Sacubitrilo / Valsartán: a jump of quality in the treatment of the heart inadequacy

Authors

  • Sergio Luis Montes de Oca Zubizarreta Universidad de Ciencias Médicas de Pinar del Río, Policlínico Universitario Raúl Sánchez Rodríguez, Pinar del Río. Pinar del río, Cuba Author
  • Ariagna Albert Victorero Universidad de Ciencias Médicas de Pinar del Río, Hospital Clínico Quirúrgico «Dr. León Cuervo Rubio», Pinar del Río. Pinar del Río, Cuba Author
  • Iraida Aguilar Cuba Universidad de Ciencias Médicas de Pinar del Río, Policlínico Universitario Raúl Sánchez Rodríguez, Pinar del Río. Pinar del río, Cuba Author
  • Dianelys Careaga Valido Universidad de Ciencias Médicas de Pinar del Río, Policlínico Universitario Raúl Sánchez Rodríguez, Pinar del Río. Pinar del río, Cuba Author

DOI:

https://doi.org/10.56294/hl2024.668

Keywords:

Heart inadequacy, Fraction of ejection of the left ventricle, Inhibitor of the neprilisina , angiotensina receiver, Aleatory clinical studies

Abstract

Introduction: The advances in the prevention, diagnosis and treatment of the cardiovascular illnesses have been excellent, taking place significant reductions of the rates of mortality; it has not happened this way with the heart inadequacy; the high indexes of hospitalization, disability, morbilidad, mortality that takes place, took to the necessity of developing new fármacos, fruit of this the obtaining of Sacubitrilo/Valsartán, medication that inhibits system renina-angiotensina-aldosterona, was and it retards the degradation of the péptidos natriuréticos. The results of several studies took to that from the year 2021 were included in the basic pillars for the treatment of the inadequacy. Method: He/she was carried out a search in several bibliographical databases, revising the clinical studies published on the use of the medication. Results: The PARADIGM-HF was the first rehearsal that showed its benefits, with significant reduction of the mortality and the hospitalizations; other publications have confirmed their effectiveness, security, tolerance and improvement of the functional and renal capacity. Conclusions: The weight of the accumulated evidence, with the use of Sacubitrilo/Valsartán is incontrastable and its introduction in the clinical practice, he/she will go consolidating its indication in the treatment protocols that a revolutionary change will imply in the presage and with it the so yearned reduction of the mortality and the hospital entrance.

References

1. Greene SJ, Ayodele I, Pierce JB, Khan MS, Lewsey SC, Yancy CW, Alhanti B, Van Spall HGC, Allen LA, Fonarow GC. Elegibilidad y beneficios proyectados del inicio rápido de la terapia médica cuádruple para la insuficiencia cardíaca recién diagnosticada [impreso en línea el 25 de marzo de 2024]. JACC Heart Fail. doi: 10.1016/j.jchf.2024.03.001.https://www.sciencedirect.com/science/ar- ticle/pii/S2213177924002440?via%3Dihub

2. C Mozzini, M Pagani. Los caballeros de la insuficiencia cardíaca. Cur Prob Cardiol 2023; 48: 101

3. Tsao CW, Aday AW, Almarzooq ZI, et al. Estadísticas de enfermedades cardíacas y accidentes cerebrovasculares: actualización pre de 2022: un informe de la Asociación Estadounidense del Corazón. Circulación. 2022; 145:e153–e639.

4. Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW, American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circulation 2020; 141:139-596.

5. Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Abrigos AJS. Carga global de insuficiencia cardíaca: una revisión exhaustiva y actualizada de la epidemiología. Cardiovasc Res 2023; 118: 3272–87.

6. Bragazzi NL, Zhong W, Shu J, et al. Carga de la insuficiencia cardíaca y causas subyacentes en 195 países y territorios entre 1990 y 2017. Eur J Prevent Cardiol. 2021; 28:1682–1690.

7. Directrices médicas rápidas e intensivas dirigidas por pautas en el tratamiento de la insuficiencia cardíaca: cinco principios básicos. Circulation 2024 ;150:422–424. DOI: 10.1161/Circulation AHA.124.070228.

