Myocardial infarction: nifedipine did not affect mortality.

Clinical bottom line (level 1b)

  1. In patients with myocardial infarction, nifedipine did not improve mortality at 28 days.
  2. Patients with myocardial infarction who were already taking beta-blockers did not have an altered prognosis.
  3. In patients who had a myocardial infarction, nifedipine produced more side effects (NNH = 43 at 28 days) .
Wilcox et al: British Medical Journal 1986; 293: 1204-1208
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The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: university and district hospitals in UK

4491 patients (aged 40% were 51-60 years, 67% male) suspected acute myocardial infarction with 24h of onset of symptoms, diagnosed on symptoms, ECG and enzyme criteria

Excluded if
  • pregnancy or possibility <4 weeks from study entry
  • systolic BP <100 mmHg or diastolic <50 mmHg, or HR>120 bpm
  • severe heart failure requiring inotropes/ vasodilators
  • severe hepatic or renal dysfunction


    • Control Group: (n = 2251, 2251 analysed): placebo capsules given as below
    Experimental Group: (n = 2240, 2240 analysed): nifedipine 10 mg capsules, given sublingually, then repeated at 4-8 hrs if BP>100 and HR<120, and converted to oral dosing 6hrly

    100% followed for 28 days mortality and side effects

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNH
    (95% CI)
    mortality 28 days 141
    (6.26%)    		 150
    (6.70%)    		 -7%
    (-34% to 14%)    		 -0.43%
    (-1.87% to 1.01%)    		 231
    (NNT = 99 to infinity;
    NNH = 53 to infinity)
    mortality (prior beta-blockade) 28 days 38
    (9.03%)    		 38
    (9.36%)    		 -4%
    (-59% to 32%)    		 -0.33%
    (-4.27% to 3.61%)    		 300
    (NNT = 28 to infinity;
    NNH = 23 to infinity)
    side effects 28 days 96
    (4.26%)    		 148
    (6.61%)    		 -55%
    (-99% to -21%)    		 -2.34%
    (-3.67% to -1.02%)    		 43
    (27 to 98)

    Comments

    1. Trial performed before widespread thrombolysis, but unlikely to be affected by this change.

    Citation

    1. Wilcox RG, Hampton JR, Banks DC, et al: Trial of early nifedipine in acute myocardial infarction: the Trent study. British Medical Journal 1986; 293: 1204-1208
    Contributor: Bob Phillips and Clare Wotton, November 1999
    Reviewer:

    Clinical Question.
    Patient myocardial infarction
    Intervention or Exposure nifedipine 10mg sublingual/orally
    Comparison placebo
    Outcome mortality