The Effects of Enalapril on Mortality and the Development of Heart failure in Asymptomatic Patients with Reduced Left Ventricular Ejection Fractions - SOLVD-Prevention

Jul 10, 2003
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Date Published:
01/01/1992
Date Updated:
07/10/2003
Original Posted Date:
07/10/2003
References

Description:

Enalapril vs. placebo for hospitalization and mortality in heart failure.

Hypothesis:

Enalapril reduces mortality incidence of symptomatic heart failure, and rate of hospitalization for heart failure.

Study Design

Study Design:

Patients Screened: 39,924
Patients Enrolled: 4,228
NYHA Class: I=(67%), II=(33%)
Mean Follow Up: 37 months (15 - 62)
Mean Patient Age: 59
Female: 12
Mean Ejection Fraction: 28%

Patient Populations:

LVEF <35%
Absence of substantive congestive heart failure symptoms

Exclusions:

Receiving digitalis, diuretics or vasodilators
(Remainder same as SOLVD Treatment Trial)

Primary Endpoints:

All-cause mortality
Cardiovascular mortality
Death or hospitalization for congestive heart failure

Secondary Endpoints:

Development of congestive heart failure
Development of congestive heart failure and anti-CHF therapy
First hospitalization for CHF
Multiple hospitalizations for CHF
Death or development of CHF
Death or hospitalization for CHF

Drug/Procedures Used:

Enalapril (starting at 2.5 mg bid titrating up to 10 mg bid)

Concomitant Medications:

Digoxin (12.5%)
Diuretics (16.5%)
Nitrates (30%)
Antiarrhythmics (15%)
Beta blockers (24%)
Calcium channel blockers (35%)
Anticoagulants (12%)
Antiplatelets (55%)

Principal Findings:

Trend toward reduced mortality in Enalapril group versus placebo (RR 8% ; p = 0.3).
Significant reduction by Enalapril in combined endpoint of death/development of CHF (RR 29%; p < 0.001)
Fewer patients died or were hospitalized with congestive heart failure (RR 20%; p < 0.001)

Interpretation:

Enalapril reduces risk of development of heart failure and hospitalization for heart failure in patients without substantive symptoms and EF < 35%. There was a trend toward fewer cardiovascular deaths in patients receiving Enalapril. This study indicates that ACE inhibitors are first line therapy in early heart failure manifested by left ventricular systolic dysfunction with no or minimal symptoms.

References:

1. N Engl J Med 1992;327:685-69. Final results
2. Am J Cardiol 1995;75:1244-9. Ventricular arrhythmia substudy
3. Am J Cardiol 1996;78:890-5. Quality of life

Keywords: Enalapril, Heart Failure, Ventricular Dysfunction, Left


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