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Abstract：
BACKGROUND: To date, there is limited literature regarding the association between dipeptidyl peptidase-4 (DPP-4) inhibitors and pancreatic carcinoma.
OBJECTIVE: To describe the comparative incidence of DPP-4 inhibitors and pancreatic carcinoma as reportedly available in the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. The goal was to provide health care practitioners a general understanding of the drug-disease occurrence.
METHODS: This is a case/noncase study utilizing Empirica Signal software to query FAERS from November 1968 to December 31, 2013. The software was used to calculate a disproportionality statistic--namely, the empirical Bayesian geometric mean (EBGM)--for reports of DPP-4 inhibitors-associated pancreatic carcinoma. The FDA considers an EBGM significant if the fifth percentile of the distribution is at least 2, defined as an EB05 ≥ 2. With use of a disproportionality analysis, DPP-4 inhibitors were compared with all agents listed in FAERS.
RESULTS: A total of 156 patients experienced pancreatic carcinoma while receiving DPP-4 inhibitor therapy. An EB05 of 10.3 was determined for sitagliptin, 7.1 for saxagliptin, 4.9 for linagliptin, and 1.4 for alogliptin, compared with all other agents included in FAERS. Although an EB05 > 2 was achieved in 2 other antihyperglycemic agents, the findings were not consistent within their medication classes.
CONCLUSIONS: There appears to be a statistical association between DPP-4 inhibitor use and pancreatic carcinoma. Causality cannot be inferred from the data provided. Additional clinical studies are needed to further explore this statistical association.
OBJECTIVE: To describe the comparative incidence of DPP-4 inhibitors and pancreatic carcinoma as reportedly available in the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. The goal was to provide health care practitioners a general understanding of the drug-disease occurrence.
METHODS: This is a case/noncase study utilizing Empirica Signal software to query FAERS from November 1968 to December 31, 2013. The software was used to calculate a disproportionality statistic--namely, the empirical Bayesian geometric mean (EBGM)--for reports of DPP-4 inhibitors-associated pancreatic carcinoma. The FDA considers an EBGM significant if the fifth percentile of the distribution is at least 2, defined as an EB05 ≥ 2. With use of a disproportionality analysis, DPP-4 inhibitors were compared with all agents listed in FAERS.
RESULTS: A total of 156 patients experienced pancreatic carcinoma while receiving DPP-4 inhibitor therapy. An EB05 of 10.3 was determined for sitagliptin, 7.1 for saxagliptin, 4.9 for linagliptin, and 1.4 for alogliptin, compared with all other agents included in FAERS. Although an EB05 > 2 was achieved in 2 other antihyperglycemic agents, the findings were not consistent within their medication classes.
CONCLUSIONS: There appears to be a statistical association between DPP-4 inhibitor use and pancreatic carcinoma. Causality cannot be inferred from the data provided. Additional clinical studies are needed to further explore this statistical association.
摘要：
背景：迄今为止，关于二肽基肽酶-4(DPP-4)抑制剂与胰腺癌之间的相关性的文献有限.
目的：描述食品和药物管理局（FDA）不良事件报告系统（FAERS）数据库中报道的DPP-4抑制剂和胰腺癌的比较发病率。目标是为医疗保健从业人员提供对药物疾病发生的一般理解。
方法：这是一项案例/非案例研究，从1968年11月至2013年12月31日，利用EmpiricaSignal软件查询FAERS。该软件用于计算不成比例的统计数据-即，经验贝叶斯几何平均值（EBGM）-用于DPP-4抑制剂相关胰腺癌的报道。如果分布的第五个百分位数至少为2，定义为EB05≥2，则FDA认为EBGM具有重要意义。通过使用不相称性分析，将DPP-4抑制剂与FAERS中列出的所有药物进行比较。
结果：共有156例患者在接受DPP-4抑制剂治疗时出现胰腺癌。西格列汀的EB05为10.3，沙格列汀为7.1，4.9利格列汀，1.4用于阿格列汀，与FAERS中包含的所有其他药物相比。尽管在2种其他抗高血糖药物中EB05>2，这些发现在他们的药物类别中并不一致.
结论：使用DPP-4抑制剂与胰腺癌之间似乎存在统计学关联。从提供的数据中无法推断因果关系。需要更多的临床研究来进一步探索这种统计关联。
目的：描述食品和药物管理局（FDA）不良事件报告系统（FAERS）数据库中报道的DPP-4抑制剂和胰腺癌的比较发病率。目标是为医疗保健从业人员提供对药物疾病发生的一般理解。
方法：这是一项案例/非案例研究，从1968年11月至2013年12月31日，利用EmpiricaSignal软件查询FAERS。该软件用于计算不成比例的统计数据-即，经验贝叶斯几何平均值（EBGM）-用于DPP-4抑制剂相关胰腺癌的报道。如果分布的第五个百分位数至少为2，定义为EB05≥2，则FDA认为EBGM具有重要意义。通过使用不相称性分析，将DPP-4抑制剂与FAERS中列出的所有药物进行比较。
结果：共有156例患者在接受DPP-4抑制剂治疗时出现胰腺癌。西格列汀的EB05为10.3，沙格列汀为7.1，4.9利格列汀，1.4用于阿格列汀，与FAERS中包含的所有其他药物相比。尽管在2种其他抗高血糖药物中EB05>2，这些发现在他们的药物类别中并不一致.
结论：使用DPP-4抑制剂与胰腺癌之间似乎存在统计学关联。从提供的数据中无法推断因果关系。需要更多的临床研究来进一步探索这种统计关联。
