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Question: Does use of varenicline for tobacco cessation increase risk for treatment-emergent, cardiovascular (CV) serious adverse events in adult tobacco users? Review scope: Included studies compared varenicline with an inactive control in current adult tobacco users and reported adverse events. The primary outcome was treatment-emergent, CV serious adverse events defined as any ischemic or arrhythmic adverse CV event (myocardial infarction, unstable angina, coronary revascularization, coronary artery disease, arrhythmia, transient ischemic attack, stroke, sudden death or CV-related death, or congestive heart failure) occurring during drug treatment or within 30 days of drug discontinuation. Review methods: MEDLINE, Cochrane Library, ClinicalTrials.gov, and Clinical Study Results registry (all 2005 to Sep 2011), reviews and reference lists were searched for randomized controlled trials (RCTs). 22 RCTs (n = 9232, 49% to 100% men, median treatment duration 12 wk, median follow-up for adverse events 16 wk, median study duration 25 wk) met selection criteria. For 3 RCTs, the drug manufacturer (Pfizer) or study authors were contacted for data on timing of CV serious adverse events. 20 RCTs included cigarette smokers, and 2 RCTs included smokeless tobacco users. 13 RCTs included patients with current or past CV disease; 9 RCTs excluded patients with history of CV disease or did not specify timing of CV history for exclusion. Varenicline dose was 1 mg twice daily in 21 RCTs, and 3 of these RCTs also included lower doses. 1 RCT assessed varenicline, 1 mg, once daily. All RCTs were double-blind and had adequate descriptions of randomization, loss to follow-up, and CV serious adverse events. Main results: Varenicline did not increase CV serious adverse events compared with placebo (Table). Conclusion: In adult tobacco users, varenicline for tobacco cessation did not increase treatment-emergent, cardiovascular serious adverse events compared with placebo. [ABSTRACT FROM AUTHOR]