The potential risks of pancreatitis and pancreatic cancer with GLP-1-based therapies are far outweighed by the proven and potential (cardiovascular) benefits

Diabetic Medicine

Volumn 30, Issue 10, 2013, Pages 1148-1155

  Ryder, R E J ^a  

^a CITY HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALOGLIPTIN; DIPEPTIDYL PEPTIDASE IV INHIBITOR; EXENDIN 4; GLIMEPIRIDE; GLUCAGON LIKE PEPTIDE 1; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; INCRETIN; INSULIN GLARGINE; LINAGLIPTIN; LIRAGLUTIDE; LIXISENATIDE; METFORMIN; PLACEBO; ROSIGLITAZONE; SAXAGLIPTIN; SITAGLIPTIN; SULFONYLUREA;

ACUTE PANCREATITIS; APOPTOSIS; CANCER RISK; CARDIOTOXICITY; CARDIOVASCULAR RISK; CHRONIC PANCREATITIS; DIABETES MELLITUS; DRUG INDUCED CANCER; GALLSTONE; GLYCEMIC CONTROL; HEMORRHAGIC PANCREATITIS; HUMAN; HYPERTRIGLYCERIDEMIA; HYPOGLYCEMIA; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; OBESITY; PANCREAS CANCER; PANCREAS DISEASE; PANCREAS ISLET BETA CELL; PANCREATITIS; REVIEW; THYROID CANCER; THYROID MEDULLARY CARCINOMA;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CARDIOVASCULAR DISEASES; DIABETES MELLITUS, TYPE 2; DIABETIC ANGIOPATHIES; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; FEMALE; GLUCAGON-LIKE PEPTIDE 1; HUMANS; INCRETINS; MALE; PANCREATIC NEOPLASMS; PANCREATITIS; PATIENT SELECTION; PEPTIDES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTORS, GLUCAGON; RISK ASSESSMENT; RISK FACTORS; VENOMS;

EID: 84884711320     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/dme.12301     Document Type: Review

References (56)

