Prospective Randomized Amlopidine Survival Evaluation - PRAISE
Amlodipine vs placebo for mortality and cardiovascular morbidity in severe chronic heart failure.
Is the use of the calcium-channel antagonist amlopidine in patients with severe chronic heart failure safe and/or efficacious?
Patients Screened: not reported
Patients Enrolled: 1153
NYHA Class: IIIB or IV
Mean Follow Up: 6-33 months (median 13.8)
Mean Patient Age: average 65 years
Mean Ejection Fraction: <30%
NYHA Class IIIB or IV and ejection fraction <30% despite therapy with digoxin, diuretics, and an ACE inhibitor
Unstable angina or MI in prior month, cardiac arrest or sustained ventricular tachycardia or ventricular fibrillation in prior year, stroke or cardiac revascularization in prior 3 months, SBP <85 mm Hg or ≥160 mm Hg, active myocarditis, constrictive pericarditis, uncorrected primary valvular disease, severe concomitant disease, serum creatinine >3.0 mg/dL
Mortality and cardiovascular morbidity (hospitalization for 24 hours for MI, pulmonary edema, severe hypoperfusion, ventricular tachycardia or ventricular fibrillation)
all cause mortality
Amlopidine 10 mg/day (5 mg/day x 2 weeks) or placebo. Nitrates allowed but other vasodilators, beta-blockers, calcium channel blockers, and Class IC antiarrhyhtmic agents were prohibited
The amlopidine group had a nonsignificant 9% lower incidence of the primary endpoint (39% vs. 42%; p = 0.31). Amlodipine group also had a nonsignificant 16% mortality reduction (33% vs. 38%; p = 0.07). Among nonischemic patients (63.5% of enrolled patients), amlopidine was associated with a 46% lower mortality rate (p < 0.001) and 31% lower incidence of primary endpoint(p = 0.04).
Amlodipine was not associated with a significant increase or decrease in mortality and morbidity among patients with severe CHF.
N Engl J Med 1996;335: 1107–1114.
Keywords: Morbidity, Digoxin, Nitrates, Diuretics, Heart Failure, Amlodipine, Calcium Channel Blockers, Vasodilator Agents
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