Citation

Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S. Circulation 2010; 121(2): 221-229.

Copyright

(Copyright © 2010, American Heart Association, Publisher Lippincott Williams and Wilkins)

DOI

10.1161/CIRCULATIONAHA.109.869008

PMID

unavailable

Abstract

BACKGROUND: Smoking cessation is a key component of secondary cardiovascular disease prevention. Varenicline, a partial α4β2 nicotinic acetylcholine receptor agonist, is effective for smoking cessation in healthy smokers, but its efficacy and safety in smokers with cardiovascular disease are unknown.

METHODS and Results: A multicenter, randomized, double-blind, placebo-controlled trial compared the efficacy and safety of varenicline with placebo for smoking cessation in 714 smokers with stable cardiovascular disease. Participants received varenicline (1 mg twice daily) or placebo, along with smoking-cessation counseling, for 12 weeks. Follow-up lasted 52 weeks. The primary end point was carbon monoxide-confirmed continuous abstinence rate for weeks 9 through 12 (last 4 weeks of treatment). The continuous abstinence rate was higher for varenicline than placebo during weeks 9 through 12 (47.0% versus 13.9%; odds ratio, 6.11; 95% confidence interval [CI], 4.18 to 8.93) and weeks 9 through 52 (19.2% versus 7.2%; odds ratio, 3.14; 95% CI, 1.93 to 5.11). The varenicline and placebo groups did not differ significantly in cardiovascular mortality (0.3% versus 0.6%; difference,-0.3%; 95% CI,-1.3 to 0.7), all-cause mortality (0.6% versus 1.4%; difference,-0.8%; 95% CI,-2.3 to 0.6), cardiovascular events (7.1% versus 5.7%; difference, 1.4%; 95% CI,-2.3 to 5.0), or serious adverse events (6.5% and 6.0%; difference, 0.5%; 95% CI,-3.1 to 4.1). As a result of adverse events, 9.6% of varenicline and 4.3% of placebo participants discontinued study drug.

CONCLUSIONS: Varenicline is effective for smoking cessation in smokers with cardiovascular disease. It was well tolerated and did not increase cardiovascular events or mortality; however, trial size and duration limit definitive conclusions about safety. CLINICAL TRIAL REGISTRATION INFORMATION-: URL: http://www.clinicaltrials.gov/ ct2/show/NCT00282984. Unique identifier: NCT00282984. © 2010 American Heart Association. All rights reserved.

Language: en

Keywords

adult; human; female; male; aged; insomnia; suicidal ideation; depression; randomized controlled trial; mortality; behavior change; scoring system; suicide attempt; clinical trial; Smoking; dissociative disorder; mood disorder; emotional disorder; fatigue; article; major clinical study; vomiting; controlled study; sexual dysfunction; dysthymia; cognitive defect; priority journal; controlled clinical trial; double blind procedure; headache; neurosis; carbon monoxide; anxiety disorder; constipation; confusion; drug safety; placebo; cigarette smoking; drug efficacy; diarrhea; nausea; drug withdrawal; multicenter study; dysphoria; restlessness; delirium; nightmare; cardiovascular disease; side effect; apathy; phobia; Cerebrovascular disorders; smoking cessation; dyspepsia; dizziness; tobacco dependence; Cardiovascular diseases; libido disorder; mood change; attention disturbance; vital sign; abnormal dreaming; listlessness; rhinopharyngitis; varenicline; Peripheral vascular diseases; Trials