Prospects for use of Vericiguat in HFrEF: Implications of VICTORIA Trial Results. Advisory Board Summary
https://doi.org/10.18087/cardio.2023.4.n2403
Abstract
In September 2021, an online meeting of the Council of Experts was held. The proposed focus of discussion was publishing the results of an international prospective, randomized, double-blind, placebo-controlled study VICTORIA. The objective of the VICTORIA study was evaluation of the efficacy and safety of supplementing a standard therapy with vericiguat at a target dose of 10 mg twice a day as compared to placebo for prevention of cardiovascular death and hospitalization for heart failure (HF) in patients with clinical manifestations of chronic HF and left ventricular ejection fraction <45% who have recently had an episode of decompensated HF. The aim of the meeting was interpretation of the VICTORIA study results on efficacy and safety of vericiguat for a potential use in a Russian population of patients after a recent episode of decompensated chronic HF with reduced ejection fraction.
About the Authors
Yu. N. BelenkovRussian Federation
Academician of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, Director of the Ostroumov Hospital Therapy Clinic of the I. M. Sechenov
Moscow
Competing Interests:
The authors of this documents declare making scientific presentations at symposia and/or performing as experts at events organized by AO Bayer.
G. P. Arutyunov
Russian Federation
Corresponding Member of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, Head of the Department of Internal Diseases and General Physiotherapy
Moscow
Competing Interests:
The authors of this documents declare making scientific presentations at symposia and/or performing as experts at events organized by AO Bayer.
V. Yu. Mareev
Russian Federation
Doctor of Medical Sciences, Professor, Chief Researcher, Medical Research and Educational Center
Moscow
Competing Interests:
The authors of this documents declare making scientific presentations at symposia and/or performing as experts at events organized by AO Bayer.
N. A. Koziolova
Russian Federation
Doctor of Medical Sciences, Professor, Head of the Department of Propaedeutics of Internal Diseases No. 2
Perm
Competing Interests:
The authors of this documents declare making scientific presentations at symposia and/or performing as experts at events organized by AO Bayer.
M. Yu. Sitnikova
Russian Federation
Doctor of Medical Sciences, Professor, Head of the Research Department of Heart Failure and Professor of the Department of Therapy
Saint Petersburg
Competing Interests:
The authors of this documents declare making scientific presentations at symposia and/or performing as experts at events organized by AO Bayer.
F. T. Ageev
Russian Federation
Doctor of Medical Sciences, Professor, Head of the Scientific and Dispensary Departmen
Moscow
Competing Interests:
The authors of this documents declare making scientific presentations at symposia and/or performing as experts at events organized by AO Bayer.
S. R. Gilyarevsky
Russian Federation
Doctor of Medical Sciences, Professor of the Department of Clinical Pharmacology and Therapy
Moscow
Competing Interests:
The authors of this documents declare making scientific presentations at symposia and/or performing as experts at events organized by AO Bayer.
A. I. Chesnikova
Russian Federation
Doctor of Medical Sciences, Professor of the Department of Internal Diseases No. 1
Rostov-on-Don
Competing Interests:
The authors of this documents declare making scientific presentations at symposia and/or performing as experts at events organized by AO Bayer.
S. S. Yakushin
Russian Federation
Doctor of Medical Sciences, Professor, Head of the Department of Hospital Therapy with a course of Medical and Social Expertise
Ryazan
Competing Interests:
The authors of this documents declare making scientific presentations at symposia and/or performing as experts at events organized by AO Bayer.
N. B. Perepech
Russian Federation
Doctor of Medical Sciences, Professor, Head of the Department of Hospital Therapy with a course of Medical and Social Expertise
Saint Petersburg
Competing Interests:
The authors of this documents declare making scientific presentations at symposia and/or performing as experts at events organized by AO Bayer.
Yu. V. Mareev
Russian Federation
Candidate of Medical Sciences, Researcher at the Department of Clinical Cardiology
Moscow
Competing Interests:
The authors of this documents declare making scientific presentations at symposia and/or performing as experts at events organized by AO Bayer.