8. Keshavani S, Shah S, Ayodele I, Chiswell K, Alhanti B, Allen LA, et al. Distintas vías fisiopatológicas en mujeres y hombres con insuficiencia cardíaca. Eur J Heart Fail 2022; 24:1532-1544. doi:10.1002/ejhf.2534 1

9. McDonald TA, Metra N, Adamo M, et al. Actualización centrada en 2023 de las directrices ESC del 2021 para el diagnóstico y tratamiento de la insuficiencia aguda y crónica. Eur Heart J. 2023; 44:3627-3639.

10. Maddox TM, Januzzi JL Jr, Allen LA, Breathett K, Brouse S, Butler J, Davis LL, Fonarow GC, Ibrahim NE, Lindenfeld J, Masoudi FA, Motiwala SR, Oliveros E, Walsh MN, Wasserman A, Yancy CW, Youmans QR. 2024 Vía de decisión por consenso de expertos del ACC para el tratamiento de la insuficiencia cardíaca con fracción de eyección reducida: un informe del Comité de Supervisión del Conjunto de Soluciones del Colegio Americano de Cardiología. J Am Coll Cardiol 2024;83 (15):1444-1488.

11. Paul A. Heidenreich, Biykem Bozkurt, David Aguilar, Larry A. Allen, Joni J. Byun, Monica M. Colvin, Anita Deswal, Mark H. Drazner, Shannon M. Dunlay, Linda R. Evers, James C. Fang, Savitri E. Fedson, Gregg C. Fonarow, Salim S. Hayek, Adrian F. Hernandez, Prateeti Khazanie, Michelle M. Kittleson, Christopher S. Lee, Mark S. Link, Carmelo A. Milano, Lorraine C. Nnacheta, Alexander T. Sandhu, Lynne Warner Stevenson, Orly Vardeny, Amanda R. Vest, and Clyde W. Yancy. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 Mar 24: S0735-1097(21)08394-7.

12. Sánchez M, Manito N. Sacubitrilo/Valsartán: un cambio de paradigma en el tratamiento de la insuficiencia cardiaca con fracción de eyección reducida. SEC Monogr. 2017; 5(2):1-6.

13. Mebazaa A, Davison B, Chioncel O, et al. Seguridad, tolerabilidad y eficacia del aumento de la dosis de terapias médicas dirigidas por las directrices para la insuficiencia cardíaca aguda (STRONG-HF): un ensayo multinacional, abierto y aleatorizado. Lanceta. 2022; 400:1938–1952.

14. McMurray J, Packer M, Desai A, Gong J, Lefkowitz M, Rizkala A, et al, for the PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in Heart failure. N Engl J Med 2014; 371:993-1004

15. The CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med 1987; 316:1429-1435.

16. The SOLVD Investigators. Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions. N Engl J Med. 1992; 327:685-91.

17. Pocock SJ, McMurray JJV, Collier TJ. Making sense of statistics in clinical trial reports: part 1 of a 4-part series on statistics for clinical trials. J Am Coll Cardiol. 2015; 66:2536-49.

18. U.S. Food and Drug Administration. ENTRESTO (sacubitril and valsartan). Highlights of prescribing information [Consultado 12 diciembre 2024] Disponible en: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207620Orig1s000lbl.pdf.

19. European Medicines Agency. Assessment report. Entresto. Procedure No. EMEA/H/C/004062/0000 [Consultado 12 diciembre 2022]. Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004062/WC500197538.pdf.

20. Docherty KF, Vaduganathan M, Solomon SD, et al. Sacubitril/valsartan: neprilysin inhibition 5 years after PARADIGM-HF. JACC Heart Fail. 2020 Oct; 8(10):800-810. doi: 10.1016/j.jchf.2020.06.020.

21. Schwinger R.H.G. Pathophysiology of heart failure. Cardiovasc. Diagn. Ther. 2021; 11(1): 263–276. DOI: 10.21037/cdt-20-302.

