Increased Risk of Lethal Stroke

Queensland, Australia - Men and women who smoke face similar stroke risks, but female smokers may be at greater risk for a more deadly and less common type of stroke, according to a new study. Researchers examined data from more than 80 international studies published between 1966 and 2013 and found that smoking is associated with a more than 50 percent increased risk of ischemic stroke in both men and women. An ischemic stroke is the most common type of stroke, and occurs when a blood clot blocks blood flow to the brain. But women who smoked were 17 percent more likely to suffer a bleeding (hemorrhagic) stroke than men who smoked, according to the findings, which were published in the journal Stroke. The researchers also found evidence that men and women who smoke can significantly reduce their risk of stroke by quitting smoking. Hormones and the way nicotine affects blood fats may explain the increased risk for bleeding strokes among women who smoke, the study authors said. They noted that women who smoke have greater increases in fats, cholesterol and triglycerides than men who smoke. "Cigarette smoking is a major risk factor for stroke for both men and women, but fortunately, quitting smoking is a highly effective way to lower your stroke risk," study lead author Rachel Huxley, a professor in the School of Population Health at the University of Queensland, in Australia, said in a journal news release. "Tobacco-control policies should be a mainstay of primary stroke prevention programs." Although the research showed an association between women smoking and an increased risk of hemorrhagic stroke, it did not prove a cause-and-effect relationship.

For more information: http://www.nlm.nih.gov/medlineplus/news/fullstory_139993.html?utm_medium=email&utm_source=govdelivery

COPD World News Week of August 25, 2013

Quitting smoking in pregnancy tied to benefit for baby

New York, NY - Women who quit smoking immediately before or after becoming pregnant gain more weight during and after pregnancy - but their babies are less likely to be born small than those born to smokers, a new study suggests. Researchers in Denmark found that women who quit smoking gained about six more pounds during their pregnancies than those who continued to smoke and a similar amount in the year after giving birth. On the other hand, women who quit smoking early in pregnancy and non-smokers gave birth to babies of similar birth weights, on average. Babies of women who kept smoking were more likely to be born at a low weight. "The big thing to get out of this study is that quitting early in pregnancy is as helpful in respect to the birth weight of your baby as never having smoked while you were pregnant," Dr. Amber Samuel, a maternal-fetal medicine expert at Emory University School of Medicine in Atlanta, said. "I think that can be an inspiration to moms who are looking to make a change in their lives." According to the American Cancer Society, between 10 and 15 percent of women smoke during pregnancy. Studies have linked smoking to premature birth and other complications, such as birth defects, low birth weight and stillbirth. Infants have a three to four times higher risk of dying from sudden infant death syndrome, or "crib death," if their mothers smoke during and after pregnancy. Children exposed to secondhand smoke also have more ear infections, pneumonia, bronchitis, asthma and other health problems. The new study included 1,774 women who were part of the "Smoke-free Newborn" study conducted in Copenhagen, Denmark, between 1996 and 1999. Twice during pregnancy, researchers surveyed women about their smoking status. To double-check whether women who said they quit smoking really did, their saliva was checked for cotinine - created when nicotine is broken down in the body. About 38 percent of women were smokers before becoming pregnant, and half of them quit right before or soon after, Dr. Line Rode of Copenhagen University Hospital and colleagues found. During pregnancy, non-smokers gained almost 30 pounds, on average, smokers gained 29 pounds and quitters gained 35 pounds. Among women who quit smoking, 8 percent had babies born below the 10th percentile for birth weight, based on general Scandinavian records. In comparison, 22 percent of smokers had babies whose weight fell below that cut-off. Babies with low birth weight are at higher risk for infections, breathing and respiratory disorders, delayed growth and social development and learning disabilities. One year after giving birth, half of quitters were able to stay off cigarettes. Non-smokers and relapsed quitters both gained between 1.5 and 2 pounds post-pregnancy, successful quitters gained 7 pounds and smokers lost about half a pound, according to findings published in Obstetrics and Gynecology. "One strength of the study is that it tried to ferret out whether women who say they quit smoking actually did quit," Samuel, who was not involved in the research, told Reuters Health. On the other hand, she said the results may not apply to the current U.S. population. "There were very few obese women in this study," Samuel said. According to the Institute of Medicine, women with a normal pre-pregnancy weight should gain between 25 and 35 pounds during pregnancy and obese women should gain 11 to 20 pounds. Excessive weight gain during pregnancy is linked to birth complications and medical problems for the mother, such as gestational diabetes. Extra weight that stays on after pregnancy can increase a woman's risk for obesity, diabetes and heart disease. Samuel said most women in this study did not gain enough weight to offset the long-term benefits of not smoking. She said it's not possible to put a time frame on how late into pregnancy a woman can quit smoking and still see benefits for her baby, since the researchers did not analyze their results based on when, exactly, women kicked the habit.

