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Efficacy of Varenicline for Smoking Cessation

Efficacy of Varenicline for Smoking Cessation To the Editor: In their clinical trials of varenicline for smoking cessation, Dr Gonzales and colleagues,1 Dr Jorenby and colleagues,2 and Dr Tonstad and colleagues3 used broad exclusion criteria, particularly for psychiatric disorders of major depressive disorder within the past year; history of or a current panic disorder, psychosis, bipolar disorder, or eating disorder; or alcohol or drug abuse or dependency within the past year. In addition, Tonstad et al3 excluded potential participants who were taking antidepressants, antipsychotics, or mood stabilizers or anticonvulsants. However, it is estimated that 30% of smokers have some form of mental illness.4 Moreover, Lasser et al5 estimated that persons diagnosed as having a mental disorder within the past month consumed 44% of all cigarettes smoked in the United States. Therefore, the extensive psychiatric exclusion criteria in these trials may make it difficult to apply their results to the general population of smokers. In addition, patients with psychiatric disorders are frequently heavy smokers. Rates of quitting smoking are lower in smokers with psychiatric disorders.5 Therefore, from a public health perspective, the effect of varenicline also should be assessed in individuals with psychiatric disorders. Finally, the participants included in the 3 studies examining the effect of varenicline on smoking cessation were not assessed using structured interviews for the diagnosis of psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, or the International Statistical Classification of Diseases, 10th Revision. Appropriate instruments include the Diagnostic Interview Schedule and the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Because such instruments are necessary to make an accurate research diagnosis, the study results may have been biased. Back to top Article Information Financial Disclosures: None reported. References 1. Gonzales D, Rennard SI, Nides M. et al. for the Varenicline Phase 3 Study Group. Varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006;296:47-5516820546Google ScholarCrossref 2. Jorenby DE, Hays JT, Rigotti NA. et al. for the Varenicline Phase 3 Study Group. Efficacy of varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006;296:56-6316820547Google ScholarCrossref 3. Tonstad S, Tonnesen P, Hajek P. et al. for the Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006;296:64-7116820548Google ScholarCrossref 4. Leonard S, Adler LE, Benhammou K. et al. Smoking and mental illness. Pharmacol Biochem Behav. 2001;70:561-57011796154Google ScholarCrossref 5. Lasser K, Boyd JW, Woolhandler S, Himmelstein DU, McCormick D, Bor DH. Smoking and mental illness: a population-based prevalence study. JAMA. 2000;284:2606-261011086367Google ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Efficacy of Varenicline for Smoking Cessation

JAMA , Volume 296 (21) – Dec 6, 2006

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Publisher
American Medical Association
Copyright
Copyright © 2006 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.296.21.2555-a
Publisher site
See Article on Publisher Site

Abstract

To the Editor: In their clinical trials of varenicline for smoking cessation, Dr Gonzales and colleagues,1 Dr Jorenby and colleagues,2 and Dr Tonstad and colleagues3 used broad exclusion criteria, particularly for psychiatric disorders of major depressive disorder within the past year; history of or a current panic disorder, psychosis, bipolar disorder, or eating disorder; or alcohol or drug abuse or dependency within the past year. In addition, Tonstad et al3 excluded potential participants who were taking antidepressants, antipsychotics, or mood stabilizers or anticonvulsants. However, it is estimated that 30% of smokers have some form of mental illness.4 Moreover, Lasser et al5 estimated that persons diagnosed as having a mental disorder within the past month consumed 44% of all cigarettes smoked in the United States. Therefore, the extensive psychiatric exclusion criteria in these trials may make it difficult to apply their results to the general population of smokers. In addition, patients with psychiatric disorders are frequently heavy smokers. Rates of quitting smoking are lower in smokers with psychiatric disorders.5 Therefore, from a public health perspective, the effect of varenicline also should be assessed in individuals with psychiatric disorders. Finally, the participants included in the 3 studies examining the effect of varenicline on smoking cessation were not assessed using structured interviews for the diagnosis of psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, or the International Statistical Classification of Diseases, 10th Revision. Appropriate instruments include the Diagnostic Interview Schedule and the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Because such instruments are necessary to make an accurate research diagnosis, the study results may have been biased. Back to top Article Information Financial Disclosures: None reported. References 1. Gonzales D, Rennard SI, Nides M. et al. for the Varenicline Phase 3 Study Group. Varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006;296:47-5516820546Google ScholarCrossref 2. Jorenby DE, Hays JT, Rigotti NA. et al. for the Varenicline Phase 3 Study Group. Efficacy of varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006;296:56-6316820547Google ScholarCrossref 3. Tonstad S, Tonnesen P, Hajek P. et al. for the Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006;296:64-7116820548Google ScholarCrossref 4. Leonard S, Adler LE, Benhammou K. et al. Smoking and mental illness. Pharmacol Biochem Behav. 2001;70:561-57011796154Google ScholarCrossref 5. Lasser K, Boyd JW, Woolhandler S, Himmelstein DU, McCormick D, Bor DH. Smoking and mental illness: a population-based prevalence study. JAMA. 2000;284:2606-261011086367Google ScholarCrossref

Journal

JAMAAmerican Medical Association

Published: Dec 6, 2006

References