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西格列汀治疗2型糖尿病患者的心血管结局研究
Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes


Jennifer B. Green ... 心脑血管疾病 糖尿病 • 2015.07.16

摘要


背景

在2型糖尿病(T2DM)合并心血管疾病患者的常规治疗中加入二肽基肽酶4(dipeptidyl peptidase 4,DPP-4)抑制剂西格列汀,目前缺少长期使用对心血管事件影响的数据。

 

方法

在本项随机、双盲研究中,我们纳入了14,671例患者,在现有治疗基础上加用西格列汀或安慰剂。我们根据要求鼓励开放式使用降糖治疗,旨在使所有患者达到适合个人的血糖目标。为确定西格列汀疗效是否不劣于安慰剂,我们使用相对危险度1.3作为上限。主要心血管结局是包括心血管死亡、非致死性心肌梗死、非致死性卒中或因不稳定型心绞痛住院治疗的复合事件。

 

结果

在中位随访期3.0年期间,两组糖化血红蛋白水平有小的差异(西格列汀组对比安慰剂组最小二乘平均差异为-0.29个百分点;95%可信区间(CI)为-0.32~ -0.27)。总体上,西格列汀组和安慰剂组患者达到了主要研究结局的分别有839例(11.4%;4.06/100人·年)和851例(11.6%;4.17/100人年)。西格列汀组主要复合心血管结局不劣于安慰剂组(风险比,0.98;95% CI,0.88~1.09;P<0.001)。两组患者因为力衰竭(心力衰竭)住院率无差异[风险比,1.00;95% CI,0.83~1.20;P=0.98)。两组间急性胰腺炎(P=0.07)或胰腺癌的发生率无显著差异(P=0.32)。

 

结论

对已确诊合并心血管疾病的T2DM患者在常规治疗基础上,在常规治疗中加用西格列汀并未出现增加主要心血管不良事件发生、心衰住院或其他不良事件的风险(默沙东公司[Merck Sharp & Dohme]资助,TECOS ClinicalTrails. gov注册号为NCT00790205)。





作者信息

Jennifer B. Green, M.D., M. Angelyn Bethel, M.D., Paul W. Armstrong, M.D., John B. Buse, M.D., Ph.D., Samuel S. Engel, M.D., Jyotsna Garg, M.S., Robert Josse, M.B., B.S., Keith D. Kaufman, M.D., Joerg Koglin, M.D., Scott Korn, M.D., John M. Lachin, Sc.D., Darren K. McGuire, M.D., M.H.Sc., Michael J. Pencina, Ph.D., Eberhard Standl, M.D., Ph.D., Peter P. Stein, M.D., Shailaja Suryawanshi, Ph.D., Frans Van de Werf, M.D., Ph.D., Eric D. Peterson, M.D., M.P.H., and Rury R. Holman, M.B., Ch.B., for the TECOS Study Group*
From the Duke Clinical Research Institute, Duke University School of Medicine, Durham (J.B.G., J.G., M.J.P., E.D.P.) and University of North Carolina School of Medicine, Chapel Hill (J.B.B.) — both in North Carolina; Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, United Kingdom (M.A.B., R.R.H.); Canadian VIGOUR Centre, University of Alberta, Edmonton, AB (P.W.A.) and St. Michael’s Hospital, University of Toronto, Toronto (R.J.) — both in Canada; Merck, Kenilworth, NJ (S.S.E., K.D.K., J.K., S.K., P.P.S., S.S.); George Washington University Biostatistics Center, Rockville, MD (J.M.L.); University of Texas Southwestern Medical Center, Dallas (D.K.M.); Munich Diabetes Research Group, Helmholtz Center, Neuherberg, Germany (E.S.); and University of Leuven, Leuven, Belgium (F.V.W.). Address reprint requests to Dr. Holman at the Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, Churchill Hospital, Oxford OX3 7LJ, United Kingdom, or atrury.holman@dtu.ox.ac.uk. *A complete list of members in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) Study Group is provided in Supplementary Appendix 1, available at NEJM.org.

 

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