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利司那肽在2型糖尿病合并急性冠脉综合征患者中的应用
Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome


Marc A. Pfeffer ... 糖尿病 • 2015.12.03

摘要


背景

2型糖尿病患者,特别是在同时患有心血管病的患者,心血管患病率及死亡率比在其他大多数人群都高。我们评估了利司那肽,一种胰高血糖素样肽1(Glucagon-like peptide 1,GLP-1)受体激动剂,对近期发生急性冠脉事件的2型糖尿病患者的疗效。

 

方法

我们随机安排了最近180内天发生心机梗死或因不稳定型心绞痛入院的2型糖尿病患者,在当地标准治疗之外,接受利司那肽或安慰剂治疗。本试验的设计有足够的统计功效来评估利司那肽是否不劣于,或者优于安慰剂,该评估是通过规定心血管死亡、心肌梗死、卒中或不稳定型心绞痛入院复合终点事件风险比的95%可信区间的上限分别小于1.3或1.0进行的。

 

结果

我们对经历了随机分组的6,068名患者进行了中位数为25个月的随访。利司那肽组发生主要终点事件者为406例(13.4%),安慰剂组为399例(13.2%)(风险比为1.02;95%可信区间[CI]为0.89~1.17),表明利司那肽不劣于安慰剂(P<0.001),但没有显示出优于安慰剂(P=0.81)。两组间因心力衰竭的住院率(利司那肽组的风险比为0.96;95% CI,0.75~1.23)或死亡率(风险比为0.94;95% CI,0.78~1.13)并无显著性差异。利司那肽组的严重不良事件、严重低血糖、胰腺炎、胰腺肿瘤及过敏反应与安慰剂组相比,也无显著增加。

 

结论

常规治疗加利司那肽,在2型糖尿病合并近期发生急性冠脉综合征的患者中没有显著改变心血管事件或其他严重不良事件的发生率(由赛诺菲公司[Sanofi]资助;ELIXA在ClinicalTrials.gov注册号为NCT01147250)。





作者信息

Marc A. Pfeffer, M.D., Ph.D., Brian Claggett, Ph.D., Rafael Diaz, M.D., Kenneth Dickstein, M.D., Ph.D., Hertzel C. Gerstein, M.D., Lars V. Køber, M.D., Francesca C. Lawson, M.D., Lin Ping, M.D., Xiaodan Wei, Ph.D.,
 Eldrin F. Lewis, M.D., M.P.H., Aldo P. Maggioni, M.D.,
 John J.V. McMurray, M.D., Ph.D., Jeffrey L. Probstfield, M.D., 
Matthew C. Riddle, M.D., Scott D. Solomon, M.D., and Jean­Claude Tardif, M.D., for the ELIXA Investigators*
From the Cardiovascular Division, Brigham and Women’s Hospital, and Harvard Medi­ cal School — both in Boston (M.A.P., B.C., E.F.L., S.D.S.); EstudiosClínicos Latino­ américa, Rosario, Argentina (R.D.); Univer­ sity of Bergen, Stavanger University Hos­ pital, Stavanger, Norway (K.D.); McMaster University, Hamilton, ON, Canada (H.C.G.); Rigshospitalet Copenhagen University Hos­ pital, Copenhagen (L.V.K.); Sanofi U.S., Bridgewater, NJ (F.C.L., L.P., X.W.); Re­ search Center of the Italian Association of Hospital Cardiologists, Florence (A.P.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom ( J.J.V.M.); Uni­ versity of Washington Medical Center, Seattle (J.L.P.); Oregon Health and Sci­ence University, Portland (M.C.R.); and Montreal Heart Institute, Université de Montréal, Montreal (J.C.T.). Address re­ print requests to Dr. Pfeffer at the Cardio­ vascular Division, Brigham and Women’s Hospital, 75 Francis St., Boston, MA02115, or at mpfeffer@rics.bwh.harvard.edu. *A list of the investigators and committee members in the Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) trial is provided in the Supplementary Appendix, available at NEJM.org.

 

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