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2型糖尿病的西班牙裔/拉丁裔患者中的提尔泽帕提德:SURPASS计划的一个子组分析
Juan Pablo Frías1, Rodolfo J Galindo2, Hui Wang3
1Velocity Clinical Research, Los Angeles, CA 90057, USA.
The Journal of clinical endocrinology and metabolism
|August 21, 2023
概括
在2型糖尿病的西班牙裔/拉丁裔和非西班牙裔/拉丁裔患者中,蒂尔泽帕提德显著降低了HbA1c和体重. 在所有患者群体中,该药物耐受性良好,有效性和安全性相似.
科学领域:
- 内分泌学 在内分泌学.
- 代谢疾病 代谢疾病
- 药理学 药理学是指药理学的学科.
背景情况:
- 蒂尔泽帕提德是一种双重依赖葡萄糖的胰岛素型多 (GIP) 和类似葡萄糖-1 (GLP-1) 受体激动剂,是治疗2型糖尿病的新型治疗剂.
- 全球SURPASS第三阶段计划研究了tirezepatide在不同患者群体中的疗效和安全性.
研究的目的:
- 评估特泽帕提德在西班牙裔/拉丁裔和非西班牙裔/拉丁裔2型糖尿病患者的疗效和安全性.
- 为了在SURPASS临床试验中比较tirzepatide对血糖控制和人体体重的影响,跨越种族子组.
主要方法:
- 从SURPASS-1到-4试验中对5679名患者进行了探索性分析,其中包括2895名西班牙裔/拉丁裔族裔.
- 患者接受了提尔泽帕提德 (5,10或15毫克),安慰剂或活性比较剂 (西马格卢提德,胰岛素德格卢迪克,胰岛素格拉).
- 糖化血红蛋白A1c (HbA1c) 和体重的变化在第40周或第52周被评估,在西班牙裔/拉丁裔和非西班牙裔/拉丁裔子组中也评估了安全结果.
主要成果:
- 与比较者 (P<0.05) 相比,蒂尔泽帕蒂德治疗导致HbA1c (1.9%2.7%在西班牙裔/拉丁裔患者中,1.7%2.5%在非西班牙裔/拉丁裔患者中) 和体重 (5.312.4公斤在西班牙裔/拉丁裔患者中,6.517.1公斤在非西班牙裔/拉丁裔患者中) 显著降低.
- 小组中的效率趋势与整个试验群体的效率趋势相似.
- 治疗引起的不良事件,主要是胃肠道疾病和低血糖症,在各个种族小组中发生的低率相似.
结论:
- 蒂尔泽帕提德在降低HbA1c和体重方面表现出显著的有效性,对于2型糖尿病的西班牙裔/拉丁裔和非西班牙裔/拉丁裔患者.
- 蒂尔泽帕提德的安全性概况在两个族裔子组之间是一致且有利.
- 亚组和整体研究人群之间的可比有效性和安全性趋势支持tirezepatide在各种糖尿病患者中的实用性.
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