Incretin based drugs and risk of acute pancreatitis in patients with type 2 diabetes: Cohort study

BMJ (Online)

Volumn 348, Issue , 2014, Pages

  Faillie, Jean Luc ^a,b,c   Azoulay, Laurent ^a,d   Patenaude, Valerie ^a   Hillaire Buys, Dominique ^c,e   Suissa, Samy ^a,d  

^a MCGILL UNIVERSITY   (Canada)

^b UNIVERSITÉ DE TOULOUSE   (France)

^c MONTPELLIER UNIVERSITY HOSPITAL   (France)

^d MCGILL UNIVERSITY   (Canada)

^e UMR 1058 University of Montpellier   (France)

Author keywords

[No Author keywords available]

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ACARBOSE; DIPEPTIDYL PEPTIDASE IV; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLUCAGON LIKE PEPTIDE 1; GLUCAGON LIKE PEPTIDE 1 DERIVATIVE; INCRETIN; LINAGLIPTIN; METFORMIN; SAXAGLIPTIN; SITAGLIPTIN; SULFONYLUREA; VILDAGLIPTIN;

ACUTE PANCREATITIS; ADULT; ARTICLE; CLINICAL PRACTICE; COHORT ANALYSIS; CONTROLLED STUDY; FEMALE; GENERAL PRACTICE; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; PROPENSITY SCORE; PROPORTIONAL HAZARDS MODEL; SENSITIVITY ANALYSIS; UNITED KINGDOM;

ACUTE DISEASE; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; FEMALE; FOLLOW-UP STUDIES; GLUCAGON-LIKE PEPTIDE 1; HUMANS; HYPOGLYCEMIC AGENTS; INCRETINS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; PANCREATITIS; SULFONYLUREA COMPOUNDS;

EID: 84899547978     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.g2780     Document Type: Article

References (44)

