Efficacy and safety of darusentan in patients with resistant hypertension: results from a randomized, double-blind, placebo-controlled dose-ranging study.
Efficacy and safety of darusentan in patients with resistant hypertension: results from a randomized, double-blind, placebo-controlled dose-ranging study.
复制标题
DOI：
10.1111/j.1524-6175.2007.07244.x
复制
发表时间：
2007-10-01
期刊：
影响因子：
--
通讯作者：
Gerber, Michael J
中科院分区：
文献类型：
--
作者：
Black, Henry R;Bakris, George L;Gerber, Michael J
在这项随机、双盲、安慰剂对照的2期强制剂量滴定研究中，115例顽固性高血压患者接受bb0 /=3抗高血压药物（包括全剂量利尿剂）的背景治疗，随机分为2:1，分别增加达鲁森坦（10,50,100,150和300mg）、选择性内皮素受体拮抗剂或匹配安慰剂的剂量，每天一次，持续10周。与安慰剂相比，达鲁森坦治疗以剂量依赖的方式降低了平均收缩压和舒张压水平；在第10周（300 mg剂量）观察到最大的降低（收缩期，-11.5+/-3.1 mm Hg [P= 0.015]；舒张期，-6.3+/-2.0 mm Hg [P= 0.002]）。从基线到第10周，Darusentan （300 mg）也降低了平均24小时、白天和夜间的动态血压。一般来说，达鲁桑坦的耐受性很好；轻至中度水肿和头痛是最常见的不良事件。这项研究证明了一种新型降压药在高血压预防、检测、评估和治疗联合全国委员会第七次报告中被分类为耐药的患者中的临床益处。
In this phase 2, randomized, double-blind, placebo-controlled forced dose-titration study, 115 patients with resistant hypertension, receiving background therapy with >/=3 antihypertensive medications including a diuretic at full doses, were randomized 2:1 to increasing doses of darusentan (10, 50, 100, 150, and 300 mg), a selective endothelin receptor antagonist, or matching placebo once daily for 10 weeks. Darusentan treatment decreased mean systolic and diastolic blood pressure levels in a dose-dependent fashion compared with placebo; the largest reductions were observed at week 10 (300-mg dose) (systolic, -11.5+/-3.1 mm Hg [P=.015;] diastolic, -6.3+/-2.0 mm Hg [P=.002]). Darusentan (300 mg) also decreased mean 24-hour, daytime, and nighttime ambulatory blood pressures from baseline to week 10. Darusentan was generally well tolerated; mild to moderate edema and headache were the most common adverse events. This study demonstrates a clinical benefit from a new class of antihypertensive agent in patients classified as resistant by the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure guidelines.