University of Chicago Medicine, Chicago, IL, USA.
Takeda Development Center Americas, Inc, Deerfield, IL, USA.
J Clin Hypertens (Greenwich). 2018 Apr;20(4):694-702. doi: 10.1111/jch.13230. Epub 2018 Mar 4.
An open-label, long-term study evaluated safety and tolerability of azilsartan medoxomil/chlorthalidone (AZL-M/CLD) vs olmesartan/hydrochlorothiazide (OLM/HCTZ) in hypertensive participants with stage 3 chronic kidney disease. Initial therapy was AZL-M/CLD 20/12.5 mg (n = 77) or OLM/HCTZ 20/12.5 mg (n = 76), but could be up-titrated (AZL-M/CLD to 40/25 mg; OLM/HCTZ to 40/25 mg [US] or 20/25 mg [Europe]) with other agents added during weeks 4-52. Primary endpoint was proportion of participants with ≥ 1 adverse event (AE) through week 52. Baseline demographics were similar. AEs did not differ between groups (88.3%, AZL-M/CLD vs 76.3%, OLM/HCTZ; P = .058). AZL-M/CLD showed greater systolic BP reductions after initial dosing (P = .037) but not during long-term follow-up (P = .588). A greater proportion of participants up-titrated to the highest dose with OLM/HCTZ (48.7%) vs AZL-M/CLD (29.9%) (P = .021) and were taking additional antihypertensive medications (26.3% vs 16.9%). Both AZL-M/CLD and OLM/HCTZ showed similar efficacy and tolerability.
一项开放标签、长期研究评估了阿齐沙坦酯/氯噻酮（AZL-M/CLD）与奥美沙坦/氢氯噻嗪（OLM/HCTZ）在伴有 3 期慢性肾病的高血压患者中的安全性和耐受性。初始治疗为 AZL-M/CLD 20/12.5mg（n=77）或 OLM/HCTZ 20/12.5mg（n=76），但在第 4-52 周期间可加用其他药物进行滴定（AZL-M/CLD 增至 40/25mg；OLM/HCTZ 增至 40/25mg[美国]或 20/25mg[欧洲]）。主要终点是第 52 周时≥1 例不良事件（AE）的参与者比例。基线人口统计学特征相似。两组间 AE 无差异（88.3%，AZL-M/CLD 与 76.3%，OLM/HCTZ；P=0.058）。AZL-M/CLD 在初始给药后收缩压降低更显著（P=0.037），但在长期随访期间无差异（P=0.588）。更多的 OLM/HCTZ （48.7%）而非 AZL-M/CLD（29.9%）（P=0.021）患者滴定至高剂量，并服用了其他降压药物（26.3%比 16.9%）。AZL-M/CLD 和 OLM/HCTZ 均显示出相似的疗效和耐受性。