1. 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: 534-539.
2. Gale EAM. GLP-1 based agents and acute pancreatitis. Br Med J 2013; 346: f1263.
3. 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: 2595-2604.
4. Butler PC, Elashoff M, Elashoff R, Gale EAM. A critical analysis of the clinical use of incretin-based therapies: are the GLP-1 therapies safe? Diabetes Care 2013; 36: 2118-2125.
5. Cohen D. Has pancreatic damage from glucagon suppressing diabetes drugs been underplayed? Br Med J 2013; 346: f3680.
6. Gale EAM. Incretin therapy: should adverse consequences have been anticipated? Br Med J 2013; 346: f3617.
7. Channel 4, UK. Diets, Drugs and Diabetes. A 'Dispatches current affairs programme' screened on British television's Channel 4 at 20.00 h on 10 June 2013.
8. Godlee F. Secrecy does not serve us well. Br Med J 2013; 346: f3819.
9. Montori VM. Helping patients make sense of the risks of taking GLP-1 agonists. Br Med J 2013; 346: f3692.
10. Institute for Safe Medication Practices. Perspectives on GLP-1 Agents for Diabetes. 2013. Available at www.ismp.org/QuarterWatch/pdfs/2012Q3.pdf Last accessed 30 June 2013.
11. 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: 150-156.
12. Preis SR, Hwang SJ, Coady S, Pencina MJ, D'Agostino RB Sr, Savage PJ et al. Trends in all-cause and cardiovascular disease mortality among women and men with and without diabetes mellitus in the Framingham Heart Study, 1950 to 2005. Circulation 2009; 119: 1728-1735.
13. Bhatt DL, Eagle KA, Ohman EM, Hirsch AT, Goto S, Mahoney EM et al. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. J Am Med Assoc 2010; 304: 1350-1357.
14. Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM et al. Heart disease and stroke statistics-2011 update: a report from the American Heart Association. Circulation 2011; 123: e18-e209.
15. Nauck MA. A critical analysis of the clinical use of incretin-based therapies: the benefits by far outweigh the potential risks. Diabetes Care 2013; 36: 2126-2132.
16. Engel SS, Williams-Herman DE, Golm GT, Clay RJ, Machotka SV, Kaufman KD et al. Sitagliptin: review of preclinical and clinical data regarding incidence of pancreatitis. Int J Clin Pract 2010; 64: 984-990.
17. Matveyenko AV, Dry S, Cox HI, Moshtaghian A, Gurlo T, Galasso R et al. Beneficial endocrine but adverse exocrine effects of sitagliptin in the human islet amyloid polypeptide transgenic rat model of type 2 diabetes: interactions with metformin. Diabetes 2009; 58: 1604-1615.
18. Stinton LM, Myers RP, Shaffer EA. Epidemiology of gallstones. Gastroenterol Clin North Am 2010; 39: 157-169.
19. Venneman NG, van Brummelen SE, van Berge-Henegouwen GP, van Erpecum KJ. Microlithiasis: an important cause of 'idiopathic' acute pancreatitis? Ann Hepatol 2003; 2: 30-35.
20. Sekimoto M, Takada T, Kawarada Y, Hirata K, Mayumi T, Yoshida M et al. JPN guidelines for the management of acute pancreatitis: epidemiology, etiology, natural history, and outcome predictors in acute pancreatitis. J Hepatobiliary Pancreat Surg 2006; 13: 10-24.
21. 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: 1019-1027.
22. 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: 2349-2354.
23. Pendergrass M, Chen W. Association between diabetes, exenatide, sitagliptin and acute pancreatitis. Diabetes 2010; 59: A160.
24. 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: 559-566.
25. 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: 1412-1418.
26. Eurich DT, 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. Br Med J 2013; 346: f2267.
27. Ryder REJ, Thong KY, Cull ML, Mills AP, Walton C, Winocour PH, on behalf of the ABCD nationwide exenatide audit contributors. The Association of British Clinical Diabetologists (ABCD) nationwide exenatide audit. Pract Diabetes Int 2010; 27: 352-357.
28. Ryder B, Thong K on behalf of the ABCD nationwide exenatide and nationwide liraglutide audit contributors. Findings from the Association of British Clinical Diabetologists (ABCD) nationwide exenatide and liraglutide audits. In: Vora J, ed. Hot topics in diabetes, 5th edn. London: Synergy, 2012, pp 49-61. Available at http://www.diabetologists-abcd.org.uk/GLP1_Audits/ABCD_Hot_Topics_2012.pdf Last accessed 19 August 2013.
29. Ryder REJ, Thong KY, Blann A, Phillips S, Barwell N, Kelly C et al. Liraglutide and acute pancreatitis in the Association of British Clinical Diabetologists (ABCD) nationwide liraglutide audit. Poster 15 (late breaking), ABCD Spring Meeting, Solihull, UK, 18-19 April 2013. Available at http://www.diabetologists-abcd.org.uk/GLP1_Audits/Liraglutide_Pancreatitis_Poster_ABCD_Apr2013.pdf Last accessed 30 June 2013.
