Gao Pingjin, Mei Kezhi, Li Hongwei, Dai Qiuyan, Guo Xingui, Zhang Daifu, Jin Zhimin, You Hua, Ding Hong, Lü Ke, Zhou Shuxian, Peng Xiaoling, Xu Hui, Yin Pengfei, Yu Licheng, Pi Lin, Hua Qi, Yang Ming, Yu Xiaowei
Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Guangzhou Red Cross Hospital, Guangzhou, Guangdong, China.
Curr Ther Res Clin Exp. 2015 Oct 9;90:99-105. doi: 10.1016/j.curtheres.2015.09.001. eCollection 2019.
Amlodipine (AML) is the initial therapy most commonly prescribed for patients with hypertension in China. However, AML monotherapy is often less effective in achieving blood pressure (BP) control than other agents.
We performed a clinical study to evaluate efficacy and safety of a combination therapy with AML, olmesartan (OLM), or an OLM/hydrochlorothiazide (HCTZ) compound for Chinese patients with mild-to-moderate hypertension.
In the clinical trial, patients were initially treated with OLM 20 mg/d combined with AML 5 mg/d. Then OLM was uptitrated to 40 mg/d or changed to an OLM/HCTZ (20/12.5 mg/d) compound if the patients did not reach the target of seated diastolic BP <90 mm Hg (<80 mm Hg in patients with diabetes) after 8 weeks.
The overall response rate of the combination therapy was 59.2% (95% CI, 54.23%-63.97%) at Week 2 and gradually increased to 97.1% (95% CI, 94.93%-98.47%) at the end of the study (Week 16).
The combination therapy with OLM or OLM/HCTZ was well tolerated. The total incidence of adverse events was 42.9% (n = 176). Most of the adverse events were mild in severity (39.5%; n = 162) and not associated with the drugs (33.2%). In conclusion, combination therapy with AML, OLM, or OLM/HCTZ can significantly lower BP safely and achieve a high BP control rate in patients with mild-to-moderate hypertension in China. ClinicalTrial.org identifier: ChiCTR-ONC-12001963.
氨氯地平（AML）是中国高血压患者最常处方的初始治疗药物。然而，AML单药治疗在实现血压（BP）控制方面往往比其他药物效果更差。
我们进行了一项临床研究，以评估AML、奥美沙坦（OLM）或OLM/氢氯噻嗪（HCTZ）复方联合治疗中国轻至中度高血压患者的疗效和安全性。
在临床试验中，患者最初接受20mg/d的OLM联合5mg/d的AML治疗。如果患者在8周后未达到坐位舒张压<90mmHg（糖尿病患者<80mmHg）的目标，则将OLM剂量上调至40mg/d或改为OLM/HCTZ（20/12.5mg/d）复方。
联合治疗的总有效率在第2周时为59.2%（95%CI，54.23%-63.97%），并在研究结束时（第16周）逐渐升至97.1%（95%CI，94.93%-98.47%）。
OLM或OLM/HCTZ联合治疗耐受性良好。不良事件的总发生率为42.9%（n = 176）。大多数不良事件为轻度（39.5%；n = 162），且与药物无关（33.2%）。总之，AML、OLM或OLM/HCTZ联合治疗可在中国轻至中度高血压患者中安全显著降低血压并实现高血压控制率。ClinicalTrial.org标识符：ChiCTR-ONC-12001963。
