A Prospective Observational Study on the Clinical Safety and Efficacy of Sacubitril and Valsartan in Heart Failure Management

Suraj Kumar G; Dharma Raju G; Rama Krishna B; Sridhar G; Manjula B

doi:10.38022/ajhp.v6i2.143

G. Suraj Kumar Department of Pharmacy Practice, Avanthi Institute of Pharmaceutical Sciences, Gunthapally, Hyderabad, Telangana, India.
editor@ajhp.online
G. Dharma Raju Department of Pharmacy Practice, Avanthi Institute of Pharmaceutical Sciences Gunthapally, Hyderabad, Telangana, India.
B. Rama Krishna Department of Pharmacy Practice, Avanthi Institute of Pharmaceutical Sciences Gunthapally, Hyderabad, Telangana, India.
G.Sridhar Department of Pharmacy Practice, Avanthi Institute of Pharmaceutical Sciences Gunthapally, Hyderabad, Telangana, India.
B. Manjula Department of Pharmaceutics, Avanthi Institute of Pharmaceutical Sciences Gunthapally, Hyderabad, Telangana, India.

DOI https://doi.org/10.38022/ajhp.v6i2.143

Abstract

Heart failure is a major cardiovascular disorder affecting millions of people worldwide and is associated with high morbidity, mortality, and frequent hospitalisation. Reduced ejection fraction (EF) is a significant indicator of disease severity and poor prognosis. The combination of Sacubitril and Valsartan has emerged as an effective therapeutic option for improving cardiac function and reducing hospitalisation in heart failure patients. The present prospective observational study was conducted to evaluate the safety and efficacy of sacubitril/valsartan in heart failure management over a period of six months at Gleneagles Hospitals. A total of 60 patients diagnosed with heart failure and reduced ejection fraction were included in the study. Patient data were collected from case records, prescriptions, laboratory reports, and medication history. Demographic distribution showed a higher prevalence among males (62%) compared to females (38%), with the majority of patients belonging to the age group of 61–70 years (33.33%). Out of 60 patients, 52 (87%) showed improvement in ejection fraction after initiation of sacubitril/valsartan therapy, indicating significant therapeutic efficacy. Furthermore, 50 patients (83.33%) demonstrated reduced frequent hospitalisation and improved quality of life. Safety evaluation revealed that 50 patients experienced no adverse drug reactions, while only 10 patients reported mild adverse effects such as hyperkalemia, angioedema, hypotension, and renal impairment. The findings conclude that sacubitril/valsartan therapy significantly improves ejection fraction, reduces hospital admissions, and provides a favourable safety profile in heart failure patients.

Keywords: Heart failure, Sacubitril, Valsartan, Ejection fraction, Hospitalisation, Safety, Therapeutic efficacy

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References

1. Savarese G, Lund LH. Global public health burden of heart failure. Card Fail Rev. 2017;3(1):7-11.
2. Roger VL. Epidemiology of heart failure. Circ Res. 2013;113(6):646-659.
3. McDonagh TA, Metra M, Adamo M, et al. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021;42(36):3599-3726.
4. Bozkurt B, Coats AJS, Tsutsui H, et al. Universal definition and classification of heart failure. J Card Fail. 2021;27(4):387-413.
5. Yancy CW, Jessup M, Bozkurt B, et al. ACC/AHA guideline for the management of heart failure. Circulation. 2017;136(6):e137-e161.
6. Sacubitril McMurray JJV, Packer M, Desai AS, et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):993-1004.
7. Velazquez EJ, Morrow DA, DeVore AD, et al. Angiotensin-neprilysin inhibition in acute decompensated heart failure. N Engl J Med. 2019;380(6):539-548.
8. Solomon SD, McMurray JJV, Anand IS, et al. Angiotensin receptor-neprilysin inhibition in heart failure with preserved ejection fraction. N Engl J Med. 2019;381(17):1609-1620.
9. R. Prasad P. L., S. Govindaraj, P, Jahnavi, P. Popatrao Taru, T. Tummala, P. Vidiyala, N. Vidiyala, P. Balaji .Metal Oxide Functionalized Nanoparticles for the Treatment of Bacterial Infection: Synthesis,Characterization, and Therapeutic Applications. J. Appl. Organomet. Chem., 2025, 5(3), 232-257.
10. Pulusu VS, Chilamula S, Holkunde A, Gunturi R, Vidiyala P, Anekalla TR. Microplastics in the Environment: Sources, Detection Techniques, and Analytical Challenges. Open Access Libr. J. 2025;12:1-33.
11. Docherty KF, Jhund PS, Inzucchi SE, et al. Effects of sacubitril/valsartan across the spectrum of ejection fraction. Lancet. 2020;396(10244):121-128.
12. Agrawal R, Proudfoot C, Rajput T. Real-world effectiveness and safety of sacubitril/valsartan in heart failure: a systematic review. Int J Cardiol. 2021;331:202-208.
13. Kommu S, Berg RL. Efficacy and safety of sacubitril/valsartan compared with RAAS inhibitors: a systematic review and meta-analysis. Heart Fail Rev. 2022;27(2):567-579.
14. Januzzi JL Jr, Prescott MF, Butler J, et al. Association of change in NT-proBNP following initiation of sacubitril/valsartan with cardiac structure and function. JAMA. 2019;322(11):1085-1095.
15. Pulusu VS, Chilamula S, Holkunde A, Gunturi R, Vidiyala P, Bashetty SR. Microplastics and nanoplastics: Environmental pathways, ecological impacts, and regulatory perspectives. Open Access Library Journal. 2025;12(12):1-31.
16. Velmurugan R, Ravikumar L, Teriveedhi VK, Vidiyala P, Jahnavi P, Vodeti R, Elumalai S. Optimized Idronoxil-Loaded Polycaprolactone Nanoparticles for Targeted Liver Cancer Therapy: A Novel Approach in Drug Delivery Systems.
17. Desai AS, Solomon SD, Shah AM, et al. Effect of sacubitril-valsartan vs enalapril on aortic stiffness in heart failure. J Am Coll Cardiol. 2019;73(3):327-336.
18. Packer M, McMurray JJV, Desai AS, et al. Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure. Circulation. 2015;131(1):54-61.
19. Jhund PS, Solomon SD, Docherty KF, et al. Efficacy of sacubitril/valsartan according to baseline risk in heart failure. Eur Heart J. 2021;42(44):4410-4419.