...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Drug Design, Development and Therapy >Comparison of efficacy and safety between two different irbesartan, generic vs branded, in the treatment of Korean patients with mild-to-moderate hypertension: an 8-week, multicenter, randomized, open-label, Phase IV clinical study
【24h】

Comparison of efficacy and safety between two different irbesartan, generic vs branded, in the treatment of Korean patients with mild-to-moderate hypertension: an 8-week, multicenter, randomized, open-label, Phase IV clinical study

机译：两种不同的厄贝沙坦（普通药物和品牌药物）在韩国轻度至中度高血压患者中的疗效和安全性比较：一项为期8周，多中心，随机，开放标签的IV期临床研究

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Purpose: This study aimed to compare the efficacy and safety of generic and branded irbesartan for 8 weeks in patients with mild-to-moderate essential hypertension. Patients and methods: We screened 221 patients with mild-to-moderate hypertension. After exclusion per study criteria, 177 subjects were randomized to receive 150 mg generic irbesartan (n=91) or branded irbesartan (n=86) as the intention to treat set. The primary efficacy endpoint of this study was the change in mean sitting diastolic blood pressure (SiDBP) from baseline to 8 weeks between the generic and branded irbesartan groups. The secondary efficacy endpoints were the change in mean SiDBP at Week 4 from baseline and the change in mean sitting systolic blood pressure (SiSBP) at Weeks 4 and 8 from baseline in both groups. All safety issues were evaluated. Results: At Week 8, the generic and branded irbesartan groups showed significantly reduced SiDBP (?10.3±8.0, ?10.7±7.7 mmHg, all P 0.0001) compared with baseline values, and the mean between-group difference in SiDBP change after 8 weeks of treatment was ?0.4±1.2 mmHg, showing the non-inferiority of generic irbesartan vs branded irbesartan. Furthermore, secondary efficacy, which was the mean change of SiDBP from baseline at 4 weeks, was comparable between the two groups (?9.4±8.1 vs ?9.9±7.4 mmHg, P =0.69). There were no between-group differences in mean changes of SiSBP after 4 or 8 weeks of treatment ( P =0.78, P =0.97, respectively), or in the incidence of adverse effects (16.7 vs 24.4%, P =0.20). Conclusion: Generic irbesartan treatment in patients with mild-to-moderate essential hypertension has shown effective antihypertensive effects comparable with the branded irbesartan treatment, with similar incidence of adverse effects.
机译：目的：本研究旨在比较普通和品牌厄贝沙坦在轻度至中度原发性高血压患者中8周的疗效和安全性。患者和方法：我们筛查了221例轻度至中度高血压患者。根据研究标准排除后，将177名受试者随机分为150毫克通用厄贝沙坦（n = 91）或品牌厄贝沙坦（n = 86）作为治疗意向。这项研究的主要疗效终点是仿制和品牌厄贝沙坦组从基线到8周平均舒张期舒张压（SiDBP）的变化。次级疗效终点是两组的第4周的平均SiDBP相对于基线的变化以及第4周和第8周的平均静坐收缩压（SiSBP）的变化。对所有安全问题进行了评估。结果：在第8周时，普通和品牌厄贝沙坦组与基线值相比，SiDBP显着降低（？10.3±8.0，？10.7±7.7 mmHg，所有P <0.0001），且8周后SiDBP的平均组间差异变化治疗几周为±0.4±1.2 mmHg，显示一般厄贝沙坦与品牌厄贝沙坦的非劣效性。此外，两组之间的继发功效是SiDBP从基线开始的平均变化，在两组之间相当（？9.4±8.1 vs？9.9±7.4 mmHg，P = 0.69）。在治疗4周或8周后，SiSBP的平均变化（P分别为0.78，P = 0.97）或不良反应发生率（16.7对24.4％，P = 0.20）没有组间差异。结论：对于轻度至中度原发性高血压患者，常规厄贝沙坦治疗已显示出与品牌厄贝沙坦治疗相当的有效降压作用，且不良反应发生率相似。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号