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Randomized Controlled Trial
. 2009 Dec 14;169(22):2148-55.
doi: 10.1001/archinternmed.2009.426.

Comparative effectiveness of 5 smoking cessation pharmacotherapies in primary care clinics

Stevens S Smith  1 , Danielle E McCarthy, Sandra J Japuntich, Bruce Christiansen, Megan E Piper, Douglas E Jorenby, David L Fraser, Michael C Fiore, Timothy B Baker, Thomas C Jackson
Affiliations
Randomized Controlled Trial

Comparative effectiveness of 5 smoking cessation pharmacotherapies in primary care clinics

Stevens S Smith et al. Arch Intern Med. .

Abstract

Background: Randomized efficacy clinical trials conducted in research settings may not accurately reflect the benefits of tobacco dependence treatments when used in real-world clinical settings. Effectiveness trials (eg, in primary care settings) are needed to estimate the benefits of cessation treatments in real-world use.

Methods: A total of 1346 primary care patients attending routine appointments were recruited by medical assistants in 12 primary care clinics. Patients were randomly assigned to 5 active pharmacotherapies: 3 monotherapies (nicotine patch, nicotine lozenge, and bupropion hydrochloride sustained release [SR]) and 2 combination therapies (patch + lozenge and bupropion SR + lozenge). Patients were referred to a telephone quit line for cessation counseling. Primary outcomes included 7-day point prevalence abstinence at 1 week, 8 weeks, and 6 months after quitting and number of days to relapse.

Results: Among 7128 eligible smokers (> or =10 cigarettes per day) attending routine primary care appointments, 1346 (18.9%) were enrolled in the study. Six-month abstinence rates for the 5 active pharmacotherapies were the following: bupropion SR, 16.8%; lozenge, 19.9%; patch, 17.7%; patch + lozenge, 26.9%; and bupropion SR + lozenge, 29.9%. Bupropion SR + lozenge was superior to all of the monotherapies (odds ratio, 0.46-0.56); patch + lozenge was superior to patch and bupropion monotherapies (odds ratio, 0.56 and 0.54, respectively).

Conclusions: One in 5 smokers attending a routine primary care appointment was willing to make a serious quit attempt that included evidence-based counseling and medication. In this comparative effectiveness study of 5 tobacco dependence treatments, combination pharmacotherapy significantly increased abstinence compared with monotherapies. Provision of free cessation medications plus quit line counseling arranged in the primary care setting holds promise for assisting large numbers of smokers to quit. Trial Registration clinicaltrials.gov Identifier: NCT00296647.

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Figures

Figure 1
Figure 1
CONSORT Diagram
Figure 2
Figure 2. Abstinence rates at Post-Quit Study Endpoints
Figure 3
Figure 3
Cox Regression Survival Analysis: Survival Curves
See this image and copyright information in PMC

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