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SOLVD (Studies of Left Ventricular Dysfunction). Enalapril vs placebo in 6,794 patients Ejection fraction < 35% End points include: Delaying the progression of heart failure Improving signs and symptoms Reducing mortality
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SOLVD(Studies of Left Ventricular Dysfunction) • Enalapril vs placebo in 6,794 patients • Ejection fraction < 35% • End points include: • Delaying the progression of heart failure • Improving signs and symptoms • Reducing mortality • Treatment arm - 2,568 symptomatic class II-III patients most on digitalis and diuretics • Prevention arm - 4,226 asymptomatic class I-II patients, most on no concomitant therapy N Engl J Med 1991:325:293-302
SOLVD Treatment TrialAll Cause Mortality 16% Risk Reduction p = 0.0036 N Engl J Med 1991;325:293-302
Benefits of Enalapril • Patients: Symptomatic HF patients with LVD (EF < 35%) • Increased Survival • 32% at 3 months • 28% at 6 months • 21% at 12 months • 18% at 24 months • 12% at 36 months • 12% at 48 months • 11% reduction of overall mortality at end of study (P=0.0036) The SOLVD Investigators, N Engl J Med. 1991;325:293
SOLVD Treatment TrialMortality or Hospitalization for CHF 26% Risk Reduction p<0.0001 N Engl J Med 1991;325:293-302
SOLVD Treatment-Enalapril Symptomatic HF Patients with LVD (EF < 35%) (NYHA Class II-III) 30% Reduction p<0.001 971 683 Number of Hospitalizations Due to Heart failure The SOLVD Investigators, N Engl J Med, 1991
SOLVD Treatment-Enalapril Symptomatic HF Patients with LVD (EF < 35%) (NYHA Class II-III) 33% Reduction p<0.001 234 157 Number of Readmissions for Heart failure The SOLVD Investigators, N Engl J Med, 1991
SOLVD Treatment Trial • Implications: • Treating 1,000 patients for 3 years • Prevents about 50 deaths • Prevents about 350 hospitalizations
Benefits of Enalapril • Patients: Symptomatic HF patients with LVD (EF < 35%) • Decreased hospitalizations • 48% at 3 months • 51% at 6 months • 46% at 12 months • 23% at 24 months • 28% at 36 months • 30% reduction of overall hospitalization at end of study (P<0.0001) • Convenient once - or twice - daily dosing The SOLVD Investigators, N Engl J Med. 1991;325:293
SOLVD Treatment Trial Conclusions • Hospitalizations: • Risk reduced by 20% (p<0.001) • Significant reduction in CHF hospitalization by 1/3 (p<0.0001) • Sustained benefit over 4 years N Engl J Med 1991;325:293-302
SOLVD Prevention TrialAll Cause Mortality Risk Reduction 8% P=0.30 N Engl J Med 1992;327:685-91
SOLVD Prevention TrialDeath or Development of CHF Risk Reduction 29% p<0.001 N Engl J Med 1992;327:685-91
SOLVD Prevention TrialFirst Hospitalization for CHF Risk Reduction 36% p<0.001 N Engl J Med 1992;327:685-91
SOLVD Prevention Trial N Engl J Med 1992;327:685-91
SOLVD Prevention- Enalapril Asymptomatic HF Patients w/ LVD (EF < 35%) (NYHA Class I-II) 32% Fewer First Hospitalizations p<0.001 273 184 Number of First Hospitalizations for Heart Failure The SOLVD Investigators, N Engl J Med, 1992.