Randomized Dose-Response Study of the New Dual Endothelin Receptor Antagonist Aprocitentan in Hypertension
Randomized Dose-Response Study of the New Dual Endothelin Receptor Antagonist Aprocitentan in Hypertension
复制标题
DOI：
10.1161/hypertensionaha.119.14504
复制
发表时间：
2020-04-01
期刊：
影响因子：
8.3
通讯作者：
Bellet, Marc
中科院分区：
文献类型：
--
作者：
Verweij, Pierre;Danaietash, Parisa;Bellet, Marc
本研究探讨了内皮素A/内皮素B受体双重拮抗剂aprocitentan在原发性高血压患者中的剂量反应特征。在一项随机、双盲、平行研究设计中，坐位舒张压（BP）为90-109 mm Hg的合格患者接受了5、10、25或50 mg普拉西坦、安慰剂或赖诺普利20 mg作为阳性对照，每日一次，持续8周。在基线、第2周、第4周和第8周，在患者休息无人值守（无人值守自动办公室BP）的情况下获得多个自动办公室BP读数。在基线和第8周监测24小时的动态血压。在单盲安慰剂导入期后，490例合格患者随机进入双盲期，其中409例患者按照方案完成了8周治疗。Aprocitentan 10、25和50 mg从基线至第8周降低了坐位收缩压/舒张压（安慰剂校正后分别降低：7.05/4.93、9.90/6.99和7.58/4.95 mm Hg，P
This study examined the dose-response characteristics of aprocitentan, a dual endothelin A/endothelin B receptor antagonist, in patients with essential hypertension. In a randomized, double-blind, parallel study design, eligible patients with a sitting diastolic blood pressure (BP) of 90-109 mm Hg received aprocitentan 5, 10, 25, or 50 mg, placebo, or lisinopril 20 mg as a positive control once daily for 8 weeks. Multiple automated office BP readings were obtained with patients resting unattended (unattended automated office BP) at baseline, weeks 2, 4, and 8. Ambulatory BP was monitored for 24 hours at baseline and week 8. After a single-blind placebo run-in period, 490 eligible patients were randomized to the double-blind phase, with 409 patients completing 8 weeks of therapy per protocol. Aprocitentan 10, 25, and 50 mg decreased sitting systolic/diastolic unattended automated office BP from baseline to week 8 (placebo-corrected decreases: 7.05/4.93, 9.90/6.99, and 7.58/4.95 mm Hg, respectively, P