Circulation, Vol 82, 774-780, Copyright © 1990 by American Heart Association
BF Uretsky, M Jessup, MA Konstam, GW Dec, CV Leier, J Benotti, S Murali, HC Herrmann and JA Sandberg
A multicenter double-blind, randomized, placebo-controlled trial of oral
enoximone, a phosphodiesterase inhibitor, was conducted in 102 outpatients
(50 receiving enoximone and 52 receiving placebo) with moderate to
moderately severe congestive heart failure. All were on a long-term regimen
of digoxin and diuretics without vasodilators and converting enzyme
inhibitors. Symptom score was obtained, and exercise testing was performed
monthly for 4 months. There were no differences between groups in symptoms
or exercise duration at the end of 4 months. A subgroup undergoing analysis
of oxygen consumption with measurement of anaerobic threshold during
exercise showed an increase (p less than 0.05) in anaerobic threshold at 1
month with enoximone. (2.7 +/- 0.8 ml O2/kg/min) compared with placebo
(-0.8 +/- 1.2 ml O2/kg/min). This improvement was not sustained at 4 months
(0.5 +/- 1.7 ml O2/kg/min with enoximone and 0.2 +/- 1.5 ml O2/kg/min with
placebo). The dropout rate was significantly higher (p less than 0.02) with
enoximone (46%) than with placebo (25%). Adverse effects other than death
were slightly, but not significantly, higher with enoximone (32%) than with
placebo (22%). During therapy, five deaths occurred in the enoximone group,
and none occurred in the placebo group (p less than 0.05). Two deaths were
sudden, two were from progressive congestive heart failure, and one was
from acute myocardial infarction. With intention-to-treat analysis and
inclusion of patients who were removed from therapy because of lack of
study drug effect, 10 deaths occurred in the enoximone group, and three
occurred in the placebo group (p less than 0.05).(ABSTRACT TRUNCATED AT 250
WORDS)
ARTICLES
Multicenter trial of oral enoximone in patients with moderate to moderately severe congestive heart failure. Lack of benefit compared with placebo. Enoximone Multicenter Trial Group
Presbyterian-University Hospital, Pittsburgh, PA 15213.
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