Bupropion SR for Smoking Relapse Prevention
Bupropion SR for Smoking Relapse Prevention
Abstract & Commentary
Synopsis: This study found that persons who stopped smoking using long-term sustained-release bupropion delayed smoking relapse and had less weight gain.
Source: Hays JT, et al. Ann Intern Med. 2001;135:423-433.
Despite treatment advances, smoking relapse after successful intervention for smoking cessation occurs in 70-80% of patients within 6-12 months.1 Bupropion has been proven an effective intervention for smoking cessation.2 It is effective for initiating abstinence from smoking and is safe for long-term therapy. The purpose of this study was to evaluate the efficacy of bupropion to prevent smoking relapse after initial abstinence.
Hays and colleagues conducted a multicenter, prospective, randomized, placebo-controlled trial recruiting participants through advertisements and press releases. The patients were included if they smoked more than 15 cigarettes per day, were motivated to stop smoking, and in good health. Exclusion criteria included personal or family history of seizure disorder, anorexia nervosa or bulimia, pregnancy, lactation, and depression. At the baseline visit and continuing through study week 7, all participants received open-label, sustained-release bupropion 300 mg/d. Participants were eligible for randomization if they were abstinent from smoking at week 7, confirmed by an expired carbon monoxide level 10 ppm or less. Patients were randomized to follow-up treatment with either 45 weeks of bupropion or placebo. The participants returned for 14 visits during the double-blind phase and 5 visits during the follow-up year. The main outcomes were: 1) weekly point prevalence abstinence during medication; 2) continuous abstinence during medication; 3) time to first relapse; and 4) weight gain.
Of 1006 total volunteers interested in stopping smoking, 784 met the study criteria and were enrolled in the open-label phase of the study. Among them only 461 (58.8%) were biochemically confirmed abstinent from smoking at week 7. Of these, 32 were withdrawn and 429 patients were randomly assigned to receive placebo or bupropion for the 45-week medication phase. A total of 347 (80.9%) participants completed the 45-week medication phase and 317 (73.9%) completed the study.
At the end of the medication phase, the point prevalence abstinence rate was significantly higher in the bupropion group than in the placebo group (55.1% vs 42.3%). One year later, at the end of the study, the point prevalence abstinence was similar between groups (41.6% vs 40.0%). The median time to smoking relapse was 65 days for the placebo group and 156 days for the bupropion group (P = 0.021). The number of participants with continuous abstinence was significantly higher in the bupropion group at 17 weeks of randomization (52.3% vs 42.3%). No significant difference was seen at the end of drug treatment or after completion of follow-up. Of the 118 participants without smoking relapse during the entire study, the mean weight gain was 8.6 kg for placebo compared to 6.9 kg for bupropion group (P = 0.012). Adverse effects included insomnia, headache, and dry mouth and were similar in frequency between the 2 groups.
Comment by David Ost, MD, FACP, & Lingamurthy Ravi, MD
Although the use of sustained-release bupropion delayed relapse after initial smoking cessation, this effect was not maintained after discontinuation of therapy. The median time to smoking relapse was more than doubled in the group receiving sustained-release bupropion compared with placebo. A second significant finding was the attenuation in postcessation weight gain among participants treated with sustained-release bupropion compared with placebo. The results differ from the findings of other studies for smoking cessation that evaluated postcessation weight gain. Both nicotine gum and nicotine nasal spray have been shown to attenuate weight gain after smoking cessation, but rebounded after medical treatment has stopped.3-5 Bupropion treatment was well tolerated in this study, with the most common side effects being insomnia and headache. The strength of this study includes large sample size and multiple study centers in a randomized placebo-controlled trial.
In clinical practice, the decision to treat patients with longer-term bupropion therapy as compared to shorter-course therapy would depend on the perceived risk of early relapse. Risk stratification of this sort might improve relapse rates. This study suggests that while persons who have stopped smoking benefit from extended treatment, this benefit is lost within 1 year of discontinuing therapy.
Dr. Ost, Assistant Professor of Medicine, NYU School of Medicine, Director of Interventional Pulmonology, Division of Pulmonary and Critical Care Medicine, Northshore University Hospital, Manhasset, NY, is Associate Editor of Internal Medicine Alert. Dr. Ravi is a Resident, Department of Medicine, Nassau County Medical Center, Stony Brook, NY.
References
1. Fiore MC, et al. JAMA. 1994;271:1940-1947.
2. Hurt Rd, et al. N Engl J Med. 1997;337:1195-1202.
3. Nides M, et al. Health Psychol. 1994;13:354-361.
4. Leishow SJ, et al. Arch Fam Med. 1992;1:233-237.
5. Sutherland G, et al. Lancet. 1992;340:324-329.
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