Sustained release bupropion (amfebutamone) is a non-nicotine agent that is
indicated as an aid to smoking cessation.
In 2 large well designed clinical trials, sustained release bupropion 300 m
g/day (the recommended dose) fur 7 or 9 weeks was associated with considera
bly and significantly higher smoking abstinence rates (continuous abstinenc
e and 7-day point prevalence rates) than placebo during treatment and at fo
llow-up at 6 and 12 months. Point prevalence rates at 12 months in 2 studie
s were 23.1 and 30.3% with bupropion, whereas values for placebo were 12.4
and 15.6%. Continuous abstinence rates at 12 months, available from 1 trial
, were 18.4% with bupropion and 5.6% with placebo. Furthermore, bupropion w
as associated with significantly higher quitting rates than nicotine patch
in a comparative study. Combination therapy with bupropion and nicotine pat
ch provided slightly higher abstinence rates than bupropion alone, although
differences were not statistically significant. The combination was superi
or to nicotine patch alone.
Data from a preliminary report of long term bupropion treatment (52 weeks)
showed that the drug was associated with significantly higher continuous ab
stinence rates than placebo only to 6 months. However, point prevalence abs
tinence rates were significantly higher with bupropion than placebo to 18 m
onths.
Bupropion 300 mg/day recipients reported nicotine withdrawal symptoms durin
g treatment; however, the symptoms were significantly less severe with bupr
opion than placebo. Patients receiving bupropion 300 mg/day or bupropion in
combination with nicotine patch for smoking cessation generally gained les
s bodyweight than placebo recipients. The benefits of bupropion for prevent
ing weight grain persisted after the completion of long term, but not short
term therapy.
Bupropion was well tolerated in clinical trials, and the only adverse event
s that were significantly more common with bupropion than placebo were inso
mnia and dry mouth. Data published so far suggest that sustained release bu
propion has a low potential for inducing seizures (seizure rate approximate
to 0.1% in patients with depression).
Conclusions: Bupropion is an effective and well tolerated smoking cessation
intervention. Further studies with long term follow-up will be useful in d
etermining whether abstinence rates are maintained with bupropion. In addit
ion, clarification of its efficacy in comparison with other therapies used
for smoking cessation would help to establish its clinical value. The reduc
ed potential for weight gain with bupropion and the ability to use bupropio
n in combination with nicotine replacement therapy make the drug a useful t
reatment option for smoking cessation.