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Pancreatitis associated with the use of GLP-1 analogs and DPP-4 inhibitors: a case/non-case study from the French Pharmacovigilance Database.
Faillie, Jean-Luc; Babai, Samy; Crépin, Sabrina; Bres, Virginie; Laroche, Marie-Laure; Le Louet, Hervé; Petit, Pierre; Montastruc, Jean-Louis; Hillaire-Buys, Dominique.
Afiliación
  • Faillie JL; Department of Medical Pharmacology and Toxicology, Pharmacovigilance Regional Center, CHRU Montpellier, 371 Avenue du Doyen Gaston Giraud, 34295, Montpellier, France, jl-faillie@chu-montpellier.fr.
Acta Diabetol ; 51(3): 491-7, 2014.
Article en En | MEDLINE | ID: mdl-24352344
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.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pancreatitis / Diabetes Mellitus Tipo 2 / Péptido 1 Similar al Glucagón / Inhibidores de la Dipeptidil-Peptidasa IV Tipo de estudio: Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Acta Diabetol Asunto de la revista: ENDOCRINOLOGIA Año: 2014 Tipo del documento: Article Pais de publicación: Alemania

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pancreatitis / Diabetes Mellitus Tipo 2 / Péptido 1 Similar al Glucagón / Inhibidores de la Dipeptidil-Peptidasa IV Tipo de estudio: Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Acta Diabetol Asunto de la revista: ENDOCRINOLOGIA Año: 2014 Tipo del documento: Article Pais de publicación: Alemania