Эмпаглифлозин и сердечная недостаточность: согласованное мнение экспертов по результатам онлайн-совещания и обсуждения исследования EMPEROR-Preserved

1. Краием Н., Поляков Д.С., Фомин И.В., и др. Динамика распространенности хронической сердечной недостаточности и сахарного диабета в Нижегородской области с 2000 по 2017 год. Кардиология. 2018;58(2S):25-32 [Kraiem N, Poliakov DS, Fomin IV, et al. Dynamics of the prevalence of chronic heart failure and diabetes mellitus in the Nizhny Novgorod region from 2000 to 2017. Kardiologiia. 2018;58(2S):25-32 (in Russian)]. DOI:10.18087/cardio.2439 
2. Фомин И.В. Хроническая сердечная недостаточность в Российской Федерации: что сегодня мы знаем и что должны делать. Российский кардиологический журнал. 2016;8:7-13 [Fomin IV. Chronic heart failure in the Russian Federation: what we know today and what we should do. Rossiiskii kardiologicheskii zhurnal. 2016;8:7-13 (in Russian)]. DOI:10.15829/1560-4071-2016-8-7-13 
3. Mamas MA, Sperrin M, Watson MC, et al. Do patients have worse outcomes in heart failure than in cancer? A primary care-based cohort study with 10-year follow-up in Scotland. Eur J Heart Fail. 2017;19(9):1095-104. DOI:10.1002/ejhf.822
4. Levy D, Kenchaiah S, Larson MG, et al. Long-term trends in the incidence of and survival with heart failure. N Engl J Med. 2002;347(18):1397-402. DOI:10.1056/NEJMoa020265
5. Maggioni AP, Dahlström U, Filippatos, et al. EURObservational Research Programme: regional differences and 1-year follow-up results of the Heart Failure Pilot Survey (ESC-HF Pilot); Heart Failure Association of the European Society of Cardiology (HFA). Eur J Heart Fail. 2013;15(7):808-17. DOI:10.1093/eurjhf/hft050
6. Терещенко С.Н., Галявич А.С., Ускач Т.М., и др. Хроническая сердечная недостаточность. Клинические рекомендации 2020. Российский кардиологический журнал. 2020;25(11):311-74 [Tereshchenko SN, Galiavich AS, Uskach TM, et al. Chronic heart failure. Clinical guidelines 2020. Rossiiskii kardiologicheskii zhurnal. 
2020;25(11):311-74 (in Russian)]. DOI:10.15829/1560-4071-2020-4083 
7. 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
8. Rosano GMC, Moura B, Metra M, et al. Patient profiling in heart failure for tailoring medical therapy. A consensus document of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2021;23(6):872-81. DOI:10.1002/ejhf.2206
9. Kapoor JR, Kapoor R, Ju C, et al. Precipitating Clinical Factors, Heart Failure Characterization, and Outcomes in Patients Hospitalized With Heart Failure With Reduced, Borderline, and Preserved Ejection Fraction. JACC Heart Fail. 2016;4(6):464-72. DOI:10.1016/j.jchf.2016.02.017
10. Агеев Ф.Т., Овчинников А.Г. Сердечная недостаточность с промежуточной фракцией выброса левого желудочка: существует ли клиническая необходимость выделения ее в отдельную подгруппу? Кардиология. 2018;58(12S):4-10 [Ageev FT, Ovchinnikov AG. Heart failure with intermediate ejection fraction of the left ventricle: is there a clinical need to separate it into a separate subgroup? Kardiologiia. 2018;58(12S):4-10 (in Russian)]. DOI:10.18087/cardio.2609 
11. Koh AS, Tay WT, Teng THK, et al. A comprehensive population based characterization of heart failure with mid range ejection fraction: Characteristics and outcomes in HFmrEF. Eur J Heart Fail. 2017;19(12):1624-34. DOI:10.1002/ejhf.945
12. Дедов И.И., Шестакова М.В., Викулова О.К. Эпидемиология сахарного диабета в Российской Федерации: клинико-статистический анализ по данным Федерального регистра сахарного диабета. Сахарный диабет. 2017;20(1):13-41 [Dedov II, Shestakova MV, Vikulova OK. Epidemiology of Diabetes Mellitus in the Russian Federation: Clinical and Statistical Analysis According to the Federal Register of Diabetes Mellitus. Sakharnyi diabet. 2017;20(1):13-41 (in Russian)]. DOI:10.14341/DM8664 
