Nicotine Tob Res. 2004 Feb;6(1):27-37.
Gender differences in smoking cessation in a placebo-controlled trial of bupropion with behavioral counseling.

Collins BN, Wileyto EP, Patterson F, Rukstalis M, Audrain-McGovern J, Kaufmann V, Pinto A, Hawk L, Niaura R, Epstein LH, Lerman C.

University of Pennsylvania, Tabacco Research Center, Philadelphia, PA 19104, USA.

Among smokers, women may be at greater risk than men for developing smoking-related diseases, perhaps because they have greater difficulty quitting smoking, as suggested by numerous studies. In the present study, we hypothesized that bupropion would reduce this gender disparity among 314 women and 241 men enrolled in a placebo-controlled, randomized trial using behavioral counseling plus 10 weeks of bupropion (300 mg). Prolonged abstinence and biochemically verified point prevalence outcomes were measured at end of treatment (8 weeks after the quit date) and at 6-month follow-up. A logistic regression model of 6-month prolonged abstinence and a Cox regression (survival analysis) model revealed a significant gender by smoking rate by drug interaction and a main effect for marital status. This three-way interaction suggests that bupropion particularly benefited men who smoked more than one pack of cigarettes per day at baseline and, conversely, women who smoked a pack or less. The point prevalence logistic regression model showed no evidence that either gender or smoking rate modified the effect of treatment. These results suggest that bupropion treatment may reduce the gender disparity in prolonged abstinence rates among lighter smokers.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14982685&dopt=Abstract Bupropion Wellbutrin




Nicotine Tob Res. 2004 Feb;6(1):55-61.
A multicenter, randomized, double-blind, placebo-controlled, 6-month trial of bupropion hydrochloride sustained-release tablets as an aid to smoking cessation in hospital employees.

Dalsgareth OJ, Hansen NC, Soes-Petersen U, Evald T, Hoegholm A, Barber J, Vestbo J.

Department of Respiratory Medicine, HS Hvidovre University Hospital, Denmark.

Despite changes in smoking behavior, one-third of the Danish population continues to smoke. Many of these smokers are hospital employees. This 6-month, multicenter, parallel group, randomized, double-blind, placebo-controlled study evaluated treatment with bupropion hydrochloride sustained release (Zyban) compared with placebo as an aid to smoking cessation in health care workers. A total of 336 hospital employees who smoked at least 10 cigarettes daily were randomized (2:1) to 7 weeks of treatment with bupropion (n=222) or placebo (n=114). All participants were motivated to quit smoking and received behavioral counseling. Continuous smoking abstinence during weeks 4-7 was the primary endpoint, and long-term smoking abstinence was among the secondary endpoints. Of the original participants, 212 completed the 6-month trial. Continuous smoking abstinence at week 7 was achieved by 43% in the bupropion group and 18% in the placebo group, p<.001. After 26 weeks, 18% and 7%, respectively, were continuously abstinent, p=.008. Side-effects were frequent but simple and reversible in both groups, and generally consistent with the findings of previous studies. Dizziness, insomnia, and pruritus appeared more frequently in the bupropion group than in the placebo group. Bupropion was effective as an aid to smoking cessation in a broad group of hospital employees in Denmark.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14982688&dopt=Abstract Bupropion Wellbutrin

partners.org

OBJECTIVES: To assess potential infant exposure to bupropion and its active metabolites in breast milk such as would occur during treatment to prevent post-partum relapse to tobacco use, and to compare the concentrations of bupropion in urine and saliva with plasma and breast milk. DESIGN AND SETTING: Cohort study, outpatient clinical research centre. SUBJECTS: Ten healthy post-partum volunteers who agreed to take bupropion for seven days, pump and discard their breast milk, and have samples of breast milk, plasma, saliva, and urine analysed. INTERVENTION: Bupropion 150 mg a day for three days and then 300 mg a day for four days. MAIN OUTCOME MEASURES: Concentrations of bupropion and its active metabolites (hydroxybupropion, erythrohydrobupropion, threohydrobupropion) in breast milk, plasma, saliva, and urine. Determination of average infant exposure. RESULTS: The calculated average dosage of bupropion in breast milk was 6.75 microg/kg/day. Therefore, the average infant exposure is 0.14% of the standard adult dose of bupropion, corrected for the difference in body weight. Considering the sum of bupropion and its active metabolites, the average infant exposure is expected to be 2% of the standard maternal dose on a molar basis. The concentration of bupropion and its active metabolites in breast milk was not associated with age, body mass index, use of oral contraceptive pills, age of infant, or the frequency of breast feeding at the time the study was initiated. The coefficient of determination (r2) between the concentration of bupropion in breast milk and in urine was 0.77 (p < 0.01). CONCLUSIONS: Bupropion and its active metabolites are present in the breast milk of lactating women. The concentrations

