Efficacy and tolerability of eplerenone and losartan in hypertensive of eplerenone and black and white patients

Efficacy and tolerability of eplerenone and losartan in hypertensive of eplerenone and black and white patients
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DOI:
10.1016/s0735-1097(03)00054-8
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发表时间:
2003-04-02
影响因子:
24
通讯作者:
Saunders, E
Saunders, E
中科院分区:
医学1区
文献类型:
--
作者:
Flack, JM;Oparil, S;Saunders, E

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本研究的目的是评估选择性醛固酮阻滞剂依普利酮单药治疗黑人和白色高血压患者的疗效和耐受性。背景原发性高血压和心血管肾靶器官损害在美国黑人成年人中比白色成年人更普遍。中度高血压患者随机分为依普利酮50 mg、血管紧张素II受体拮抗剂氯沙坦50 mg或安慰剂组,每日一次。如果血压仍然不受控制,则增加剂量。主要终点是治疗16周后平均舒张压(DBP)的变化。结果:安慰剂组、依普利酮组和氯沙坦组DBP较基线的校正平均变化分别为-5.3 ± 0.7、-10.3 ± 0.7和-6.9 ± 0.6 mmHg(平均SE,p < 0.001依普利酮对比安慰剂,p < 0.001依普利酮对比氯沙坦)。在黑人患者中,安慰剂组、依普利酮治疗组和氯沙坦治疗组的DBP分别降低了-4.8 +/- 1.0、-10.2 +/- 0.9和-6.0 +/- 0.9 mmHg(平均值+/- SE,p < 0.001依普利酮对安慰剂,p < 0.001依普利酮对氯沙坦),而在白色患者中,DBP降低-6.4 +/- 1.0,分别为-11.1 +/- 1.1和-8.4 +/- 1- 1.0 mmHg(依普利酮与安慰剂相比p <0.001,依普利酮与氯沙坦相比p = 0.068)。对于收缩压(SBP)的降低,依普利酮在所有患者合并和黑人患者中上级安慰剂和氯沙坦,在白色患者中上级安慰剂。依普利酮降低高肾素患者SBP和DBP的效果与氯沙坦相当,但对低肾素患者的疗效优于氯沙坦。同样,依普利酮在不同基线醛固酮水平的患者中至少与氯沙坦一样有效。结论依普利酮对黑人和白色患者的降压效果相当,对黑人患者的降压效果上级氯沙坦。
OBJECTIVES The purpose of this study was to evaluate the efficacy and tolerability of monotherapy with the selective aldosterone blocker eplerenone in both black and white patients with hypertension.BACKGROUND Essential hypertension and cardiovascular-renal-target organ damage is more prevalent in black than white adults in the U.S.METHODS Black (n = 348) and white (n = 203) patients with mild-to-moderate hypertension were randomized to double-blind treatment with eplerenone 50 mg, the angiotensin Il receptor antagonist losartan 50 mg, or placebo once,daily. Doses were increased if blood pressure remained uncontrolled. The primary end point was change in mean diastolic blood pressure (DBP) after 16 weeks of therapy.RESULTS Adjusted mean changes from baseline in DBP were -5.3 +/- 0.7, -10.3 +/- 0.7, and -6.9 +/- 0.6 mm Hg in the placebo, eplerenone-treated, and losartan-treated groups, respectively (mean SE, p < 0.001 eplerenone vs. placebo, p < 0.001 eplerenone vs. losartan). In black patients, DBP decreased by -4.8 +/- 1.0, -10.2 +/- 0.9, and -6.0 +/- 0.9 mm Hg for the placebo, eplerenone-treated, and losartan-treated groups, respectively (mean +/- SE, p < 0.001 eplerenone vs. placebo, p < 0.001 eplerenone vs. losartan), whereas in white patients, DBP decreased by -6.4 +/- 1.0, -11.1 +/- 1.1, and -8.4 +/- 1- 1.0 mm Hg, respectively (p 0.001 eplerenone vs. placebo, p = 0.068 for eplerenone vs. losartan). For reduction of systolic blood pressure (SBP), eplerenone was superior to placebo and losartan in all patients combined and in black patients, and was superior to placebo in white patients. Eplerenone was as effective as losartan in reducing SBP and DBP in the high renin patient, but more effective than losartan in the low renin patient. Similarly, eplerenone was at least as effective as losartan in patients with differing baseline levels of aldosterone. Both eplerenone and losartan were well tolerated.CONCLUSIONS The antihypertensive effect of eplerenone was equal in black and white patients and was superior to losartan in black patients.