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Varenicline for smoking cessation linked to increased risk of serious harmful cardiac events
Date:7/4/2011

The use of varenicline to stop smoking is associated with a 72% increased risk of a serious adverse cardiovascular event, states an article in CMAJ (Canadian Medical Association Journal) (pre-embargo link only) http://www.cmaj.ca/embargo/cmaj110218.pdf.

Heart disease is a common cause of serious illness and death in smokers and is often a reason for people to stop smoking. Varenicline is one of the most commonly used drugs to help people quit smoking worldwide. When varenicline was launched in 2006, the US Food and Drug Administration (FDA) safety reviewers reported that existing data indicated it could raise the risk of adverse cardiac events. The FDA recently updated the label for Chantix based on a small increased risk of cardiovascular events among smokers with heart disease.

A team of researchers from Johns Hopkins University School of Medicine, Baltimore, Maryland; the University of East Anglia, Norwich, United Kingdom; and Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, sought to investigate the serious cardiac effects of varenicline in tobacco users (smokers or smokeless tobacco users) compared with placebos in clinical trials. They looked at 14 trials that included 8216 patients (4908 people on varenicline and 3308 taking placebos). All trials except one excluded people with a history of heart disease.

In the study, 52 of 4908 (1.06%) participants taking varenicline had adverse events compared with 27 of 3308 (0.82%) participants on placebo. Seven of the 4908 people taking varenicline died compared with 7 of 3308 receiving placebo.

"Among tobacco users varenicline use was associated with a significantly increased risk of serious adverse cardiovascular events greater than 72%," writes Dr. Sonal Singh, Johns Hopkins University School of Medicine, Baltimore, Maryland, with coauthors.

"However, despite achieving more than twofold higher rates of a
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Contact: Kim Barnhardt
kim.barnhardt@cmaj.ca
613-520-7116 x2224
Canadian Medical Association Journal
Source:Eurekalert

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