Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Ruijin 2nd Road 197, 200025, Shanghai, China.
Clin Drug Investig. 2012 Nov;32(11):729-34. doi: 10.1007/s40261-012-0003-7.
There is limited information on the long-term efficacy and safety of olmesartan medoxomil in the management of hypertension in Chinese patients. We therefore conducted the present multicentre, single-arm, prospective, observational study to investigate the 24-week efficacy and safety of olmesartan medoxomil in patients with mild to moderate hypertension.
Eligible patients (diastolic blood pressure [BP] 90-109 mmHg and systolic BP <180 mmHg off antihypertensive medication) were started on olmesartan medoxomil 20 mg once daily, with the possible up-titration to 40 mg once daily during 24 weeks of follow-up, to control clinic BP to the target level (<140/90 and <130/80 mmHg in diabetes mellitus). In a subset of enrolled patients, 24-h ambulatory and home BP monitoring were also performed.
In the intent-to-treat analysis (n = 348), at 24 weeks of follow-up, the mean ± SD changes from baseline in clinic systolic/diastolic BP were 21.2 ± 14.2/16.0 ± 8.8 mmHg (p < 0.001). The proportions of patients who achieved the goal BP for systolic, diastolic and both were 81, 80 and 75 %, respectively. Olmesartan medoxomil also significantly (p < 0.001) reduced systolic/diastolic BP measured at patients' homes by 17.7 ± 13.1/12.1 ± 7.9 mmHg from baseline (n = 109), and reduced mean 24-h, daytime and night-time ambulatory BP by 13.3 ± 16.3/7.6 ± 9.5 mmHg, 13.9 ± 17.4/8.0 ± 10.4 mmHg and 12.3 ± 18.1/6.8 ± 10.2 mmHg, respectively (n = 87). Seven (2.0 %) serious adverse events were reported during follow-up.
In Chinese hypertensive patients, olmesartan medoxomil is efficacious in lowering BP as assessed by three different BP-measuring methods and has an acceptable long-term safety and tolerability profile.
在高血压患者的管理中，有关奥美沙坦酯的长期疗效和安全性的信息有限。因此，我们进行了这项多中心、单臂、前瞻性、观察性研究，以评估奥美沙坦酯在轻中度高血压患者中的 24 周疗效和安全性。
符合条件的患者（舒张压[BP]90-109mmHg，抗高血压药物停药时收缩压<180mmHg）开始服用奥美沙坦酯 20mg，每日一次，在 24 周的随访期间，可能滴定至 40mg，每日一次，以将诊室血压控制在目标水平（糖尿病患者<140/90mmHg和<130/80mmHg）。在入组患者的亚组中，还进行了 24 小时动态血压监测和家庭血压监测。
在意向治疗分析（n=348）中，在 24 周的随访期间，与基线相比，诊室收缩压/舒张压的平均（±SD）变化分别为 21.2±14.2/16.0±8.8mmHg（p<0.001）。达到收缩压、舒张压和两者目标的患者比例分别为 81%、80%和 75%。奥美沙坦酯还显著（p<0.001）降低了 109 例患者家庭血压的收缩压/舒张压，从基线下降了 17.7±13.1/12.1±7.9mmHg，还显著降低了 87 例患者的 24 小时平均、白天和夜间动态血压，降幅分别为 13.3±16.3/7.6±9.5mmHg、13.9±17.4/8.0±10.4mmHg和 12.3±18.1/6.8±10.2mmHg。在随访期间，报告了 7 例（2.0%）严重不良事件。
在高血压中国患者中，奥美沙坦酯在降低血压方面是有效的，并且具有可接受的长期安全性和耐受性。
