Smoking cessation in patients with chronic obstructive pulmonary disease: a double-blind, placebo-controlled, randomised trial.
BACKGROUND
Tobacco smoking is associated with chronic obstructive pulmonary disease (COPD) in more than 80% of cases. Our aim was to investigate the effect of sustained-release bupropion (amfebutamone) (SR) in promoting abstinence from smoking in patients with COPD.


METHODS
In a double-blind, randomised, placebo-controlled trial 404 individuals with mild or moderate COPD who smoked 15 or more cigarettes per day, were assigned bupropion SR (150 mg twice daily) or placebo for 12 weeks. All patients received smoking cessation counselling. Study medication was taken for 1 week before patients attempted to stop smoking. The primary efficacy endpoint was the complete and continuous abstinence from smoking from the beginning of week 4 to the end of week 7. Participants were followed up at month 6. Analysis was by intention to treat.


RESULTS
All patients were chronic smokers with a smoking history of about 51 pack-years. Continuous smoking abstinence rates from week 4 to 7 were significantly higher in participants receiving bupropion SR than in those receiving placebo (28% [57/204] vs 16% [32/200], p=0.003). Continuous abstinence rates from weeks 4 to 12 (18% [36/204] vs 10% [20/200]) and weeks 4 to 26 (16% [32/204] vs 9% [18/200]) were also higher in participants receiving bupropion SR than in those taking placebo (p<0.05). Furthermore, symptoms of tobacco craving and withdrawal were attenuated in those receiving bupropion SR. Seven individuals discontinued study medication because of adverse events.


CONCLUSIONS
Bupropion SRis a well-tolerated and effective aid to smoking cessation in people with mild to moderate COPD.
Tashkin
D
D
Division of Pulmonary and Critical Care Medicine, Department of Medicine, UCLA School of Medicine, 90095, Los Angeles CA, USA. dtashkin@mednet.ucla.edu
Kanner
R
R
Bailey
W
W
Buist
S
S
Anderson
P
P
Nides
M
M
Gonzales
D
D
Dozier
G
G
Patel
M K
MK
Jamerson
B
B
D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage*; D016642:Bupropion / Q000008:administration & dosage*; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016015:Logistic Models; D008173:Lung Diseases, Obstructive / Q000150:complications* / Q000175:diagnosis / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D011336:Probability; D012016:Reference Values; D012129:Respiratory Function Tests; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D014029:Tobacco Use Disorder / Q000150:complications*; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D016642:Bupropion