Benowitz NL, et al. - This study was conducted to evaluate the relative cardiovascular safety risk of smoking cessation treatments varenicline, bupropion, and nicotine replacement therapy. Researchers did not find evidence that smoking cessation pharmacotherapies increase the risk of serious cardiovascular adverse events during or after treatment.

Methods

• The study was a double-blind, randomized, triple-dummy, placebo- and active-controlled trial (Evaluating Adverse Events in a Global Smoking Cessation Study [EAGLES]) and its nontreatment extension trial.
• It was carried out at 140 multinational centers.
• Study participants included smokers, with or without established psychiatric diagnoses, who received at least 1 dose of study medication (n = 8,058), along with a subset of those who completed 12 weeks of treatment plus 12 weeks of follow up and agreed to be followed up for an additional 28 weeks (n = 4,595).
• Among the 8,058 participants, 3,553 (44.1%) were male (mean [SD] age, 46.5 [12.3] years).
• Varenicline, 1 mg twice daily; bupropion hydrochloride, 150 mg twice daily; and nicotine replacement therapy, 21-mg/d patch with tapering served as the interventions.
• The primary end point was the time to development of a major adverse cardiovascular event (MACE: cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) during treatment.
• The occurrence of MACE and other pertinent cardiovascular events (MACE+: MACE or new-onset or worsening peripheral vascular disease requiring intervention, coronary revascularization, or hospitalization for unstable angina) served as the secondary end points.

Results

• Data illustrated a low incidence of cardiovascular events during treatment and follow-up (<0.5% for MACE; <0.8% for MACE+), and no significant variances were seen among treatments.
• Furthermore, there were no marked treatment differences in the time to cardiovascular events, blood pressure, or heart rate.
• Findings did not disclose any major difference in time to onset of MACE for either varenicline or bupropion treatment vs placebo (varenicline: hazard ratio, 0.29; 95% CI, 0.05-1.68 and bupropion: hazard ratio, 0.50; 95% CI, 0.10-2.50).