Effectiveness and Safety of Sacubitril/Valsartan in Heart Failure in India: A Retrospective Real-world (SAVE) Study

Abstract

Background: Sacubitril/Valsartan is one of the pillars of heart failure (HF) management. Little is known about its uses or impact in real-world practice in the Indian population. We evaluated the effectiveness and Safety of Sacubitril/Valsartan in Heart Failure in India. Methods: This retrospective analysis involved newly diagnosed adult patients of HF (class I–IV, per physician clinical assessment and discretion), treated in a tertiary care hospital during period of February–April 2023 and received Sacubitril/Valsartan. N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels were measured in addition to demographics, clinical symptoms, comorbidities, and left ventricular ejection fraction (LVEF). Following three months of Sacubitril/Valsartan medication, changes in LVEF, NT-proBNP levels, and clinical symptoms (graded from 1 to 10, with 10 being the maximum severity) were assessed. Results: Out of 60 patients eligible for the study, 57% were males and 43% were females. Mean body weight was 60.26 ± 7.00 kg, while mean BP was 130/81 mmHg. 60% patients had both type 2 diabetes and hypertension as comorbidity. There was 23% improvement in LVEF (from mean LVEF of 34 to 42, P < .0001), with a significant decrease in NT-proBNP levels (mean 1220.5 pg/mL to 118.1 pg/mL, P < .0001) after treatment with Sacubitril/Valsartan for 3 months, resulted in marked improvement in clinical symptoms of breathlessness (mean score decreased from 6 to 2, P < .05), edema (mean score decreased from 5.5 to 1.8, P < .05) and palpitations (mean score decreased from 2.4 to 1.1, P < .05. 50 mg BD was the most commonly used dose of Sacubitril/Valsartan (70% patients), followed by 100 mg BD (25% patients) and rest (5%) with 200 mg BD dose. Treatment with Sacubitril/Valsartan was well tolerated, with <5% patients reporting hypotension. Conclusion: The findings of this real-world study suggest Sacubitril/Valsartan was associated with an increase in ejection fraction translating into symptomatic improvement in Indian patients of HF.