Open AccessEfficacy and Safety of the Selective Aldosterone Blocker Eplerenone in Japanese Patients With Hypertension: A Randomized, Double‐Blind, Placebo‐Controlled, Dose‐Ranging Study
Author(s) -
Saruta Takao,
Kageyama Shigeru,
Ogihara Toshio,
Hiwada Kunio,
Ogawa Masayo,
Tawara Kazuji,
Gatlin Marjorie,
Garthwaite Susan,
Bittman Richard,
Patrick Jeffrey
Publication year - 2004
Publication title -
the journal of clinical hypertension
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.909
H-Index - 67
eISSN - 1751-7176
pISSN - 1524-6175
DOI - 10.1111/j.1524-6175.2004.03146.x
Subject(s) - eplerenone , medicine , tolerability , dose ranging study , placebo , blood pressure , aldosterone , spironolactone , essential hypertension , plasma renin activity , endocrinology , renin–angiotensin system , urology , cardiology , adverse effect , double blind , pathology , alternative medicine
Approximately 40% of Japanese patients with essential hypertension, including low‐renin hypertension, are inadequately managed. Low‐renin hypertension generally responds poorly to angiotensin‐converting enzyme inhibitors and angiotensin‐receptor blockers, but may respond more optimally to diuretics, calcium channel blockers, and aldosterone blockers. This multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, dose‐ranging study evaluated the efficacy and safety of the selective aldosterone blocker eplerenone in 193 Japanese patients with essential hypertension. Although not a study inclusion criterion, baseline active plasma renin levels were consistently low (5.7–10.1 mU/L); most patients met the criteria for low‐renin hypertension (≤42.5 mU/L; normal range, 7–76 mU/L). Patients received placebo or eplerenone 50, 100, or 200 mg once daily for 8 weeks. Systolic blood pressure decreased significantly (−6.8 to −10.6 mm Hg vs. −2.1 mm Hg; p ≤0.0245 vs. placebo) at all eplerenone doses; diastolic pressure decreased significantly at 100 and 200 mg doses (−6.9 to −7.5 mm Hg vs. −3.0 mm Hg; p ≤0.0022 vs. placebo). Eplerenone offers significant blood pressure reduction with good tolerability in Japanese patients with hypertension, including those with low‐renin hypertension.