Comparative effectiveness of 5 smoking cessation pharmacotherapies in primary care clinics.

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.

[1]  Megan E. Piper,et al.  A randomized placebo-controlled clinical trial of 5 smoking cessation pharmacotherapies. , 2009, Archives of general psychiatry.

[2]  Hermann Brenner,et al.  Cost-effective primary care-based strategies to improve smoking cessation: more value for money. , 2009, Archives of internal medicine.

[3]  R. Borland,et al.  In-practice management versus quitline referral for enhancing smoking cessation in general practice: a cluster randomized trial. , 2008, Family practice.

[4]  Tobacco Use and Dependence Guideline Panel.  Treating Tobacco Use and Dependence: 2008 Update , 2008 .

[5]  S. Shiffman,et al.  Use of smoking-cessation treatments in the United States. , 2008, American journal of preventive medicine.

[6]  J. Gerberding,et al.  Cigarette smoking among adults--United States, 2007. , 2008, MMWR. Morbidity and mortality weekly report.

[7]  G. Giovino,et al.  The tobacco epidemic in the United States. , 2007, American journal of preventive medicine.

[8]  C. Husten,et al.  Cigarette smoking among adults--United States, 2006. , 2007, MMWR. Morbidity and mortality weekly report.

[9]  L. Tanoue,et al.  Annual Smoking-Attributable Mortality, Years of Potential Life Lost, and Productivity Losses—United States, 1997–2001 , 2007 .

[10]  Christopher N. Barnes,et al.  Validity of Self-reported Smoking Status among Participants in a Lung Cancer Screening Trial , 2006, Cancer Epidemiology Biomarkers & Prevention.

[11]  Shu-Hong Zhu,et al.  Benefits of telephone care over primary care for smoking cessation: a randomized trial. , 2006, Archives of internal medicine.

[12]  J. Hollis,et al.  The feasibility of connecting physician offices to a state-level tobacco quit line. , 2006, American journal of preventive medicine.

[13]  N. Rigotti,et al.  The association between patient-reported receipt of tobacco intervention at a primary care visit and smokers' satisfaction with their health care. , 2005, Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco.

[14]  Tanja Popovic,et al.  Annual smoking-attributable mortality, years of potential life lost, and productivity losses--United States, 1997-2001. , 2005, MMWR. Morbidity and mortality weekly report.

[15]  Timothy B Baker,et al.  Integrating smoking cessation treatment into primary care: an effectiveness study. , 2004, Preventive medicine.

[16]  L. Stead,et al.  Physician advice for smoking cessation. , 2004, The Cochrane database of systematic reviews.

[17]  H. Javitz,et al.  Effectiveness of bupropion sustained release for smoking cessation in a health care setting: a randomized trial. , 2004, Archives of internal medicine.

[18]  Shu-Hong Zhu,et al.  Evidence of real-world effectiveness of a telephone quitline for smokers. , 2002, The New England journal of medicine.

[19]  P. B. Gold,et al.  Naturalistic, self-assignment comparative trial of bupropion SR, a nicotine patch, or both for smoking cessation treatment in primary care. , 2002, The American journal on addictions.

[20]  S. Shiffman,et al.  Efficacy of a nicotine lozenge for smoking cessation. , 2002, Archives of internal medicine.

[21]  W. Velicer,et al.  Biochemical verification of tobacco use and cessation. , 2002, Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco.

[22]  S. Shiffman,et al.  Use of FDA-approved pharmacologic treatments for tobacco dependence--United States, 1984-1998. , 2000, MMWR. Morbidity and mortality weekly report.

[23]  Patricia Dolan Mullen,et al.  Treating tobacco use and dependence: clinical practice guideline , 2000 .

[24]  P. Rutigliano,et al.  The timeline followback reports of psychoactive substance use by drug-abusing patients: psychometric properties. , 2000, Journal of consulting and clinical psychology.

[25]  Aker,et al.  A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. , 1999, The New England journal of medicine.

[26]  Darrell R. Schroeder,et al.  A Comparison of Sustained-Release Bupropion and Placebo for Smoking Cessation , 1997 .

[27]  Diane C. Thompson,et al.  The validity of self-reported smoking: a review and meta-analysis. , 1994, American journal of public health.

[28]  L. Kozlowski,et al.  The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. , 1991, British journal of addiction.