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• W2113308458 abstract "<h3>Background</h3> 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. <h3>Methods</h3> 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. <h3>Results</h3> 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%;<i>P</i><.001 vs both doses). Weeks 9 through 52 abstinence rates were greater in the 1.0-mg group (22.4%;<i>P</i><.001) and the 0.5-mg group (18.5%;<i>P</i><.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. <h3>Conclusion</h3> Varenicline tartrate, 0.5 mg and 1.0 mg twice daily, is efficacious for smoking cessation." @default.
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• W2113308458 date "2006-08-14" @default.
• W2113308458 modified "2023-10-03" @default.
• W2113308458 title "Efficacy and Safety of the Novel Selective Nicotinic Acetylcholine Receptor Partial Agonist, Varenicline, for Smoking Cessation" @default.
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• W2113308458 doi "https://doi.org/10.1001/archinte.166.15.1571" @default.
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