Copyright © 1999 by the European Society of Cardiology.
Long-term survival in severe heart failure in patients treated with enalapril; ten year follow-up of CONSENSUS I
a Department of Medicine, Sahlgrenska University Hospital/Östra, Göteborg, Sweden
b Department of Cardiology, National Hospital, University of Oslo, Oslo, Norway
c MRL, MSD, Blue Bell, Pennsylvania, U.S.A.
accepted April 19, 1998
Abstract
Background
The CONSENSUS trial was the first study to show prognostic improvement by an ACE inhibitor. Patients in NYHA class IV heart failure were treated with enalapril or placebo. After study completion (average 183 days) all patients were offered open-label enalapril therapy. This paper reports on the survival at the 10-year follow up of the patients randomized in the CONSENSUS trial.
Methods
All 35 participating centres in CONSENSUS I were asked to complete a questionnaire on the survival status at 1 November 1996 of patients randomized in CONSENSUS.
Results
At 10-year follow up, one patient was lost to follow-up. Five patients, all in the enalapril group, were long-term survivors (P=0·004). Averaged over the duration of the trial (double-blind plus open-label extension) the risk reduction was 30% (P=0·008), with a 95% confidence interval of 11% to 46%. At the end of the double-blind study period, mortality was considerably higher among patients who did not receive open ACE inhibitor therapy compared to those who did.
Conclusion
After a treatment period of, on average, 6 months, enalapril was shown to be effective. The effect was sustained for at least 4 years i.e. for another 3·5 years. The present follow-up is the first heart failure trial where the full life-cycle has been followed from randomization. In severe heart failure, mortality is significantly reduced by enalapril. On average, the beneficial effect is maintained for several years and overall survival time is prolonged by 50% (from 521 to 781 days).
Key Words: Congestive heart failure • prognosis • ACE inhibitors
1 Correspondence:Karl Swedberg, MD, PhD, Department of Medicine, Sahlgrenska University Hospital at Östra, 416 85 Göteborg, Sweden.
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