"Valsartan, Captopril, or Both in Myocardial Infarction Complicated by Heart Failure, Left Ventricular Dysfunction, or Both". The New England Journal of Medicine. 2003. 349:1893-1906.
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Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Noninferiority 10 Tolerability and Safety 11 Discussion 12 Funding 13 Further Reading
In high-risk patients with myocardial infarction complicated by left ventricular systolic dysfunction, heart failure, or both, how does the efficacy of valsartan, captopril, or the combination of both compare in terms of mortality?
Valsartan is as effective as captopril for improving survival and reducing cardiovascular morbidity in high-risk patients following myocardial infarction. The combination of valsartan and captopril does not improve survival and increases the rate of adverse events.
ACE inhibitors like captopril have established benefits post-myocardial infarction in patients with left ventricular dysfunction, heart failure, or both. The Valsartan in Acute Myocardial Infarction (VALIANT) trial compared the angiotensin-receptor blocker valsartan, the ACE inhibitor captopril, and their combination, finding that valsartan is as effective as captopril in high-risk post-myocardial infarction patients regarding mortality and cardiovascular morbidity. Combining valsartan with captopril did not improve survival and increased the rate of adverse events.
International guidelines recommend ACE inhibitors as first-line therapy for patients with myocardial infarction complicated by heart failure or left ventricular dysfunction.
- Randomized, double-blind trial - N=14,703 - Valsartan (n=4909) - Valsartan plus captopril (n=4885) - Captopril (n=4909) - Median follow-up: 24.7 months
Inclusion Criteria - Age ≥18 years - Acute myocardial infarction (0.5 to 10 days before) - Complicated by heart failure, left ventricular systolic dysfunction (ejection fraction ≤0.35 or ≤0.40 depending on ventriculography method), or both
Exclusion Criteria - Intolerance or contraindication to ACE inhibitors or angiotensin-receptor blockers - Significant valvular disease or other severely limiting diseases
Baseline Characteristics - Similar across all groups
- Valsartan initiated at 20 mg, goal to reach 160 mg twice daily - Valsartan + captopril initiated at combined doses, goal to reach valsartan 80 mg twice daily and captopril 50 mg three times daily - Captopril initiated at 6.25 mg, goal to reach 50 mg three times daily
Primary Outcome - Similar mortality rates across all groups
- Rates of secondary composite cardiovascular outcomes were similar across groups
Noninferiority - Valsartan demonstrated noninferiority to captopril regarding mortality
Tolerability and Safety - The combination group experienced the most drug-related adverse events - With monotherapy, valsartan associated with more hypotension and renal dysfunction, while captopril associated with cough, rash, and taste disturbance
Discussion The VALIANT trial's findings indicate valsartan as a clinically effective alternative to captopril in high-risk patients post-myocardial infarction. The choice between these two treatments may depend on clinical experience, tolerability, safety, convenience, and cost.
Supported by a grant from Novartis Pharmaceuticals.
For additional information on this trial, read the full text available at: [NEJM URL].