Preview

Diabetes mellitus

Advanced search

New indications for exenatide therapy of type 2 diabetes mellitus

https://doi.org/10.14341/2072-0351-5496

Abstract

Obesity associated with the enhanced risk of cardiovascular disorders plays a key role in the evolvement and progression of type 2 diabetes mellitus(DM2). Incretin mimetics are the sole class of hypoglycemic agents that not only effectively correct hyperglycemia but also reduce body weight. Exenatide(Byetta) is the first drug of this class approved for the use as monotherapy. This paper presents a detailed review of the available data on thescope of exenatide effects and the results of its clinical studies that confirm high efficiency of Byetta used for both monotherapy and combined therapyof DM2.

About the Authors

Olga Konstantinovna Vikulova
Endocrinological Research Centre, Moscow


Marina Vladimirovna Shestakova
Endocrinological Research Centre, Moscow


References

1. Look AHEAD Research Group, Pi-Sunyer X., Blackburn G., Brancati F.L., Bray G.A., Bright R., Clark J.M., Curtis J.M.Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial // Diabetes Care. - 2007. - 30. - Р. 1374-1383.

2. Feldstein A.C., Nichols G.A., Smith D.H. et al. Weight change in diabetes and glycemic and blood pressure control // Diabetes Care. - 2008. - 31. - Р. 1960-1965.

3. Nelson K.M., Reiber G., Boyko E.J. NHANES III, Diet and exerciseamong adults with type 2 diabetes: findings from the third national health and nutrition examination survey (NHANES III) // Diabetes Care. - 2002. - 25. - Р. 1722-1728.

4. Nathan D.M., Buse J.B., Davidson M.B. et al. American Diabetes Association; European Association for Study of Diabetes, Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy, A consensus statement ofthe American Diabetes Association and the European Association forthe Study of Diabetes // Diabetes Care. - 2009. - 32(1). - Р. 193-203.

5. Dupre J., Ross S.A., Watson D., Brown J.C. Stimulation of insulin secretion by gastric inhibitory polypeptide in man // J. Clin. Endocrinol. Metab. - 1973. - 37. - Р. 826-828.

6. Schmidt W.E., Siegel E.G., Creutzfeldt W. Glucagon-like peptide-1 but not glucagon-like peptide-2 stimulates insulin release from isolated rat pancreatic islets // Diabetologia. - 1985. - 28. - Р. 704-707.

7. Shah P., Vella A., Rizza R.A. Glucagon physiology, pathophysiology and prospects of glucagons antagonists for the treatment of diabetes // Int. Diabetes. Monitor. - 2005. - 17(6) . - Р. 3-10.

8. Wettergren A., Schjoldager B., Mortensen P.E. et al. Truncated GLP-1 (proglucagon 78-107-amide) inhibits gastric and pancreatic functions in man // Dig. Dis. Sci. - 1993. - 38. - Р. 665-673.

9. Gutzwiller J.P., Drewe J., Goke B. et al. Glucagon-like peptide-1 promotes satiety and reduces food intake in patients with diabetes mellitus type 2 // Am. J. Physiol. - 1999. - 276. - Р. 1541-1544.

10. Vilsbol T., Krarup T., Madsbad S., Holst J.J. Defective amplification of the late phase insulin response to glucose by GIP in obese Type II diabetic patients // Diabetologia. - 2002. - 45. - Р. 1111-1119.

11. Nauck M.A., Heimesaat M.M., Orskov C. et al. Preserved incretin activity of glucagon-like peptide-1 (7-36 amide) but not of synthetic human gastric inhibitory polypeptide in patients with type-2 diabetes mellitus // J. Clin. Invest. - 1993. - 91. - Р. 301-307.

12. Deacon C.F., Johnsen A.H., Holst J.J. Degradation of glucagon-like peptide- 1 by human plasma in vitro yields an N-terminally truncated peptide that is a major endogenous metabolite in vivo // J. Clin. Endocrinol. Metab. - 1995. - 80. - Р. 952-957.

13. Nielsen L.L., Young A.A., Parkers D.G. Pharmacology of exenatide (synthetic exendin-4): a potential therapeutic for improved glycemic control of type 2 diabetes // Regul. Rept. - 2004. - 117. - Р. 77-88.

14. Holst J.J. GLP-1 receptor agonists for the treatment of diabetes // Int. Diabetes. Monitor. 2005; 17(6): Р. 11-18

15. Fehse F.C., Trautmann M.E., Holst J.J., Halseth A.E. et al. Exenatide augments first- and second-phase insulin secretion in response to intravenous glucose in subjects with type 2 diabetes // J. Clin. Endocrinol. Metab. - 2005. - 90. - Р. 5991-5997.

16. Degn K.B., Brock B., Juhl C.B. et al. Effect of intravenous infusion of exenatide (synthetic exendin-4) on glucose-dependent insulin secretion and couter regulation during hypoglycemia // Diabetes. - 2004. - 53(9). - Р. 2397-2403.

17. Kolterman O., Kim D.D., Shen L., Ruggles J.A. et al. Pharmacokinetics, pharmacodynamics, and safety of exenatide in patients with type 2 diabetes mellitus // Am. J. Health. Syst. Pharm. - 2005. - 62. - Р. 173-181.

