Varenicline was associated with a 72% increased risk of serious adverse cardiovascular events compared with placebo (OR 1.72) among tobacco users.
Meta-Analysis (n=8,216)
Double-blind
Does varenicline increase the risk of serious adverse cardiovascular events compared with placebo among tobacco users?
Varenicline use in tobacco users is associated with a significantly increased risk of serious adverse cardiovascular events compared to placebo, raising important safety concerns that must be weighed against the benefits of smoking cessation.
Effect estimate: OR 1.72 (95% CI 1.09-2.71)
Absolute Event Rate: 1.06% vs 0.82%
BACKGROUND: There have been postmarketing reports of adverse cardiovascular events associated with the use of varenicline, a widely used smoking cessation drug. We conducted a systematic review and meta-analysis of randomized controlled trials to ascertain the serious adverse cardiovascular effects of varenicline compared with placebo among tobacco users. METHODS: We searched MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews, websites of regulatory authorities and registries of clinical trials, with no date or language restrictions, through September 2010 (updated March 2011) for published and unpublished studies. We selected double-blind randomized controlled trials of at least one week's duration involving smokers or people who used smokeless tobacco that reported on cardiovascular events (ischemia, arrhythmia, congestive heart failure, sudden death or cardiovascular-related death) as serious adverse events asociated with the use of varenicline. RESULTS: We analyzed data from 14 double-blind randomized controlled trials involving 8216 participants. The trials ranged in duration from 7 to 52 weeks. Varenicline was associated with a significantly increased risk of serious adverse cardiovascular events compared with placebo (1.06% 52/4908 in varenicline group v. 0.82% 27/3308 in placebo group; Peto odds ratio OR 1.72, 95% confidence interval CI 1.09-2.71; I(2) = 0%). The results of various sensitivity analyses were consistent with those of the main analysis, and a funnel plot showed no publication bias. There were too few deaths to allow meaningful comparisons of mortality. INTERPRETATION: 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.
Singh et al. (2011) conducted a meta-analysis in Tobacco use (n=8,216). Varenicline vs. Placebo was evaluated on Any ischemic or arrhythmic adverse cardiovascular event (OR 1.72, 95% CI 1.09-2.71). Varenicline was associated with a 72% increased risk of serious adverse cardiovascular events compared with placebo (OR 1.72) among tobacco users.