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Clinical and economic evaluation of extended-release metformin for the treatment of prediabetes and its impact on the budget and target indicators of federal healthcare projects

https://doi.org/10.14341/DM13471

Abstract

BACKGROUND: Patients with prediabetes have an increased risk of developing type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). However, the economic impact of using medications to treat prediabetes has been insufficiently studied.

AIM: The purpose of the study is to perform a clinical and economic evaluation of extended-release (XR) metformin for the treatment of prediabetes, assess its healthcare budgetary impact, and determine its potential to contribute to achieving the target indicators of Federal healthcare programs.

MATERIALS AND METHODS: We compared XR metformin therapy with no medication therapy among patients aged 40–59 years with prediabetes, for whom lifestyle interventions had failed to achieve adequate glycemic control. A Markov model was developed to describe the number of patients with prediabetes over a 10-year horizon using comparison variants, the incidence of adverse cardiovascular events, and mortality from all and cardiovascular causes. The analysis accounted for out-of-pocket expenditures for pharmacotherapy and public healthcare system costs for the management and monitoring of prediabetes and its complications, including T2DM.

RESULTS: Over a 10-year period, the use of XR metformin in patients with prediabetes could prevent 63 524 deaths, including 41.6 thousand from CVD. The estimated additional annual out-of-pocket expenditures for 100% coverage with XR metformin are approximately 4.3 billion RUB. Due to reducing the incidence of T2DM and CVD, budget savings on T2DM and CVD treatment, outpatient care, and the purchase of medical devices over 10 years are estimated at 4.7 billion RUB per year. From a healthcare system perspective (public healthcare + out-of-pocket expenditures), the average net annual savings are 410 million RUB.

CONCLUSION: The use of XR metformin in patients with prediabetes can reduce the rate of progression to T2D, the incidence of serious CVD events, and mortality (both all-cause and cardiovascular) and thus contribute to achieving the goals set in the federal projects "Combatting Cardiovascular Diseases" and "Combatting Diabetes Mellitus." Moreover, using XR metformin in patients with prediabetes could lead to a net reduction in public healthcare expenditures, with the long-term savings exceeding the additional costs borne by individuals for metformin therapy.

About the Authors

N. A. Avxentyev
Financial Research Institute; Pharmaceutical Analytics Middle East FZ-LLC
Russian Federation

Nikolay A. Avxentyev - PhD in Economic sciences.

3/2 Nastasyinsky Lane, 125375 Moscow


Competing Interests:

none



O. V. Vasyukova
Endocrinology Research Centre
Russian Federation

Olga V. Vasyukova - MD, PhD.

Moscow


Competing Interests:

none



O. M. Drapkina
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Oksana M. Drapkina - .MD, PhD, Professor, Academician of the RAS

Moscow


Competing Interests:

none



L. Yu. Drozdova
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Liubov Y. Drozdova - MD, PhD.

Moscow


Competing Interests:

none



S. K. Zyryanov
RUDN University; City Clinical Hospital № 24
Russian Federation

Sergey K. Zyryanov - MD, PhD, Professor.

Moscow


Competing Interests:

none



E. R. Kovaleva
LLC «Merck»
Russian Federation

Elena R. Kovaleva

Moscow


Competing Interests:

none



A. S. Makarov
Pharmaceutical Analytics Middle East FZ-LLC
United Arab Emirates

Aleksandr S. Makarov

Ras Al Khaimah


Competing Interests:

none



Yu. V. Makarova
Financial Research Institute; Pharmaceutical Analytics Middle East FZ-LLC
United Arab Emirates

Yuliya V. Makarova

Ras Al Khaimah


Competing Interests:

none



O. L. Rozenson
LLC «Merck»
Russian Federation

Oleg L. Rozenson - MD, PhD.

Moscow


Competing Interests:

none



V. V. Salukhov
Military Medical Academy named after S.M. Kirov
Russian Federation

Vladimir V. Salukhov - MD, PhD, Professor.

St. Petersburg


Competing Interests:

none



A. V. Sineglazova
Kazan State Medical University
Russian Federation

Albina V. Sineglazovа - MD, PhD, Professor.

Kazan


Competing Interests:

none



O. Y. Sukhareva
Endocrinology Research Centre
Russian Federation

Olga Y. Sukhareva - MD, PhD, Associate Professor.

Moscow


Competing Interests:

none



M. V. Shestakova
Endocrinology Research Centre
Russian Federation

Marina V. Shestakova - MD, PhD, Professor, Academician of the RAS.

Moscow


Competing Interests:

none



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Supplementary files

1. Figure 1. Markov model of the study.
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Type Исследовательские инструменты
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2. Figure 2. Probability of occurrence of the studied cardiovascular events in patients with prediabetes, type 2 diabetes mellitus, and normoglycemia.
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Type Исследовательские инструменты
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3. Figure 3. Sensitivity analysis results for the total number of prevented deaths over 10 years, cases.
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Type Исследовательские инструменты
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4. Figure 4. Sensitivity analysis results for the average annual change in discounted costs over 10 years, million rubles.
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Type Исследовательские инструменты
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For citations:


Avxentyev N.A., Vasyukova O.V., Drapkina O.M., Drozdova L.Yu., Zyryanov S.K., Kovaleva E.R., Makarov A.S., Makarova Yu.V., Rozenson O.L., Salukhov V.V., Sineglazova A.V., Sukhareva O.Y., Shestakova M.V. Clinical and economic evaluation of extended-release metformin for the treatment of prediabetes and its impact on the budget and target indicators of federal healthcare projects. Diabetes mellitus. 2026;29(2):169-182. (In Russ.) https://doi.org/10.14341/DM13471

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ISSN 2072-0351 (Print)
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