18. Edwards C.M.B., Stanley S.A., Davis R. et al. Exendin-4 reduses fasting and postprandial glucose decreases energy intake in healthy volunteers // Am. J. Physiol. Endocrinol. Metab. - 2001. - 281(1). - E155-161.

19. DeFronzo R., Ratner R., Han J. et al. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes // Diabetes Care. - 2005. - 28(5). - Р. 1092- 1100.

20. Buse J., Henry R., Han J. et al. Effests of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes // Diabetes Care. - 2004. - 27(11). - Р. 2628-2635.

21. Kendall D.M., Riddle M.C., Rosenstock J. et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea // Diabetes Care. - 2005. - 28(5). - Р. 1083-1091.

22. Zinman B., Hoogwerf B.J., Garcia S.D. et al. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes // Ann. Intern. Med. - 2007. - 146. - Р. 477-485.

23. Klonoff D.C., Buse J.B., Nielsen L.L., Guan X., Bowlus C.L., Holcombe J.H., Wintle M.E., and Maggs D.G. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years // Current Medical Research and OpinionR. - 2008. - 24(1). - Р. 275-286.

24. Heine R.J., Van Gaal L.F., Johns D., Mihm M., et al. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial // Ann. Intern. Med. - 2005. - 143(8). - Р. 559-569.

25. Barnett A.H., Burger J., Johns D., Brodows R. et al. Tolerability and efficacy of exenatide and titrated insulin glargine in adult patients with type 2 diabetes previously uncontrolled with metformin or a sulfonylurea: a multinational, randomized, open-label, two-period crossover noninferiority trial // Clinical Therapeutics. - 2007. - 29. - Р. 2333-2348.

26. Nauck M.A., Duran S., Kim D., Johns D. et al. A comparison of a twicedaily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: a non-inferiority study // Diabetologia. - 2007. - 50. - Р. 259-267.

27. Moretto T.J., Milton D.R., Ridge T.D., MacConell L.A., Okerson T., Wolka A.M., and Brodows R.G. Efficacy and Tolerability of Exenatide Monotherapy Over24 Weeks in Antidiabetic Drug-Naive Patients with Type 2Diabetes: A Randomized, Double-Blind, Placebo-Controlled, ParallelGroup Study // Clinical Therapeutics. - 2008. - 30(8). - Р. 1448-1460.

28. Nelson P., Poon Т., Guan X. et al. The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes // Diabetes Tecknol. Tker. - 2007. - 9. - Р. 317-326.

29. Poon Т., Nelson P., Shen L. et al. Exenatide improves glycemic control and reduces body weight in subjects with type 2 diabetes: a dose-ranging study // Diabetes Tecknol. Tker. - 2005. - 7. - Р. 467-477.

30. Apovian C.M., Bergenstal R.M., Cuddihy R.M. et al. Effects of Exenatide Combined with Lifestyle Modification in Patients with Type 2 Diabetes // The American Journal of Medicine. - 2010. - 123(5). - 468. - e9-e17.

31. Bunck M.C., Diamant M.,, Eliasson B. et al. Exenatide affected circulating cardiovascular risk biomarkers independently of changes in body composition // Diabetes Care publish ahead of print, published online April 27, 2010, Available at http://care.diabetesjournals.org.

32. Okerson T., Yan P., Stonehouse A., Brodows R. Effects of exenatide on systolic blood pressure in subjects with type 2 diabetes // Am. J. Hypertens. - 2010. - 23(3). - Р. 334-339.

33. Lewington S., Clarke R., Qizilbash N. et al. for the Prospective Studies Collaboration, Age-specific relevance of usual blood pressure to vascular mortality: A meta analysis of individual data for one million adults in 61 prospective studies // Lancet. - 2002. - 360. - Р. 1903-1913.

34. Wajchenberg B.L. ƒ-cell failure in diabetes and preservation by clinical treatment // Endocrine Reviews. - 2007. - 28(2). - Р. 187-218.

35. Amori R.E., Lau J., Pittas A.G. Efficacy and safety of incretin therapy in type 2 diabetes, Systemic review and meta-analysis // JAMA. - 2007. - 298. - Р. 194-206.

36. Fineman M.S., Shen L.Z., Taylor K., Kim D.D., Baron A.D. Effectiveness of progressive dose-escalation of exenatide (exendin-4) in reducing doselimiting effects in subjects with type 2 diabetes // Diabetes Metab. Res. Rev. - 2004. - 20. - Р. 411-417.

37. Food and Drug Administration Information for Healthcare Professionals Exenatide (marketed as Byetta), Available at www.fda.gov/cder/drug/InfoSheets/HCP/exenatideHCP,htm Accessed Jan 17, 2008.


Review

For citations:


Vikulova O.K., Shestakova M.V. New indications for exenatide therapy of type 2 diabetes mellitus. Diabetes mellitus. 2010;13(3):98-104. (In Russ.) https://doi.org/10.14341/2072-0351-5496

Views: 2302


ISSN 2072-0351 (Print)
ISSN 2072-0378 (Online)