Chen Shao-xing, Zhang Jin, Chen Shao-liang, Chen Jun-zhu, Yan Xiao-wei, Ke Yuan-nan, DU Feng-he, Zhang Cheng-zong, Qin Yong-wen, Pu Kui, Zhu Ding-liang
Department of Hypertension, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai Institute of Hypertension, Shanghai 200025, China.
Zhonghua Xin Xue Guan Bing Za Zhi. 2008 Apr;36(4):300-4.
To evaluate the efficacy and safety of a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide (HCTZ) 12.5 mg (TH) to telmisartan 80 mg (T) in Chinese patients who failed to respond adequately to treatment with T.
This is a multi-center, randomized, double-blind, double-dummy clinical study. A total of 699 eligible hypertensive patients entered a one-week screening phase prior to the eight-week open-label T period. At the end of eight weeks, 345 patients who failed to respond to T (DBP > or = 90 mm Hg, 1 mm Hg = 0.133 kPa) were randomized to receive either TH (175 patients) or T (170 patients) for another eight weeks. Sitting and standing BP were taken 24 hours post-dose and adverse events were documented at visit with 4 weeks interval. Laboratory, ECG and physical examination were performed at screening, at baseline and at the final visit.
After 8 weeks treatment, (1) The mean trough reduction in sitting diastolic blood pressure (SiDBP) from baseline in TH group was greater than that in T group (10.1 mm Hg vs 7.7 mm Hg, P = 0.0017). The mean trough reduction in sitting systolic blood pressure (SiSBP) from baseline was 14.2 mm Hg in TH group and 7.4 mm Hg in T group (P < 0.0001). (2) The mean trough reduction in standing DBP and standing SBP from baseline were significantly greater in TH group (8.7 mm Hg and 12.9 mm Hg) compared those in T group (7.3 mm Hg and 7.0 mmHg, P = 0.0350, P < 0.0001). (3) The number and percentage of responders in TH group (129, 74.6%) were significantly higher than in T group (100, 59.2%, P = 0.0016). (4) The incidence of the study drug-related adverse events was similar between TH and T group (3.5% vs. 3.6%, P > 0.05).
TH was more effective than T in patients not responded adequately to T in Chinese hypertensive patients.
评估替米沙坦80mg与氢氯噻嗪（HCTZ）12.5mg固定剂量复方制剂（TH）对比替米沙坦80mg（T）治疗对T治疗反应欠佳的中国患者的疗效和安全性。
这是一项多中心、随机、双盲、双模拟临床研究。共有699例符合条件的高血压患者在为期8周的开放标签T治疗期前进入为期1周的筛选期。8周结束时，345例对T治疗无反应（舒张压≥90mmHg，1mmHg = 0.133kPa）的患者被随机分为接受TH治疗（175例患者）或T治疗（170例患者），再治疗8周。给药后24小时测量坐位和立位血压，每4周随访记录不良事件。在筛选期、基线期和末次随访时进行实验室检查、心电图检查和体格检查。
治疗8周后，（1）TH组坐位舒张压（SiDBP）自基线的平均谷值降幅大于T组（10.1mmHg对7.7mmHg，P = 0.0017）。TH组坐位收缩压（SiSBP）自基线的平均谷值降幅为14.2mmHg，T组为7.4mmHg（P < 0.0001）。（2）TH组立位DBP和立位SBP自基线的平均谷值降幅显著大于T组（分别为8.7mmHg和12.9mmHg）（T组分别为7.3mmHg和7.0mmHg，P = 0.0350，P < 0.0001）。（3）TH组的有效者数量及百分比（129例，74.6%）显著高于T组（100例，59.2%，P = 0.0016）。（4）TH组和T组研究药物相关不良事件的发生率相似（3.5%对3.6%，P > 0.05）。
在中国高血压患者中，对于对T治疗反应欠佳的患者，TH比T更有效。