For more information: http://www.nlm.nih.gov/medlineplus/news/fullstory_139926.html?utm_medium=email&utm_source=govdelivery

COPD World News Week of August 18, 2013

European regulator backs approval of Novartis' COPD therapy Ultibro Breezhaler

London, UK - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding approval of Novartis' Ultibro Breezhaler (indacaterol/glycopyrronium) as a maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD), the company reported. The inhaled therapy, which combines a long-acting beta-adrenergic agonist (LABA) and a long-acting muscarinic antagonist (LAMA), was developed under the name QVA149. Novartis noted that Ultibro is the "first once-daily fixed-dose combination of both a LABA and a LAMA bronchodilator to gain [a] positive CHMP opinion." David Epstein, head of the company's pharmaceuticals unit, remarked that the committee's decision "supports a major breakthrough in the treatment of COPD, where many patients do not have adequate treatment options." Epstein added that COPD "is projected to be the third leading cause of death by 2020." The CHMP's decision was supported by data from five trials from the IGNITE clinical programme, which included the SPARK study. Novartis noted that in the trials, Ultibro demonstrated significant improvements in bronchodilation compared to its two components alone, Pfizer's Spiriva (tiotropium) and placebo, providing a rapid onset within five minutes, and sustained bronchodilation during a 24-hour period, which was maintained for up to 26 weeks, along with symptomatic improvements. The company said the symptomatic improvements included breathlessness, exercise tolerance, rescue medication use and health-related quality of life. Novartis indicated that regulatory submissions and reviews of Ultibro are ongoing globally, and a US filing for the fixed-dose combination treatment is expected at the end of 2014. Analysts at Berenberg said Ultibro could generate annual sales of around $2.3 billion by 2021, of which $1.7 billion could be generated outside the US.

For more information: http://www.novartis.com/newsroom/media-releases/1718973.shtml

COPD World News Week of August 11, 2013

Parental smoking tied to kids' risk of lighting up

New York, NY - Children born to parents with a history of cigarette smoking are more likely to light up than kids of people who never smoked, according to a new U.S. study. Despite falling smoking rates across age groups, researchers found that children raised by current or even former smokers were about three times more likely to be smokers themselves during their teenage years than kids raised by parents who never smoked. "Things are getting better, but we can see it's best among the consistent non-smoking households," said Mike Vuolo, the study's lead author from Purdue University in West Lafayette, Indiana. Previous research has produced similar results, but the new study was based on 23 years of data on the smoking patterns of the parents in the study - 214 people who were ninth grade students in 1988 - to see whether their habits from adolescence onward were tied to their children's risk of smoking. For example, Vuolo and his colleague, who published their findings in Pediatrics, were able to compare the children of never-smokers and people who had smoked consistently since high school. They had data on 314 children of the original group of teens. In 2011, the kids of the second generation - all at least 11 years old - were asked if they had smoked cigarettes within the last year. Sixteen percent said yes. Among the children of parents who had never smoked, about 8 percent reported smoking cigarettes during the past year. That compared to between 23 percent and 29 percent of the children of current or former smokers. The researchers also looked at the parents' "trajectories" of smoking for clues about the parental influence on the children's behavior. They found that 23 percent of kids whose parents had smoked as adolescents but quit or reduced their smoking as young adults were smokers themselves. Among kids whose parents had smoked little or not at all in high school but started smoking in adulthood, 29 percent were smokers. And 25 percent of children whose parents had smoked consistently since high school were smokers. In addition, children who said they had smoked during the last year were more likely to be older, to display more symptoms of depression and to have low grades and low self-esteem. They were also more likely to feel distant from their parents and to have an older sibling who smoked. While the study can't prove that parental smoking caused the children to adopt the habit, Dr. Jonathan Winickoff, who has studied teen smoking behavior but wasn't involved in the new research, said the new results support past findings. "I think the first confirmatory result is that if you are a parent who smokes, your teenage child has a three-fold increased risk of smoking," Winickoff, an associate professor in Harvard Medical School's Department of Pediatrics in Boston, said. He added that there are several theories on why children of smokers may be at an increased risk of picking up the habit, including modeling their parents' behaviors, easy access to cigarettes and being "primed" for an addiction through second-hand smoke exposure. He cautioned, however, that the new study can't determine whether a child's risk of becoming a smoker falls if the parents stop smoking early-on, such as in their early adult years, because the group that contained those early quitters also included some current light smokers. "They can't say - based on these data - whether earlier parental quitting is associated with less smoking in their kids," he said. The researchers also warn that their findings may not apply to all smokers, because only 15 percent of the people included in their survey had a bachelor's degree or more education and most had their first child at a fairly young age. Vuolo added that they don't know whether these smoking rates in the second generation are an improvement over the past because they're only looking at one point in time. Going forward, they will be able to look at smoking rates over time as they collect more data. "We're going to be able to answer that question," he said.

