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Smokers using varenicline to quit the habit at greater risk of heart attack
Date:7/4/2011

Healthy, middle-aged smokers who take the most popular smoking cessation drug on the market have a 72 percent increased risk of being hospitalized with a heart attack or other serious heart problems compared to those taking a placebo, a Johns Hopkins-led study suggests.

"People want to quit smoking to reduce the risk of cardiovascular disease but in this case they're taking a drug that increases the risk for the very problems they're trying to avoid," says Sonal Singh, M.D., M.P.H., an assistant professor of general internal medicine at the Johns Hopkins University School of Medicine and the lead author of the research.

In the study, described in the Canadian Medical Association Journal, Singh and his colleagues reviewed and analyzed 14 double-blind, randomized, controlled clinical trials involving more than 8,200 healthy people who received either varenicline (made by Pfizer and sold in the United States under the brand-name Chantix) or a placebo. Whereas the number of people who died in each group was the same (seven), the increased risk of a major harmful cardiovascular event requiring hospitalization such as a heart attack or arrhythmia was 72 percent in the varenicline arms. None of the studies followed people for longer than a year. The average age of study participants was less than 45 years and the majority were men.

Varenicline has been shown to modestly increase the chances of a successful quit attempt, compared to unassisted smoking cessation attempts. But overall, the majority of smokers who quit do so without any pharmaceutical assistance at all.

Moreover, Singh noted, varenicline already carries a boxed warning the Food and Drug Administration's highest level of caution because of its association with suicidal thoughts and behaviors. "We notified the FDA of our cardiovascular safety concerns with Chantix earlier this year," Singh says.

On June 16, the FDA announced that on the basis of a 700-
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Contact: Stephanie Desmon
sdesmon1@jhmi.edu
410-955-8665
Johns Hopkins Medical Institutions
Source:Eurekalert

Page: 1 2

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