Efficacy and pathogenetic justification for the use of vildagliptin in patients with type 2 diabetes mellitus

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V.I. Pankiv


Background. Dipeptidyl peptidase­4 inhibitors, ­having incretin activity, influence the main pathogenetic mecha­nisms of type 2 diabetes mellitus (DM). Vildagliptin is an innovative dipeptidyl peptidase­4 inhibitor with unique pharmacokinetic characteristics, the efficacy and safety of which have been studied in placebo­controlled studies. The purpose: to study the pharmacotherapeutic efficacy, safety and tolerability of Gliptar produced by PJSC “Kievmedpreparat” (Ukraine) in the treatment of patients with type 2 DM. Materials and methods. The study included 49 patients with type 2 DM. They received metformin monotherapy at a dose of at least 1,000 mg daily for at least the last six months. Duration of type 2 DM averaged 6.2 ± 1.8 years. The patients formed two groups for follow­up. The first group consisted of 29 patients who were still taking metformin doses up to 2,000 mg/day and additionally received Gliptar (vildagliptin) at a dose of 50 mg twice daily. Patients in the second group (n = 20) continued to receive metformin twice daily at a dose of 2,000 mg/day. Results. After 12 weeks in patients of the first group on the background of metformin therapy combined with vildagliptin, the level of HbA1c decreased significantly to 6.42 ± 0.21 %, fasting glycemia — to 6.14 ± 0.22 mmol/l, postprandial glycemia — to 8.63 ± 0.23 mmol/l. On the background of combined treatment, patients with type 2 DM had a decrease in body weight by 1.18 kg, as well as a tendency to decrease in body mass index from 31.49 ± 1.08 kg/m2 to 29.98 ± 0.76 kg/m2. After treatment, the level of immunoreactive insulin in the first group was 14.08 ± 1.83 µU/ml (baseline 21.11 ± 2.03 µU/ml), HOMA­IR — 3.14 ± 0.21 (baseline 6.28 ± 1.42). A significant decrease in carbohydrate metabolism and insulin resistance can be assessed as a positive trend in combination therapy. Conclusions. Given the benefits of dual therapy in the treatment of patients with type 2 DM, according to conventional step­by­step therapy, in the second stage it is advisable to prescribe vildagliptin to patients who receive metformin and who have not reached the target glycemic control. Combination therapy of vildagliptin and metformin provides a comprehensive effect on cardiovascular risk factors in the form of preventing hyperinsulinemia and reducing insulin resistance.

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How to Cite
Pankiv, V. “Efficacy and Pathogenetic Justification for the Use of Vildagliptin in Patients With Type 2 Diabetes Mellitus”. INTERNATIONAL JOURNAL OF ENDOCRINOLOGY (Ukraine), vol. 15, no. 7, Dec. 2019, pp. 529-34, doi:10.22141/2224-0721.15.7.2019.186055.
Original Researches


Mathieu C, Kozlovski P, Paldánius PM, et al. Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance. Eur Endocrinol. 2017 Aug;13(2):68-72. doi: 10.17925/EE.2017.13.02.68.

Hayashi T, Murayama H, Shinfuku Y, Taniguchi T, Tsumiyama I, Oyama N. Safety and efficacy of vildagliptin: 52-week post-marketing surveillance of Japanese patients with type 2 diabetes in combination with other oral antidiabetics and insulin. Expert Opin Pharmacother. 2019 Nov 5:1-10. doi: 10.1080/14656566.2019.1685500.

Hemmingsen B, Sonne DP, Metzendorf MI, Richter B. Dipeptidyl-peptidase (DPP)-4 inhibitors and glucagon-like peptide (GLP)-1 analogues for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2017 May 10;5:CD012204. doi: 10.1002/14651858.CD012204.pub2.

Yavropoulou MP, Pikilidou M, Kotsa K, Michopoulos A, Papakonstantinou E, Yovos JG. Efficacy and tolerability of vildagliptin as first line treatment in patients with diabetes type 2 in an outpatient setting. J Diabetes Metab Disord. 2015 Aug 22;14:68. doi: 10.1186/s40200-015-0194-6.

Nauck MA. A critical analysis of the clinical use of incretin-based therapies: The benefits by far outweigh the potential risks. Diabetes Care. 2013 Jul;36(7):2126-32. doi: 10.2337/dc12-2504.