For more information:  http://www.nlm.nih.gov/medlineplus/news/fullstory_139478.html

COPD World News Week of August 4, 2013

Tobacco Firm Pursues 'Safer' Cigarette

London, UK - A major tobacco company appears to be serious about developing a lower-risk cigarette, sponsoring clinical tests with prototypes containing reduced levels of toxic components. London-based British American Tobacco (BAT) said Monday that it would launch a 6-month controlled study of "reduced toxicant" cigarettes in which effects on respiratory function will be evaluated in current smokers. It follows an earlier, shorter trial published last month that evaluated the prototypes for effects on blood biomarkers of toxicant exposure. The prototypes described in that study contained tars and nicotine at levels similar to conventional cigarettes but with reduced levels of a variety of nitrosamines, aromatic amines, carbonyls, and polycyclic aromatic hydrocarbons. The new study, the protocol for which is published online in Biomed Central Public Health, won't come close to satisfying FDA requirements for marketing a reduced-risk cigarette. The agency said in a guidance document issued last year that it would need studies evaluating numerous aspects of such a product's overall impact on public health, besides the product's direct impacts on users' health. Whether the product's availability will influence non-smokers or ex-smokers to take up smoking or dissuade current smokers from quitting tobacco entirely. Whether the product's marketing may affect "consumer understanding and perceptions". The regulations allow companies to market cigarettes as simply reducing exposure to harmful chemicals, avoiding the need to demonstrate improved clinical health outcomes in users relative to smoking conventional cigarettes. But firms must still show that the reduced exposure "is reasonably likely to produce measurable and substantial reduction in morbidity and mortality" when evaluated in later studies. These requirements flesh out the 2009 legislation that gave the FDA authority to regulate tobacco products.

For more information: http://www.medpagetoday.com/PrimaryCare/Smoking

COPD World News Week of July 28, 2013

COPD Tied to Tiny Brain Bleeds

Ghent, Belgium - People with the lung condition called chronic obstructive pulmonary disease (COPD) are at increased risk for bleeding in the brain, a new study finds. Researchers looked at 165 people with COPD and 645 people with normal lung function and found that those with COPD were more likely to have what are called cerebral micro-bleeds. The more severe a patient's breathing problems, the more likely they were to have micro-bleeds, according to the study, published online July 19 in the American Journal of Respiratory and Critical Care Medicine. Cerebral micro-bleeds are an indicator of disease in the brain's small blood vessels (cerebral small vessel disease), which is an important cause of age-related mental decline and disability. It was known that people with COPD are at increased risk for large vessel disease, but these new findings "indicate that COPD might affect both large and small vessels," study author Lies Lahousse, of Ghent University Hospital in Belgium, said in a journal news release. The results also show that methods of preventing cerebral micro-bleeds in COPD patients need to be developed, Lahousse said. Although the study found a link between having COPD and higher risk of cerebral micro-bleeds, it did not establish a cause-and-effect relationship.

