Effect of dapagliflozin therapy on achieving cardiovascular mortality target indicators in patients with heart failure

Aim. To assess the effect of therapy with sodium glucose co-transporter type 2 inhibitor dapagliflozin in patients with heart failure with reduced ejection fraction (CHrEF) on the state cardiovascular mortality target indicators.

Material and methods. All adult Russian patients with NYHA class II-IV HFrEF (left ventricular ejection fraction ≤40%) were considered as the target population. The characteristics of patients in the study corresponded to those in the Russian Hospital HF Registry (RUS-HFR). The study suggests that the use of dapagliflozin in addition to standard therapy will be expanded by 10% of the patient population annually in 2022-24. Cardiovascular mortality modeling was performed based on the extrapolation of DAPA-HF study result. The number of deaths that can be prevented was calculated when using dapagliflozin in addition to standard therapy. Further, the contribution of prevented deaths with dapagliflozin therapy to the achievement of federal and regional cardiovascular mortality target indicators (1, 2 and 3 years) was calculated.

Results. The use of dapagliflozin in addition to standard therapy for patients with NYHA class II-IV CHrEF with the expansion of dapagliflozin therapy by 10% of the patient population annually will additionally prevent 1729 cardiovascular death in the first year. This will ensure the implementation of cardiovascular mortality target indicators in Russia in 2022 by 11,8%. In the second year, 3769 cardiovascular deaths will be prevented, which will ensure the implementation of target indicators in 2023 by 17,2%. In the third year, 5465 cardiovascular deaths prevented, which will ensure the implementation of implementation of target indicators in 2024 by 18,7%.

Conclusion. The use of dapagliflozin in addition to standard therapy for patients with NYHA class II-IV CHrEF will ensure the implementation of implementation of target indicators in 2024 by 18,7%.

1. Federal state statistics service. (In Russ.) Федеральная служба государственной ста - тистики. https://rosstat.gov.ru/folder/12781.

2. Mortality from diseases of the circulatory system (per 100 thousand population). Unified interdepartmental information and statistical system. (In Russ.) https://fedstat.ru/indicator/55382.

3. Resolution of the Government of the Russian Federation of 26.12.2017 N 1640 (ed. of 24.07.2021) “On approval of the state program of the Russian Federation “Development of healthcare”. (In Russ.)

4. Decree of the Government of the Russian Federation of July 30, 1994 N 890 “On state support for the development of the medical industry and improving the provision of medicines and medical devices to the population and healthcare institutions” (with amendments and additions). (In Russ.) http://base.garant.ru/101268/#ixzz6MEF1Tj6V.

5. Resolution of the Government of the Russian Federation of 11.12.2020 No. 2081 “On Amendments to the State Program of the Russian Federation “Development of healthcare” and the Recognition of Certain Acts of the Government of the Russian Federation as Invalid”. (In Russ.) http://publication.pravo.gov.ru/Document/View/0001202012150049?rangeSize=1.

6. Resolution of the Government of the Russian Federation No. 1254 of July 24, 2021 “On Amendments to Appendix No. 10 to the State Program of the Russian Federation “Development of Healthcare”. (In Russ.) http://publication.pravo.gov.ru/Document/View/0001202108020037.

7. Boytsov SA, Shalnova SA, Deev AD. The epidemiological situation as a factor determining the strategy for reducing mortality in the Russian Federation. Terapevticheskii arkhiv. 2020;92(1):4-9. (In Russ.) doi:10.26442/00403660.2020.01.000510.

8. Shlyakhto EV, Zvartau NE, Villevalde SV, et al. Cardiovascular risk management system: prerequisites for developing, organization principles, target groups. Russian Journal of Cardiology. 2019;(11):69-82. (In Russ.) doi:10.15829/1560-4071-2019-11-69-82.

9. Mareev VYu, Fomin IV, Ageev FT, et al. Russian Heart Failure Society, Russian Society of Cardiology. Russian Scientific Medical Society of Internal Medicine Guidelines for Heart failure: chronic (CHF) and acute decompensated (ADHF). Diagnosis, prevention and treatment. Kardiologiia. 2018;58(6S):8-158. (In Russ.) doi:10.18087/cardio.2475.

10. Fomin IV. Chronic heart failure in russian federation: what do we know and what to do. Russian Journal of Cardiology. 2016;(8):7-13. (In Russ.) doi:10.15829/1560-4071-2016-8-7-13.

11. Mareev YuV, Mareev VYu. Characteristics and treatment of hospitalized patients with CHF. Kardiologiia. 2017;57(4S):19-30. (In Russ.) doi:10.18087/cardio.2433.

12. Bubnova MG, Shlyakhto EV, Aronov DM, et al. Coronavirus disease 2019: features of comprehensive cardiac and pulmonary rehabilitation. Russian Journal of Cardiology. 2021;26(5):4487. (In Russ.) doi:10.15829/1560-4071-2021-4487.

13. Drapkina OM, Boytsov SA, Omelyanovskiy VV, et al. Socio-economic impact of heart failure in Russia. Russian Journal of Cardiology. 2021;26(6):4490. (In Russ.) doi:10.15829/1560-4071-2021-4490.

14. Russian Society of Cardiology (RSC). 2020 Clinical practice guidelines for Chronic heart failure. Russian Journal of Cardiology. 2020;25(11):4083. (In Russ.) doi:10.15829/1560-4071-2020-4083.

15. McDonagh TA, Metra M, Adamo M, et al.; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021;42(36):3599-726. doi:10.1093/eurheartj/ehab368.

16. McMurray J, Solomon S, Inzucchi S, et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019;381:1995-2008. doi:10.1056/NEJMoa1911303.

17. Zhuravleva MV, Tereshchenko SN, Zhirov IV, et al. Effect of dapagliflozin in patients with heart failure on reducing cardiovascular mortality. Russian Journal of Cardiology. 2020;25(10):4142. (In Russ.) doi:10.15829/1560-4071-2020-4142.

18. Bassi NS, Ziaeian B, Yancy CW, Fonarow GC. Association of Optimal Implementation of Sodium-Glucose Cotransporter 2 Inhibitor Therapy With Outcome for Patients With Heart Failure. JAMA Cardiol. 2020;5(8):948-51. doi:10.1001/jamacardio.2020.0898.

19. Instructions for the medical use of the drug dapagliflozin. (In Russ.) http://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=fb3abda5-69f1-4b85-8c92-7ca08263b61c&t=.

20. Sitnikova MY, Yurchenko AV, Lyasnikova EA, et al. Experience of creation and the first results of the russian hospital register of chronic heart failure (RUS-HFR) in three subjects of the Russian Federation. Translational Medicine. 2014;(1):73-81. (In Russ.) doi:10.18705/2311-4495-2014-0-1-73-81.

21. List of instructions based on the results of the appeal to citizens of the Russian Federation on June 23, 2020. (PR-1081 item 1 l) from 08.07.2020. (In Russ.) http://kremlin.ru/acts/assignments/orders/63625.

22. Solov’eva AE, Yakovlev AN, Villeval’de SV, et al. Prescription drug coverage in high cardiovascular risk patients as an important part of the national goals achievement. Vestnik Roszdravnadzora. 2019;4:20-7. (In Russ.) doi:10.35576/article_5d651dbc201140.18252870.