The human GLP-1 analog liraglutide and the pancreas: Evidence for the absence of structural pancreatic changes in three species

Diabetes

Volumn 61, Issue 5, 2012, Pages 1243-1249

  Nyborg, Niels C B ^a   Mølck, Anne Marie ^a   Madsen, Lars W ^a   Knudsen, Lotte Bjerre ^a  

^a NOVO NORDISK A S   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

LIRAGLUTIDE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; CARCINOGENICITY; CONTROLLED STUDY; EXPERIMENTAL MONKEY; FEMALE; HISTOPATHOLOGY; MALE; MOUSE; NONHUMAN; PANCREAS; PANCREATITIS; PRIORITY JOURNAL; RAT;

ANIMALS; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLUCAGON-LIKE PEPTIDE 1; HUMANS; MACACA FASCICULARIS; MALE; MICE; PANCREAS; PANCREATITIS; RATS; RATS, SPRAGUE-DAWLEY;

EID: 84860577431     PISSN: 00121797     EISSN: 1939327X     Source Type: Journal    
DOI: 10.2337/db11-0936     Document Type: Article

References (37)

1. Drucker DJ, Sherman SI, Gorelick FS, Bergenstal RM, Sherwin RS, Buse JB. Incretin-based therapies for the treatment of type 2 diabetes: evaluation of the risks and benefits. Diabetes Care 2010;33:428-433
2. Denker PS, Dimarco PE. Exenatide (exendin-4)-induced pancreatitis: a case report. Diabetes Care 2006;29:471 (Pubitemid 44106551)
3. Ahmad SR, Swann J. Exenatide and rare adverse events. N Engl J Med 2008;358:1970-1971; discussion 1971-1972
4. 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
5. 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
6. Koehler JA, Baggio LL, Lamont BJ, Ali S, Drucker DJ. Glucagon-like peptide-1 receptor activation modulates pancreatitis-associated gene expression but does not modify the susceptibility to experimental pancreatitis in mice. Diabetes 2009;58:2148-2161
7. Knudsen LB, Nielsen PF, Huusfeldt PO, et al. Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration. J Med Chem 2000;43:1664-1669 (Pubitemid 30304999)
8. Drucker DJ, Dritselis A, Kirkpatrick P. Liraglutide. Nat Rev Drug Discov 2010;9:267-268
9. Marre M, Shaw J, Brändle M, et al.; LEAD-1 SU Study Group. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with type 2 diabetes (LEAD-1 SU). Diabet Med 2009;26:268-278
10. Nauck M, Frid A, Hermansen K, et al.; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care 2009;32:84-90
11. Garber A, Henry R, Ratner R, et al.; LEAD-3 (Mono) Study Group. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet 2009; 373:473-481 [North American Edition]
12. Zinman B, Gerich J, Buse JB, et al. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care 2009;32:1224-1230 [Erratum in Diabetes Care 2010;33:692]
13. Russell-Jones D, Vaag A, Schmitz O, et al.; Liraglutide Effect and Action in Diabetes 5 (LEAD-5) Met+SU Study Group. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Diabetologia 2009;52:2046-2055
14. Buse JB, Rosenstock J, Sesti G, et al.; LEAD-6 Study Group. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet 2009;374:39-47
15. Organisation for Economic Co-operation and Development. OECD series on principles of good laboratory practice and compliance monitoring [article online], 1998. Available from http://www.oecd.org/officialdocuments/ displaydocumentpdf/?cote=env/mc/chem(98)17&doclanguage=en. Accessed 1 June 2011
16. Medicines and Healthcare Products Regulatory Agency. Guide to UK GLP regulations [article online], 1999. Available from http://www.mhra.gov.uk/ howweregulate/medicines/inspectionandstandards/goodlaboratorypractice/ guidance/index.htm#l1. Accessed 1 June 2011
17. Crissman JW, Goodman DG, Hildebrandt PK, et al. Best practices guideline: toxicologic histopathology. Toxicol Pathol 2004;32:126-131 (Pubitemid 38250001)