13. Khatibzadeh S, Farzadfar F, Oliver J, et al. Worldwide risk factors for heart failure: a systematic review and pooled analysis. Int J Cardiol. 2013;168(2):1186-94. DOI:10.1016/j.ijcard.2012.11.065
14. Tsao CW, Lyass A, Enserro D, et al. Temporal Trends in the Incidence of and Mortality Associated With Heart Failure With Preserved and Reduced Ejection Fraction. JACC Heart Fail. 2018;6(8):678-85. DOI:10.1016/j.jchf.2018.03.006
15. Ощепкова Е.В., Лазарева Н.В., Салтыкова Д.Ф., Терещенко С.Н. Первые результаты Российского регистра хронической сердечной недостаточности. Кардиология. 2015;55(5):22-8 [Oshchepkova EV, Lazareva NV, Saltykova DF, Tereshchenko SN. First results of the Russian register of chronic heart failure. Kardiologiia. 2015;55(5):22-8 (in Russian)]. DOI:10.18565/cardio.2015.5.22-28 
16. Shah KS, Xu H, Matsouaka RA, et al. Heart Failure With Preserved, Borderline, and Reduced Ejection Fraction: 5-Year Outcomes. J Am Coll Cardiol. 2017;70(20):2476-86. DOI:10.1016/j.jacc.2017.08.074
17. Zinman B, Wanner C, Lachin JM, et al.; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373(22):2117-28. DOI:10.1056/NEJMoa1504720
18. Fitchett D, Zinman B, Wanner C, et al. Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME trial. Eur Heart J. 2016;37(19):1526-34. DOI:10.1093/eurheartj/ehv728
19. Barnett AH, Mithal A, Manassie J, et al. Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014;2(5):369-84. DOI:10.1016/S2213-8587(13)70208-0
20. Scheen AJ. Sodium-glucose cotransporter type 2 inhibitors for the treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2020;16:556-77. DOI:10.1038/s41574-020-0392-2
21. Cowie M, Fisher M. SGLT2 inhibitors: mechanisms of cardiovascular benefit beyond glycaemic control. Nat Rev Cardiol. 2020;17:761-72. DOI:10.1038/s41569-020-0406-8
22. Anker SD, Khan MSh, Shahid I, et al. Sodium-glucose co-transporter 2 inhibitors in heart failure with preserved ejection fraction: reasons for optimism. Eur J Heart Fail. 2021;23(8):1250-5. DOI:10.1002/ejhf.2279
23. Packer M, Anker SD, Butler J, et al. Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med. 2020;383(15):1413-24. 
DOI:10.1056/NEJMoa2022190
24. Anker SD, Butler J, Filippatos G, et al. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. EMPEROR-Preserved Trial Investigators. N Engl J Med. 2021;385(16):1451-61. DOI:10.1056/NEJMoa2107038
25. Packer M, Butler J, Filippatos GS, et al. Evaluation of the effect of sodium-glucose co-transporter 2 inhibition with empagliflozin on morbidity and mortality of patients with chronic heart failure and a reduced ejection fraction: rationale for and design of the EMPEROR-Reduced trial. Eur J Heart Fail. 2019;21(10):1270-8. DOI:10.1002/ejhf.1536
26. Виноградова Н.Г., Поляков Д.С., Фомин И.В. Анализ смертности у пациентов с ХСН после декомпенсации при длительном наблюдении в условиях специализированной медицинской помощи и в реальной клинической практике. Кардиология. 2020;60(4) [Vinogradova NG, Poliakov DS, Fomin IV. Analysis of mortality in patients with CHF after decompensation during long-term follow-up in specialized medical care and in real clinical practice. Kardiologiia. 2020;60(4) (in Russian)]. DOI:10.18087/cardio.2020.4.n1014 
27. Williams DM, Evans M. Are SGLT-2 Inhibitors the Future of Heart Failure Treatment? The EMPEROR-Preserved and EMPEROR-Reduced Trials. Diabetes Ther. 2020;11(9):1925-34. DOI:10.1007/s13300-020-00889-9
28. McMurray JJV, Packer M. How Should We Sequence the Treatments for Heart Failure and a Reduced Ejection Fraction?: A Redefinition of Evidence-Based Medicine. Circulation. 20212;143(9):875-7. DOI:10.1161/CIRCULATIONAHA.120.052926
29. Greene SJ, Fonarow GC, DeVore AD, et al. Titration of Medical Therapy for Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2019;73(19):2365-83. DOI:10.1016/j.jacc.2019.02.015
30. Greene SJ, Butler J, Albert NM, et al. Medical Therapy for Heart Failure With Reduced Ejection Fraction: The CHAMP-HF Registry. 
