Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide
Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide
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DOI：
10.1185/03007990902820519
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发表时间：
2009-04-01
影响因子：
2.3
通讯作者：
Chan, K. Arnold
中科院分区：
文献类型：
--
作者：
Dore, David D.;Seeger, John D.;Chan, K. Arnold
目的：评估使用肠促胰岛素为基础的糖尿病治疗（艾塞那肽或西格列汀）的患者与使用具有已确定安全性特征的药物（二甲双胍或格列本脲）治疗的患者相比发生急性胰腺炎的风险和相对风险（RR）。研究设计和方法：研究人群来自使用主动药物安全性监测系统（i3 Aperio*）的大型美国商业健康保险交易数据库。本分析基于2005年6月至2008年6月的数据。使用倾向评分将艾塞那肽和西格列汀启动者队列分别与相同数量的二甲双胍或格列本脲（met/gly）启动者进行匹配，以减少随访期间结局比较中的混杂因素。患者的索赔建议胰腺疾病在6个月前队列entry.Main结果measure：索赔住院与急性胰腺炎的初步诊断（ICD-9 577.0）。在长达1年的随访期间，0.13%的艾塞那肽治疗患者和0.12%的西格列汀治疗患者发生急性胰腺炎。急性胰腺炎的风险是相当的艾塞那肽（RR 1.0; 95%置信区间（CI）0.6-1.7）和西格列汀（RR 1.0; 95% CI 0.5-2.0）相对于comparison cohols.Conclusions：这些数据并没有提供证据证明艾塞那肽或西格列汀的启动者之间的急性胰腺炎的关联相比，以满足/甘氨酸启动。这些结果受到行政、医疗保健数据库中可用数据的限制。
Objective: To estimate risk and relative risk (RR) of acute pancreatitis among patients using incretin-based diabetes therapies (exenatide or sitagliptin) compared to patients treated with agents with established safety profiles (metformin or glyburide).Research design and methods: The study population was derived from a large US commercial health insurance transaction database using an active drug safety surveillance system (i3 Aperio*). This analysis is based on data from June 2005 through June 2008. Cohorts of exenatide and sitagliptin initiators were each matched to an equal number of metformin or glyburide (met/gly) initiators using propensity scores to reduce confounding in the comparison of outcomes during follow-up. Patients with claims suggesting pancreatic disease in the 6 months prior to cohort entry were excluded.Main outcome measure: Claims for hospitalizations associated with a primary diagnosis of acute pancreatitis (ICD-9 577.0).Results: There were 27 996 exenatide initiators and 16 276 sitagliptin initiators and approximately equal numbers of matched comparators. During follow-up of up to 1 year, acute pancreatitis occurred among 0.13% of patients treated with exenatide and 0.12% of patients treated with sitagliptin. The risk of acute pancreatitis was comparable for initiators of exenatide (RR 1.0; 95% confidence interval (CI) 0.6-1.7) and sitagliptin (RR 1.0; 95% CI 0.5-2.0) relative to the comparison cohorts.Conclusions: These data do not provide evidence for an association of acute pancreatitis among initiators of exenatide or sitagliptin compared to met/gly initiators. These results are limited by the data available in an administrative, healthcare database.