30. Ryder REJ, Thong KY, on behalf of the ABCD nationwide exenatide audit contributors. Incidence of acute pancreatitis in the Association of British Clinical Diabetologists (ABCD) nationwide exenatide audit. 2013. Available at http://www.diabetologists-abcd.org.uk/GLP1_Audits/pancreatitis_incidence_exenatide_audit.pdf Last accessed 30 June 2013.
31. Cohen D. Reports of pancreatitis are 20-30 times more likely with GLP-1 drugs, analysis finds. Br Med J 2013; 346: f2607.
32. 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 2011; 1-9.
33. Khan SE. Incretin therapy and islet pathology-a time for caution. Diabetes 2013; 62: 2178-2180.
34. Shyangdan DS, Royle PL, Clar C, Sharma P, Waugh NR. Glucagon-like peptide analogues for type 2 diabetes mellitus: systematic review and meta-analysis. BMC Endocr Disord 2010; 10: 20.
35. Barnett AH, O'Hare JP. Incretins and pancreatic cancer: Cardiovascular benefits of incretins. Br Med J 2013; 347: f4382.
36. Monami M, Cremasco F, Lamanna C, Colombi C, Desideri CM, Iacomelli I et al. Glucagon-like peptide-1 receptor agonists and cardiovascular events: a meta-analysis of randomized clinical trials. Exp Diabetes Res 2011; 27: 57-64.
37. Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. Br Med J 2000; 321: 405-412.
38. Bose AK, Mocanu MM, Carr RD, Brand CL, Yellon DM. Glucagon-like peptide 1 can directly protect the heart against ischemia/reperfusion injury. Diabetes 2005; 54: 146-151.
39. Shannon RP, Angeli FS. Beyond glucose: cardiovascular effects of incretins and dipeptidyl peptidase-4 substrates. Eur Heart J Suppl 2012; 14: B14-B21.
40. Klonoff DC, Buse JB, Nielsen LL, Guan X, Bowlus CL, Holcombe JH et al. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin 2008; 24: 275-286.
41. Bunck MC, Diamant M, Eliasson B, Cornér A, Shaginian RM, Heine RJ et al. Exenatide affects circulating cardiovascular risk biomarkers independently of changes in body composition. Diabetes Care 2010; 33: 1734-1737.
42. Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol 2013; 12: 48.
43. Ratner R, Han J, Nicewarner D, Yushmanova I, Hoogwerf BJ, Shen L. Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes. Cardiovasc Diabetol 2011; 10: 22.
44. McGill JB. Liraglutide: effects beyond glycaemic control in diabetes treatment. Int J Clin Pract 2010; 64 (Suppl s167): 28-34.
45. Rizzo M, Nikolic D, Banach M, Giglio RV, Patti M, Di Bartolo V et al. The effects of liraglutide on glucose, inflammatory markers and lipoprotein metabolism: current knowledge and future perspective. Clin Lipidol 2013; 8: 173-181.
46. Marso SP, Lindsey JB, Stolker JM, House JA, Martinez Ravn G, Kennedy KF et al. Cardiovascular safety of liraglutide assessed in a patient-level pooled analysis of phase 2: 3 liraglutide clinical development studies. Diab Vasc Dis Res 2011; 8: 237-240.
47. European Medicines Agency. Lyxumia. Summary of Product Characterisics. 2013. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002445/WC500140401.pdf Last accessed 30 June 2013.
48. Wohlfart P, Linz W, Hübschle T, Linz D, Huber J, Hess S et al. Cardioprotective effects of lixisenatide in rat myocardial ischemia-reperfusion injury studies. J Transl Med 2013; 11: 84.
49. Lenski M, Kazakov A, Marx N, Böhm M, Laufs U. Effects of DPP-4 inhibition on cardiac metabolism and function in mice. J Mol Cell Cardiol 2011; 51: 906-918.
50. Mosenzon O, Raz I. Potential cardiovascular effects of dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes: current evidence and ongoing trials. Eur Heart J Suppl 2012; 14: B22-B29.
51. Rathmann W, Kostev K, Gruenberger JB, Dworak M, Bader G, Giani G. Treatment persistence, hypoglycaemia and clinical outcomes in type 2 diabetes patients with dipeptidyl peptidase-4 inhibitors and sulphonylureas: a primary care database analysis. Diabetes Obes Metab 2013; 15: 55-61.
52. ® (saxagliptin). 2013. Available at http://m.news.bms.com/press-release/astrazeneca-and-bristol-myers-squibb-announce-top-line-results-savor-timi-53-cardiovas Last accessed 20 June 2013.
53. Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B et al. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J 2011; 162: 818-825.
54. White WB, Bakris GL, Bergenstal RM, Cannon CP, Cushman WC, Fleck P et al. EXamination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome. Am Heart J 2011; 162: 620-626.
55. 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; doi: 10.1056/NEJMoa1307684 [Epub ahead of print].
56. 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; doi: 10.1056/NEJMoa1305889 [Epub ahead of print].