J Am Coll Cardiol. 2018;72(4):351-66. DOI:10.1016/j.jacc.2018.04.070
31. Schernthaner G, Shehadeh N, Ametov AS, et al. Worldwide inertia to the use of cardiorenal protective glucose-lowering drugs (SGLT2i and GLP-1 RA) in high-risk patients with type 2 diabetes. Cardiovasc Diabetol. 2020;19(1):185. DOI:10.1186/s12933-020-01154-w

________________________________________________

1. Kraiem N, Poliakov DS, Fomin IV, et al. Dynamics of the prevalence of chronic heart failure and diabetes mellitus in the Nizhny Novgorod region from 2000 to 2017. Kardiologiia. 2018;58(2S):25-32 (in Russian). DOI:10.18087/cardio.2439 
2. Fomin IV. Chronic heart failure in the Russian Federation: what we know today and what we should do. Rossiiskii kardiologicheskii zhurnal. 2016;8:7-13 (in Russian). DOI:10.15829/1560-4071-2016-8-7-13 
3. Mamas MA, Sperrin M, Watson MC, et al. Do patients have worse outcomes in heart failure than in cancer? A primary care-based cohort study with 10-year follow-up in Scotland. Eur J Heart Fail. 2017;19(9):1095-104. DOI:10.1002/ejhf.822
4. Levy D, Kenchaiah S, Larson MG, et al. Long-term trends in the incidence of and survival with heart failure. N Engl J Med. 2002;347(18):1397-402. DOI:10.1056/NEJMoa020265
5. Maggioni AP, Dahlström U, Filippatos, et al. EURObservational Research Programme: regional differences and 1-year follow-up results of the Heart Failure Pilot Survey (ESC-HF Pilot); Heart Failure Association of the European Society of Cardiology (HFA). Eur J Heart Fail. 2013;15(7):808-17. DOI:10.1093/eurjhf/hft050
6. Tereshchenko SN, Galiavich AS, Uskach TM, et al. Chronic heart failure. Clinical guidelines 2020. Rossiiskii kardiologicheskii zhurnal. 2020;25(11):311-74 (in Russian).
DOI:10.15829/1560-4071-2020-4083 
7. 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
8. Rosano GMC, Moura B, Metra M, et al. Patient profiling in heart failure for tailoring medical therapy. A consensus document of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2021;23(6):872-81. DOI:10.1002/ejhf.2206
9. Kapoor JR, Kapoor R, Ju C, et al. Precipitating Clinical Factors, Heart Failure Characterization, and Outcomes in Patients Hospitalized With Heart Failure With Reduced, Borderline, and Preserved Ejection Fraction. JACC Heart Fail. 2016;4(6):464-72. DOI:10.1016/j.jchf.2016.02.017
10. Ageev FT, Ovchinnikov AG. Heart failure with intermediate ejection fraction of the left ventricle: is there a clinical need to separate it into a separate subgroup? Kardiologiia. 2018;58(12S):4-10 (in Russian). DOI:10.18087/cardio.2609 
11. Koh AS, Tay WT, Teng THK, et al. A comprehensive population based characterization of heart failure with mid range ejection fraction: Characteristics and outcomes in HFmrEF. Eur J Heart Fail. 2017;19(12):1624-34. DOI:10.1002/ejhf.945
12. Dedov II, Shestakova MV, Vikulova OK. Epidemiology of Diabetes Mellitus in the Russian Federation: Clinical and Statistical Analysis According to the Federal Register of Diabetes Mellitus. Sakharnyi diabet. 2017;20(1):13-41 (in Russian). DOI:10.14341/DM8664 
13. Khatibzadeh S, Farzadfar F, Oliver J, et al. Worldwide risk factors for heart failure: a systematic review and pooled analysis. Int J Cardiol. 2013;168(2):1186-94. DOI:10.1016/j.ijcard.2012.11.065
