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The Effects of the Angiotensin-Converting-Enzyme Inhibitor Zofenopril on Mortality and Morbidity after Anterior Myocardial Infarction - SMILE
Description:
Zofenopril for morbidity and mortality in acute MI.
Hypothesis:
Zofenopril started early after anterior myocardial infarction improves both short and long-term morbidity and mortality.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 1,556
NYHA Class: not given
Mean Follow Up: 1.5 months
Mean Patient Age: 64
Female: 28
Mean Ejection Fraction: not given
Patient Populations:
Ages 18-80 years
Presenting within 24 hours after chest pain representing anterior MI by ECG criteria
Not eligible for thrombolytic therapy
Exclusions:
Cardiogenic shock
Systolic BP < 100 mmHg
Creatinine > 2.5
History of CHF
ACE inhibitor treatment
Primary Endpoints:
Death or severe CHF during treatment period (6 weeks)
Secondary Endpoints:
Mild to moderate CHF at 6 weeks
Nonfatal recurrent MI
Angina
Cumulative one year mortality
Drug/Procedures Used:
Zofenopril (target dose of 30 mg bid)
Concomitant Medications:
Beta blockers (20%)
nitrates (44%)
calcium channel blockers (10%)
aspirin (54%)
digitalis (7%)
diuretics (18%)
Principal Findings:
Death or severe CHF at 6 weeks significantly reduced in the Zofenopril group (7.1% Zofenopril group versus 10.6% placebo).
Cumulative reduction in risk of death or severe CHF was 34% (95% CI 8-54%; p = 0.018).
Reduction in risk was 46% (p = 0.018) for severe CHF and 25% (p = 0.19) for death.
After one year, 29% reduced risk of death in Zofenopril group (p = 0.011).
Interpretation:
"Treatment with zofenopril significantly improved both short-term and long-term outcome when started within 24 hours after onset of acute anterior myocardial infarction and continued for six weeks." (From Abstract)
References:
1. Controlled Clinical Trials 1994;15:201-10. Trial design
2. N Engl J Med 1995;332:80-85. Final results
3. Am J Cardiol 1996;78:317-22. CHF substudy
Keywords: Thrombolytic Therapy, Myocardial Infarction, Morbidity, Chest Pain, Electrocardiography, Captopril
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