在EXAMINE试验中对2型糖尿病患者的高灵敏性Troponin I和心血管结果的连续测量 (对用aloogliptin对照心血管结果的检查)
Matthew A Cavender1, William B White2, Petr Jarolim2
1From University of North Carolina, Chapel Hill (M.A.C.); Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington (W.B.W.); Department of Pathology (P.J.) and TIMI Study Group (D.A.M.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; University of Chicago, IL (G.L.B.); Memphis Veterans Affairs Medical Center, University of Tennessee College of Medicine (W.C.C.); Takeda Development Center Americas, Inc., Deerfield, IL (S.K.); Baim Institute for Clinical Research, Boston, MA (Q.C., C.P.C.); Harvard School of Public Health, Boston, MA (C.R.M.); and Inserm 1143, Université de Lorraine, Nancy, France (F.Z.). matt.cavender@unc.edu.
在2型糖尿病患者中,高敏感性心脏素I (hsTnI) 水平与心血管事件相关. 连续的hsTnI评估可以识别高风险的个体, 以制定个性化预防策略.
科学领域:
- 心脏病学
- 内分泌学
- 生物标志物研究
背景情况:
- 最近患有急性冠状动脉综合征 (ACS) 的2型糖尿病患者患有心血管事件的高风险.
- 高灵敏性心脏素I (hsTnI) 是心肌损伤的敏感生物标志物.
- 在ACS后的T2DM患者中,hsTnI变化与心血管结果之间的关系需要进一步阐明.
研究的目的:
- 在急性冠状动脉综合征 (ACS) 后,研究2型糖尿病 (T2DM) 患者的连续高敏感性心脏素I (hsTnI) 水平与心血管结果之间的关联.
- 确定hsTnI水平是否可以识别患有重复心血管事件的高风险患者.
- 对高hsTnI患者心血管结局的影响进行评估.
主要方法:
- 来自EXAMINE试验 (NCT00968708) 的数据分析,该试验是IIIb期临床结局试验.
- 包括3808名T2DM和最近的ACS患者,在事件发生后至少30天随机选择.
- 使用阿博特ARCHITECT测定方法在基线和6个月测量hsTnI;主要终点是心血管死亡,心肌梗塞或中风.
主要成果:
- 在基线时,93% 的患者有可检测的hsTnI,其中16% 超过了99 个百分点的上限.
- 在基线和6个月的hsTnI水平上升与心血管事件有很强的相关性 (P< 0. 001).
- 在6个月内,hsTnI持续升高的患者与无法检测的患者相比,心血管死亡,心肌梗塞或中风的风险显著增加.
结论:
- 连续的hsTnI评估发现,即使没有临床认可的事件,T2DM患者中也有很高的心血管事件风险.
- 动态或持续升高的hsTnI值表明hsTnI的风险增加,这表明hsTnI在个性化T2DM患者的预防策略中的作用.
- 与安慰剂相比,阿洛格利平没有改变高hsTnI的患者的心血管风险.
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