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Smoking Cessation With Varenicline, a Selective 42 Nicotinic Receptor Partial Agonist

Results From a 7-Week, Randomized, Placebo- and Bupropion-Controlled Trial With 1-Year Follow-up

Mitchell Nides, PhD; Cheryl Oncken, MD, MPH; David Gonzales, PhD; Stephen Rennard, MD; Eric J. Watsky, MD; Rich Anziano, MS; Karen R. Reeves, MD; for the Varenicline Study Group

Arch Intern Med. 2006;166:1561-1568.

Background  Currently available smoking cessation therapies have limited success rates. Varenicline tartrate is a novel, selective nicotinic receptor partial agonist developed specifically for smoking cessation. This study evaluated the efficacy, tolerability, and safety of 3 varenicline doses for smoking cessation. Bupropion hydrochloride was included as an active control.

Methods  A phase 2, multicenter, randomized, double-blind, placebo-controlled study of healthy smokers (18-65 years old). Subjects were randomized to varenicline tartrate, 0.3 mg once daily (n = 128), 1.0 mg once daily (n = 128), or 1.0 mg twice daily (n = 127), for 6 weeks plus placebo for 1 week; to 150-mg sustained-release bupropion hydrochloride twice daily (n = 128) for 7 weeks; or to placebo (n = 127) for 7 weeks.

Results  During the treatment phase, the continuous quit rates for any 4 weeks were significantly higher for varenicline tartrate, 1.0 mg twice daily (48.0%; P<.001) and 1.0 mg once daily (37.3%; P<.001), than for placebo (17.1%). The bupropion rate was 33.3% (P = .002 vs placebo). The carbon monoxide–confirmed continuous quit rates from week 4 to week 52 were significantly higher in the varenicline tartrate, 1.0 mg twice daily, group compared with the placebo group (14.4% vs 4.9%; P = .002). The bupropion rate was 6.3% (P = .60 vs placebo). Discontinuation owing to treatment-emergent adverse events was 15.9% for bupropion, 11.2% to 14.3% for varenicline, and 9.8% for placebo. No dose-related increases occurred in adverse events for varenicline.

Conclusions  Varenicline tartrate demonstrated both short-term (1 mg twice daily and 1 mg once daily) and long-term efficacy (1 mg twice daily) vs placebo. Varenicline was well tolerated and may provide a novel therapy to aid smoking cessation.

Author Affiliations: Los Angeles Clinical Trials, Los Angeles, Calif (Dr Nides); Department of Medicine, University of Connecticut Health Center, Farmington (Dr Oncken); Smoking Cessation Center, Department of Medicine, Oregon Health & Science University, Portland (Dr Gonzales); Pulmonary Division, University of Nebraska Medical Center, Omaha (Dr Rennard); and Pfizer Global Research and Development, Pfizer Global Pharmaceuticals, Groton, Conn (Drs Watsky and Reeves and Mr Anziano).

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