模拟长效胰岛素和心血管事件的随机对照试验,使用2型糖尿病患者的真实世界数据
Wanning Wang1,2, Pauline Reynier2, Michael Webster-Clark2,3
1Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.
Pharmacoepidemiology and drug safety
|January 6, 2026
概括
这项研究模仿了DEVOTE试验,使用现实世界的数据来评估2型糖尿病 (T2DM) 患者的重大心血管不良事件 (MACE),这些患者接受了胰岛素德格卢迪克与glargine. 结果与在整体和符合条件人群中进行的DEVOTE试验一致.
科学领域:
- 心脏病学 心脏病学
- 内分泌学 在内分泌学.
- 现实世界的证据研究研究.
背景情况:
- 随机对照试验 (RCT) 具有高的内部有效性,但有限的概括性.
- 现实世界数据 (RWD) 可以提高临床试验结果的概括性.
- 没有先前的研究模拟了使用RWD的RCT来评估2型糖尿病 (T2DM) 患者的心血管风险,这些患者使用长效胰岛素类似物.
研究的目的:
- 模仿使用RWD的DEVOTE试验来评估重大心血管不良事件 (MACE) 的风险.
- 在T2DM患者中比较insulin degludec和insulin glargine之间的MACE风险.
- 在不同患者亚群中评估RWD模拟和原始RCT之间的发现一致性.
主要方法:
- 使用英国临床实践研究数据链接,模拟DEVOTE试验.
- 创建DEVOTE符合条件和不符合条件的子群体.
- 应用Cox比例危险模型与治疗权重的逆概率 (IPTW) 来估计危险比率 (HRs) 和置信区间 (CI).
主要成果:
- 分析包括总人口中的10430名患者.
- 整体 (HR: 1.36,95% CI: 0.83,1.86) 和DEVOTE符合条件 (HR: 1.07,95% CI: 0.63,1.58) 的人群显示了与DEVOTE试验 (HR: 0.91,95% CI: 0.78,1.06) 兼容的结果.
- 由于事件数量低,DEVOTE不合格的人群表现出更宽的置信区间和分歧的点估计 (HR: 2.19,95% CI: 0.30,3.83).
结论:
- 在T2DM患者中,与胰岛素德格卢德克相比胰岛素格拉因相关的MACE风险在现实世界总人口和DEVOTE合格子人口之间一致.
- 在DEVOTE不合格子群中观察到不一致的点估计.
- RWD仿真可以为T2DM中长效胰岛素类型的RCT发现的概括性提供有价值的见解.
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