Smoking
Varenicline produce higher continuous smoking abstinence rates
By JAMA
Jul 5, 2006 - 7:09:00 PM

In a study, Douglas E. Jorenby, Ph.D., of the University of Wisconsin School of Medicine and Public Health, Madison, Wis., and colleagues with the Varenicline Phase 3 Study Group conducted a study designed identical to that of Gonzales et al to assess the efficacy and safety of varenicline for smoking cessation compared with placebo and bupropion SR during initial treatment and long-term follow-up.

This randomized, double-blind, placebo-controlled trial was conducted at 14 research centers between June 2003 and March 2005 and consisted of a 12-week treatment period with follow-up of smoking status to week 52. The study included 1,027 adult smokers, 65 percent of whom completed the study. The participants were randomized to varenicline twice daily (n = 344), bupropion SR twice daily (n = 342) or placebo (n = 341) for 12 weeks, plus weekly brief smoking cessation counseling.

The researchers found that varenicline produced higher continuous abstinence rates than placebo at all time points. During the last 4 weeks of treatment (weeks 9-12), 43.9 percent of participants in the varenicline group were continuously abstinent from smoking compared with 17.6 percent in the placebo group and 29.8 percent in the bupropion SR group. For weeks 9 through 24, 29.7 percent of participants in the varenicline group were continuously abstinent compared with 13.2 percent in the placebo group and 20.2 percent in the bupropion group. For weeks 9 through 52, 23 percent of participants in the varenicline group were continuously abstinent compared with 10.3 percent in the placebo group and 14.6 percent in the bupropion SR group.

�At the end of the treatment period, the odds of quitting smoking with varenicline were significantly greater than the odds of quitting with either placebo or bupropion SR,� the authors write.

Treatment was discontinued due to adverse events by 10.5 percent of participants in the varenicline group, 12.6 percent in the bupropion SR group, and 7.3 percent in the placebo group. The most common adverse event with varenicline was nausea, which occurred in 101 participants (29.4 percent).

�Reducing smoking rates in the U.S. population will require a combination of efforts from individuals, health care systems, insurers, and policy makers as part of a comprehensive tobacco-control strategy. Advances can be made by improving the use of existing smoking cessation treatments and by developing better treatments. Varenicline ...has demonstrated a robust ability to increase cessation rates (short-term and long-term) compared with both placebo and a first-line smoking cessation medication (bupropion SR), and may represent an advance in the treatment of tobacco dependence,� the authors conclude.

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