Varenicline did not increase the rate of cardiovascular (CV) serious adverse events, according to data from a systematic review and meta-analysis published in the Journal of the American Heart Association.

Varenicline, an alpha4-beta2 nicotinic acetylcholine receptor partial agonist, is an effective option for smoking cessation. Previous studies, however, have shown opposing data regarding its CV safety. Researchers evaluated 38 randomized controlled trials enrolling over 12,000 patients that compared varenicline with placebo for smoking cessation. The trials reported CV adverse events and/or all-cause mortality during the treatment period or within 30 days of discontinuation.

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Study data showed events were generally rare in both varenicline and placebo arms (75/7213 vs. 43/5493). No difference was seen for CV serious adverse events in the varenicline arm vs. placebo (RR 1.03, 95% CI: 0.64–1.64). Further, rates of death were rare in both arms (11/7213 vs. 9/5493, respectively). Pooled data of all-cause mortality also found no difference between the groups (RR 0.88, 95% CI: 0.50–1.52) even when stratified by patients with (RR 1.24, 95% CI 0.40–3.83) and without (RR 0.77, 95% CI: 0.40–1.47) CV disease.

Researchers concluded there was no evidence that varenicline increased the rate of CV serious adverse events; rates were comparable among those with and without CV disease. Varenicline should continue to be used for smoking cessation, they added.

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