A multicenter, randomised, double-blind, placebo-controlled 6 month trial to evaluate efficacy and tolerability of bupropion hydrochloride sustained release (SR) tablets as treatment for nicotine dependency in healthcare workers and as an aid to smoking

Source: Annual Congress 2002 - Smoking prevention and cessation

Session: Smoking prevention and cessation
Session type: Oral Presentation
Number: 3821

Disease area: Airway diseases

Abstract

INTRODUCTION
Bupropion hydrochloride SR tablets ; Zyban® facilitates smoking cessation in smokers.
OBJECTIVES
Primary; efficacy and tolerability of Zyban® vs. placebo in a 7 week treatment period.
Secondary; efficacy, tolerability and safety profile of Zyban® in a 26 week follow-up period.
METHODS
Randomised, double-blind, placebo-controlled study of smoking hospital employees, motivated for smoking cessation.
335 participants in the Intent-to-Treat population received Zyban® or placebo (2:1) for 7 weeks.
Smoking cessation guidance and motivational support at baseline and all subsequent visits (3, 7, 12 and 26 weeks).
Target quit date 9 days after baseline.
Participants kept a diary of cigarettes smoked and received motivational support before and after target quit date.
Based on the Intention-to-Treat principle with analyses performed after the database was authorised.
RESULTS
95 of 221 participants (43%) in the Zyban® group vs. 21 of 114 (18%) in the placebo group were continuous tobacco abstainers from weeks 4 to 7; Odds Ratio (OR) 3.34 [95% Cl: 1.94, 5.75] (p< 0.001).
For weeks 4 to 12, 59 of 221 (27%) vs. 14 of 114 (12%) participants abstained from smoking; OR 2.60 [95% Cl: 1.38, 4.90](p=0.002).
For weeks 4 to 26, 39 of 221 (18%) vs. 8 of 114 (7%) participants abstained from smoking; OR 2.84 [95% Cl: 1.28, 6.30] (p=0.008).
Rate of adverse events were similar except for insomnia, dizziness and skin problems, which appeared more frequently in the Zyban® group (28% vs. 18%, 8% vs. <1%, and 15% vs. 7%).
Rate of withdrawal due to adverse events was similar in both groups: 26 of 221 (12%) vs. 9 of 114 (8%).
CONCLUSION
Zyban® is significantly more effective than placebo in helping hospital employed smokers quit tobacco and treatment is well-tolerated.

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Citations should be made in the following way:
O. J. Dalsgard, J. Vestbo, on Behalf of the Zyban Hospital Study Group (Copenhagen, Denmark). A multicenter, randomised, double-blind, placebo-controlled 6 month trial to evaluate efficacy and tolerability of bupropion hydrochloride sustained release (SR) tablets as treatment for nicotine dependency in healthcare workers and as an aid to smoking. Eur Respir J 2002; 20: Suppl. 38, 3821

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