Sharma Akhilesh, Bagchi Ananda, Kinagi Satish B, Sharma Yogesh Kumar, Baliga Vidyagauri P, Bollmall Chandrashekhar
Medical Services Department, Glenmark Pharmaceuticals Ltd., Glenmark House, HDO Corporate Building, Chakala, Andheri (East), Mumbai 400099, India.
Clin Ther. 2007 Dec;29(12):2667-76. doi: 10.1016/j.clinthera.2007.12.017.
The aim of this study was to evaluate the efficacy and tolerability of a new fixed-dose combination (FDC) of telmisartan 40 mg + amlodipine 5 mg (T+A) compared with amlodipine 5-mg monotherapy (A) in adult Indian patients with stage II hypertension.
This comparative, Phase III, 12-week, multicenter, prospective, randomized, double-blind study was conducted in Indian patients aged 18 to 65 years with established stage II hypertension. Patients were treated with oral FDC of T+A or A QD before breakfast for 12 weeks; blood pressure (BP) and heart rate were measured in the sitting position. Primary efficacy end points were reduction in clinical systolic BP (SBP)/ diastolic BP (DBP) from baseline to study end and number of responders (ie, patients who achieved target SBP/ DBP <130/<80 mm Hg) at end of study. Tolerability was assessed by treatment-emergent adverse events, identified using physical examination, laboratory analysis, and electrocardiography.
A total of 210 patients were enrolled in the study; 203 patients (143 men, 60 women) completed the study while 7 were lost to follow-up (4 patients in the T+A group and 3 in the A group) and considered with-drawn. At study end, statistically significant percentage reductions from baseline within groups and between groups were observed in SBP (T+A [-27.4%]; A [-16.6%]) and DBP (T+A [-20.1%]; A [-13.3%]) (all, P < 0.05). Response rates were 87.3% (89/102) in the T+A group and 69.3% (70/101) in the A group (P < 0.05). The prevalences of adverse events were not significantly different between the 2 treatment groups (T+A, 16.0% [17/106]; A, 15.4% [16/104]). Peripheral edema was reported in 8.5% patients (9/106) in the T+A group compared with 13.5% (14/104) in the A group, and cough was reported in 3.8% patients (4/106) in the T+A group and 1.0% (1/104) patients in the A group; these differences did not reach statistical significance. The incidences of headache, dizziness, and diarrhea were similar between the 2 groups.
Among these Indian patients with stage II hypertension, the FDC of T+A was found to be significantly more effective, with regard to BP reductions, than A, and both treatments were well tolerated.
本研究旨在评估替米沙坦40mg+氨氯地平5mg（T+A）的新型固定剂量复方制剂与氨氯地平5mg单药治疗（A）相比，在成年印度II期高血压患者中的疗效和耐受性。
这项比较性、III期、12周、多中心、前瞻性、随机、双盲研究在年龄为18至65岁、确诊为II期高血压的印度患者中进行。患者早餐前口服T+A或A的固定剂量复方制剂，每日一次，共治疗12周；测量坐位时的血压（BP）和心率。主要疗效终点是从基线到研究结束时临床收缩压（SBP）/舒张压（DBP）的降低以及研究结束时达到目标SBP/DBP<130/<80mmHg的应答者数量。通过治疗中出现的不良事件评估耐受性，不良事件通过体格检查、实验室分析和心电图确定。
共有210名患者纳入研究；203名患者（143名男性，60名女性）完成研究，7名患者失访（T+A组4名，A组3名）并被视为退出研究。在研究结束时，观察到两组内和组间SBP（T+A[-27.4%]；A[-16.6%]）和DBP（T+A[-20.1%]；A[-13.3%]）较基线均有统计学意义的百分比降低（均P<0.05）。T+A组的应答率为87.3%（89/102），A组为69.3%（70/101）（P<0.05）。两个治疗组之间不良事件的发生率无显著差异（T+A组为16.0%[17/106]；A组为15.4%[16/10]）。T+A组8.5%的患者（9/106）报告有外周性水肿，而A组为13.5%（14/104）；T+A组3.8%的患者（4/106）报告有咳嗽，A组为1.0%（1/104）；这些差异无统计学意义。两组头痛、头晕和腹泻的发生率相似。
在这些印度II期高血压患者中，发现T+A的固定剂量复方制剂在降低血压方面比A显著更有效，且两种治疗耐受性良好。
