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Valsartan in Acute Myocardial Infarction Trial Investigators

VALIANT Trial. Valsartan in Acute Myocardial Infarction Trial Investigators . Presented at American Heart Association Scientific Sessions 2003 Marc A. Pfeffer, et al. N Engl J Med 2003;349:1893-906. VALIANT Trial.

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Valsartan in Acute Myocardial Infarction Trial Investigators

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  1. VALIANT Trial Valsartan in Acute Myocardial Infarction Trial Investigators Presented at American Heart Association Scientific Sessions 2003 Marc A. Pfeffer, et al. N Engl J Med 2003;349:1893-906

  2. VALIANT Trial 14,703 post-MI patients with left ventricular systolic dysfunction, heart failure, or both Randomized, double-blind, multicenter • Captopril monotherapy • Titrated to 50 mg 3x/d • n=4,909 • Valsartan + captopril • Valsartan titrated to 80 mg 2x/d • Captopril titrated to 50 mg 3x/d • n=4,885 • Valsartan monotherapy • Titrated to 160 mg 2x/d • n=4,909 • Endpoints (follow-up mean 24.7 months): • Primary – Death from any cause during follow-up • Secondary – Death from cardiovascular causes, reinfarction, or hospitalization for heart failure N Engl J Med 2003;349:1893-906

  3. VALIANT Trial CV Death, re-MI, or hospitalization for HF* Valsartan vs captopril HR 0.95, p=0.20 Combo vs captopril HR 0.97, p=0.37 All-cause Mortality* Valsartan vs captopril HR 1.00, 97.5% CI 0.90-1.11, p=0.98 Combo vs captopril HR 0.98, 97.5% CI 0.89-1.09, p=0.73 * Met criteria for non-inferiority of valsartan vs captopril N Engl J Med 2003;349:1893-906

  4. VALIANT Trial Adverse events Valsartan vs captopril, p=NS Combo vs captopril, p<0.05 • In the valsartan group, hypotension and renal dysfunction occurred more frequently • In the captopril group, cough, rash, and taste disturbance occurred more frequently N Engl J Med 2003;349:1893-906

  5. VALIANT Trial • Among patients with myocardial infarction complicated by LV dysfunction, heart failure, or both, treatment with valsartan, an angiotensin-receptor blocker, alone or in combination with captopril, an ACE inhibitor, did not meet the primary endpoint of all cause mortality compared with captopril monotherapy for superiority • However, the trial did meet the criteria of non-inferiority for all-cause mortality and for CV death, reinfarction, or hospitalization for heart failure for valsartan vs captopril • Adverse events  in valsartan/captopril arm vs valsartan group or captopril arm

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