Varenicline linked to increased chance for serious CV events

Singh S. CMAJ. 2011;doi:10.1503/cmaj.110218.

The use of varenicline, a medication used for smoking cessation, was associated with an increased risk for serious adverse CV events, results from a meta-analysis suggested.

The researchers analyzed data from 14 double blind, randomized controlled trials that included 8,216 participants. The studies included smokers or users of smokeless tobacco who had reported CV events such as ischemia, arrhythmia, congestive HF, sudden death or CV-related death as serious adverse events linked with the use of the drug. The trials ranged in duration from 7 weeks to 1 year.

According to the results, the use of varenicline (Chantix, Pfizer) was associated with an increased risk for serious adverse CV events (52 of 4,908 patients) vs. placebo (27 of 3,308 patients; 1.06% vs. 0.82%; Peto OR=1.72; 95% CI, 1.09-2.71). The researchers said there were not enough patients in the analysis to allow meaningful comparisons of mortality.

“Our meta-analysis raises safety concerns about the potential for an increased risk of serious adverse CV events associated with the use of varenicline among tobacco users,” the researchers concluded. “Despite the limitations of our analysis, our findings have potential regulatory and clinical implications.”

In an addendum, the researchers said the FDA had announced the addition of a warning to the product label of varenicline regarding “the small increased risk of certain adverse CV events associated with the use of varenicline among smokers with CVD.”

Disclosure: The study researchers report no relevant financial disclosures.

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