References
1. Armstrong PW, Roessig L, Patel MJ, Anstrom KJ, Butler J, Voors AA et al. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of the Oral Soluble Guanylate Cyclase Stimulator. JACC: Heart Failure. 2018;6(2):96–104. DOI: 10.1016/j.jchf.2017.08.013
2. Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J et al. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. The New England Journal of Medicine. 2020;382(20):1883–93. DOI: 10.1056/NEJMoa1915928
3. Greene SJ, Fonarow GC, Butler J. Risk Profiles in Heart Failure: Base-line, Residual, Worsening, and Advanced Heart Failure Risk. Circulation: Heart Failure. 2020;13(6):e007132. DOI: 10.1161/CIRCHEARTFAILURE.120.007132
4. Bozkurt B, Coats AJ, Tsutsui H, Abdelhamid M, Adamopoulos S, Albert N et al. Universal Definition and Classification of Heart Failure: A Report of the Heart Failure Society of America, Heart Failure Association of the European Society of Cardiology, Japanese Heart Failure Society and Writing Committee of the Universal Definition of Heart Failure. Journal of Cardiac Failure. 2021;27(4):387–413. DOI: 10.1016/j.cardfail.2021.01.022
5. Fomin I.V. Chronic heart failure in Russian Federation: what do we know and what to do. Russian Journal of Cardiology. 2016;8:7–13. DOI: 10.15829/1560-4071-2016-8-7-13
6. Vinogradova N.G., Polyakov D.S., Fomin I.V. The risks of re-hospitalization of patients with heart failure with prolonged follow-up in a specialized center for the treatment of heart failure and in real clinical practice. Kardiologiia. 2020;60(3):59–69. ]. DOI: 10.18087/cardio.2020.3.n1002
7. Butler J, Djatche LM, Sawhney B, Chakladar S, Yang L, Brady JE et al. Clinical and Economic Burden of Chronic Heart Failure and Reduced Ejection Fraction Following a Worsening Heart Failure Event. Advances in Therapy. 2020;37(9):4015–32. DOI: 10.1007/s12325-020-01456-1
8. Breitenstein S, Roessig L, Sandner P, Lewis KS. Novel sGC Stimulators and sGC Activators for the Treatment of Heart Failure. Hand-book of Experimental Pharmacology. 2017;243:225–47. DOI: 10.1007/164_2016_100
9. Sandner P, Follmann M, Becker‐Pelster E, Hahn MG, Meier C, Freitas C et al. Soluble GC stimulators and activators: Past, present and future. British Journal of Pharmacology. 2021;bph.15698. [Epub ahead of print]. DOI: 10.1111/bph.15698
10. Ezekowitz JA, O’Connor CM, Troughton RW, Alemayehu WG, Westerhout CM, Voors AA et al. N-Terminal Pro-B-Type Natriuretic Peptide and Clinical Outcomes. JACC: Heart Failure. 2020;8(11):931–9. DOI: 10.1016/j.jchf.2020.08.008
11. Lam CSP, Mulder H, Lopatin Y, Vazquez‐Tanus JB, Siu D, Ezekowitz J et al. Blood Pressure and Safety Events With Vericiguat in the VICTORIA Trial. Journal of the American Heart Association. 2021;10(22):e021094. DOI: 10.1161/JAHA.121.021094
12. Ezekowitz JA, Zheng Y, Cohen-Solal A, Melenovský V, Escobedo J, Butler J et al. Hemoglobin and Clinical Outcomes in the Vericiguat Global Study in Patients With Heart Failure and Reduced Ejection Fraction (VICTORIA). Circulation. 2021;144(18):1489–99. DOI: 10.1161/CIRCULATIONAHA.121.056797
13. Voors AA, Mulder H, Reyes E, Cowie MR, Lassus J, Hernandez AF et al. Renal function and the effects of vericiguat in patients with worsening heart failure with reduced ejection fraction: insights from the VICTORIA (Vericiguat Global Study in Subjects with HFrEF) trial. European Journal of Heart Failure. 2021;23(8):1313–21. DOI: 10.1002/ejhf.2221
14. McMurray JJV, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR et al. Angiotensin–niprilysin Inhibition versus enalapril in heart failure. New England Journal of Medicine. 2014;371(11):993–1004. DOI: 10.1056/NEJMoa1409077
15. McMurray JJV, Solomon SD, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. New England Journal of Medicine. 2019;381(21):1995–2008. DOI: 10.1056/NEJMoa1911303
16. Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P et al. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. New England Journal of Medicine. 2020;383(15):1413–24. DOI: 10.1056/NEJMoa2022190
17. Adams KF, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT et al. Characteristics and outcomes of patients hospitalized for heart failure in the United States: Rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). American Heart Journal. 2005;149(2):209–16. DOI: 10.1016/j.ahj.2004.08.005
18. Chioncel O, Mebazaa A, Harjola V-P, Coats AJ, Piepoli MF, Crespo-Leiro MG et al. Clinical phenotypes and outcome of patients hospitalized for acute heart failure: the ESC Heart Failure Long-Term Registry: Outcome of patients hospitalized for acute heart failure. European Journal of Heart Failure. 2017;19(10):1242–54. DOI: 10.1002/ejhf.890
19. Arutyunov A.G., Dragunov D.O., Arutyunov G.P., Rylova A.K., Pashkevich D.D., Viter K.V. et al. First open study of syndrome of acute decompensation of heart failure and concomitant diseases in Russian Federation: independent registry ORAKUL. Kardiologiia. 2015;55(5):12–21.
20. Sitnikova M.Yu., Lyasnikova E.A., Yurchenko A.V., Trukshina M.A., Kuular A.A., Galenko V.L. et al. Results of 3 years work of the Russian hospital register of chronic heart failure (RUssian hoSpital Heart Failure Registry – RUS-HFR): relationship between management and outcomes in patients with chronic heart failure. Kardiologiia. 2018;58(10S):9–19. DOI: 10.18087/cardio.2483
21. Polyakov D.S., Fomin I.V., Valikulova F.Yu., Vaisberg A.R., Kraiem N., Badin Yu.V. et al. The EPOCHA-CHF epidemiological program: decompensated chronic heart failure in real-life clinical practice (EPO-CHA-D-CHF). Russian Heart Failure Journal. 2016;17(5):299–305. DOI: 10.18087/rhfj.2016.5.2239
Review
For citations:
Belenkov Yu.N., Arutyunov G.P., Mareev V.Yu., Koziolova N.A., Sitnikova M.Yu., Ageev F.T., Gilyarevsky S.R., Chesnikova A.I., Yakushin S.S., Perepech N.B., Mareev Yu.V. Prospects for use of Vericiguat in HFrEF: Implications of VICTORIA Trial Results. Advisory Board Summary. Kardiologiia. 2023;63(4):3-10. (In Russ.) https://doi.org/10.18087/cardio.2023.4.n2403