Bupropion SR for smoking cessation in smokers with cardiovascular disease: a multicentre, randomised study.
OBJECTIVE
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 (150 mg 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; P<0.001). 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%, P<0.001). Weekly point prevalence abstinence was significantly higher for participants who received bupropion SR compared with placebo at weeks 3, 7, 26 and 52 (P<0.001). In both groups, there were no clinically significant changes in blood pressure and heart rate throughout the treatment phase. Overall, 6% of the participants (n=36) discontinued study medication due to an adverse event (bupropion SR, n=17; placebo, n=19).


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.
Tonstad
S
S
Department of Preventative Cardiology, Ullevål University Hospital, N-0407, Oslo, Norway. serena.tonstad@ulleval.no
Farsang
C
C
Klaene
G
G
Lewis
K
K
Manolis
A
A
Perruchoud
A P
AP
Silagy
C
C
van Spiegel
P I
PI
Astbury
C
C
Hider
A
A
Sweet
R
R
D000328:Adult; D000368:Aged; D016642:Bupropion / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000150:complications*; D018765:Dopamine Uptake Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012907:Smoking / Q000009:adverse effects; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D016896:Treatment Outcome
D018765:Dopamine Uptake Inhibitors; D016642:Bupropion