1. Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial.
- Author
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Benowitz, Neal L, Pipe, Andrew, West, Robert, Hays, J Taylor, Tonstad, Serena, McRae, Thomas, Lawrence, David, St Aubin, Lisa, and Anthenelli, Robert M
- Subjects
Humans ,Cardiovascular Diseases ,Bupropion ,Incidence ,Risk Factors ,Double-Blind Method ,Smoking Cessation ,Middle Aged ,Female ,Male ,Varenicline ,Smoking Cessation Agents ,Tobacco Use Cessation Devices ,Outcome Assessment ,Health Care ,Clinical Research ,Substance Misuse ,Cardiovascular ,Prevention ,Tobacco Smoke and Health ,Brain Disorders ,Clinical Trials and Supportive Activities ,Tobacco ,Patient Safety ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Good Health and Well Being ,Clinical Sciences ,Opthalmology and Optometry ,Public Health and Health Services - Abstract
ImportanceQuitting smoking is enhanced by the use of pharmacotherapies, but concerns have been raised regarding the cardiovascular safety of such medications.ObjectiveTo compare the relative cardiovascular safety risk of smoking cessation treatments.Design, setting, and participantsA 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.InterventionsVarenicline, 1 mg twice daily; bupropion hydrochloride, 150 mg twice daily; and nicotine replacement therapy, 21-mg/d patch with tapering.Main outcomes and measuresThe 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).ResultsOf 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 (
- Published
- 2018