TYPE 2 DIABETES MELLITUS AND CONCOMITANT DISEASES: ADVANTAGES OF USE OF DIPEPTIDYL PEPTIDASE-4 INHIBITOR SAXAGLIPTIN (ONGLYZA ®)


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Abstract

The main objective of the treatment of type 2 diabetes mellitus (DM2) is achievement of optimal glycemic control, which significantly reduces the risk of severe complications due to chronic hyperglycemia. However, the management of DM2 patients is associated with a number of problems caused by its frequent combination with other diseases such as obesity, chronic kidney disease, nonalcoholic fatty liver disease, and cardiovascular diseases. In this situation, the doctor is often faced with the choice of antihyperglycemic therapy, since the presence of concomitant diseases limits the administration of a number of oral antihyperglycemic drugs. From this point of view, dipeptidyl peptidase-4 inhibitor saxagliptin is of interest, which is characterized by effective reducing blood glucose levels, low risk of hypoglycemia, no increased risk of cardiovascular disease and a neutral effect on body weight. This provides a broad prospects for application of saxagliptin in DM2 patients with concomitant diseases of the kidneys, liver and cardiovascular system.

References

  1. Stratton IM, Adler AI, Neil AW, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000;321:405-12.
  2. American Association of Clinical Endocrinologists. State of diabetes complications in America: a comprehensive report issued by the American Association of Clinical Endocrinologists. 2007. http://multivu.prnewswire.com/mnr/AACE/2007/docs/ Diabetes_ Complications_Report.pdf. Accessed April 2, 2010.
  3. Khazai NB, Beck GR Jr, Umpierrez GE. Diabetes and fractures: an overshadowed association. Curr Opin Endocrinol Diabetes Obes 2009;16(6):435-45.
  4. American Diabetes Association. Standards of medical care in diabetes-2010. Diabetes Care 2010;33(1):S11-S61.
  5. Nathan DM, Buse JB, Davidson MB, et al; American Diabetes Association; European Association for the Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009;32(1):193-203.
  6. Rodbard HW, Jellinger PS, Davidson JA, et al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology consensus panel on type 2 diabetes mellitus: an algorithm for glycemic control. Endocr Pract 2009;15(6):541-59.
  7. Алгоритмы специализированной помощи больным сахарным диабетом. 2011. Вып. 5.
  8. National Kidney Foundation: KDOQI clinical practice guidelines and clinical practice recommendations for diabetes and chronic kidney disease. Am J Kidney Dis 2007;49:S1-S180.
  9. Kahn SE, Haffner SM, Heise MA, et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006;355(23):2427-443.
  10. Lago RM, Singh PP, Nesto RW. Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: a meta-analysis of randomized clinical trials. Lancet 2007;370:1129-136.
  11. Nissen SE, Wolski K. Rosiglitazone Revisited: An Updated Metaanalysis of Risk for Myocardial Infarction and Cardiovascular Mortality. Arch Intern Med 2010;170:1191-201.
  12. Boulton DW, Geraldes M. Safety, tolerabilty, pharmacokinetics and pharmacodynamics of once-daily oral doses of saxagliptin for 2 weeks in type 2 diabetic and healthy subjects [abstract no. 606-P plus poster]. 67th Scientific Sessions of the American Diabetes Association. Chicago (IL), 2007 Jun 22-26.
  13. Kim YB, Kopcho LM, Kirby MS, et al. Mechanism of Gly-Pro-pNA cleavage catalyzed by dipepti-dyl peptidase-IV and its inhibition by saxagliptin (BMS-477118). Arch Biochem Biophys 2006;445:9-18.
  14. Dhillon S, Weber J. Saxagliptin. Drugs 2009;69 (15):2103-114.
  15. Maheux P, et al. Efficacy of Saxagliptin in Relation to Baseline HbA1c in a Pooled Analysis of Three Add-on Pivotal Randomised Phase 3 Clinical Trials. EASD 2010:825.
  16. Food and Drug Administration: Guidance for Industry. Diabetes Mellitus-Evaluation Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. 2008. Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/ucm071627.pdf. Accessed September 2010.
