Varenicline Use Linked to Adverse Cardiovascular Events

Increased risk of serious adverse cardiovascular events with varenicline use for tobacco users

TUESDAY, July 5 (HealthDay News) -- Use of the smoking-cessation drug varenicline is associated with an increase in the risk of serious adverse cardiovascular events among tobacco users, according to a meta-analysis published online July 4 in CMAJ, the journal of the Canadian Medical Association.

Sonal Singh, M.D., M.P.H., from the Johns Hopkins University School of Medicine in Baltimore, and colleagues reviewed available literature from September 2010 to March 2011 to compare and assess the risk of serious adverse cardiovascular events between varenicline and placebo among tobacco users. A total of 14 randomized controlled trials (RCTs), involving 8,216 participants (smokers or people who used smokeless tobacco), and varying between seven to 52 weeks in duration, were included in the analysis. The RCTs reported cardiovascular events (ischemia, arrhythmia, congestive heart failure, sudden death, or cardiovascular-related death) as serious adverse events linked to the use of varenicline.

The investigators found that compared with placebo, varenicline use was associated with a significantly increased risk of serious adverse cardiovascular events (0.82 percent in placebo group and 1.06 percent in varenicline; odds ratio, 1.72). The results from several sensitivity analyses and those of the main analysis were consistent and there was no publication bias. Meaningful comparisons of mortality could not be done due to the low number of deaths.

"Our meta-analysis raises safety concerns about the potential for an increased risk of serious adverse cardiovascular events associated with the use of varenicline among tobacco users," the authors write.

One of the study authors disclosed financial ties to Pfizer.

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