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与使用胰高血糖素样肽-1(GLP-1)类似物和二肽基肽酶-4(DPP-4)抑制剂相关的胰腺炎:来自法国药物警戒数据库的病例/非病例研究。

Pancreatitis associated with the use of GLP-1 analogs and DPP-4 inhibitors: a case/non-case study from the French Pharmacovigilance Database.

作者信息

Faillie Jean-Luc, Babai Samy, Crépin Sabrina, Bres Virginie, Laroche Marie-Laure, Le Louet Hervé, Petit Pierre, Montastruc Jean-Louis, Hillaire-Buys Dominique

机构信息

Department of Medical Pharmacology and Toxicology, Pharmacovigilance Regional Center, CHRU Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France,

出版信息

Acta Diabetol. 2014;51(3):491-7. doi: 10.1007/s00592-013-0544-0. Epub 2013 Dec 19.

Abstract

In the recent past, concerns have raised regarding the potential risk of acute pancreatitis among type 2 diabetic patients using incretin-based drugs such as glucagon-like peptide 1 (GLP-1) analogs and dipeptidyl peptidase 4 (DPP-4) inhibitors. The aim of this study is to investigate the association between exposure to incretin-based drugs and the occurrence of pancreatitis reported in the French Pharmacovigilance Database. The case/non-case method was performed from serious adverse drug reactions (ADRs) involving antihyperglycemic agents (except insulin alone) reported to the French pharmacovigilance system between March 2008 (first marketing of an incretin-based drug in France) and March 2013. Cases were defined as reports of pancreatitis, and all other serious ADRs were considered non-cases. Disproportionality was assessed by calculating reporting odds ratios (ROR) adjusted for age, gender, history of pancreatitis, other antihyperglycemic drugs and other drugs associated with a higher risk of pancreatitis. Among 3,109 serious ADRs, 147 (4.7 %) reports of pancreatitis were identified as cases and 2,962 reports (95.3 %) of other ADRs as non-cases. Among the cases, 122 (83.0 %) involved incretin-based drugs. Disproportionality was found for all incretin-based drugs (adjusted ROR: 15.7 [95 % CI 9.8-24.9]), all GLP-1 analogs (29.4 [16.0-53.8]), exenatide (28.3 [12.8-62.3]), liraglutide (30.4 [15.4-60.0]), all DPP-4 inhibitors (12.1 [7.3-20.0]), sitagliptin (12.4 [7.3-21.0]), saxagliptin (15.1 [4.3-52.7]), and vildagliptin (7.4 [3.1-17.6]). Temporal analysis found disproportionality for incretin-based drugs since their first year of marketing in France. Compared with other antihyperglycemic agents, use of incretin-based drugs is associated with an increased risk of reported pancreatitis in France.

摘要

最近,人们对2型糖尿病患者使用胰高血糖素样肽1(GLP-1)类似物和二肽基肽酶4(DPP-4)抑制剂等肠促胰岛素类药物引发急性胰腺炎的潜在风险表示担忧。本研究旨在调查法国药物警戒数据库中报告的肠促胰岛素类药物暴露与胰腺炎发生之间的关联。采用病例/非病例方法,研究对象为2008年3月(法国首次上市肠促胰岛素类药物)至2013年3月期间向法国药物警戒系统报告的涉及抗高血糖药物(仅胰岛素除外)的严重药物不良反应(ADR)。病例定义为胰腺炎报告,所有其他严重ADR视为非病例。通过计算经年龄、性别、胰腺炎病史、其他抗高血糖药物以及与胰腺炎风险较高相关的其他药物调整后的报告比值比(ROR)来评估不成比例性。在3109例严重ADR中,147例(4.7%)胰腺炎报告被确定为病例,2962例(95.3%)其他ADR报告为非病例。在病例中,122例(83.0%)涉及肠促胰岛素类药物。所有肠促胰岛素类药物均发现不成比例性(调整后ROR:15.7 [95% CI 9.8 - 24.9]),所有GLP-1类似物(29.4 [16.0 - 53.8])、艾塞那肽(28.3 [12.8 - 62.3])、利拉鲁肽(30.4 [15.4 - 60.0])、所有DPP-4抑制剂(12.1 [7.3 - 20.0])、西他列汀(12.4 [7.3 - 21.0])、沙格列汀(15.1 [4.3 - 52.7])和维格列汀(7.4 [3.1 - 17.6])。时间分析发现,自肠促胰岛素类药物在法国上市的第一年起就存在不成比例性。与其他抗高血糖药物相比,在法国,使用肠促胰岛素类药物与报告的胰腺炎风险增加相关。

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