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Bupropion SR for smoking cessation in smokers with cardiovascular disease: a multicentre, randomised study

Tonstad, S. ; Farsang, C. ; Klaene, G. ; Lewis, K. ; Manolis, A. ; Perruchoud, A.P. ; Silagy, C. ; van Spiegel, P.I. ; Astbury, C. ; Hider, A. ; Sweet, R.

In: European Heart Journal, 2003, vol. 24, no. 10, p. 946-955

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    Titre
    • Bupropion SR for smoking cessation in smokers with cardiovascular disease: a multicentre, randomised study
    Auteur
    • Tonstad, S.. Department of Preventative Cardiology, Ullevål University Hospital, N-0407 Oslo, Norway
    • Farsang, C.. St. Imre Hospital, Budapest, Hungary
    • Klaene, G.. Department of Cardiology and Pneumology, Hospital AK Altona, Hamburg, Germany
    • Lewis, K.. Help2Quit Centre, Royal Shrewsbury Hospital, Shrewsbury, UK
    • Manolis, A.. Tzannio General Hospital, Piraeus, Greece
    • Perruchoud, A.P.. University of Basel, Basel, Switzerland
    • Silagy, C.. Monash Medical Centre, Monash Institute of Public Health Services Research, Victoria, Australia
    • van Spiegel, P.I.. Department of Pulmonary Medicine, Slotervaart Hospital, Amsterdam, The Netherlands
    • Astbury, C.. GlaxoSmithKline Research and Development, Greenford, Middlesex, UK
    • Hider, A.. GlaxoSmithKline Research and Development, Greenford, Middlesex, UK
    • Sweet, R.. GlaxoSmithKline Research and Development, Greenford, Middlesex, UK
    Type de document
    • Postprint
    Identifiant OAI-PMH
    • oai:doc.rero.ch:295800
    Summary
    Aim To investigate the safety and efficacy of bupropion sustained release (bupropion SR) in promoting abstinence from smoking in subjects with cardiovascular disease (CVD). Methods Six hundred twenty-nine subjects with CVD who smoked ≥10 cigarettes/day were randomised in a double-blind, multicentre study to receive bupropion SR (150mg twice daily) or placebo for 7 weeks, with a follow-up of 52 weeks. Primary efficacy endpoint: continuous abstinence from smoking from weeks 4 to 7. Secondary endpoints: continuous abstinence (weeks 4-12, 4-26 and 4-52) and weekly point prevalence abstinence. All participants received brief motivational support. Safety was evaluated throughout the study. Results Continuous smoking abstinence rates from weeks 4 to 7 were significantly higher in subjects receiving bupropion SR compared with placebo (43 vs. 19%, odds ratio [OR]=3.27, 95% confidence interval [CI] 2.24-4.84; \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \(P{<}0.001\) \end{document}). Continuous abstinence rates from weeks 4 to 26 and 4 to 52 continued to be more than double for bupropion SR compared with placebo (27 vs. 11%; 22 vs. 9%, \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \(P{<}0.001\) \end{document}). Weekly point prevalence abstinence was significantly higher for participants who received bupropion SR compared with placebo at weeks 3, 7, 26 and 52 \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \((P{<}0.001)\) \end{document}. In both groups, there were no clinically significant changes in blood pressure and heart rate throughout the treatment phase. Overall, 6% of the participants \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \((n=36)\) \end{document} discontinued study medication due to an adverse event (bupropion SR, \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \(n=17\) \end{document}; placebo, \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \(n=19\) \end{document}). Conclusions After 7 weeks of bupropion SR treatment, more than twice as many smokers with CVD had quit smoking at 1 year compared with placebo. The safety profile of bupropion SR was similar to that previously observed in general smoking populations