For more information: http://www.nlm.nih.gov/medlineplus/news/fullstory_138888.html

COPD World News Week of July 21, 2013

Homeless Face Hidden Epidemic of Smoking

Boston, MA - The rate of addiction to cigarettes is extremely high among Americans who are homeless, experts say, and this population needs better access to methods of helping them quit. There are up to 3.5 million homeless people in the United States and three-quarters of them smoke cigarettes, "a rate that's four times higher than in the general population," say doctors writing in the July 18 issue of the New England Journal of Medicine. As a consequence, "homeless people seem to be dying of smoking-related causes at high rates," said Dr. Travis Baggett, an instructor of medicine at Harvard University. Baggett has been tracking the health problems of 28,000 homeless people in Boston for more than six years as part of his involvement with the Boston Health Care for the Homeless Program. "Cancer is the second leading cause of death overall [for homeless people] and heart disease is the third leading cause of death overall," he said. "The leading type of cancer death was lung cancer." Treatment of those diseases is expensive and paid for by taxpayer-funded programs, which gives all Americans an economic incentive to tackle the issue. But Baggett and other experts say there's also a moral imperative to help homeless smokers quit. "They've sadly been a target of the tobacco industry," Cheryl Healton, president and CEO of Legacy, a national non-profit that promotes public health, pointed out. "Over time, the tobacco epidemic has become more and more concentrated among those least in a position to pay for cessation services and access health care," she said. According to Baggett, once a homeless person starts smoking, health care workers often don't view quitting smoking as their top priority. That's because homeless people may appear to have more urgent needs -- namely finding food and shelter. "A chronic problem like smoking seems like it maybe shouldn't be the most pressing issue at the forefront of what we're tackling with them. I can certainly understand that," said Baggett, who admits that he didn't discuss smoking with his homeless patients for a long time. However, he said, "as you take a step back and look at the public health implications and public health impact, what we're finding is difficult to ignore." And Baggett said that health care workers often make a mistake when they assume that people who are homeless don't want help to quit. "The vast majority of homeless people, just like any other type of patient we see, they want to be healthy. They want to feel better," he said. "There's something that's reaffirming about addressing issues like exercise and smoking, even with people who are living in extreme circumstances because there's something normalizing and affirming about that," Baggett added. What's more, Baggett said a strong case can be made for the idea that an addiction to tobacco, which is expensive, is a factor that may keep people from escaping the streets. "It's not just a financial cost, it's also an opportunity cost, because [of] all the time that's spent getting money for cigarettes." he said. "It's probably contributing to keeping people in the cycle of poverty."

For more information: http://www.nlm.nih.gov/medlineplus/news/fullstory_138803.html

COPD World News Week of July 14, 2013

Anti-Smoking Policies Will Prevent 7 Million Deaths Worldwide by 2050

Washington, DC - Anti-tobacco policies really do stop people from smoking and save millions of lives, a new study finds. Tobacco control measures enacted in 41 countries between 2007 and 2010 will prevent about 7.4 million premature deaths by 2050, according to the study published June 30 in the Bulletin of the World Health Organization. "It's a spectacular finding that by implementing these simple tobacco control policies, governments can save so many lives," study lead author David Levy, a professor of oncology at Georgetown University Medical Center in Washington, D.C., said in a medical center news release. Levy's team used a modeling exercise to predict the number of lives that will be saved. The measures the countries implemented include: protecting people from tobacco smoke, offering smokers help to quit, warning people about the dangers of tobacco, banning tobacco ads, promotion and sponsorship, and raising taxes on tobacco. "In addition to some 7.4 million lives saved, the tobacco control policies we examined can lead to other health benefits, such as fewer adverse birth outcomes related to maternal smoking, including low birth weight, and reduced health-care costs and less loss of productivity due to less smoking-related disease," Levy added. Dr. Douglas Bettcher, director of the department of non-communicable diseases at the World Health Organization, added that wider implementation of these anti-smoking measures would allow the prevention of millions more smoking-related deaths. "Tobacco use is the single most preventable cause of death in the world, with 6 million smoking-attributable deaths per year today, and these deaths are projected to rise to 8 million a year by 2030, if current trends continue," Bettcher said in the news release. "By taking the right measures, this tobacco epidemic can be entirely prevented." The 41 countries in the study included a total of nearly one billion people, or one-seventh of the world's population in 2008. The total number of smokers in those countries was nearly 290 million in 2007, the study authors noted.

