A critical analysis of the clinical use of incretin-based therapies: The benefits by far outweigh the potential risks

Diabetes Care

Volumn 36, Issue 7, 2013, Pages 2126-2132

  Nauck, Michael A ^a  

^a Diabetes Center   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ALOGLIPTIN; AMYLASE; CALCITONIN; DIPEPTIDYL PEPTIDASE IV INHIBITOR; EXENDIN 4; GLUCAGON LIKE PEPTIDE 1 RECEPTOR; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; LINAGLIPTIN; LIRAGLUTIDE; PLACEBO; SAXAGLIPTIN; SITAGLIPTIN; TRIACYLGLYCEROL LIPASE; VILDAGLIPTIN;

ABDOMINAL PAIN; ACUTE PANCREATITIS; ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR MORTALITY; CHRONIC PANCREATITIS; DIARRHEA; DRUG WITHDRAWAL; GASTROINTESTINAL SYMPTOM; HEART RATE; HUMAN; INFECTION; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; PANCREAS CANCER; PANCREATITIS; PULSE RATE; RISK BENEFIT ANALYSIS; THYROID CARCINOMA; THYROID MEDULLARY CARCINOMA; THYROID PARAFOLLICULAR CELL; UNSPECIFIED SIDE EFFECT; VOMITING;

ANIMALS; HUMANS; INCRETINS;

EID: 84879231610     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc12-2504     Document Type: Article

References (50)

