Myocardial infarction: nifedipine did not alter mortality rates.

Clinical bottom line (level 1b-)

  1. In patients with myocardial infarction, administration of nifedipine did not alter mortality.
Goldbourt et al: Archives Internal Medicine 1993; 153: 345-353
Expires March 2003

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: 14 cardiac care units in Israel

1358 patients (aged mean 64y (SD 8y), 74% male) acute myocardial infarction (by clinical, ECG and enzyme criteria) with anterior location, high LDH, hypertension, angina, previous MI or heart failure (NHYA class >2)

Excluded if
  • aged <50 or >79 years
  • perceived need for open calcium antagonist
  • systolic blood pressure <90 mmHg
  • intolerance to nifedipine
  • other (non-coronary) heart disease
  • previous heart surgery
  • ECG evidence of LBBB or Wolff-Parkinson-White syndrome
  • post-hoc exclusions included failure to meet MI criteria, lack of a further risk factor for cardiac death, or inability to reach maximum doses of medication


    • Control Group: (n = 678, 678 analysed): placebo tablets
    Experimental Group: (n = 680, 680 analysed): nifedipine 10mg 4hrly for 6 days, then 15mg 6hrly for 6 months

    100% followed for 6 months

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNH
    (95% CI)
    mortality 6 months 90
    (13.3%)    		 105
    (15.4%)    		 -16%
    (-51% to 10%)    		 -2.17%
    (-5.90% to 1.56%)    		 46
    (NNT = 64 to infinity;
    NNH = 17 to infinity)

  • Only 430 patients completed the full 6 months of nifedipine therapy. Results in this subgroup were essentially the same as the full study.

    • Comments

    1. The study does not exclude a 10% reduction in risk, which may be considered valuable in the setting of acute myocardial infarction.

    Citation

    1. Goldbourt U, Behar S, Reicher-Reiss H, et al: Early administraion of nifedipine in suspected acute myocardial infarction: The secondary prevention reinfarction Israel nifedipine trial 2 study. Archives Internal Medicine 1993; 153: 345-353
    Contributor: Bob Phillips and Clare Wotton, December 1999
    Reviewer:

    Clinical Question.
    Patient acute myocardial infarction
    Intervention or Exposure nifedipine
    Outcome death