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Secondary Prevention Reinfarction Israeli Nifedipine Trial - SPRINT
Description:
Nifedipine for mortality in acute myocardial infarction.
Hypothesis:
Nifedipine would lower mortality and morbidity in survivors of myocardial infarction.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 4,545
Mean Follow Up: 10 months
Mean Patient Age: 58
Female: not detailed
Mean Ejection Fraction: not available
Patient Populations:
Adults suffering acute myocardial infarction
Five to seven days post event
Patient capable of tolerating Nifedipine
Heart failure not an entry criterion
Exclusions:
Patients requiring calcium channel therapy
Noncoronary heart disease
Previous cardiac surgery
Pacemaker implantation
Severe pulmonary hypertension
Uncontrollable congestive heart failure preceding myocardial infarction
Persistent hypotension (systolic blood pressure < 90 mmHg)
Cerebral vascular accident
Left bundle branch block
WPW syndrome
Primary Endpoints:
Total mortality
Secondary Endpoints:
Cardiovascular mortality
Morbidity
Drug/Procedures Used:
Nifedipine 30 mg/day
Concomitant Medications:
Beta blockers (20%)
Digitalis (14%)
Diuretics (30%)
Antiarrhythmic drugs (30%)
Vasodilators (47%)
Anticoagulants (1%)
Antiplatelet drug (20%)
Principal Findings:
One-year postdischarge mortality was 5.0% in the placebo group and 5.9% among patients receiving nifedipine (P = 0.37).
Mortality rates after 5 years of follow-up in 2138 patients previously randomized to 1 year of nifedipine therapy and placebo were 18.4% and 18.3%, respectively. The 5-year mortality risk ratio associated with randomization to nifedipine over 1 year, adjusted for age, gender, past MI, angina, diabetes, hypertension, MI location, and therapy, was 1.00 (95% CI: 0.81-1.22).
Interpretation:
Mortality during intermediate term follow-up after myocardial infarction was not beneficially or detrimentally affected by Nifedipine as administered in this trial. Recurrent myocardial infarction rates were also not diminished. Despite the theoretical considerations that the drug could be beneficial, Nifedipine has no secondary protective effect in patients after acute myocardial infarction. Subset analysis did not reveal that heart failure patients fared differently. These results do not support an association between nifedipine therapy and a late harmful effect on long-term mortality.
References:
1. European Hrt Jrnl 1988;9:354-64. Final results
2. Am Heart J 1997;133:290-6. Diabetic subgroup
3. Cardiovascular Drugs & Therapy. 1998;12:171-6. 5-year follow-up
Keywords: Odds Ratio, Myocardial Infarction, Follow-Up Studies, Heart Failure, Nifedipine, Hypertension, Calcium Channel Blockers, Diabetes Mellitus
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