Current indicating limitations in gliptines, GLP1-receptor agonists and basal insulin analogues


Authors: Emil Martinka
Authors‘ workplace: Národný endokrinologický a diabetologický ústav, diabetologické oddelenie, primár doc. MUDr. Emil Martinka, PhD., Ľubochňa ;  MMM Consulting, Bratislava
Published in: Forum Diab 2013; 2(2): 130-139
Category:

Overview

Type 2 diabetes mellitus is a very heterogeneous disorder whose pathogenic mechanisms progresses also after diagnosis of the disease. Prognosis of this disease in terms of metabolic control depends primarily on its quality during the first 10-15 years of treatment. Treatment requires individualized approach with the use of the widest possible range of pharmaceuticals already in the early stages. In terms of clinical practice, it is therefore necessary that these pharmaceutical agents are available also in terms of covering by insurance companies and indicating limitations. Recently, our range of availability of innovative pharmaceuticals significantly improved especially in gliptines, basal insulin analogues and GLP1-receptor agonists.

Key words:
basal insulin analogues – gliptines – indicating restrictions


Sources

1. Albers JW, Herman WH, Pop-Bussui H et al. Effect of Prior Intensive Insulin Treatment During the Diabetes Control and Complications Trial (DCCT) on Peripheral Neuropathy in Type 1 Diabetes During the Epidemiology of Diabetes Interventions and Complications (EDIC) Study. Diabetes Care 2010; 33(5): 1090–1096.

2. Aschner P, Kipnes MS, Lunceford JK et al. Eff ect of the Dipeptidyl Peptidase-4 Inhibitor Sitagliptin as Monotherapy on Glycemic Control in Patients With Type 2 Diabetes. Diabetes Care. 2006; 29(12): 2632–2637.

3. Bosi E, Camisasca RP, Collober C et al. Eff ects of vildagliptin on glukose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin. Diabetes Care 2007; 30(4): 890–895.

4. Dejager S, Schweizer A, Foley J. Evidence to support the use of vildagliptín monotherapy in the treatment of type 2 diabetes mellitus. Vasc Health Risk Manag 2012; 8: 339–348.

5. Del Prato S, Barnett AH, Huisman H et al. Eff ect of linagliptin monotherapy on glycaemic control and markers of β-cell function in patients with inadequately controlled type 2 diabetes: a randomized controlled trial. Diabetes Obes Metab 2011; 13(3): 258–267.

6. Fadini GP, Boscaro E et al. The oral dipeptidyl peptidase-4 inhibitor sitagliptin increases circulating endothelial progenitor cells in patiens with type 2 diabetes mellitus. Diabetes Care 2010; 33(7): 1607–1609.

7. Frederich R, Alexander JH, Fiedorek FT et al. A systematic assessment of cardiovascular outcomes in the saxagliptin drug development program for type 2 diabetes.Postgrad Med 2010; 122(3): 16–27.

8. Ferrannini E, Fonseca V, Zinman et al. Fifty-two-week effi cacy and safety of vildagliptin vs. glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy. Diabetes Obes Metab 2009; 11(2): 157–166.

9. Gallwitz B, Uhlig-Laske B, Bhattacharaya S et al. Linagliptin has similar efficacy to glimepiride but improved cardiovascular safety over 2 years in patients with type 2 diabetes inadequately controlled on metformin. 71th Scientific Sessions of the ADA, San Diego, California 2011: Late Breaker 39.

10. Gallwitz B, Rosenstock J, Rauch T et al. 2-year effi cacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomized, double-blind, non-inferiority trial. Lancet 2012; 380(9840): 475–483.

11. Garber AJ, Foley JE, Banerji MA et al. Eff ects of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea.Diabetes Obes Metab 2008; 10(11):1047–1056.

12. Göke B, Hershon K, Kerr D et al. Effi cacy and Safety of Vildagliptin monotherapy during 2 year treatment of drug naive patients with type 2 diabetes: Comparison with metformin. Horm Metab Res 2008; 40(12): 892–895.

13. Hermansen K, Kipnes M, Luo E et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab 2007; 9(5): 733–745.

14. Holman R et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008; 359(15): 1577–1589.

15. Charbonnel B, Karasik A, Liu J et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled on metformin alone. Diabetes Care 2006; 29(12): 2638–2643.

16. Inzucchi SE, Bergenstal RM, Buse JB et al. Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach. Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012; 35(6): 1364–1379.

17. Johansen OE, Neubacher D, Eynatten M et al. 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. Dostupné z DOI: <http://doi: 10.1186/1475–2840–11–3>.

18. JA Johnson, SR Majumdar, SH Simpson. Decreased mortality associated with the use of metformin compared with sulfonylurea monotherapy in type 2 diabetes. Diabetes Care 2002; 25(12): 2244–2248.

19. Jose E, Inzucchi E. Cardiovascular eff ects of the DPP-4 inhibitors. Diab Vasc Dis Res 2012; 9(2):109–16. Dostupné z DOI: <http://doi: 10.1177/1479164111436236>.

20. Kothny W, Foley J, Kozlovski P et al. Improved glycaemic control with vildgliptin added to insulin, with or without metformin in patients with type 2 diabetes mellitus. Diabetes Obes Metab 2013; 15(3): 252–257. Dostupné z DOI: <http://doi: 10.1111/dom.12020>.

