The Efficacy and Safety of the Novel Aldosterone Antagonist Eplerenone in Children with Hypertension: A Randomized, Double-Blind, Dose-Response Study
Received 7 October 2009; received in revised form 29 December 2009; accepted 22 February 2010. published online 19 April 2010.
Objectives
To determine the efficacy and safety of eplerenone therapy in children with hypertension.
Study design
A total of 304 children age 4-16 years with systolic blood pressure (SBP) ≥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.
Reprint requests: Jennifer S. Li MD, MHS, Box 3090, Duke University Medical Center, Durham, NC 27710.
Funded by Pfizer, Inc. J.L. is a consultant to Pfizer, Inc and Sanofi-Aventis. J.F. is a consultant to Pfizer, Inc, Gilead Sciences, Inc, Shire Pharmaceuticals, and Novartis Pharmaceuticals. M.P., M.O., and H.S. were employees of Pfizer, Inc during the study. The other authors declare no conflicts of interest.
ABSTRACT