The Effects of Enalapril on Mortality in Severe Congestive Heart failure - CONSENSUS

Jul 10, 2003
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Date Published:
01/01/1987
Date Updated:
07/10/2003
Original Posted Date:
07/10/2003
References

Description:

Enalapril vs. placebo for 6-month mortality in severe heart failure after MI.

Hypothesis:

Enalapril added to conventional therapy for heart failure improves survival in patients with severe heart failure.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 253
NYHA Class: 100% Class IV
Mean Follow Up: 6 months (20 months)
Mean Patient Age: 70
Female: .30
Mean Ejection Fraction: not measured

Patient Populations:

Severe CHF (NYHA Class IV)
Patients receiving optimal treatment with digitalis/diuretics
Enlarged heart on CXR

Exclusions:

Treatment with ACE inhibitor
Acute pulmonary edema
Aortic or mitral stenosis
MI within prior 2 months
Unstable angina
Planned cardiac surgery
Cor pulmonale
Significant renal insufficiency

Primary Endpoints:

6 month all cause mortality
Cardiovascular cause for death

Secondary Endpoints:

12 month and long-term (intention-to-treat)

Drug/Procedures Used:

Enalapril 10 mg - 40 mg QD
Mean dose 18.4 mg/day

Concomitant Medications:

Digoxin (93%)
Diuretics (98%)
Nitrates (46%)
Hydralazine (2%)
Prazosin (7%)
Antiarrhythmics (15%)

Principal Findings:

Overall mortality at 6 months was 44% in placebo group and 26% in Enalapril (risk reduction 40%; p = 0.002).

Mortality rate was reduced in Enalapril group by 31% at 1 year.

Reduction in mortality was found among patients with progressive heart failure and there was no effect on sudden cardiac death mortality.

There was a significant improvement in NYHA Class in Enalapril group as well as a reduction in heart size, and reduced requirement for other heart failure medications.

All surviving patients in a double-blind study comparing the effects of enalapril and placebo on survival in severe congestive heart failure were recommended to be treated with active drug after stopping the trial. Two-year follow-up from the end of the blinded trial demonstrated that among 77 survivors of 127 patients originally allocated to the group with enalapril, 38 were still alive. Of 126 patients allocated to the group with placebo 58 survived the blinded study, and after 2-year follow-up 26 were still alive. Thus, the difference between the original treatment groups remained, despite that treatment with enalapril was made available to all surviving patients and that those in the group with enalapril were sicker at baseline than those in the group with placebo.

Interpretation:

Enalapril added to conventional therapy of digitalis and diuretics improves symptoms and survival in severe heart failure. Despite this beneficial effect, one year mortality in the treatment group remained high. The benefit from enalapril was sustained at up to 2 years after the end of the trial.

References:

1. N Engl J Med 1987;316:1429-35. Final results
2. Am J Cardiol 1992;69:103-7. 2-year extended follow-up

Keywords: Cardiomegaly, Survivors, Enalapril, Risk Reduction Behavior, Diuretics, Heart Failure, Digitalis Glycosides, Death, Sudden, Cardiac


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