The efficacy and safety of the novel aldosterone antagonist eplerenone in children with hypertension: a randomized, double-blind, dose-response study.
OBJECTIVE
To determine the efficacy and safety of eplerenone therapy in children with hypertension.


METHODS
A total of 304 children age 4-16 years with systolic blood pressure (SBP) >or=95th percentile were randomized to low-dose (25 mg daily), middle-dose (25 mg twice daily), or high-dose (50 mg twice daily) eplerenone (phase A), then rerandomized to active therapy or placebo for another 4 weeks (phase B). The primary endpoint was change in SBP in phase B.


RESULTS
During phase A, mean SBP decreased from baseline by 8 mm Hg, and diastolic blood pressure (DBP) decreased by up to 3.8 mm Hg; no dose-response relationship was demonstrated. Mean differences in SBP from placebo during phase B were -2.61 for the low-dose group, +2.32 for the middle-dose group, and -2.76 mm Hg for the high-dose group; only the reduction in the high-dose group was statistically significant (P = .048). No significant effects on DBP of eplerenone therapy relative to placebo were detected. Eplerenone was well tolerated, with a rate of adverse events comparable to that of placebo.


CONCLUSIONS
Short-term treatment with eplerenone reduced blood pressure in children with hypertension and had acceptable tolerability.
Li
Jennifer S
JS
Division of Pediatric Cardiology and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27710, USA. jennifer.li@duke.edu
Flynn
Joseph T
JT
Portman
Ronald
R
Davis
Ira
I
Ogawa
Masayo
M
Shi
Harry
H
Pressler
Milton L
ML
D000293:Adolescent; D001794:Blood Pressure; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000077545:Eplerenone; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D000451:Mineralocorticoid Receptor Antagonists / Q000627:therapeutic use*; D010919:Placebos; D012449:Safety; D013148:Spironolactone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D000451:Mineralocorticoid Receptor Antagonists; D010919:Placebos; D013148:Spironolactone; D000077545:Eplerenone