  17. Food and Drug Administration, Center of Drug Evaluation and Research. Endocrinologic and metabolic drugs advisory committee meeting: summary minutes. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM192026.pdf. Accessed April 1, 2009.
  18. Wolf R, Frederich R, Fiedorek F, et al. Evaluation of CV risk in saxagliptin clinical trials. 8-LB poster. 69th Annual Scientific Sessions of the American Diabetes Association. New Orleans (LA), 2009 Jun 5-9.
  19. Bristol-Myers Squibb, AstraZeneca. Bristol-Myers Squibb, AstraZeneca commence SAVOR-TIMI 53 trial of ONGLYZA for type 2 diabetes. March 2010 (press release) http://www.news-medical.net/news/20100310/Bristol-Myers-Squibb-AstraZeneca-commence-SAVOR-TIMI-53-trial-of-ONGLYZA-for-type-2-diabetes.aspx.
  20. Levey AS, Coresh J, Balk E, et al. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med 2003;139:137-47.
  21. Center for Disease Control. National diabetes fact sheet 2007. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2007.pdf. Accessed January 10, 2011.
  22. Coresh J, Astor BC, Greene T, Eknoyan G, Levey AS: Prevalence of chronic kidney disease and decreased kidney function in the adult US population: Third National Health and Nutrition Examination Survey. Am J Kidney Dis 2003;41:1-12.
  23. Koro CE, Lee BH, Bowlin SJ. Antidiabetic medication use and prevalence of chronic kidney disease among patients with type 2 diabetes mellitus in the United States. Clinical Therapeutics 2009;31(11):2608-617.
  24. Tonelli M, Wiebe N, Culleton B, et al. Chronic kidney disease and mortality risk: a systematic review. J Am Soc Nephrol 2006;17:2034-047.
  25. Dalrymple LS, Katz R, Kestenbaum B, et al. Chronic kidney disease and the risk of end-stage renal disease versus death. J Gen Intern Med 2010;19.
  26. Boulton D, Tang A, Patel C, et al. Pharmacokinetics of dipeptidylpepetidase-4 inhibitor saxagliptin in subjects with renal impairment [abstract no. P357]. 11th European Congress of Endocrinology, Istanbul, 2009 Apr 25-29.
  27. Nowicki M, et al. Saxagliptin improves glycemic control and is well tolerated in patients with type 2 diabetes mellitus and renal impairment compared with placebo. Diabetes Obes Metab 2011;13(6):523-32.
  28. Rosenstock J, Gross J, Salinas C, et al. Long-Term Safety and Efficacy of Saxagliptin After 4-Year Follow-Up of Patients With Type 2 Diabetes. ADA 2011:1086.
  29. Mannucci E, Ognibene A, Cremasco F, et al. Effect of metformin on glucagon-like peptide 1 (GLP-1) and leptin levels in obese nondiabetic subjects. Diabetes Care 2001;24:489-94.
  30. Lenhard JM, Croom DK, Minnick DT, et al. Reduced serum dipeptidyl peptidase-IV after metformin and pioglitazone treatments. Biochem Biophys Res Comm 2004;324:92-97.
  31. Sanyal AJ. AGA technical review on nonalcoholic fatty liver disease. Gastroenterology 2002;123(5):1705-25.
  32. Adams LA, Angulo P, Lindor KD. Nonalcoholic fatty liver disease. C M A J 2005;172(7):899-905.
  33. Angulo P. Non-alcoholic fatty liver disease. N Engl J Med 2002;346:1221-31.
  34. Patel C, Castaneda L, Frevert U, et al. Single-dose pharmacokinetics and safety of saxagliptin in subjects with hepatic impairment compared with healthy subjects [abstract no. 537-P]. Diabetes 2008;57(1):A160.
  35. Göke B, et al. Saxagliptin is non-inferior to glipizide in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: a 52-week randomised controlled trial. Int J Clin Pract 2010;64(12):1619-31.
  36. Göke B, et al. Saxagliptin vs Glipizide as Add-On Therapy to Metformin for Type 2 Diabetes Mellitus (T2DM): Long-Term Safety and Efficacy. ADA 2011:1110.
  37. Rao A, et al. Is the combination of sulfonylureas and metformin associated with an increased risk of cardiovascular disease or all-cause mortality? Diabetes Care 2008;31:1672-78.

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