Coronary artery disease: transdermal nicotine helped smokers to give up.

Clinical bottom line (level 1b)

  1. Patients with stable coronary artery disease who smoked and wished to give up and were given transdermal nicotine, were more likely to give up smoking (NNT = 7 at 5 weeks) .
  2. There was no clear difference in adverse effects leading to withdrawal from the trial.
Working Group for the Study of Transdermal Nicotine in Patients with Coronary Artery Disease : Archives of Internal Medicine 1994; 154: 989-995
Expires March 2003

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: four centres, USA

156 patients (aged mean 56 years, 62% male) smokers with stable coronary artery disease who wished to stop smoking. coronary artery disease documented by at least one of:
  • coronary angiography showing a 60% or more obstruction of at least one major coronary artery
  • documented MI
  • clinical history typical of angina pectoris together with an exercise treadmill test result or nuclear scan consistent with myocardial ischaemia
  • prior coronary artery bypass surgery or coronary angioplasty


Excluded if
  • aged <21 or >70
  • smoked less than one pack of cigarettes a day
  • wished to become pregnant
  • acute myocardial infarction within 3 months
  • unstable angina
  • vasospastic conditions
  • symptomatic valvular heart disease
  • uncontrolled congestive heart failure
  • serious ventricular arrhythmias
  • second degree or higher atrioventricular block
  • insulin dependent diabetes mellitus
  • active peptic ulcer disease
  • any condition that would preclude use of transdermal systems


    • Note:
  • Patients were randomised according to a central, non stratified randomisation scheme.


    • Control Group: (n = 79, 79 analysed): transdermal placebo
    Experimental Group: (n = 77, 77 analysed): transdermal nicotine, 14 mg of nicotine per 24 hours
    All patients received weekly group counseling sessions. Concomitant medications were permitted.
    99% followed for 5 weeks
    Outcome notes:
    • no smoking cessation : determined from patients diary reports and expired carbon monoxide levels of 8 ppm or less
    • withdrawal due to adverse effects : nausea, palpitations, malaise, chest pain, increased angina intensity, bypass surgery performed, new ECG changes, hospitalised, dizziness, paraesthesia, dyspnoea, rash

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    no smoking cessation 5 weeks 62
    (78.5%)    		 49
    (63.6%)    		 19%
    (1% to 34%)    		 14.8%
    (0.79% to 28.9%)    		 7
    (3 to 130)
    withdrawal due to adverse effects 5 weeks 8
    (10.1%)    		 3
    (3.90%)    		 62%
    (-40% to 89%)    		 6.23%
    (-1.70% to 14.2%)    		 16
    (NNT = 7 to infinity;
    NNH = 59 to infinity)

    Comments

    1. Further studies of similar long-term (>5 weeks) designs are required to obtain the conclusive acceptance.
    2. 20% of the patients dropped out.

    Citation

    1. Working Group for the Study of Transdermal Nicotine in Patients with Coronary Artery Disease , : Nicotine replacement therapy for patients with coronary artery disease. Archives of Internal Medicine 1994; 154: 989-995
    Contributor: Clare Wotton and Bob Phillips, July 2000
    Reviewer: Hidenori Kawanishi

    Clinical Question.
    Patient smokers with stable coronary artery disease
    Intervention or Exposure transdermal nicotine
    Comparison transdermal placebo
    Outcome cessation, adverse effects