For more information: http://www.nlm.nih.gov/medlineplus/news/fullstory_138311.html
 

COPD World News Week of July 7, 2013

Weight Gain May Limit Effects of Smoking Cessation

Bloomington, IN - Postmenopausal women who gained weight after they stopped smoking lost some of smoking cessation's protection against heart disease, particularly if they were diabetic, data from the Women's Health Initiative showed. Diabetic women who gained 11 lbs. or more after they stopped smoking had a risk of coronary heart disease (CHD) similar to that of diabetic women who continued to smoke, reported Juhua Luo, PhD, of Indiana University School of Public Health in Bloomington, and colleagues. Weight gain attenuated, but did not negate, the cardiac benefits of smoking cessation in non-diabetic women, they wrote in a research letter in the July 3 issue of JAMA. "In this study, smoking cessation was associated with a lower risk of CHD among postmenopausal women with and without diabetes," Luo's group concluded. Weight gain following smoking cessation weakened this association, especially for women with diabetes who gained 5 kg [11 lbs.] or more, although power was limited in this subgroup due to the small number of cases." Smoking cessation substantially reduces the risk of cardiovascular disease, although some evidence suggests that weight gain after smoking cessation might weaken the benefits of quitting. Limited data have indicated that weight gain in diabetic patients does not reduce the cardiovascular benefits of smoking cessation. However, the study had limited statistical power to evaluate outcomes in diabetic patients and the more specific outcome of CHD, the authors noted. To clarify the potential effects of weight gain on CHD risk reduction after smoking cessation, the authors analyzed data from the Women's Health Initiative (WHI), specifically examining the association between smoking cessation, weight gain, and subsequent CHD risk among postmenopausal women with and without diabetes. The WHI involved 161,808 postmenopausal women recruited during 1993 to 1998 at 40 sites in the U.S. Follow-up occurred at 6- to 12-month intervals. Smoking status was self-reported at baseline and at year three. Never smokers and former smokers did not smoke at either time. Newly quit smokers had stopped between baseline and year three, and current smokers smoked at baseline and 3 years. Diabetes also was self-reported and defined by a positive history at baseline or year 3. The analysis involved study participants who were free of cancer and cardiovascular disease at baseline or free of CHD at year 3. Follow-up continued until diagnosis of CHD, death, loss to follow-up, or Sept. 30, 2010. During a mean follow-up of 8.8 years, 3,381 WHI participants developed CHD. The incidence was 3.3 per 1,000 person-years in never smokers, 3.7 in former smokers, 7.6 in current smokers, and 5.3 in participants who had newly quit. Among 98,053 participants without diabetes, the newly quit subgroup had an adjusted hazard ratio for CHD of 0.74 compared with current smokers. Former smokers had an HR of 0.39 versus current smokers. In the 6,338 women with diabetes, those who had newly quit smoking had a CHD HR of 0.36 versus current smokers, and former smokers had a HR of 0.41. Among women who gained less than 5 kg, the association between smoking status and CHD was similar to the overall results of women with and without diabetes. Non-diabetic women who were former smokers and gained 5 to 10 kg or more than 10 kg (22 lbs.) had a lower CHD risk compared with current smokers, but newly quit smokers who gained 5 to 10 kg or more than 10 kg did not. Among diabetic women who gained 5 to 10 kg, smoking cessation (either newly quit or former smokers) did not reduce CHD risk compared with current smokers. The subgroup of diabetic women who gained more than 10 kg was too small to ascertain associations with smoking cessation and CHD risk, the authors stated. Another study limitation was that it included only postmenopausal women and did not account for changes in smoking, weight, or diabetes status after year three.

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