Acta Diabetologica

, Volume 51, Issue 3, pp 491–497

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

  • Jean-Luc Faillie
  • Samy Babai
  • Sabrina Crépin
  • Virginie Bres
  • Marie-Laure Laroche
  • Hervé Le Louet
  • Pierre Petit
  • Jean-Louis Montastruc
  • Dominique Hillaire-Buys
  • The French Pharmacovigilance Centers Network
Original Article

DOI: 10.1007/s00592-013-0544-0

Cite this article as:
Faillie, JL., Babai, S., Crépin, S. et al. Acta Diabetol (2014) 51: 491. doi:10.1007/s00592-013-0544-0

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.

Keywords

Type 2 diabetes mellitus Glucagon-like peptide 1 analogs Dipeptidyl peptidase 4 inhibitors Pancreatitis Pharmacovigilance 

Copyright information

© Springer-Verlag Italia 2013

Authors and Affiliations

  • Jean-Luc Faillie
    • 1
    • 5
  • Samy Babai
    • 2
  • Sabrina Crépin
    • 3
  • Virginie Bres
    • 1
  • Marie-Laure Laroche
    • 3
  • Hervé Le Louet
    • 2
  • Pierre Petit
    • 1
  • Jean-Louis Montastruc
    • 4
    • 5
  • Dominique Hillaire-Buys
    • 1
    • 6
  • The French Pharmacovigilance Centers Network
  1. 1.Department of Medical Pharmacology and Toxicology, Pharmacovigilance Regional CenterCHRU MontpellierMontpellierFrance
  2. 2.Pharmacovigilance Regional CenterCHU CréteilCréteilFrance
  3. 3.Department of Pharmacology and Toxicology, Pharmacovigilance Regional CenterCHU LimogesLimogesFrance
  4. 4.Department of Medical and Clinical Pharmacology, Pharmacovigilance Regional CenterCHU ToulouseToulouseFrance
  5. 5.Department of Pharmacoepidemiology, Faculty of MedicineINSERM U1027ToulouseFrance
  6. 6.Faculty of MedicineINSERM U1058MontpellierFrance

Personalised recommendations