Paul Krebs, PhD; Scott E. Sherman, MD, MPH
Does use of varenicline for tobacco cessation increase risk for treatment-emergent, cardiovascular (CV) serious adverse events in adult tobacco users?
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.
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.
Varenicline did not increase CV serious adverse events compared with placebo (Table).
In adult tobacco users, varenicline for tobacco cessation did not increase treatment-emergent, cardiovascular serious adverse events compared with placebo.
Varenicline vs placebo for tobacco cessation in adult tobacco users*
*CV = cardiovascular; other abbreviations defined in Glossary. Weighted event rate, RRI, and CI calculated from control event rate and relative risk in article using a fixed-effect model. 8 randomized controlled trials (n = 1596) with 0 events in both groups were included in the calculation of the control event rate but not in the calculation of the RRI.
†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.
Krebs P, Sherman SE. Review: Varenicline for tobacco cessation does not increase CV serious adverse events. Ann Intern Med. ;157:JC2–2. doi: 10.7326/0003-4819-157-4-201208210-02002
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Published: Ann Intern Med. 2012;157(4):JC2-2.
Cardiology, Coronary Risk Factors, Smoking, Tobacco, Alcohol, and Other Substance Abuse.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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