14. Tsao CW, Lyass A, Enserro D, et al. Temporal Trends in the Incidence of and Mortality Associated With Heart Failure With Preserved and Reduced Ejection Fraction. JACC Heart Fail. 2018;6(8):678-85. DOI:10.1016/j.jchf.2018.03.006
15. Oshchepkova EV, Lazareva NV, Saltykova DF, Tereshchenko SN. First results of the Russian register of chronic heart failure. Kardiologiia. 2015;55(5):22-8 (in Russian). DOI:10.18565/cardio.2015.5.22-28 
16. Shah KS, Xu H, Matsouaka RA, et al. Heart Failure With Preserved, Borderline, and Reduced Ejection Fraction: 5-Year Outcomes. J Am Coll Cardiol. 2017;70(20):2476-86. DOI:10.1016/j.jacc.2017.08.074
17. Zinman B, Wanner C, Lachin JM, et al.; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373(22):2117-28. DOI:10.1056/NEJMoa1504720
18. Fitchett D, Zinman B, Wanner C, et al. Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME trial. Eur Heart J. 2016;37(19):1526-34. DOI:10.1093/eurheartj/ehv728
19. Barnett AH, Mithal A, Manassie J, et al. Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014;2(5):369-84. DOI:10.1016/S2213-8587(13)70208-0
20. Scheen AJ. Sodium-glucose cotransporter type 2 inhibitors for the treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2020;16:556-77. DOI:10.1038/s41574-020-0392-2
21. Cowie M, Fisher M. SGLT2 inhibitors: mechanisms of cardiovascular benefit beyond glycaemic control. Nat Rev Cardiol. 2020;17:761-72. DOI:10.1038/s41569-020-0406-8
22. Anker SD, Khan MSh, Shahid I, et al. Sodium-glucose co-transporter 2 inhibitors in heart failure with preserved ejection fraction: reasons for optimism. Eur J Heart Fail. 2021;23(8):1250-5. DOI:10.1002/ejhf.2279
23. Packer M, Anker SD, Butler J, et al. Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med. 2020;383(15):1413-24. 
DOI:10.1056/NEJMoa2022190
24. Anker SD, Butler J, Filippatos G, et al. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. EMPEROR-Preserved Trial Investigators. N Engl J Med. 2021;385(16):1451-61. DOI:10.1056/NEJMoa2107038
25. Packer M, Butler J, Filippatos GS, et al. Evaluation of the effect of sodium-glucose co-transporter 2 inhibition with empagliflozin on morbidity and mortality of patients with chronic heart failure and a reduced ejection fraction: rationale for and design of the EMPEROR-Reduced trial. Eur J Heart Fail. 2019;21(10):1270-8. DOI:10.1002/ejhf.1536
26. Vinogradova NG, Poliakov DS, Fomin IV. Analysis of mortality in patients with CHF after decompensation during long-term follow-up in specialized medical care and in real clinical practice. Kardiologiia. 2020;60(4) (in Russian). DOI:10.18087/cardio.2020.4.n1014 
27. Williams DM, Evans M. Are SGLT-2 Inhibitors the Future of Heart Failure Treatment? The EMPEROR-Preserved and EMPEROR-Reduced Trials. Diabetes Ther. 2020;11(9):1925-34. DOI:10.1007/s13300-020-00889-9
28. McMurray JJV, Packer M. How Should We Sequence the Treatments for Heart Failure and a Reduced Ejection Fraction?: A Redefinition of Evidence-Based Medicine. Circulation. 20212;143(9):875-7. DOI:10.1161/CIRCULATIONAHA.120.052926
29. Greene SJ, Fonarow GC, DeVore AD, et al. Titration of Medical Therapy for Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2019;73(19):2365-83. DOI:10.1016/j.jacc.2019.02.015
30. Greene SJ, Butler J, Albert NM, et al. Medical Therapy for Heart Failure With Reduced Ejection Fraction: The CHAMP-HF Registry. 