22. Vardeny O, Claggett B, Packer M, Zile MR, Rouleau J, Swedberg K, Teerlink JR, Desai AS, Lefkowitz M, Shi V, McMurray JJ, Solomon SD. Efficacy of sacubitril/valsartan vs. enalapril at lower than target doses in heart failure with reduced ejection fraction: the PARADIGM-HF trial. European Journal of Heart Failure. 2016; 18(10):1228-34.

23. Casasnovas P, González L, Blázquez J, Chochowski P, Mirete C, Guillamón A, de Diego C, Corcoles J. Impacto del tratamiento con sacubitrilo-valsartán en pacientes con ICC con FEVI deprimida. Rev Clin Esp. 2017; 217 (Espec Congr):522.

24. Böhm M, Young R, Jhund PS, Solomon SD, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Swedberg K, Zile MR, Packer M, McMurray JJ. Systolic blood pressure, cardiovascular outcomes and efficacy and safety of sacubitril/valsartan (LCZ696) in patients with chronic heart failure and reduced ejection fraction: results from PARADIGM-HF. European Heart Journal. 2017; 38(15):1132-43.

25. Damman K, Gori M, Claggett B, Jhund PS, Senni M, et al. Renal effects and associated outcomes during angiotensin-neprilysin inhibition in heart failure. JACC Heart Fail. 2018; Apr 5: 1779¬-2213.

26. Niu CY, Yang SF, Ou SM, Wu CH, Huang PH, Hung CL, Lin CC, Li SY. Sacubitril/valsartan in patients with heart failure and concomitant end-stage kidney disease. J Am Heart Assoc. 2022 Sep 20; 11(18):e026407.

27. Safia Chatur, Brendon L. Neuen, Brian L. Claggett, Iris E. Beldhuis, Finnian R. Mc Causland, Akshay S. Desai, Jean L. Rouleau, Michael R. Zile, Martin P. Lefkowitz, Milton Packer, John J.V. McMurray, Scott D. Solomon J. Effects of sacubitril/valsartan across the spectrum of renal impairment in patients with heart failure Am Coll Cardiol. 2024 Jun, 83 (22) 2148–2159.

28. Chandra A, Lewis EF, Claggett BL, Desai AS, Packer M, Zile MR, Swedberg K, Rouleau JL, Shi VC, Lefkowitz MP, Katova T, McMurray JJV, Solomon SD. Effects of Sacubitril/Valsartan on physical and social activity limitations in patients with heart failure: A secondary analysis of the PARADIGM-HF Trial. JAMA Cardiol. 2018; 3(6):498-505.

29. Morales-Parra MP, Salazar-Niño JF, Caycedo-González LA, González-Torres DV, Jaramillo-Jaramillo M, Buitrago-Sandoval AF, González-Robledo G. Experiencia con sacubitril/valsartán en una clínica de falla cardiaca. Revista Colombiana de Cardiología. 2019; 27(1): 7-12.

30. Januzzi JL Jr, Prescott MF, Butler J, Felker GM, Maisel AS, McCague K, Camacho A, Piña IL, Rocha RA, Shah AM, Williamson KM, Solomon SD. Association of Change in N-Terminal Pro-B-Type Natriuretic Peptide Following Initiation of Sacubitril-Valsartan Treatment with Cardiac Structure and Function in Patients with Heart Failure with Reduced Ejection Fraction. JAMA. 2019; 2: 1-11.

31. Vaduganathan M, Claggett BL, Jhund PS y col. Estimación de los beneficios de por vida de las terapias farmacológicas integrales que modifican la enfermedad en pacientes con insuficiencia cardíaca con fracción de eyección reducida: un análisis comparativo de tres ensayos controlados aleatorios. Lanceta. 2020; 396:121–128.

32. Robert J. Mentz, MD Jonathan H. Ward, PharmD Adrian F. Hernandez, MD, MHS Serge Lepage, MD David A. Morrow, MD, MPH Samiha Sarwat, PhD Kavita Sharma, MD Randall C. Starling, MD, MPH Eric J. Velazquez, MD Kristin M. Williamson, PharmD Akshay S. Desai, MD, MPH Shelley Zieroth, MD Scott D. Solomon, MD Eugene Braunwald. Angiotensin-neprilysin inhibition in patients with mildly reduced or preserved ejection fraction and worsening heart failure. PARAGLIDE-HF Investigators. J Am Coll Cardiol. 2023, 0 (0). Ahead of print.