1. Drucker DJ, Nauck MA. The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet 2006;368: 1696-1705
2. Nauck MA. Incretin-based therapies for type 2 diabetes mellitus: properties, functions, and clinical implications. Am J Med 2011;124(Suppl.):S3- S18
3. Deacon CF. Incretin-based treatment of type 2 diabetes: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors. Diabetes Obes Metab 2007;9 (Suppl. 1):23-31
4. Deacon CF. Dipeptidyl peptidase-4 inhibitors in the treatment of type 2 diabetes: a comparative review. Diabetes Obes Metab 2011;13:7-18
5. Matveyenko AV, Dry S, Cox HI, 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
6. Nachnani JS, Bulchandani DG, Nookala A, et al. Biochemical and histological effects of exendin-4 (exenatide) on the rat pancreas. Diabetologia 2010;53:153-159
7. Gier B, Matveyenko AV, Kirakossian D, Dawson D, Dry SM, Butler PC. Chronic GLP-1 receptor activation by exendin-4 induces expansion of pancreatic duct glands in rats and accelerates formation of dysplastic lesions and chronic pancreatitis in the Kras(G12D) mouse model. Diabetes 2012;61:1250-1262
8. Butler PC, Matveyenko AV, Dry S, Bhushan A, Elashoff R. Glucagon-like peptide-1 therapy and the exocrine pancreas: innocent bystander or friendly fire? Diabetologia 2010;53:1-6
9. Bjerre Knudsen L, Madsen LW, Andersen S, et al. Glucagon-like peptide-1 receptor agonists activate rodent thyroid C-cells causing calcitonin release and C-cell proliferation. Endocrinology 2010;151:1473-1486
10. Pratley RE, Nauck M, Bailey T, et al.; 1860-LIRA-DPP-4 Study Group. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet 2010;375:1447-1456
11. Bergenstal RM, Wysham C, Macconell L, et al.; DURATION-2 Study Group. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet 2010;376:431-439
12. 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
13. Nyborg NC, Mølck AM, Madsen LW, Knudsen LB. The human GLP-1 analog liraglutide and the pancreas: evidence for the absence of structural pancreatic changes in three species. Diabetes 2012; 61:1243-1249
14. Ahmad SR, Swann J. Exenatide and rare adverse events. N Engl J Med 2008;358: 1970-1971; discussion 1971-1972
15. Tatarkiewicz K, Smith PA, Sablan EJ, et al. Exenatide does not evoke pancreatitis and attenuates chemically induced pancreatitis in normal and diabetic rodents. Am J Physiol Endocrinol Metab 2010;299:E1076-E1086
16. Koehler JA, Baggio LL, Lamont BJ, Ali S, Drucker DJ. Glucagon-like peptide-1 receptor activation modulates pancreatitisassociated gene expression but does not modify the susceptibility to experimental pancreatitis in mice. Diabetes 2009;58: 2148-2161
17. 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
18. 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 sitaglipcare tin compared to metformin or glyburide. Curr Med Res Opin 2009;25:1019-1027
19. Dore DD, Bloomgren GL, Wenten M, et al. A cohort study of acute pancreatitis in relation to exenatide use. Diabetes Obes Metab 2011;13:559-566
20. Wenten M, Gaebler JA, Hussein M, et al. Relative risk of acute pancreatitis in initiators of exenatide twice daily compared with other anti-diabetic medication: a follow-up study. Diabetic Med 2012;29: 1412-1418
21. Pendergrass M, Chen W. Association between diabetes, exenatide, sitagliptin and acute pancreatitis (Abstract). Diabetes 2010;59(Suppl. 1):A160
22. 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
23. Kiriyama S, Gabata T, Takada T, et al. New diagnostic criteria of acute pancreatitis. J Hepatobiliary Pancreat Sci 2010;17: 24-36
24. Singh S, Chang H-Y, Richards TM, Weiner JP, Clark JM, Segal JB. Glucagonlike 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
25. SteinbergW, De Vries H,Wadden TA, Bjørn Jensen C, Svendsen CB, Rosenstock J. Longitudinal monitoring of lipase and amylase in adults with type 2 diabetes and obesity: evidence from two phase 3 randomized clinical trials with the oncedaily GLP-1 analog liraglutide (Abstract). Gastroenterol 2012;142(Suppl. 1):S850-S851
26. Steinberg W, Rosenstock J, De Vries H, Bloch Thomsen A, Svendsen CB, Wadden TA. Elevated serum lipase activity in adults with type 2 diabetes and no gastrointestinal symptoms (Abstract). Gastroenterol 2012;142(Suppl. 1):S93-S94
27. Flint A, Raben A, Astrup A, Holst JJ. Glucagonlike peptide 1 promotes satiety and suppresses energy intake in humans. J Clin Invest 1998;101:515-520
28. Vincent A, Herman J, Schulick R, Hruban RH, Goggins M. Pancreatic cancer. Lancet 2011;378:607-620
29. 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 glucagonproducing neuroendocrine tumors. Diabetes 2013;62:2595-2604
30. In't Veld P, De Munck N, Van Belle K, et al. Beta-cell replication is increased in donor organs from young patients after prolonged life support. Diabetes 2010; 59:1702-1708
31. Yachida S, Jones S, Bozic I, et al. Distant metastasis occurs late during the genetic evolution of pancreatic cancer. Nature 2010;467:1114-1117
32. Hegedüs L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab 2011; 96:853-860
33. Aschebrook-Kilfoy B, Ward MH, Sabra MM, Devesa SS. Thyroid cancer incidence patterns in the United States by histologic type, 1992-2006. Thyroid 2011;21:125-134
34. Gier B, Butler PC, Lai CK, Kirakossian D, DeNicola MM, Yeh MW. Glucagon like peptide-1 receptor expression in the human thyroid gland. J Clin Endocrinol Metab 2012;97:121-131
35. Waser B, Beetschen K, Pellegata NS, Reubi JC. Incretin receptors in non-neoplastic and neoplastic thyroid C cells in rodents and humans: relevance for incretin-based diabetes therapy. Neuroendocrinology 2011;94:291-301
36. Monami M, Ahrén B, Dicembrini I,Mannucci E. Dipeptidyl peptidase-4 inhibitors and cardiovascular risk: a meta-analysis of randomized clinical trials. Diabetes ObesMetab 2013; 15:112-120
37. 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
38. Marso SP, Lindsey JB, Stolker JM, 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
39. Williams-Herman D, Engel SS, Round E, et al. Safety and tolerability of sitagliptin in clinical studies: a pooled analysis of data from 10,246 patients with type 2 diabetes. BMC Endocr Disord 2010;10:7
40. Schweizer A, Dejager S, Foley JE, Couturier A, Ligueros-Saylan M, Kothny W. Assessing the cardio-cerebrovascular safety of vildagliptin: meta-analysis of adjudicated events from a large phase III type 2 diabetes population. Diabetes Obes Metab 2010;12: 485-494
41. Frederich R,McNeill R, Berglind N, Fleming D, Chen R. The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naïve patients with type 2 diabetes mellitus: a randomized controlled trial. Diabetol Metab Syndr 2012;4:36
42. Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol 2012;11:3
43. White JR. Alogliptin for the treatment of type 2 diabetes. Drugs Today (Barc) 2011; 47:99-107
44. Gallwitz B, Rosenstock J, Rauch T, et al. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet 2012;380: 475-483
45. Ussher JR, Drucker DJ. Cardiovascular biology of the incretin system. Endocr Rev 2012;33:187-215
46. Ligueros-Saylan M, Foley JE, Schweizer A, Couturier A, Kothny W. An assessment of adverse effects of vildagliptin versus comparators on the liver, the pancreas, the immune system, the skin and in patients with impaired renal function from a large pooled database of phase II and III clinical trials. Diabetes Obes Metab 2010;12:495-509
47. Nyström T, Gutniak MK, Zhang Q, et al. Effects of glucagon-like peptide-1 on endothelial function in type 2 diabetes patients with stable coronary artery disease. Am J Physiol Endocrinol Metab 2004;287: E1209-1215
48. Drucker DJ, Buse JB, Taylor K, et al.; DURATION-1 Study Group. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet 2008;372: 1240-1250
49. Stettler C, Bearth A, Allemann S, et al. QTc interval and resting heart rate as long-term predictors of mortality in type 1 and type 2 diabetes mellitus: a 23-year follow-up. Diabetologia 2007;50:186-194
50. Engel SS, Williams-Herman DE, Golm GT, et al. Sitagliptin: review of preclinical and clinical data regarding incidence of pancreatitis. Int J Clin Pract 2010;64: 984-990