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• W2766430201 abstract "With regard to our recently published article reporting the results of a randomized, controlled trial on the effects of varenicline (March 2011),1Tashkin DP Rennard S Hays JT Ma W Lawrence D Lee TC Effects of varenicline on smoking cessation in patients with mild to moderate COPD: a randomized controlled trial.Chest. 2011; 139: 591-599Abstract Full Text Full Text PDF PubMed Scopus (180) Google Scholar Kotz and van Schayck question the justifiability of placebo use as the only comparator in randomized controlled trials of pharmacotherapy for smoking cessation in patients with COPD. They go on to state that “The use of a placebo is only acceptable in studies in which no current proven intervention exists.” What they fail to appreciate is that both the smokers with COPD who were allocated to the placebo and active arms of the varenicline trial received the benefit of counseling for smoking cessation during weekly clinic visits over the 12-week double-blind treatment period and on seven subsequent clinic visits and five telephone visits over the remainder of the 40-week follow-up period. Counseling is effective, and its effectiveness increases with intensity and total amount of counseling time according to the US Public Health Service Clinical Practice Guideline on treating tobacco use and dependence.2Fiore MC Jaen CR Baker TR et al.Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. US Department of Health and Human Services, Rockville, MD2008Google Scholar Thus, the patients treated with placebo were exposed to a level of counseling for smoking cessation that most likely exceeds that which smokers outside of the study would generally receive. Very few previous studies of pharmacotherapy for smokers with COPD have been published. In one such study, as noted by Kotz and Schayck, smokers with COPD who had received bupropion achieved significantly higher continuous abstinence rates than smokers treated with placebo at 3 and 6 months,3Tashkin D Kanner R Bailey W et al.Smoking cessation in patients with chronic obstructive pulmonary disease: a double-blind, placebo-controlled, randomised trial.Lancet. 2001; 357: 1571-1575Abstract Full Text Full Text PDF PubMed Scopus (363) Google Scholar implying that the smokers treated with placebo in the varenicline COPD trial were deprived of an effective pharmacologic aid for smoking cessation as a positive control. However, the bupropion COPD trial, which included a follow-up period up to 1 year, failed to demonstrate a significant difference between bupropion and placebo in continuous abstinence rates at the end of the follow-up period. Consequently, it has not been convincingly demonstrated that bupropion is an effective pharmacologic aid for smoking cessation and sustained abstinence in smokers with COPD. In the absence of evidence that alternative pharmacologic aids for smoking cessation have long-term efficacy in smokers with COPD, we believe that the use of a placebo arm in the varenicline COPD trial (in which all subjects received the benefits of counseling) was justified in order to test the hypothesis that varenicline plus counseling is an effective treatment strategy for promoting long-term abstinence from smoking compared with counseling alone (ie, placebo medication plus counseling). Role of sponsors: Editorial support for development of this letter was provided by Abegale Templar, PhD, of UBC Scientific Solutions and was funded by Pfizer Inc. What Justifies a Placebo-Controlled Trial of Varenicline for Smoking Cessation in Patients With COPD?CHESTVol. 139Issue 4PreviewIn a recent issue of CHEST (March 2011), Tashkin et al1 present results of a double-blind, placebo-controlled, two-arm trial of varenicline for smoking cessation in patients with COPD. The question arises: Why was a trial conducted in which varenicline was compared only with a placebo (and not with another active smoking cessation drug) in this patient group? Full-Text PDF" @default.
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• W2766430201 date "2011-04-01" @default.
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• W2766430201 title "What Justifies a Placebo-Controlled Trial of Varenicline for Smoking Cessation in Patients With COPD?: Response" @default.
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• W2766430201 doi "https://doi.org/10.1378/chest.10-3032" @default.
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