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 e ffect of sustained-release bupropion (amfebutamone) (SR) in promoting absti nence from smoking in patients with COPD. Methods In a double-blind, randomised, placebo-controlled trial 404 individ uals with mild or moderate CORD who smoked 15 or more cigarettes per day, w ere assigned bupropion SR (150 mg twice daily) or placebo for 12 weeks. All patients received smoking cessation counselling. Study medication was take n for 1 week before patients attempted to stop smoking. The primary efficac y 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. Findings All patients were chronic smokers with a smoking history of about 51 pack-years. Continuous smoking abstinence rates from week 4 to 7 were si gnificantly higher in participants receiving bupropion SR than in those rec eiving placebo (28% [57/204] vs 16% [32/200], p=0.003). Continuous abstinen ce rates from weeks 4 to 12 (18% [36/204] vs 10% [20/200]) and weeks 4 to 2 6 (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 o f tobacco craving and withdrawal were attenuated in those receiving bupropi on SR. Seven individuals discontinued study medication because of adverse e vents. Interpretation Bupropion; SR is a well-tolerated and effective aid to smoki ng cessation in people with mild to moderate COPD.