Clinical trials report
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Varenicline vs Bupropion and Placebo for Smoking Cessation Gonzales D, Rennard SI, Nides M, et al.: Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA 2006, 296:47–55. Rating: ••Of outstanding importance. Introduction: Despite the fact that cigarette smoking is the leading preventable cause of mortality in the United States, approximately 20.9% of U.S. adults were current smokers in 2005, a prevalence that was unchanged from 2004. Among these 45.1 million smokers, 42.5% had stopped smoking for at least 1 day in the prior 12 months in an attempt to quit. However, the long-term success rate of those who quit on their own is only about 5%, and other interventions are often necessary to further improve long-term smoking cessation rates. As a result, more effective treatments—including novel pharmacologic agents— would be a welcome addition to the public health objective of reducing smoking rates to the Healthy People 2010 goal of 12.0%. Aims: A randomized, double-blind, parallel-group, placeboand active treatment–controlled clinical trial was conducted at 19 US centers to determine if varenicline, an B4C2 nicotinic acetylcholine receptor partial agonist, would be effective and safe to increase rates of smoking cessation. Methods: A total of 1025 otherwise healthy smokers were randomly assigned to one of three treatment arms: 1) brief counseling and varenicline titrated to 1 mg twice per day, 2) sustained-release bupropion titrated to 150 mg twice per day, or 3) placebo. The interventions lasted 12 weeks with 40 weeks of subsequent follow-up. Continuous abstinence from smoking was assessed by exhaled carbon
monoxide with the primary outcome for weeks 9 through 12 and secondary outcomes for weeks 9 through 24 and 9 through 52. Results: For weeks 9 through 12, the smoking abstinence rates for varenicline, bupropion, and placebo were 44.0%, 29.5%, and 17.7%, respectively. For weeks 9 through 52, the smoking abstinence rates were 21.9%, 16.1%, and 8.4%, respectively. Varenicline was safe and well tolerated, with low rates of study drug discontinuation due to an adverse event among participants assigned varenicline (8.6%), bupropion (15.2%), or placebo (9.0%). Discussion: The investigators concluded that the use of varenicline for smoking cessation was significantly superior to placebo at all time points. In addition, varenicline was superior to bupropion at 12 and 24 weeks and had a strong suggestion of superiority at 52 weeks.
Editor’s comments Chronic smoking remains a challenging problem for patients and clinicians alike. For patients, quitting smoking can be a difficult and long process, with successful quitting often requiring multiple attempts. For clinicians, the time and energy involved in smoking cessation counseling and follow-up can be considerable, and the low success rate can lead to a sense of pessimism and frustration [1]. As a result, new approaches to improve smoking cessation r
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