Efficacy and safety of the novel selective nicotinic acetylcholine receptor partial agonist, varenicline, for smoking cessation

Cheryl Oncken, David Gonzales, Mitchell Nides, Stephen Israel Rennard, Eric Watsky, Clare B. Billing, Richard Anziano, Karen Reeves

Research output: Contribution to journalArticle

306 Citations (Scopus)

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, nontitrated), 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.

Original languageEnglish (US)
Pages (from-to)1571-1577
Number of pages7
JournalArchives of Internal Medicine
Volume166
Issue number15
DOIs
StatePublished - Aug 28 2006

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Nicotinic Receptors
Smoking Cessation
Safety
Placebos
Nausea
Carbon Monoxide
Varenicline
Appointments and Schedules

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Efficacy and safety of the novel selective nicotinic acetylcholine receptor partial agonist, varenicline, for smoking cessation. / Oncken, Cheryl; Gonzales, David; Nides, Mitchell; Rennard, Stephen Israel; Watsky, Eric; Billing, Clare B.; Anziano, Richard; Reeves, Karen.

In: Archives of Internal Medicine, Vol. 166, No. 15, 28.08.2006, p. 1571-1577.

Research output: Contribution to journalArticle

Oncken, C, Gonzales, D, Nides, M, Rennard, SI, Watsky, E, Billing, CB, Anziano, R & Reeves, K 2006, 'Efficacy and safety of the novel selective nicotinic acetylcholine receptor partial agonist, varenicline, for smoking cessation', Archives of Internal Medicine, vol. 166, no. 15, pp. 1571-1577. https://doi.org/10.1001/archinte.166.15.1571
Oncken, Cheryl ; Gonzales, David ; Nides, Mitchell ; Rennard, Stephen Israel ; Watsky, Eric ; Billing, Clare B. ; Anziano, Richard ; Reeves, Karen. / Efficacy and safety of the novel selective nicotinic acetylcholine receptor partial agonist, varenicline, for smoking cessation. In: Archives of Internal Medicine. 2006 ; Vol. 166, No. 15. pp. 1571-1577.
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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, nontitrated), 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.",
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AU - Oncken, Cheryl

AU - Gonzales, David

AU - Nides, Mitchell

AU - Rennard, Stephen Israel

AU - Watsky, Eric

AU - Billing, Clare B.

AU - Anziano, Richard

AU - Reeves, Karen

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N2 - 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, nontitrated), 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.

AB - 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, nontitrated), 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.

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