The Efficacy and Safety of the Novel Aldosterone Antagonist Eplerenone in Children with Hypertension: A Randomized, Double-Blind, Dose-Response Study

• Published in: The Journal of pediatrics 2010-08, Vol.157 (2), p.282-287
• Main Authors: Li, Jennifer S., MD, MHS, Flynn, Joseph T., MD, MS, Portman, Ronald, MD, Davis, Ira, MD, Ogawa, Masayo, MD, Shi, Harry, MA, Pressler, Milton L., MD
• Format: Article
• Language: English
• Subjects: Adolescent; Arterial hypertension. Arterial hypotension; Biological and medical sciences; Blood and lymphatic vessels; Blood Pressure; Cardiology. Vascular system; Child; Child, Preschool; Dose-Response Relationship, Drug; Double-Blind Method; Female; General aspects; Humans; Hypertension - drug therapy; Male; Medical sciences; Mineralocorticoid Receptor Antagonists - therapeutic use; Pediatrics; Placebos; Safety; Spironolactone - analogs & derivatives; Spironolactone - therapeutic use; Treatment Outcome
• ISSN: 0022-3476; 1097-6833
• DOI: 10.1016/j.jpeds.2010.02.042

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.