Efficacy and safety of the novel selective nicotinic acetylcholine receptor partial agonist, varenicline, for smoking cessation - PubMed (original) (raw)
Randomized Controlled Trial
. 2006 Aug;166(15):1571-7.
doi: 10.1001/archinte.166.15.1571.
Affiliations
- PMID: 16908789
- DOI: 10.1001/archinte.166.15.1571
Randomized Controlled Trial
Efficacy and safety of the novel selective nicotinic acetylcholine receptor partial agonist, varenicline, for smoking cessation
Cheryl Oncken et al. Arch Intern Med. 2006 Aug.
Abstract
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.
Comment in
- New weapon to curb smoking: no more excuses to delay treatment.
Johnson BA. Johnson BA. Arch Intern Med. 2006 Aug 14-28;166(15):1547-50. doi: 10.1001/archinte.166.15.1547. Arch Intern Med. 2006. PMID: 16908786 No abstract available. - Partial agonism at nicotinic receptors with varenicline--a new approach to smoking cessation.
Doggrell SA. Doggrell SA. Expert Opin Pharmacother. 2006 Dec;7(18):2599-603. doi: 10.1517/14656566.7.18.2599. Expert Opin Pharmacother. 2006. PMID: 17150012 No abstract available.
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