Coronary heart disease: transdermal nicotine had no clear effect on major cardiac events.

Clinical bottom line (level 1b-)

  1. Patients with cardiac disease who were given transdermal nicotine to help stop smoking, had no clear difference in major cardiac events than those given placebo. The study size is far too small.
  2. Patients given transdermal nicotine had no clear difference in other serious adverse effects.
Joseph et al: New England Journal of Medicine 1996; 335 (24): 1792-1798
Expires March 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: ten Veteran's Affairs centres, USA

584 patients (aged range 45 to 82 years; mean 61, 99% male) Smoked at least 15 cigarettes per day for at least five years, tried to quit at least twice and had a level of carbon monoxide in expired air of >8 parts per million. Patients also had to have one or more of: history of myocardial infarction, history of coronary artery bypass surgery or angioplasty, stenosis of at least 50% in at least one major coronary artery, clinical history of angina, congestive heart failure, cor pulmonale, arrhythmia, peripheral vascular disease or cerebrovascular disease.

Excluded if
  • unstable angina, MI, coronary artery bypass surgery, angioplasty or hospitalisation for cardiac arrhythmia within the previous two weeks
  • history of continuous use of transdermal nicotine for >48 hours
  • current use of (and an unwillingness to stop using) other tobacco products or nicotine gum
  • presence of unstable psychiatric illness or an unstable disorder involving alcohol or controlled substance use
  • history of severe dermatitis
  • pregnancy


    • Control Group: (n = 290, 290 analysed): placebo patches
    Experimental Group: (n = 294, 294 analysed): transdermal nicotine given as a 21 mg patch for 6 weeks, a 14 mg patch for 2 weeks and a 7 mg patch for 2 weeks
    Patients were given leaflets about stopping smoking and advised not to smoke with the patches. They received brief behavioural counseling which lasted 15 minutes at the baseline visit, and for 10 minutes at each of the next two visits (week one and six). Patches were stopped if patients began smoking again.
    100% followed for ?
    Outcome notes:
    • major cardiac event : death, MI, cardiac arrest or admission for increased severity of angina, arrhythmia or congestive heart failure
    • other serious adverse effects : admission for peripheral vascular disease, cerebrovascular disease or for any other reason or outpatient visit for increased severity of atherosclerotic cardiovascular disease
    • severe side effects : sleep disturbance, skin reaction, gastrointestinal distress, dizziness, dry mouth, sweating, malaise or influenza-like symptoms

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    major cardiac event unknown 23
    (7.93%)    		 16
    (5.44%)    		 31.0%
    (-27.0% to 63.0%)    		 2.49%
    (-1.56% to 6.54%)    		 40
    (NNT = 15 to infinity;
    NNH = 64 to infinity)
    other serious adverse effects weeks 28
    (9.66%)    		 35
    (11.9%)    		 -23.0%
    (-97.0% to 23.0%)    		 -2.25%
    (-7.28% to 2.78%)    		 -44
    (NNT = 36 to infinity;
    NNH = 14 to infinity)
    severe side effects unknown 27
    (9.31%)    		 36
    (12.2%)    		 -32.0%
    (-111% to 18.0%)    		 -2.93%
    (-7.96% to 2.09%)    		 -34
    (NNT = 48 to infinity;
    NNH = 13 to infinity)

    Citation

    1. Joseph AM, Norman SM, Ferry LH, et al: The safety of transdermal nicotine as an aid to smoking cessation in patiens with cardiac disease. New England Journal of Medicine 1996; 335 (24): 1792-1798
    Contributor: Clare Wotton and Chris Ball, February 2000
    Reviewer: Kev Hopayian

    Clinical Question.
    Patient cardiac disease
    Intervention or Exposure transdermal nicotine to help stop smoking
    Comparison placebo
    Outcome death, MI or cardiac arrest