在2型糖尿病和心血管风险增加 (SURPASS- 4) 中,蒂尔泽帕提德与胰岛素相比:一个随机的,开放的,并行组的,多中心的,第3期试验
Stefano Del Prato1, Steven E Kahn2, Imre Pavo3
1Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Lancet (London, England)
|October 21, 2021
概括
在患有高心血管风险的2型糖尿病患者中,蒂尔泽帕提德显著降低了HbA1c,显示出比胰岛素格拉更高的疗效,低血糖事件较少,心血管风险没有增加.
科学领域:
- 内分泌学和新陈代谢
- 心血管医学
- 药理学
背景情况:
- 评估一新型双GIP和GLP-1受体激动剂的疗效和心血管安全性.
- 在患有2型糖尿病和高心血管风险的成年人中比较蒂尔泽帕蒂德和胰岛素格拉.
- 专注于口服降血糖药物控制不足的患者.
研究的目的:
- 与胰岛素格拉相比,评估蒂尔泽帕提德降低HbA1c水平的疗效.
- 在高危人群中评估蒂尔泽帕提德的心血管安全性.
- 为了确定低血糖的发生率与胰岛素glargine对比.
主要方法:
- 第3期,开放式,并行组研究,对2002名参与者进行随机 (1:1:1:3) 分配给提尔泽帕提德 (5, 10或15毫克) 或胰岛素格拉.
- 主要终点:52周时HbA1c变化与glargine相比,tirzepatide (10或15毫克) 没有劣势.
- 安全性评估包括主要心血管不良事件 (MACE-4) 和高达104周的低血糖症.
主要成果:
- 在52周时,提尔泽帕提德 (10mg和15mg) 的HbA1c降低明显高 (-2.43%和-2.58%) 与格拉 (-1.44%) 相比,达到非劣势.
- 不良反应包括恶心,腹和食欲下降的更高率,主要是轻度至中度的.
- 与格拉吉因 (19%) 相比,提兹帕提德的低血糖发生率较低. 没有观察到MACE-4事件的增加 (HR 0. 74).
结论:
- 在患有2型糖尿病和高心血管风险的患者中,与胰岛素格拉相比,蒂尔泽帕提德显示出较高的HbA1c降低和低血糖风险.
- 蒂尔泽帕提德治疗与良好的心血管安全性相关,没有显示过度心血管风险.
- 双GIP/GLP-1受体激动剂为这种患者群体提供了临床上有意义的治疗选择.
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