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In Reply: We are in agreement with Drs Dervaux, Kanit, and Laqueille that all smoking cessation therapies, including varenicline, merit evaluation in population-based effectiveness trials following US Food and Drug Administration approval. These varenicline trials were phase 3 clinical trials designed to investigate safety and efficacy of an investigational drug prior to Food and Drug Administration approval. The exclusion criteria that were specified, including those for psychiatric conditions, were similar to those used in prior studies of investigational drugs for smoking cessation.^1-2 They were chosen for several reasons.

First, investigational drug studies generally exclude participants with poorly controlled medical conditions or use of medications that might compromise either participant safety or evaluation of safety or treatment effects of the drug being studied. Second, because participants in the studies by Gonzales et al³ and Jorenby et al⁴ could have been assigned in a random, double-blind manner to either varenicline, bupropion, or . . . [Full Text of this Article]

Douglas E. Jorenby, PhD
dej@ctri.medicine.wisc.edu
University of Wisconsin School of Medicine and Public Health
Center for Tobacco Research and Intervention
Madison

Serena Tonstad, MD, PhD
Department of Preventive Cardiology
Ullevål University Hospital
University of Oslo
Oslo, Norway

David Gonzales, PhD
Smoking Cessation Center
Department of Medicine
Oregon Health and Science University
Portland

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