Smoking cessation pharmacotherapies may not increase the risk for serious cardiovascular adverse events during or after treatment, according to a study published by JAMA Internal Medicine.
Researchers recruited 8058 individuals and conducted a 28-week additional follow-up on a previously completed double-blind randomized triple-dummy placebo-and active-controlled trial (Evaluating Adverse Events in a Global Smoking Cessation Study [EAGLES]; ClinicalTrials.gov Identifier: NCT01574703) conducted at 140 multinational centers.
The study observed smokers with or without an established psychiatric diagnosis and assigned them to receive one of three different smoking cessation pharmacotherapies: varenicline, 1 mg twice daily; bupropion hydrochloride, 150 mg twice daily; and nicotine replacement therapy (NRT), 21 mg/d patch with tapering.
The purpose of the study was to compare the safety profiles of smoking cessation treatments with cardiovascular adverse events. The study’s primary end point was time to a major adverse cardiovascular event (MACE).
Study results demonstrated the number of medication exposure days were similar in all groups. Smoking cessation rates from weeks 9 to12 were 33.5%, 22.6%, 23.4%, and 12.5% for varenicline, bupropion, NRT, and placebo, respectively. The time to MACE or MACE+ (MACE or new-onset or worsening of peripheral vascular diseases requiring intervention, coronary revascularization, or hospitalization for unstable angina) was not significantly different (log-rank test P >.05) overall or in groups with or without psychiatric disease compared with placebo at any point in the study. In addition, there were no statistically significant differences in time to MACE+ in patients treated with varenicline or bupropion vs placebo.
There were no observable differences in incidence of any cardiovascular event across the groups, with total events of 26, 47, 14, 8, 11, 18, 3, 18, and 7 for MACE, MACE+, nonfatal MI, nonfatal stroke, new or worsening peripheral vascular disease, coronary revascularization, hospitalization for unstable angina, serious cardiac arrhythmia, and hospitalization for congestive heart failure, respectively. There were no differences in laboratory tests or electrocardiograph results between any of the treatment groups.
However, it is important to note that this study did not include individuals with unstable or acute cardiovascular disease, and therefore the study findings may not be applicable in this patient population.
Researchers concluded that there were no significant differences between treatment groups during the 12 weeks of treatment, 30 days post-treatment, and up to 52 weeks after treatment. There were also no differences in time to cardiovascular events across the treatment groups, and there were no observable effects of smoking cessation medications on heart rate or blood pressure. Therefore, clinicians should consider the use of these pharmacotherapies to assist in smoking cessation as they do not increase the risk for cardiovascular events but are beneficial in improving cardiovascular health as a result of smoking cessation.
Benowitz NL, Pipe A, West R, et al. Cardiovascular safety of varenicline, bupropion and nicotine patch in smokers [published online April 9, 2018]. JAMA Intern Med. doi:10.1001/jamainternmed.2018.0397