James M. Brophy, MD, PhD
In tobacco users, does varenicline increase risk for serious adverse cardiovascular events compared with placebo?
Included studies compared varenicline with placebo in tobacco users, had ≥ 1 week of follow-up, and reported adverse cardiovascular events (myocardial infarction, unstable angina, coronary revascularization, coronary artery disease, arrhythmias, transient ischemic attacks, stroke, sudden death or cardiovascular-related death, or congestive heart failure).
MEDLINE, EMBASE/Excerpta Medica, and Cochrane Central Register of Controlled Trials were searched to March 2011 for double-blind, randomized, controlled trials (RCTs). The US Food and Drug Administration and European Medicines Agency Web sites, ClinicalTrials.gov Results Database, and industry-sponsored Clinical Study Results Database were searched for unpublished studies. Reference lists of included trials and reviews were also searched. 14 RCTs (n = 8216, mean age range 40 to 57 y, 48% to 89% men) met inclusion criteria. 13 RCTs included persons who smoked, and 1 included users of smokeless tobacco. 13 RCTs excluded persons with a history of cardiovascular disease. Varenicline dose was 1 mg twice daily in most trials. 9 RCTs were judged to have low risk for bias (adequate sequence generation, allocation concealment and double-blinding, and clear reporting of withdrawal rates), and 5 had unclear risk for bias (incomplete reporting of randomization).
Meta-analysis showed that varenicline increased risk for serious adverse cardiovascular events compared with placebo (Table).
In tobacco users, varenicline increases risk for serious adverse cardiovascular events compared with placebo.
*Abbreviations defined in Glossary. RRI, NNH, and CI calculated from odds ratio and control event rate in article using a fixed-effect model.
†Myocardial infarction, unstable angina, coronary revascularization, coronary artery disease, arrhythmias, transient ischemic attacks, stroke, sudden death or cardiovascular-related death, or congestive heart failure.
Brophy JM. Review: Varenicline increases risk for serious adverse cardiovascular events in tobacco users. Ann Intern Med. ;155:JC4–5. doi: 10.7326/0003-4819-155-8-201110180-02005
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Published: Ann Intern Med. 2011;155(8):JC4-5.
Cardiology, Coronary Risk Factors, Prevention/Screening, Smoking.
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