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

Abstract

To determine the efficacy and safety of eplerenone therapy in children with hypertension. 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. 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. Short-term treatment with eplerenone reduced blood pressure in children with hypertension and had acceptable tolerability.