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

被引:69
作者
Faillie, Jean-Luc [1 ,2 ]
Babai, Samy [3 ]
Crepin, Sabrina [4 ]
Bres, Virginie [1 ]
Laroche, Marie-Laure [4 ]
Le Louet, Herve [3 ]
Petit, Pierre [1 ]
Montastruc, Jean-Louis [2 ,5 ]
Hillaire-Buys, Dominique [1 ,6 ]
机构
[1] CHRU Montpellier, Pharmacovigilance Reg Ctr, Dept Med Pharmacol & Toxicol, F-34295 Montpellier, France
[2] Fac Med, INSERM, U1027, Dept Pharmacoepidemiol, Toulouse, France
[3] CHU Creteil, Pharmacovigilance Reg Ctr, Creteil, France
[4] CHU Limoges, Pharmacovigilance Reg Ctr, Dept Pharmacol & Toxicol, Limoges, France
[5] CHU Toulouse, Pharmacovigilance Reg Ctr, Dept Med & Clin Pharmacol, Toulouse, France
[6] Fac Med, INSERM, U1058, Montpellier, France
关键词
Type 2 diabetes mellitus; Glucagon-like peptide 1 analogs; Dipeptidyl peptidase 4 inhibitors; Pancreatitis; Pharmacovigilance; ADVERSE DRUG-REACTIONS; TYPE-2; DIABETES-MELLITUS; INCRETIN-BASED THERAPIES; POPULATION-BASED COHORT; CLINICAL-USE; RISK; EXENATIDE; SITAGLIPTIN; CANCER; SAFETY;
D O I
10.1007/s00592-013-0544-0
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
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.
引用
收藏
页码:491 / 497
页数:7
相关论文
共 40 条
[1]
A meta-analysis of serious adverse events reported with exenatide and liraglutide: Acute pancreatitis and cancer [J].
Alves, Carlos ;
Batel-Marques, Francisco ;
Macedo, Ana F. .
DIABETES RESEARCH AND CLINICAL PRACTICE, 2012, 98 (02) :271-284
[2]
[Anonymous], 2012, ONGL SAX SUMM PROD C
[3]
[Anonymous], 2012, GALV VILD SUMM PROD
[4]
[Anonymous], 2012, JAN SIT SUMM PROD CH
[5]
[Anonymous], 2012, BYETT EX SUMM PROD C
[6]
[Anonymous], 2012, ONGL LIR SUMM PROD C
[7]
Drug-Induced Pancreatitis Incidence, Management and Prevention [J].
Balani, Anil R. ;
Grendell, James H. .
DRUG SAFETY, 2008, 31 (10) :823-837
[8]
Quantitative signal detection using spontaneous ADR reporting [J].
Bate, A. ;
Evans, S. J. W. .
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2009, 18 (06) :427-436
[9]
Marked Expansion of Exocrine and Endocrine Pancreas With Incretin Therapy in Humans With Increased Exocrine Pancreas Dysplasia and the Potential for Glucagon-Producing Neuroendocrine Tumors [J].
Butler, Alexandra E. ;
Campbell-Thompson, Martha ;
Gurlo, Tatyana ;
Dawson, David W. ;
Atkinson, Mark ;
Butler, Peter C. .
DIABETES, 2013, 62 (07) :2595-2604
[10]
Butler PC, 2013, DIABETES CARE, V36, P2118, DOI 10.2337/dc12-2713