Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical Trials
Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical Trials
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DOI：
10.2337/dc13-1210
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发表时间：
2015-06-01
期刊：
影响因子：
16.2
通讯作者：
Steinberg, William M.
中科院分区：
文献类型：
--
作者：
Jensen, Troels M.;Saha, Kishore;Steinberg, William M.
目的报告利拉鲁肽在2型糖尿病试验中胰腺炎的发生率及所有胰腺炎病例的详细资料。研究设计和方法汇总了2013年4月19日由诺和诺德公司赞助的利拉鲁肽试验（2期和3期，NN2211标识符）的数据。对所有胰腺炎病例进行了回顾。结果利拉鲁肽和活性比较物的总暴露量分别为5021和1354患者年（n = 6345和1846）。发现8例急性胰腺炎（AP）与利拉鲁肽和任何比较物（格列美脲）1例。利拉鲁肽的AP发生率为1.6例/ 1000患者年暴露（PYE），而总活性比较物为0.7例/ 1000患者年暴露（PYE）。在使用利拉鲁肽的8例AP病例中，有1例不符合AP的诊断标准。在这8例病例中，有6例存在公认的AP危险因素和/或在利拉鲁肽开始治疗后6个月发生AP。所有患者都在接受多种药物治疗。发现4例慢性胰腺炎（CP）与利拉鲁肽，没有比较物。其中1例符合CP诊断标准；这些标准没有达到，或者在剩下的三个报告中缺少信息。结论：由于观察到的病例较少，利拉鲁肽组报告的AP和CP的发生率在数值上高于比较物组。并非所有病例都符合诊断标准，并且在接受利拉鲁肽治疗的75%的AP病例中存在混杂变量，因此无法得出确切的结论。
OBJECTIVETo report the incidence of pancreatitis in type 2 diabetes trials of liraglutide and details of all pancreatitis cases.RESEARCH DESIGN AND METHODSData from Novo Nordisk-sponsored trials with liraglutide (phase 2 and 3; NN2211 identifiers) completed by 19 April 2013 were pooled. All pancreatitis cases were reviewed.RESULTSTotal exposure to liraglutide and active comparators was 5,021 and 1,354 patient years, respectively (n = 6,345 and 1,846, respectively). Eight cases of acute pancreatitis (AP) with liraglutide and one with any comparator (glimepiride) were found. The incidence of AP was 1.6 cases/1,000 patient-years exposure (PYE) for liraglutide vs. 0.7 cases/1,000 PYE for total active comparators. One of the eight AP cases reported with liraglutide did not meet diagnostic criteria for AP. In six of these eight cases, recognized risk factors for AP were present and/or the onset of AP occurred >6 months after liraglutide initiation. All patients were receiving multiple medications. Four cases of chronic pancreatitis (CP) with liraglutide and none with comparators were found. One of these four cases fulfilled diagnostic criteria for CP; these criteria were not met or information was missing in the remaining three.CONCLUSIONSBased on the small number of cases observed, the incidences of reported AP and CP were numerically greater with liraglutide than with comparators. Not all cases fulfilled diagnostic criteria, and confounding variables were present in 75% of the AP cases with liraglutide therapy, precluding firm conclusions.