18. Faccini JM, Butler WR, Friedmann JC, et al. IFSTP guidelines for the design and interpretation of the chronic rodent carcinogenicity bioassay. Exp Toxicol Pathol 1992;44:443-456 (Pubitemid 23031639)
19. Holland T, Holland C. Unbiased histological examinations in toxicological experiments (or, the informed leading the blinded examination). Toxicol Pathol 2011;39:711-714
20. Eustis SL, Boorman GA, Hayashi Y. Pathology of the Fisher rat: reference and atlas. In Exocrine Pancreas. Boorman GA, Eustis SL, Elwell MR, Montgomery JR, Eds. San Diego, CA, Academic Press, 1990, p. 95-108
21. Hansen JF, Ross PE, Makovec GT, Eustis SL, Sigler RE. Proliferative and other selected lesions of the exocrine pancreas in rats. In Guides for Toxicologic Pathology. Vol. GI-6. Washington, DC, Society of Toxicologic Pathologist, American Registry of Pathology, and Armed Forces Institute of Pathology, 1995, p. 2-7
22. Mohr U (Ed.). International Classification of Rodent Tumours: Part 1: The Rat Fascicle No. 10: Digestive System. Lyon, France, International Agency for Research on Cancer, 1997, p. 85-91
23. Denda A, Tsutsumi M, Konishi Y. Exocrine Pancreas in Pathobiology of the Aging Rat. Vol 2. Mohr U, Dungworth DL, Capen CC, Eds. Washington, DC, ILSI Press, 1994, p. 351-360
24. Koorstra JB, Feldmann G, Habbe N, Maitra A. Morphogenesis of pancreatic cancer: role of pancreatic intraepithelial neoplasia (PanINs). Langenbecks Arch Surg 2008;393:561-570
25. Hruban RH, Adsay NV, Albores-Saavedra J, et al. Pancreatic intraepithelial neoplasia: a new nomenclature and classification system for pancreatic duct lesions. Am J Surg Pathol 2001;25:579-586 (Pubitemid 32423354)
26. Working Party of the British Society of Gastroenterology; Association of Surgeons of Great Britain and Ireland; Pancreatic Society of Great Britain and Ireland; Association of Upper GI Surgeons of Great Britain and Ireland. UK guidelines for the management of acute pancreatitis. Gut 2005;54 (Suppl. 3):iii1-iii9
27. Imrie CW. Acute pancreatitis: section 14.18.3.1. In Oxford Textbook of Medicines. Vol. 2, 4th ed. Warrel DA, Cox TM, Firth JD, Benz EJ, Eds. Oxford, U.K., Oxford University Press, 2003, p. 679-687
28. Imrie CW. Chronic pancreatitis: section 14.18.3.2. In Oxford Textbook of Medicines. Vol. 2, 4th ed. Warrel DA, Cox TM, Firth JD, Benz EJ, Eds. Oxford, U.K., Oxford University Press, 2003, p. 687-696
29. Greaves P. Histopathology of preclinical toxicity Studies. 3rd ed. Greaves P, Ed. Amsterdam, NL, Academic Press, Elsevier, 2007, p. 515-527
30. Xu G, Kaneto H, Lopez-Avalos MD, Weir GC, Bonner-Weir S. GLP-1/ exendin-4 facilitates beta-cell neogenesis in rat and human pancreatic ducts. Diabetes Res Clin Pract 2006;73:107-110 (Pubitemid 43765553)
31. 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
32. Malhotra R, Singh L, Eng J, Raufman JP. Exendin-4, a new peptide from Heloderma suspectum venom, potentiates cholecystokinin-induced amylase release from rat pancreatic acini. Regul Pept 1992;41:149-156
33. Fehmann HC, Göke B, Weber V, et al. Interaction of glucagon-like peptide-1 (7-36)amide and cholecystokinin-8 in the endocrine and exocrine rat pancreas. Pancreas 1990;5:361-365 (Pubitemid 20149074)
34. Zhou J, Montrose-Rafizadeh C, Janczewski AM, et al. Glucagon-like peptide-1 does not mediate amylase release from AR42J cells. J Cell Physiol 1999;181: 470-478 (Pubitemid 29513416)
35. 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
36. 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
37. McClure HM, Chandler FW. A survey of pancreatic lesions in non-human primates. Vet Pathol Suppl 1982;19(Suppl. 7):193-209 (Pubitemid 13245948)