Preview

Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice

Advanced search

Clinical-economic assessment of the potential contribution of evogliptin to achieving the targets of the Federal project «Fight against diabetes mellitus» and reduction of population mortality

https://doi.org/10.37489/2588-0519-2024-4-55-69

EDN: CVRWTG

Abstract

Background. Since 2023, Russia has been implementing the Federal Project "Fight against diabetes mellitus" with a key objective of increasing the proportion of patients achieving a glycated hemoglobin (HbA1c) level below 7.0 %.

The aim of this study was to evaluate the contribution of expanding the use of dipeptidyl peptidase-4 inhibitors (iDPP-4) (in the example of evogliptin) in achieving the targets of the Federal Project "Fight against diabetes mellitus" and reduce mortality, as well as the budget impact analysis of such policies.

Materials and methods. The target population of the study were adult patients with diabetes mellitus type 2 (DM2) whose HbA1c levels ranged from 7.1 % to 9.0 % while on glucose-lowering therapy with metformin (MET), sulfonylureas, or their combinations, and with the absence of significant comorbidities (e. g., ischemic heart disease, cerebrovascular diseases, myocardial infarction, or diabetic nephropathy). We also included patients receiving a combination of MET and Sodium-Glucose Transport Protein 2 inhibitors. To assess the change in HbA1c levels when evogliptin is included in the treatment regimen, a mathematical model was developed based on data from the Federal register of diabetes mellitus, clinical studies on the use of iDPP-4, and expert consultations. To model mortality, we incorporated evidence from meta-analyses demonstrating that exceeding target HbA1c levels are associated with higher mortality. Only the costs of antidiabetic therapy were considered expenses. The budget impact was defined as the difference between the costs within the current treatment practices for DM2 in the study patient cohort and the expected expenses when modifying the therapeutic approach.

Results. The target population of patients who can be prescribed evogliptin in addition to existing hypoglycemic therapy is 937,225 people. Expanding the use of evogliptin in patients from the target population can reduce mortality by 851 cases in the first year and save up to 4,275 lives of patients with type 2 diabetes over a 5-year horizon. In addition, this will allow us to exceed the goal of the Federal Project "Fight against diabetes" within one year for the proportion of patients with diabetes with a glycated hemoglobin level of 7 % or less, increasing the figure to 52 % (with a target value of 42.39 %).

Conclusion. Expanding the use of evogliptin in patients with type 2 diabetes will help achieve the target indicators of the Federal Program "Fight against diabetes mellitus" and reducing population mortality.

About the Authors

N. N. Avxentyev
Financial Research Institute; Health and Market Access Consulting LLC
Russian Federation

Nikolay N. Avxentyev — Advisоr; Chief Researcher

Moscow



A. S. Makarov
Health and Market Access Consulting LLC
Russian Federation

Aleksandr S. Makarov - Leading Researcher

Moscow



I. A. Karpova
Saint Petersburg City Polyclinic No. 104 Polyclinic Branch No. 15
Russian Federation

Irina A. Karpova — PhD, Cand. Sci. (Med.), Head of the Specialist Physicians Department, Endocrinologist of the Highest Qualification Category

Saint-Petersburg



V. V. Yavlyanskaya
Endocrinological Center of the Region clinic hospital No. 2
Russian Federation

Valeria V. Yavlyanskaya — PhD, Cand. Sci. (Med), Head 

Krasnodar



References

1. Clinical recommendations "Type 2 diabetes mellitus in adults", 2022. (In Russ.)]. URL: https://cr.minzdrav.gov.ru/recomend/290_2. (дата обращени 09.09.2024).

2. Dedov II, Shestakova MV, Vikulova OK, et al. Diabetes mellitus in the Russian Federation: dynamics of epidemiological indicators according to the Federal Register of Diabetes Mellitus for the period 2010–2022. Diabetes mellitus. 2023;26(2):104-123. (In Russ.)]. doi: 10.14341/DM13035.

3. The Federal Register of Diabetes Mellitus (In Russ.)]. https://sd.diaregistry.ru/?ysclid=m4nkonri90858932829. (дата обращения: 22.04.2024).

4. Passport of the Federal project "Fight against diabetes mellitus". (In Russ.)]. https://diabetrda.ru/borba-s-saharnym-diabetom/. (дата обращения: 22.04.2024).

5. Clinical recommendations. Type 2 diabetes mellitus in adults. [Electronic resource]. (In Russ.)]. URL: https://cr.min-zdrav.gov.ru/schema/290_2. (дата обращения: 22.04.2024).

6. Moon JS, Park IR, Kim HJ, et al. Efficacy and Safety of Evogliptin Addon Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension. Diabetes Metab J. 2023 Nov;47(6):808-817. doi: 10.4093/dmj.2022.0387.

7. PubMed / National Center for Biotechnology Information. URL: https://pubmed.ncbi.nlm.nih.gov/. (дата обращения 23.10.2020).

8. Cochrane Library / Cochrane. URL: https://www.cochranelibrary.com/. (дата обращения 23.10.2020).

9. Craddy P, Palin HJ, Johnson KI. Comparative effectiveness of dipeptidylpeptidase-4 inhibitors in type 2 diabetes: a systematic review and mixed treatment comparison. Diabetes Ther. 2014 Jun;5(1):1-41. doi: 10.1007/s13300-014-0061-3.

10. Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P; Sitagliptin Study 035 Group. 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 Sep;9(5):733-45. doi: 10.1111/j.1463-1326. 2007.00744.x.

11. Oh H, Nguyen HD, Yoon IM, Kim MS. Efficacy and Tolerability of Evogliptin in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis with Bayesian Inference Through a Quality-management System. Clin Ther. 2021 Aug;43(8):1336-1355. doi: 10.1016/j.clinthera.2021.06.001.

12. Arnold LW, Wang Z. The HbA1c and all-cause mortality relationship in patients with type 2 diabetes is J-shaped: a meta-analysis of observational studies. Rev Diabet Stud. 2014 Summer;11(2):138-52. doi: 10.1900/RDS.2014.11.138.

13. Roussel R, Duran-García S, Zhang Y, et al. Double-blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase-4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoS- IT-I Study. Diabetes Obes Metab. 2019 Apr;21(4):781-790. doi: 10.1111/dom.13574.


Review

For citations:


Avxentyev N.N., Makarov A.S., Karpova I.A., Yavlyanskaya V.V. Clinical-economic assessment of the potential contribution of evogliptin to achieving the targets of the Federal project «Fight against diabetes mellitus» and reduction of population mortality. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2024;(4):55-69. (In Russ.) https://doi.org/10.37489/2588-0519-2024-4-55-69. EDN: CVRWTG

Views: 281


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2588-0519 (Print)
ISSN 2618-8473 (Online)