He YL. Clinical pharmacokinetics and pharmacodynamics of vildagliptin. Clin Pharmacokinet. 2012 Mar 1;51(3):147-62. doi: 10.2165/11598080-000000000-00000.

Rizzo MR, Barbieri M, Marfella R, Paolisso G. Reduction of Oxidative Stress and Inflammation by Blunting Daily Acute Glucose Fluctuations in Patients With Type 2 Diabetes: Role of dipeptidyl peptidase-IV inhibition. Diabetes Care. 2012 Oct;35(10):2076-82. doi: 10.2337/dc12-0199.

Bekiari E, Rizava C, Athanasiadou E, et al. Systematic review and meta-analysis of vildagliptin for treatment of type 2 diabetes. Endocrine. 2016 Jun;52(3):458-80. doi: 10.1007/s12020-015-0841-1.

He YL, Yamaguchi M, Ito H, Terao S, Sekiguchi K. Pharmacokinetics and pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes. Int J Clin Pharmacol Ther. 2010 Sep;48(9):582-95. doi: 10.5414/cpp48582.

El-Ouaghlidi A, Rehring E, Holst JJ, et al. The dipeptidyl peptidase 4 inhibitor vildagliptin does not accentuate glibenclamide-induced hypoglycemia but reduces glucose-induced glucagon-like peptide 1 and gastric inhibitory polypeptide secretion. J Clin Endocrinol Metab. 2007 Nov;92(11):4165-71. doi: 10.1210/jc.2006-1932.

Keating GM. Vildagliptin: a review of its use in type 2 diabetes mellitus. Drugs. 2014 Apr;74(5):587-610. doi: 10.1007/s40265-014-0199-3.

Fisman EZ, Tenenbaum A. Antidiabetic treatment with gliptins: focus on cardiovascular effects and outcomes. Cardiovasc Diabetol. 2015 Sep 29;14:129. doi: 10.1186/s12933-015-0294-0.

Deacon CF, Lebovitz HE. A Comparative Review of DPP-4 Inhibitors and Sulphonylureas. Diabetes Obes Metab. 2016 Apr;18(4):333-47. doi: 10.1111/dom.12610.

Bosi E, Camisasca RP, Collober C, Rochotte E, Garber AJ. Effects of Vildagliptin on Glucose Control Over 24 Weeks in Patients with Type 2 Diabetes Inadequately Controlled with Metformin. Diabetes Care. 2007 Apr;30(4):890-5. doi: 10.2337/dc06-1732.

McInnes G, Evans M, Del Prato S, et al. Cardiovascular and heart failure safety profile of vildagliptin: a meta-analysis of 17 000 patients. Diabetes Obes Metab. 2015 Nov;17(11):1085-92. doi: 10.1111/dom.12548.

Schweizer A, Dejager S, Foley JE, Kothny W. Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies. Vasc Health Risk Manag. 2011;7:49-57. doi: 10.2147/VHRM.S16925.

Strain WD, Lukashevich V, Kothny W, Hoellinger MJ, Paldánius PM. Individualised treatment targets for elderly patients with type 2 diabetes using vildagliptin add-on or lone therapy (INTERVAL): a 24 week, randomised, double-blind, placebo-controlled study. Lancet. 2013 Aug 3;382(9890):409-416. doi: 10.1016/S0140-6736(13)60995-2.

Williams R, de Vries F, Kothny W, et al. Cardiovascular safety of vildagliptin in patients with type 2 diabetes: a European multi-database, non-interventional post-authorization safety study. Diabetes Obes Metab. 2017 Oct;19(10):1473-1478. doi: 10.1111/dom.12951.

Macauley M, Hollingsworth KG, Smith FE, et al. Effect of vildagliptin on hepatic steatosis. J Clin Endocrinol Metab. 2015 Apr;100(4):1578-85. doi: 10.1210/jc.2014-3794.

Makrilakis K. The Role of DPP-4 Inhibitors in the Treatment Algorithm of Type 2 Diabetes Mellitus: When to Select, What to Expect. Int J Environ Res Public Health. 2019 Jul 30;16(15). pii: E2720. doi: 10.3390/ijerph16152720.

Douros A, Rouette J, Yin H, Yu OHY, Filion KB, Azoulay L. Dipeptidyl Peptidase-4 Inhibitors and the Risk of Bullous Pemphigoid Among Patients With Type 2 Diabetes. Diabetes Care. 2019 Aug;42(8):1496-1503. doi: 10.2337/dc19-0409.

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