J Am Coll Cardiol. 2018;72(4):351-66. DOI:10.1016/j.jacc.2018.04.070
31. Schernthaner G, Shehadeh N, Ametov AS, et al. Worldwide inertia to the use of cardiorenal protective glucose-lowering drugs (SGLT2i and GLP-1 RA) in high-risk patients with type 2 diabetes. Cardiovasc Diabetol. 2020;19(1):185. DOI:10.1186/s12933-020-01154-w

Г.П. Арутюнов1, Ю.М. Лопатин2,3, А.С. Аметов4, Ф.Т. Агеев5, М.Б. Анциферов6, С.В. Виллевальде1,7, Н.Г. Виноградова*8, Г.Р. Галстян9, А.С. Галявич10, С.Р. Гиляревский4, М.Г. Глезер11, И.В. Жиров4,5, М.В. Ильин12, А.Ю. Лебедева1,13, С.М. Недогода2, В.В. Салухов14, Е.И. Тарловская*8, С.Н. Терещенко5, И.В. Фомин8, 
Ю.Ш. Халимов14, Н.Р. Хасанов10, Д.В. Черкашин14, С.С. Якушин15 

1 ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России, Москва, Россия; 
2 ФГБОУ ВО «Волгоградский государственный медицинский университет» Минздрава России, Волгоград, Россия;
3 ГБУЗ «Волгоградский областной клинический кардиологический центр», Волгоград, Россия;
4 ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
5 ФГБУ «Национальный медицинский исследовательский центр кардиологии» Минздрава России, Москва, Россия;
6 ГБУЗ «Эндокринологический диспансер» Департамента здравоохранения г. Москвы, Москва, Россия;
7 ФГБУ «Национальный медицинский исследовательский центр им. В.А. Алмазова» Минздрава России, Санкт-Петербург, Россия;
8 ФГБОУ ВО «Приволжский исследовательский медицинский университет» Минздрава России, Нижний Новгород, Россия;
9 ФГБУ «Национальный медицинский исследовательский центр эндокринологии» Минздрава России, Москва, Россия;
10 ФГБОУ ВО «Казанский государственный медицинский университет» Минздрава России, Казань, Россия;
11 ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
12 ФГБОУ ВО «Ярославский государственный медицинский университет» Минздрава России, Ярославль, Россия;
13 ГБУЗ «Городская клиническая больница им. И.В. Давыдовского» Департамента здравоохранения г. Москвы, Москва, Россия;
14 ФГБВОУ ВО «Военно-медицинская академия им. С.М. Кирова» Минобороны России, Санкт-Петербург, Россия;
15 ФГБОУ ВО «Рязанский государственный медицинский университет им. акад. И.П. Павлова» Минздрава России, Рязань, Россия
*etarlovskaya@mail.ru
*vinogradovang@yandex.ru

________________________________________________

Gregory P. Arutyunov1, Yuri M. Lopatin2,3, Aleksandr S. Ametov4, Fail T. Ageev5, Mikhail B. Antsiferov6, Svetlana V. Villevalde1,7, Nadezhda G. Vinogradova*8, Gagik R. Galstyan9, Albert S. Galyavich10, Sergey R. Gilyarevskiy4, Maria G. Glezer11, Igor V. Zhirov4,5, Mikhail V. Ilyin12, Anastasiya Iu. Lebedeva1,13, Sergey M. Nedogoda2, Vladimir V. Salukhov14, Ekaterina I. Tarlovskaya*8, Sergey N. Tereshchenko5, Igor V. Fomin8, Iurii Sh. Khalimov14, Niaz R. Khasanov10, Dmitriy V. Cherkashin14, Sergey S. Yakushin15

1 Pirogov Russian National Research Medical University, Moscow, Russia; 
2 Volgograd State Medical University, Volgograd, Russia;
3 Volgograd Regional Clinical Cardiology Center, Volgograd, Russia;
4 Russian Medical Academy of Continuous Professional Education, Moscow, Russia;
5 National Medical Research Center of Cardiology, Moscow, Russia;
6 Endocrinology Dispensary, Moscow, Russia;
7 Almazov National Medical Research Centre, Saint Petersburg, Russia;
8 Privolzhsky Research Medical University, Nizhny Novgorod, Russia;
9 Endocrinology Research Centre, Moscow, Russia;
10 Kazan State Medical University, Kazan, Russia;
11 Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
12 Yaroslavl State Medical University, Yaroslavl, Russia;
13 Davydovsky City Clinical Hospital, Moscow, Russia;
14 Kirov Military Medical Academy, Saint Petersburg, Russia;
15 Pavlov Ryazan State Medical University, Ryazan, Russia
*etarlovskaya@mail.ru
*vinogradovang@yandex.ru