COPD: buproprion helped chronic smokers quit, but caused adverse effects

Clinical bottom line (level 2b)

  1. Chronic smokers with mild to moderate COPD who took buproprion compared with placebo were more likely to stop smoking (NN T = 13 at 12 weeks) .
  2. Patients on buproprion were more likely to have adverse effects (including insomnia, headache, dry mouth) (NN H = 7 at 12 weeks) .
Tashkin et al: Lancet 2001; 357 : 1571-1575
Expires October 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 11 respiratory clinics, USA

411 patients (aged mean 54, 55% male) chronic smokers with mild to moderate COPD (FEV1 35% to 50% predicted) who smoked 15 or more cigarettes per day

Excluded if
  • serious or unstable medical disorders that might affect lung function of for which bupropion SR was contraindicated
  • major depression
  • requirement to continue oral steroids or theophylline

    Control Group: (n = 205, 200 analysed): placebo
    Experimental Group: (n = 206, 204 analysed): buproprion SR 150 mg twice daily
    All patients received personalised counselling on stopping smoking.
    78% followed for 12 weeks
    Outcome notes:
    • adverse effect : including insomnia, headache, dry mouth

    The evidence

    Outcome Time to outcome CER EER RRR
    (95% CI)    		 ARR
    (95% CI)    		 NN T
    (95% CI)
    Continued abstinence 12 weeks 20
    (10.0%)    		 36
    (17.7%)    		 76%
    (6% to 190%)    		 7.65%
    (0.965% to 14.3%)    		 13
    (7 to 100)
    adverse effect 12 weeks 60
    (30.0%)    		 90
    (44.1%)    		 -47%
    (-91% to -13%)    		 -14.1%
    (-23.4% to -4.80%)    		 -7
    (-21 to -4)

    Comments

    1. Patients were randomised in blocks of four stratified by centre.
    2. Large numbers of patients were lost to follow-up, but in the intention-to-treat analysis, they were all assumed to have relapsed (worse-case scenario).
    3. Similar numbers in each group discontinued medication due to adverse effects.

    Citation

    1. Tashkin DP, Kanner R, Bailey W, et al: smoking cessation in patients with chronic obstructive pulmonary disease: a double-blind, placebo-controlled, randomised trial. Lancet 2001; 357 : 1571-1575
    Search Terms: from ACP Journal Club other articles noted
    Contributor: Chris Ball, October 2001
    Reviewer:

    Clinical Question.
    Patient chronic smoker with COPD
    Intervention or Exposure buproprion
    Comparison placebo
    Outcome smoking cessation
    		•