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Cheryl Oncken, MD; David Gonzales, PhD; Mitchell Nides, PhD; Stephen Rennard, MD; Eric Watsky, MD; Clare B. Billing, MS; Richard Anziano, MS; Karen Reeves, MD; for the Varenicline Study Group

Arch Intern Med. 2006;166:1571-1577.

Background  The selective nicotinic acetylcholine receptor partial agonist, varenicline tartrate, represents a novel type of therapy for smoking cessation. This study evaluated the efficacy, safety, and tolerability of 4 varenicline dose regimens, 2 with progressive dosing over the first week (eg, titrated) and 2 with a fixed dosing schedule (eg, non-titrated), for promoting smoking cessation.

Methods  This multicenter, double-blind, placebo-controlled study randomized healthy smokers (aged 18-65 years) to varenicline tartrate, 0.5 mg twice daily nontitrated (n = 129), 0.5 mg twice daily titrated (n = 130), 1.0 mg twice daily nontitrated (n = 129), 1.0 mg twice daily titrated (n = 130), or placebo (n = 129) for 12 weeks to aid in smoking cessation. A 40-week follow-up period assessed long-term efficacy. The primary efficacy measures were the carbon monoxide–confirmed 4-week continuous quit rates by pooled dosage group for weeks 4 through 7 and 9 through 12 and the continuous abstinence rates for weeks 9 through 52.

Results  Weeks 9 through 12 continuous quit rates were greater in the 1.0-mg group (49.4%) and the 0.5-mg group (44.0%) vs placebo (11.6%; P<.001 vs both doses). Weeks 9 through 52 abstinence rates were greater in the 1.0-mg group (22.4%; P<.001) and the 0.5-mg group (18.5%; P<.001) vs placebo (3.9%). Varenicline was generally well tolerated, with nausea occurring in 16% to 42% of varenicline-treated subjects. Reports of nausea were lower for the titrated vs nontitrated dosing and infrequently led to medication discontinuation.

Conclusion  Varenicline tartrate, 0.5 mg and 1.0 mg twice daily, is efficacious for smoking cessation.

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

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