TY - JOUR
TI - Outcome of patients with congestive heart failure treated with standard
versus high doses of enalapril: A multicenter study
AU - Nanas, JN
AU - Alexopoulos, G
AU - Anastasiou-Nana, MI
AU - Karidis, K and
AU - Tirologos, A
AU - Zobolos, S
AU - Pirgakis, V
AU - Anthopoulos, L and
AU - Sideris, D
AU - Stamarelopoulos, SF
AU - Moulopoulos, SD
AU - High
AU - Enalapril Dose Study Grp
JO - Journal of the American College of Cardiology
PY - 2000
VL - 36
TODO - 7
SP - 2090-2095
PB - EXCERPTA MEDICA INC-ELSEVIER SCIENCE INC
SN - 0735-1097, 1558-3597
TODO - 10.1016/S0735-1097(00)01025-1
TODO - null
TODO - OBJECTIVES We sought to prospectively and randomly compare survival with
clinical and hemodynamic variables in patients with congestive heart
failure (CHF) treated with standard versus high doses of enalapril.
BACKGROUND Angiotensin-converting enzyme (ACE) inhibitors produce
hemodynamic and symptomatic benefits in patients with CHF, but there is
still controversy about the optimal dose in this clinical setting.
METHODS Two hundred and forty-eight patients with advanced CHF (age 56.3
+/- 12 years) were randomized to receive a maximal tolerated dose of
enalapril, up to 20 mg/day in group 1 (mean dose achieved 17.9 +/- 4.3
mg/day, n = 122) and 60 mg/day in group 2 (mean dose achieved 42 +/-
19.3 mg/day, n = 126).
RESULTS At enrollment, patients in group 1 were in New York Heart
Association (NYHA) functional class 2.6 +/- 0.7 and had a mean systolic
blood pressure (SBP) of 117 +/- 18 mm Hg, a mean heart rate (HR) of 85
+/- 16 beats/min and a left ventricular ejection fraction (LVEF) of 20.0
+/- 9.8%. In group 2, patients were in NYHA class 2.6 +/- 0.7; their
SEP was 118 +/- 17 mm Hg, HR 83 +/- 15 beats/min and LVEF 18.8 +/-
8.1%. There were no significant differences in these characteristics
between the two groups of patients at enrollment. After 12 months of
follow-up, 22 (18%) of 122 patients in group 1 and 23 (18%) of 126
patients in group 2 had died (p = 0.995, with 80% power of the study to
detect a delta difference of 13%). The NYHA class was the same (1.9 +/-
0.7) in both groups; SEP was 111 +/- 16 and 111 +/- 17 mm Hg, HR 77 +/-
12 and 79 +/- 13 beats/min and LVEF 31 +/- 19% and 30 +/- 12% in
groups 1 and 2, respectively. These differences were not statistically
significant. The study had a power of 80% to detect (p = 0.05) the
following changes: 13% in death rate, 0.25 units in NYHA class, 6 mm Hg
in SEP, 5 beats/min in HR and 6% in LVEF.
CONCLUSIONS No significant differences were found in survival and
clinical and hemodynamic variables between patients receiving standard
and those receiving high doses of enalapril. (C) 2000 by the American
College of Cardiology.
ER -