33. Scott D Solomon, Muthiah Vaduganathan, Brian L Claggett, Milton Packer, Michael Zile, Karl Swedberg, Jean Rouleau, Marc A Pfeffer, Akshay Desai, Lars H Lund, Lars Koeber, Inder Anand, Nancy K Sweitzer, Gerard Linssen, Bela Merkely, Juan Luis Arango, Dragos Vinereanu, Chen-Huan Chen, Michele Senni, Antonio Sibulo, Sergey Boytsov, Victor Shi, Adel Rizkala, Martin Lefkowitz, John J V McMurray. Sacubitril/Valsartan across the spectrum of ejection fraction in heart failure. Circulation. 2019; Nov 17. [Online ahead of print]

34. Velazquez EJ, Morrow DA, DeVore AD, et al. Angiotensin-neprilysin inhibition in acute decompensated heart failure. PIONEER-HF investigators. N Engl J Med 2019; 380: 539-48.

35. Wachter R, Senni M, Belohlavek J, Straburzynska-Migaj E, Witte K, Kobalava Z, Fonseca C, Gonçalvesova E, Cavusoglu Y, Fernández A, Chaabán D, Bohmer E, Pouleur AN, Müller C, Tribouilloy C, Lonn E, Buraiki J, Gniot J, Mozheiko M, Lelonek M, Noé A, Schwende H, Bao W, Butilina D, Domingo Pascual DM,Witte K.K., TRANSITION Investigators, et al. Initiation of sacubitril/valsartan shortly after hospitalization for acutely decompensated heart failure in patients with newly diagnosed (de novo) heart failure: a subgroup analysis of the TRANSITION study. Eur J Heart Fail. 2020 Feb; 22(2):303-12.

36. Jering KS, Claggett B, Pfeffer MA, Granger C, Køber L, Lewis EF, Maggioni AP, Mann D, McMurray JV, Rouleau JL, Scott D Solomon SD, Steg PG, Van der Meer P, Wernsing M, Carter K, Guo W,Zhou Y, Lefkowitz M, Gong J, Wang Y, Merkely B, Macin SM, Shah U, Nicolau JC, Braunwald E. Prospective ARNI vs. ACE inhibitor trial to Determine Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE-MI): design and baseline characteristics. Eur J Heart Fail. 2021 Jun; 23(6):1040-48.

37. Palacios Castello C, Grande Trillo A, González de la Portilla-Concha C, Sainz Hidalgo I, Gómez Moreno S, Sánchez Brotons J, Sayago Silva I, Delgado Ariza A, Barón-Esquivias G. Sacubitrilo-valsartán: 5 años de experiencia clínica en pacientes ambulatorios con insuficiencia cardiaca. Cardioclinics.2023;58(1):16-24(enero-marzo2023). DOI: https://10.1016/j.rccl.2022.04.006

38. 2020 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. European Heart Journal 2021).

39. Heidenreich PA, Bozkurt B, Aguilar D, et al. Guía AHA/ACC/HFSA de 2022 para el tratamiento de la insuficiencia cardíaca: un informe del Colegio Americano de Cardiología Comité Conjunto de Clínica de la Asociación Estadounidense del Corazón. Directrices de práctica científica. J. Am Coll Cardiol. 2022; 79: 263–421.

Downloads

Published

2024-12-30

How to Cite

1.
Montes de Oca Zubizarreta SL, Victorero AA, Aguilar Cuba I, Careaga Valido D. Sacubitrilo / Valsartán: a jump of quality in the treatment of the heart inadequacy. Health Leadership and Quality of Life [Internet]. 2024 Dec. 30 [cited 2025 Aug. 24];3:.668. Available from: https://hl.ageditor.ar/index.php/hl/article/view/668