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Poster presentation
Efficacy and safety of varenicline for smoking
cessation
Mitchell Nides
Abstract
Objective: Varenicline is a selective nicotinic receptor
partial agonist in development as a novel treatment for
smoking cessation. We evaluated the efficacy and safety
of different varenicline doses in cigarette smokers.
Methods: Varenicline was evaluated in healthy smokers
(18 to 65 years) in two, phase 2, double-blind, randomised,
placebo-controlled trials. In study 1, subjects were randomised
to varenicline 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 versus 150 mg sustained-release
bupropion twice daily (titrated over Week 1; n=128) or
placebo (n=127) for 7 weeks. In study 2, subjects were
randomised to varenicline 0.5 mg twice daily with and
without titration (n=259), 1.0 mg twice daily with and
without titration (n=259), or placebo (n=129) for 12 weeks.
Results: In study 1, the 4-week floating window continuous
quit rates (CQRs) were higher for 1.0 mg once daily varenicline
(37.3%), 1.0 mg twice daily varenicline (48.0%), and bupropion
(33.3%) than placebo (17.1%); p=0.0003, p < 0.0001,
and p=0.0022, respectively. In study 2, the carbon monoxide-confirmed
4-week CQRs (weeks 9 to 12) were higher for the 0.5 mg
and 1mg twice daily (45.1% and 50.6%, respectively) varenicline
groups versus placebo (12.4%) (all p < 0.0001).
The CQRs for weeks 4 to 7 were also significant. Varenicline
was well tolerated; titration in study 2 mitigated the
mild to moderate self-limiting nausea.
Conclusion: Varenicline 1.0 mg to 2.0 mg daily promoted
smoking cessation and was well tolerated. Varenicline
1.0 mg twice daily was associated with a numerically higher
smoking quit rate than bupropion or placebo.
Source of funding of study/service to be presented:
Sponsored by Pfizer Global Research and Development
Statement of conflict of interest:
Research grant: Pfizer Inc.
Consultant: Pfizer Inc.
Mitchell Nides
President, Los Angeles Clinical Trials, CA, USA
mnides@laclinicaltrials.com
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