664 Varenicline Versus Bupropion SR or Placebo for Smoking Cessation: A Pooled Analysis Mitchell Nides, PhD; Elbert D. Glover, PhD, FAAHB; Victor I. Reus, MD; Arden G. Christen, DDS, MSA, MA; Barry J. Make, MD; Clare B. Billing, Jr, MS; Kathryn E. Williams, PhD Mitchell Nides, President, Los Angeles Clinical Trials, Burbank, CA. Elbert D. Glover, Professor and Chair, University of Maryland-College Park School of Public Health, Department of Public and Community Health, College Park, MD. Victor I. Reus, Professor, Department of Psychiatry, University of California, San Francisco School of Medicine Langley Porter Neu- ropsychiatric Unit, San Francisco, CA. Arden G. Chris- ten, Emeritus Professor, Indiana University School of Dentistry, Department of Oral Biology, Indianapolis, IN. Barry J. Make, COPD Program Co-Director, Na- tional Jewish Medical and Research Center, Denver, CO. Clare B. Billing, Jr, Senior Director, Clinical Statis- tics, Neurosciences and Kathryn E. Williams, Senior Director, Clinical Development, Neurosciences, Pfizer Global Research and Development, Groton, CT. Address correspondence to Dr Nides, Los Angeles Clinical Trials, 4116 W Magnolia Boulevard, Suite 100, Burbank, CA 91505. E-mail: mnides@laclinicaltrials.com Objectives : To evaluate varenicline’s efficacy for smoking cessation versus bupropion SR and placebo and to explore whether fac- tors typically predictive of absti- nence influence varenicline’s effi- cacy versus placebo, as measured by the week 9-12 continuous absti- nence rate (CAR9-12). Methods: Smokers in 2 randomized, placebo- controlled trials received varenicline 1 mg BID (n=696), bupropion SR 150 mg BID (n=671), or placebo (n=685) for 12 weeks. Nontreatment follow- up lasted 40 weeks. Results: CAR 9-12 was greater for varenicline (44.0%) versus bupropion SR (29.7%; P<0.0001) and placebo (17.7%; P<0.0001). CAR 9-12 for varenicline versus placebo was not affected by age, gender, or nicotine dependence level. Conclusions: Varenicline was more efficacious than bupropion SR or placebo. Varenicline’s efficacy versus placebo was not influenced by factors predictive of abstinence. Key words: varenicline, smok- ing cessation, nicotine partial ago- nist, tobacco dependence Am J Health Behav. 2008;32(6):664-675 T obacco smoking is the leading pre- ventable cause of death and disease and is responsible for more than 400,000 premature deaths per year in the United States alone. 1 About 1 in 5 (20.9%) adults in the United States are current smokers, and 70% of these indicate a desire to quit smoking. 1 The pervasive health effects of smok- ing place a huge burden on healthcare budgets due to smoking-related diseases. The US Centers for Disease Control and Prevention reported that from 1997 to 2001, cigarette smoking caused more than $167 billion in health-related eco- nomic losses and resulted in 5.5 million years of potential life lost annually in the United States alone. 2 Several pharmacologic therapies are available to aid smoking cessation. Nico- tine replacement therapy (NRT) and sus- tained release (SR) bupropion are approved by the US Food and Drug Administration (FDA) for smoking cessation and are cur- rently recommended as first-line thera- pies in the US Department of Health and Human Services guidelines. 3,4 Other phar-