Pulmonary Disease

Bupropion versus Placebo

A double-blind, randomized, placebo-controlled trial of bupropion for smoking cessation was conducted by Jorenby and others. Subjects were randomly assigned to receive placebo, nicotine patch (21 mg during weeks 2 to 7, 14 mg during week 8, and 7 mg during week 9), bupropion (150 mg every morning for 3 days, then 150 mg twice a day for a total of 9 weeks), or bupropion plus nicotine patch (with the previously described dosage schedules). The primary endpoints were point prevalence rates of abstinence at 6 and 12 months of follow-up. Secondary endpoints included withdrawal symptoms, body weight, and Beck Depression Inventory score. At 6 months, point prevalence rates were lower in the buproprion group than the placebo group (35% v. 19%, absolute risk reduction of 16%, number needed to treat 6). Similar results were reported for 12-month abstinence rates (buproprion 30%, placebo 16%, absolute risk reduction 14%, number needed to treat 7). The incidence of weight gain was significantly higher in the placebo group than among bupropion-treated patients. The authors concluded that bupropion alone or in combination with the nicotine patch is effective for promoting long-term smoking cessation.

Hurt and others conducted a randomized, double- blind, placebo-controlled dose-response study that compared the efficacy of sustained-release bupropion 100 mg, 150 mg, or 300 mg in 615 volunteers. The target quit date was set at 1 week after treatment initiation, and self-reported abstinence was confirmed by carbon monoxide concentration in expired air of 10 ppm or less at 7 weeks. At 6 months, point prevalent abstinence rates were 28% in the buproprion 150 mg group and 16% in the placebo group (p < 0.05). At 12 months, abstinence rates were 23% in patients treated with buproprion 150 mg and 12% in the placebo group (p < 0.05). These data translate to absolute risk reductions of 12% and 11% at 6 and 12 months, respectively, with numbers needed to treat of 8 and 9. Abstinence rates for patients receiving the 300-mg dose were also significantly higher than those in placebo-treated patients at 6 and 12 months. However, there were no significant differences in 6- or 12-month abstinence rates for patients receiving buproprion 100 mg and those receiving placebo. Common side effects included insomnia (in 21% of the placebo group, 29% of the buproprion 150 mg group, and 33% of the buproprion 300 mg group; p = 0.008 for comparison of 300-mg dose with placebo) and dry mouth (in 5% of the placebo group, 13% of the buproprion 150 mg group, and 13% of the buproprion 300 mg group; p = 0.01 for comparison of 150-mg and 300-mg doses with placebo). The 300-mg dose was more effective initially, but the 300-mg and 150-mg doses were equally effective at 1 year. The authors recommended the 300-mg dose (150 mg twice daily) on the basis of higher initial cessation rate and a similar side effect profile.
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Tashkin and others conducted a randomized, double-blind, placebo-controlled study of bupropion (150 mg daily for 3 days, then 150 mg twice daily for 80 days) for smoking cessation in subjects with (primarily) mild COPD. A total of 411 subjects underwent randomization, 404 received at least one dose of medication, and 278 completed the 6-month follow up. The primary efficacy measure was self-reported continuous abstinence for 4 weeks (weeks 4 through 7 of the trial), which was confirmed by exhaled carbon monoxide concentration of less than 10 ppm. The continuous 4-week abstinence rate was significantly higher in the buproprion group than the placebo group (28% v. 16%, p = 0.003), which translated into an absolute difference of 12% and a number needed to treat of 8. Five percent of the patients in each group were withdrawn from the study. The most common causes of withdrawal were anxiety (5 patients) and insomnia (4 patients) in the bupropion group and headache (3 patients) in the placebo group. Adverse events that were frequently reported in the buproprion and placebo groups included insomnia (24% v. 12%), headache (6% v. 6%). and dry mouth (6% v. 5%).

Ahluwalia and others conducted a randomized, placebo-controlled trial of bupropion 300 mg daily for 7 weeks in 600 African-American subjects. Slightly fewer than 30% of the subjects were characterized as having possible clinical depression. According to an intention-to- treat analysis, the abstinence rates were 36% in the bupropion group and 19% in the placebo group. At 26 weeks, the abstinence rates were 21% and 14%, respectively. Patients with continuous abstinence had lower withdrawal scores and were more likely to gain weight (although the degree of weight gain was not reported). Patients who received bupropion had lower body weight over time. Fewer symptoms of depression were reported by patients receiving bupropion during the first 7 weeks. Although the effect on smoking cessation diminished with time, abstinence rates remained higher in the buproprion group at 26 weeks. Differences in degree of weight gain and depressive symptoms were no longer significant at 26 weeks. Insomnia was reported more frequently in the bupropion group (29%) than the placebo group (21%).
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Nortriptyline versus Bupropion

Only one trial has compared the efficacy of nortriptyline with that of buproprion. This randomized, controlled trial of 220 smokers employed a 2 x 3 design: medical management versus psychological intervention, and bupropion versus nortriptyline versus placebo. Exclusion criteria were current major depressive disease or use of any psychiatric medication, prior use of nortriptyline or bupropion, or any admission to hospital for psychiatric reasons within the previous year. Medical management included advice to stop smoking, written information about smoking cessation, and monitoring of adverse effects. Time was set aside over the first 11 weeks (approximately 35 minutes in total) to discuss the patient’s progress with smoking cessation. The psychological intervention consisted of medical management plus 5 group sessions. At 24 weeks, both drugs were superior to placebo, with abstinence rates of 24%, 22%, and 16% associated with bupropion, nortriptyline, and placebo, respectively. Psychological intervention was found to be more effective than medical management, with quit rates of 26% and 16%, respectively. The incidence of withdrawal due to adverse effects was 8%, 4%, and 4% in the bupropion, nortriptyline, and placebo groups, respectively, and withdrawal from the study for any reason occurred in 15%, 10%, and 26% of the patients in these 3 groups. At 52 weeks, the abstinence rate for participants without a history of major depressive disease (approximately two-thirds of the study population) was 27% in the nortriptyline group and 24% in bupropion group; among patients who had a history of major depressive disease, the abstinence rates were 16% in the nortriptyline group and 38% in the bupropion group.