Copyright © 2003 by the European Society of Cardiology.
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Bupropion SR for smoking cessation in smokers with cardiovascular disease: a multicentre, randomised study
a Department of Preventative Cardiology, Ullevål University Hospital, N-0407 Oslo, Norway
b St. Imre Hospital, Budapest, Hungary
c Department of Cardiology and Pneumology, Hospital AK Altona, Hamburg, Germany
d Help2Quit Centre, Royal Shrewsbury Hospital, Shrewsbury, UK
e Tzannio General Hospital, Piraeus, Greece
f University of Basel, Basel, Switzerland
g Monash Medical Centre, Monash Institute of Public Health Services Research, Victoria, Australia
h Department of Pulmonary Medicine, Slotervaart Hospital, Amsterdam, The Netherlands
i GlaxoSmithKline Research and Development, Greenford, Middlesex, UK
* Corresponding author. Tel.: +22-11-79-39; fax: 22-11-99-75
E-mail address: serena.tonstad{at}ulleval.no
Received 16 December 2002; accepted 18 December 2002
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; 
). 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%, ). Weekly point prevalence abstinence was significantly higher for participants who received bupropion SR compared with placebo at weeks 3, 7, 26 and 52 
. In both groups, there were no clinically significant changes in blood pressure and heart rate throughout the treatment phase. Overall, 6% of the participants 
discontinued study medication due to an adverse event (bupropion SR, 
; placebo, 
).
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.
Key Words: Smoking cessation • Cardiovascular disease • Bupropion sustained release
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