Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers

Autor: Neal L. Benowitz, Thomas McRae, Robert West, Serena Tonstad, David Lawrence, Robert M. Anthenelli, Lisa St Aubin, Andrew L. Pipe, J. Taylor Hays
Rok vydání: 2018
Předmět:
Zdroj: JAMA Internal Medicine. 178:622
ISSN: 2168-6106
DOI: 10.1001/jamainternmed.2018.0397
Popis: IMPORTANCE: Quitting smoking is enhanced by the use of pharmacotherapies, but concerns have been raised regarding the cardiovascular safety of such medications. OBJECTIVE: To compare the relative cardiovascular safety risk of smoking cessation treatments. DESIGN, SETTING, AND PARTICIPANTS: 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 was conducted at 140 multinational centers. Smokers, with or without established psychiatric diagnoses, who received at least 1 dose of study medication (n = 8058), as well as 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 = 4595), were included. INTERVENTIONS: Varenicline, 1 mg twice daily; bupropion hydrochloride, 150 mg twice daily; and nicotine replacement therapy, 21-mg/d patch with tapering. MAIN OUTCOMES AND MEASURES: 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; secondary end points were 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). RESULTS: Of the 8058 participants, 3553 (44.1%) were male (mean [SD] age, 46.5 [12.3] years). The incidence of cardiovascular events during treatment and follow-up was low (
Databáze: OpenAIRE