21. Laviola L, Leonardini A, Melchiorre M et al. Glucagon-Like Peptide-1 Counteracts Oxidative Stress-Dependent Apoptosis of Human Cardiac Progenitor Cells by Inhibiting the Activation of the c-Jun N-terminal Protein Kinase Signaling Pathway. Endocrinology. 2012; 153(12): 5770–5781. Dostupné z DOI: <http://doi: 10.1210/en.2012–1461>.

22. Lønborg J, Vejlstrup N, Kelbæk H et al. Exenatide reduces reperfusion Indry in patients with ST-elevation myocardial infarction. Eur Heart J 2012; 33(12):1491–1499.

23. Wing RR (ed) et al. Look AHEAD Research Group. Long-term eff ects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med 2010; 170(17): 1566–1575.

24. Lukashevich V, Wang M, DelPrato S et al. Vildagliptin efficacy and safety in patients with type 2 diabetes inadfequately controlled on dual metformin plus sulfonylurea therapy. Poster 856. Presented at the 48th EASD 2012, 1–5th Oct, Berlin, Germany.

25. Makdissi A, Ghanim H Vora M et al. Sitagliptin exerts an antinfl ammatory action. J Clin Endocrinol Metab 2012; 97(9): 3333–3341. Dostupné z DOI: <http://doi:10.1210/jc.2012–1544>.

26. Nathan DM, Cleary PA, Backlund JY et al. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005; 353(25): 2643–2653.

27. Nauck MA, Meininger G, Sheng D (eds) et al. Sitagliptin Study 024 Group (2007). Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab 2007; 9(2): 194–205.

28. Nikolaidis LA, Mankad S, Sokos GG et al. Effects of glucagon like peptide -1 in patients with accute myoacardial infarction and left ventricular dysfunction after successful reperfusion. Circulation 2004; 109(8): 962–965.

29. Owens DR, Swallow R, Dugi KA et al. Efficacy and safety of linagliptin in persons with type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: a 24-week randomized study. Diabet Med 2011; 28(11):1352–1361.

30. Pratley RE, Rosenstock J, Schweizer A et al. Management of Type 2 diabetes in treatment –naive elderly patients. Diabetes Care 2007; 30(12): 3017–3020.

31. Read PA, Khan FZ, Heck PM et al. DPP-4 inhibition by sitagliptin improves myocardial response to dobutamine stress and mitigate stunning in a pilot study of patients with acute coronary syndrome. Circ Cardiovasc Image 2010; 3: 195–201.

32. Scheen A, Paquot N. Gliptin versus a sulphonylurea as add-on to metformín. The Lancet 2012; 380(9840): 450–452.

33. Schweizer A, Dejager S, Bosi E. Comparison of vildagliptin and metformín monotherapy in elderly patients with type 2 diabetes: a 24-week, double-blind, randomized trial Diabetes, Obesity and Metabolism 2009; 11(8): 804–812.

34. Schweizer A, Couturier A, Foley JE et al. Comparison between vildagliptin and metformin to sustain reductions in HbA1c over 1 year in drug-naive patients with Type 2 diabetes. Diabetic Medicine 2007; 24(9): 955–961.

35. Schweizer A, Dejager S, Foley JE et al. 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(6): 485–494.

36. Takahashi M Role of the SDF-1/CXCR4 system in myocardial infarction. Circ J 2010; 74(3): 418–423.

37. Taskinen MR, Rosenstock J, Tamminen I et al. Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Diabetes Obesity and Metabolism 2011; 13(1): 65–74.

38. Gerstein HC, Miller ME, Byington RP (eds) et al. The Action to Control Cardiovascular Risk in Diabetes Study Group. Effect of intensive glucose lowering in patients with type 2 diabetes. N Engl J Med 2008; 358(24): 2545–2559.

39. Patel A, MacMahon S, Chalmers J (eds) et al. The ADVANCE Collaborative Goup. Intensive blood glucose kontrol and Vascular Outcomes in type 2 diabetes. ADVANCE N Engl J Med 2008; 358(24): 2560–2569.

40. Finfer S, Chittock DR, Su SY (eds) et al. The NICE-SUGAR Study Investigators. Intensive versus Conventional Glucose Control in Critically Ill Patients. N Engl J Med 2009; 360(13): 1283–1297.

41. Gerstein HC, Bosch J, Dagenais GR (eds) et al. The Origin Trial Investigators. Basal Insulin and Cardiovascular and Other Outcomes in Dysglycemia. N Engl J Med 2012; 367(4): 319–328.

42. Trajenta® (linagliptin) tablets. EMA Summary of Product Characteristics. Approval 25 September 2011. Dostupné z WWW: <http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Product_Information/human/002110/WC500115745.pdf>.

43. Vilsboll T, Rosenstock J, Yki-Järvinen H et.al. Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes. Diabetes Obes Metab 2010; 12(2): 167–177.

44. Zaruba MM, Theiss HD et al. Synergy between CD26/DPP-IV inhibition and G-CSF improves cardiac function during acute myocardial infarction. Cell Stem Cell 2009; 4(4): 313–323.

Labels
Diabetology Endocrinology Internal medicine
Login
Forgotten password

Don‘t have an account?  Create new account

Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.

Login

Don‘t have an account?  Create new account