gsk.com

BACKGROUND: After initially successful smoking cessation the majority of patients relapse which stresses the addiction character of nicotine dependence. The patient and the physician, in therapeutic nihilism will not make another attempt for smoking cessation. In two randomised, double-blind, placebo-controlled trials in the US and Canada relapsed smokers, who had initially successfully quit smoking under Bupropion SR (Zyban), were again treated with Bupropion SR for smoking cessation. The encouraging results prompted us to perform a study in Germany under the conditions and temporal restraints of a routine medical practice. METHODS/PATIENTS: In this open multicentre study 321 patients of a total of 365 patients at 62 study sites were included. The patients represented a healthy population (= free of severe chronic disease) of smokers, who had relapsed after a smoking cessation attempt with Bupropion SR or nicotine replacement therapy and were currently smoking at least 20 cig./d for > 3 months. The treatment with Bupropion SR (300 mg/d) lasted 7 weeks, with initial run-in of 150 mg/d for the first three days; motivational counselling was provided during 4 clinical visits within the study duration of 26 weeks. RESULTS: 55.4 % of the patients were heavily or very heavily nicotine dependent as detected by the Fagerstrom Tolerance Questionnaire (score 6 - 11). The continuous abstinence rates for week 4 - 7 were 29.6 % (ITT) the point prevalence rates for week 26 were 30.5 % (ITT). Patients who showed a relapse had less daily cigarette consumption even after 26 weeks (10.3 cig./d versus 26.9 cig./d pretreatment). Nicotine craving reached a low plateau not earlier than week 6. Bupropion SR was well tolerated, on




Prim Care Companion J Clin Psychiatry. 2001 Feb;3(1):10-16.
Improved Health-Related Quality of Life and Reduced Productivity Loss After Treatment With Bupropion Sustained Release: A Study in Patients With Major Depression.

Dunner DL, Kwong WJ, Houser TL, Richard NE, Donahue RM, Khan ZM.

Center for Anxiety and Depression, Seattle, Wash.; and GlaxoSmithKline, Research Triangle Park, N.C.

BACKGROUND: This open-label portion of a 2-phase study assessed the effects of the antidepressant bupropion sustained release (SR) on health-related quality of life (QOL) and workplace productivity in patients with major depression. METHOD: Patients (N = 816) with DSM-IV major depression were treated with bupropion SR, 300 mg/day, for 8 weeks. The Clinical Global Impressions scale for Improvement of Illness (CGI-I) was completed at weekly clinic visits. At baseline and week 8, QOL and productivity were assessed. QOL was assessed using the Quality of Life in Depression Scale (QLDS). RESULTS: QOL and productivity were significantly improved from baseline after 8 weeks of treatment with bupropion SR. Mean QLDS scores were 18.98 and 10.36 at baseline and week 8, respectively (mean change = 8.62; p <.001). At week 8 compared with baseline, patients working at a paid job reported missing 1.58 fewer hours of work because of depression during the past 7 days, being 14.6% more effective on the job, working at reduced effectiveness less often, and incurring 6.37 fewer hours of overall lost productivity (p <.001 each variable). Improvements in QOL and productivity were significantly (p <.001) greater in bupropion SR responders (i.e., those with CGI-I scores of "very much improved" or "much improved" during the last 3 weeks of open-label therapy) than in nonresponders. CONCLUSION: Effective treatment of major depression with bupropion SR for 8 weeks is associated with improvements in QOL and reductions in lost workplace productivity. Patients who responded clinically to bupropion SR showed significantly greater