1. Drucker DJ. Biological actions and therapeutic potential of the glucagon-like peptides. Gastroenterology 2002;122:531-44.
2. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia 2012;55:1577-96.
3. Elashoff M, Matveyenko AV, Gier B, Elashoff R, Butler PC. Pancreatitis, pancreatic, and thyroid cancer with glucagon-like peptide-1-based therapies. Gastroenterology 2011;141:150-6.
4. Raschi E, Piccinni C, Poluzzi E, Marchesini G, De Ponti F. The association of pancreatitis with antidiabetic drug use: gaining insight through the FDA pharmacovigilance database. Acta Diabetol 2013;50:569-77.
5. Institute for Safe Medication Practices. Perspectives on GLP-1 agents for diabetes. 2013. www.ismp.org/QuarterWatch/pdfs/2012Q3.pdf.
6. Faillie JL, Babai S, Crepin S, Bres V, Laroche ML, Le Louet H, et al. Pancreatitis associated with the use of GLP-1 analogs and DPP-4 inhibitors: a case/non-case study from the French Pharmacovigilance Database. Acta Diabetol 2013; doi:10.1007/s00592-013-0544-0.
7. US Food and Drug Administration. Information for healthcare professionals: exenatide (marketed as Byetta)-8/2008 update. www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124713.htm.
8. US Food and Drug Administration. Safety requirements for Victoza (liraglutide). www.fda. gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm198543.htm.
9. US Food and Drug Administration. Information for healthcare professionals-acute pancreatitis and sitagliptin (marketed as Januvia and Janumet). September 25, 2009. www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm183764.htm.
10. European Medicines Agency. Januvia (sitagliptin). Summaries of product characteristics. 2012. www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000722/WC500039054.pdf.
11. European Medicines Agency. Galvus (vildagliptin). Summaries of product characteristics. 2012. www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000771/WC500020327.pdf.
12. European Medicines Agency. Onglyza (saxagliptin). Summaries of product characteristics. 2012. www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/001039/WC500044316.pdf.
13. European Medicines Agency. Byetta (exenatide). Summaries of product characteristics. 2012. www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000698/WC500051845.pdf.
14. European Medicines Agency. Onglyza (liraglutide). Summaries of product characteristics. 2012. www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/001026/WC500050017.pdf.
15. Dore DD, Bloomgren GL, Wenten M, Hoffman C, Clifford CR, Quinn SG, et al. A cohort study of acute pancreatitis in relation to exenatide use. Diabetes Obes Metab 2011;13:559-66.
16. Dore DD, Seeger JD, Arnold Chan K. 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. Curr Med Res Opin 2009;25:1019-27.
17. Eurich DT, Simpson S, Senthilselvan A, Asche CV, Sandhu-Minhas JK, McAlister FA. Comparative safety and effectiveness of sitagliptin in patients with type 2 diabetes: retrospective population based cohort study. BMJ 2013;346:f2267.
18. Funch D, Gydesen H, Tornoe K, Major-Pedersen A, Chan KA. A prospective, claims-based assessment of the risk of pancreatitis and pancreatic cancer with liraglutide compared to other antidiabetic drugs. Diabetes Obes Metab 2014:16:273-5.
19. Garg R, Chen W, Pendergrass M. Acute pancreatitis in type 2 diabetes treated with exenatide or sitagliptin: a retrospective observational pharmacy claims analysis. Diabetes Care 2010;33:2349-54.
20. Romley JA, Goldman DP, Solomon M, McFadden D, Peters AL. Exenatide therapy and the risk of pancreatitis and pancreatic cancer in a privately insured population. Diabetes Technol Ther 2012;14:904-11.
21. Wenten M, Gaebler JA, Hussein M, Pelletier EM, Smith DB, Girase P, et al. Relative risk of acute pancreatitis in initiators of exenatide twice daily compared with other anti-diabetic medication: a follow-up study. Diabet Med 2012;29:1412-8.
22. Giorda C, Picariello R, Nada E, Tartaglino B, Marafetti L, Costa G, et al. Incretin therapies and risk of hospital admission for acute pancreatitis in an unselected population of European patients with type 2 diabetes: a case-control study. Lancet Diabetes Endocrinol 2014;2:111-5.
23. Singh S, Chang HY, Richards TM, Weiner JP, Clark JM, Segal JB. Glucagon like peptide 1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus: a population-based matched case-control study. JAMA Intern Med 2013;173:534-9.
24. Cohen D. European drugs agency clashes with scientists over safety of GLP-1 drugs. BMJ 2013;347:f4838.
25. Cohen D. FDA is to assess data linking type 2 diabetes drugs with pancreatitis. BMJ 2013;346:f1808.
26. Garcia Rodriguez LA, Perez Gutthann S. Use of the UK general practice research database for pharmacoepidemiology. Br J Clin Pharmacol 1998;45:419-25.
27. Herrett E, Thomas SL, Schoonen WM, Smeeth L, Hall AJ. Validation and validity of diagnoses in the General Practice Research Database: a systematic review. Br J Clin Pharmacol 2010;69:4-14.
28. Laferrere B, Heshka S, Wang K, Khan Y, McGinty J, Teixeira J, et al. Incretin levels and effect are markedly enhanced 1 month after Roux-en-Y gastric bypass surgery in obese patients with type 2 diabetes. Diabetes Care 2007;30:1709-16.
29. Schneeweiss S, Rassen JA, Glynn RJ, Avorn J, Mogun H, Brookhart MA. High-dimensional propensity score adjustment in studies of treatment effects using health care claims data. Epidemiology 2009;20:512-22.
30. Huberman M, Langholz B. Application of the missing-indicator method in matched case-control studies with incomplete data. Am J Epidemiol 1999;150:1340-5.
31. Hosmer DW, Lemeshow S, eds. Applied logistic regression. 2nd ed. Wiley, 2000.
32. Parsons LS. Reducing bias in a propensity score matched-pair sample using greedy matching techniques. Proceedings of the Twenty-Sixth Annual SAS Users Group International Conference, Cary, NC, 2001. www2.sas.com/proceedings/sugi26/p214-26.pdf.
33. Butler AE, Campbell-Thompson M, Gurlo T, Dawson DW, Atkinson M, Butler PC. 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. Diabetes 2013;62:2595-604.
34. Butler PC, Elashoff M, Elashoff R, Gale EA. A Critical analysis of the clinical use of incretin-based therapies: are the GLP-1 therapies safe? Diabetes Care 2013;36:2118-25.
35. Drucker DJ. Incretin action in the pancreas: potential promise, possible perils, and pathological pitfalls. Diabetes 2013;62:3316-23.
36. Monami M, Dicembrini I, Mannucci E. Dipeptidyl peptidase-4 inhibitors and pancreatitis risk: a meta-analysis of randomized clinical trials. Diabetes Obes Metab 2014;16:48-56.
37. Monami M, Dicembrini I, Nardini C, Fiordelli I, Mannucci E. Glucagon-like peptide-1 receptor agonists and pancreatitis: a meta-analysis of randomized clinical trials. Diabetes Res Clin Pract 2014;1-3:269-75.
38. Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med 2013;369:1317-26.
39. White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med 2013;369:1327-35.
40. Gonzalez-Perez A, Schlienger RG, Rodriguez LA. Acute pancreatitis in association with type 2 diabetes and antidiabetic drugs: a population-based cohort study. Diabetes Care 2010;33:2580-5.
41. Noel RA, Braun DK, Patterson RE, Bloomgren GL. Increased risk of acute pancreatitis and biliary disease observed in patients with type 2 diabetes: a retrospective cohort study. Diabetes Care 2009;32:834-8.
42. Girman CJ, Kou TD, Cai B, Alexander CM, O'Neill EA, Williams-Herman DE, et al. Patients with type 2 diabetes mellitus have higher risk for acute pancreatitis compared with those without diabetes. Diabetes Obes Metab 2010;12:766-71.
43. Suissa S, Azoulay L. Metformin and the risk of cancer: time-related biases in observational studies. Diabetes Care 2012;35:2665-73.
44. Garbe E, Kloss S, Suling M, Pigeot I, Schneeweiss S. High-dimensional versus conventional propensity scores in a comparative effectiveness study of coxibs and reduced upper gastrointestinal complications. Eur J Clin Pharmacol 2013;69:549-57.