A double-blind, randomized study comparing the antihypertensive effect of eplerenone and spironolactone in patients with hypertension and evidence of primary aldosteronism
A double-blind, randomized study comparing the antihypertensive effect of eplerenone and spironolactone in patients with hypertension and evidence of primary aldosteronism
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DOI：
10.1097/hjh.0b013e3283455ca5
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发表时间：
2011-05-01
影响因子：
4.9
通讯作者：
MacDonald, Thomas M.
中科院分区：
文献类型：
--
作者：
Parthasarathy, Hari K.;Menard, Joel;MacDonald, Thomas M.
研究背景依普利酮是一种比螺内酯更有选择性的盐皮质激素受体阻滞剂，具有更少的抗雄激素副作用。我们比较了依普利酮与螺内酯治疗原发性醛固酮增多症相关高血压患者的疗效、安全性和耐受性。在单盲、安慰剂导入期后，患者以1：1的比例随机分配至螺内酯（75-225 mg，每日一次）或依普利酮（100-300 mg，每日一次）的16周双盲、治疗期，采用滴定至效应设计。患者必须符合原发性醛固酮增多症的生化标准，坐位DBP至少90 mmHg且小于120 mmHg，SBP小于200 mmHg，方可进行随机化。主要疗效终点是依普利酮与螺内酯的降压效果，以确定依普利酮在坐位DBP较基线平均变化方面的非劣效性。结果依普利酮组DBP较基线的变化（-5.6 +/-1.3SEmmHg）小于螺内酯组（-12.5 +/-1.3SEmmHg）[差异，-6.9 mmHg（-10.6，-3.3）; P
Background Eplerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. We compared the efficacy, safety and tolerability of eplerenone versus spironolactone in patients with hypertension associated with primary aldosteronism.Methods The study was multicentre, randomized, double-blind, active-controlled, and parallel group design. Following a single-blind, placebo run-in period, patients were randomized 1 : 1 to a 16-week double-blind, treatment period of spironolactone (75-225 mg once daily) or eplerenone (100-300 mg once daily) using a titration-to-effect design. To be randomized, patients had to meet biochemical criteria for primary aldosteronism and have a seated DBP at least 90 mmHg and less than 120 mmHg and SBP less than 200 mmHg. The primary efficacy endpoint was the antihypertensive effect of eplerenone versus spironolactone to establish noninferiority of eplerenone in the mean change from baseline in seated DBP.Results Changes from baseline in DBP were less on eplerenone (-5.6 +/- 1.3SE mmHg) than spironolactone (-12.5 +/- 1.3SE mmHg) [difference, -6.9 mmHg (-10.6, -3.3); P