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Donald P. Tashkin, MD, FCCP; Stephen Rennard, MD, FCCP; J. Taylor Hays, MD; Wendy Ma, MS; David Lawrence, PhD; Theodore C. Lee, MD, FCCP
Author and Funding Information

From the David Geffen School of Medicine at the University of California, Los Angeles (Dr Tashkin); the University of Nebraska Medical Center (Dr Rennard); the Mayo Clinic Nicotine Dependence Center (Dr Hays); and Pfizer Inc (Ms Ma and Drs Laurence and Lee).

Correspondence to: Donald P. Tashkin, MD, FCCP, Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, 10833 Le Conte Ave, Los Angeles, CA 90095-1690; e-mail: dtashkin@mednet.ucla.edu


Financial/nonfinancial disclosures: The authors have reported to the CHEST the following conflicts of interest: Dr Tashkin received grant support from Pfizer Inc and Nabi Pharmaceuticals and fees for attending advisory board meetings from Pfizer Inc. Dr Hays received a research grant from Pfizer Inc for the conduct of the clinical trial described in this manuscript. In the past 3 years, Dr Rennard has been a consultant or a member of an advisory board for Able Associates, Adelphi Research, Almirall/Prescott, APT Pharma/Britnall, Aradigm, AstraZeneca, Boehringer Ingelheim, Chiesi, CommonHealth, Consult Complete, COPDForum, Data-Monitor, Decision Resources, Defined Health, Dey, Dunn Group, Eaton Associates, Equinox, Gerson, GlaxoSmithKline, Infomed, KOL Connection, M Pankove, MedaCorp, MDRx Financial, Mpex, Novartis, Nycomed, Oriel Therapeutics, Otsuka, Pennside Partners, Pfizer Inc (varenicline), Pharma Ventures, Pharmaxis, Price Waterhouse, Propagate, Pulmatrix, Reckner Associates, Recruiting Resources, Roche, Schlesinger Medical, SciMed, Sudler and Hennessey, TargeGen, Theravance, UBC, Uptake Medical, and VantagePoint Management. Dr Rennard has lectured for the American Thoracic Society, AstraZeneca, Boehringer Ingelheim, California Allergy Society, Creative Educational Concept, France Foundation, Information TV, Network for Continuing Education, Novartis, Pfizer, and SOMA and has received industry-sponsored grants from AstraZeneca, Biomarck, Centocor, Mpex, Nabi Pharmaceuticals, Novartis, and Otsuka. Ms Ma is an employee of Pfizer Inc, owns Pfizer stock, and has Pfizer stock options. Dr Lawrence is an employee of Pfizer Inc, owns Pfizer stock, and has Pfizer stock options. Dr Lee is an employee of Pfizer Inc, owns Pfizer stock, and has Pfizer stock options.

Funding/Support: This study was funded by Pfizer Inc.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


© 2011 American College of Chest Physicians


Chest. 2011;139(4):969-970. doi:10.1378/chest.10-3032
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With regard to our recently published article reporting the results of a randomized, controlled trial on the effects of varenicline (March 2011),1 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.2 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,3 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.

Tashkin 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;1393:591-599. [CrossRef] [PubMed]
 
Fiore MC, Jaen CR, Baker TR, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. 2008; Rockville, MD US Department of Health and Human Services Public Health Service.
 
Tashkin 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;3579268:1571-1575. [CrossRef] [PubMed]
 

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References

Tashkin 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;1393:591-599. [CrossRef] [PubMed]
 
Fiore MC, Jaen CR, Baker TR, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. 2008; Rockville, MD US Department of Health and Human Services Public Health Service.
 
Tashkin 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;3579268:1571-1575. [CrossRef] [PubMed]
 
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