在2型糖尿病的临床试验和现实环境中的BMI变异性和心血管结果:一项IMI2 SOPHIA研究
Robert J Massey1, Yu Chen2, Marina Panova-Noeva3,4
1Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, DD1 9SY, UK.
增加的体重指数 (BMI) 变化是2型糖尿病患者主要心血管不良事件的独立风险因素. 这一发现适用于临床试验和现实世界的数据,独立于HbA1c的变异性.
科学领域:
- 心脏病学 心脏病学
- 内分泌学 在内分泌学.
- 代谢综合征是代谢综合征的一种.
背景情况:
- 体重指数 (BMI) 的变化与2型糖尿病中的心血管疾病 (CVD) 风险有关.
- 以前对临床研究和BMI变化现实数据的比较是有限的.
- 独立于HbA1c变异性的BMI变异性的独立影响仍然不清楚.
研究的目的:
- 调查BMI变化与重大心血管不良事件 (3P-MACE) 风险之间的关联.
- 将临床试验的结果与现实世界的观察数据进行比较.
- 为了确定BMI的变化是否构成独立于HbA1c变化的风险.
主要方法:
- 对Harmony Outcomes试验 (n=9198),REWIND (n=4440) 和EMPA-REG OUTCOME (n=2333) 的安慰剂组以及Tayside Bioresource现实世界的数据 (n=6980) 的分析.
- 考克斯回归模型被用来评估BMI变化 (通过平均连续变化来衡量) 和3P-MACE之间的关联.
- 3P-MACE包括非致命性中风,非致命性心肌梗塞和心血管死亡.
主要成果:
- 体重指数可变性增加1SD与3P-MACE风险增加相关,这些风险在和结果 (HR1.12,P<0.001),REWIND和Tayside Bioresource中增加.
- 与最低四分位数 (P<0.001) 相比,BMI变化的最高四分位数显示3P-MACE的风险增加了87%.
- 这种关联独立于HbA1c的变异性,但在EMPA-REG OUTCOME中没有复制.
结论:
- 增加的BMI变异性是2型糖尿病患者3P-MACE的独立风险因素.
- 这种关联在心血管结果试验和现实世界数据集中是一致的.
- 需要进一步的研究来确定BMI变化和心血管结果之间的因果关系.
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