Title : Effectiveness and safety of sacubitril/valsartan in Indian patients with heart failure in the real-world setting
Abstract:
Introduction: Sacubitril/valsartan in one of the pillars of fantastic four and has been established as an effective treatment for heart failure (HF) with reduced ejection fraction based on clinical trial data; however, little is known about its use or impact in real-world practice in Indian population.
Methods: This retrospective study was conducted on adult patients newly diagnosed with HF (class I-III, as per physician discretion) and treated with sacubitril/valsartan (Tab. Sacuval, Alkem Laboratories Ltd) between Feb - April 2023 in respective doses for at least 3 months. The captured data included demographic profile, blood pressure (BP), eGFR and comorbidities. Moreover, changes in left ventricular ejection fraction (LVEF), NT-ProBNP levels, clinical symptoms (assessed on scale of 1-10, 10 being with highest severity) were evaluated post treatment with Sacubitril/valsartan in real world settings.
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 were having both type 2 diabetes and hypertension as comorbidity. There was 23% improvement in LVEF (from mean LVEF of 34 to 42, P<0.05), with significant decrease in NT-ProBNP levels (mean 1220.5 pg/ml to 118.1 pg/ml, P<0.001) 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<0.05), edema (mean score deceased from 5.5 to 1.8, p<0.05) and palpitations (mean score decreased from 2.4 to 1.1, p<0.05. Furthermore, modest decrease in mean BP was also noted (from 130/81 mmHg to 119/76 mmHg. 50 mg BD was most commonly used dose of sacubitril/valsartan (70% patients), followed by 100 mg BD (25% patients). 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 increase in ejection fraction translating into symptomatic improvement in Indian patients of HF. Sacubitril/valsartan will continue to be of great value in clinician’s armamentarium in holistic HF management.
Audience Take Away Notes
- To the best of our knowledge, this is the first study elucidating the effectiveness and safety of sacubitril/valsartan in patients, post patent expiry with availability of good quality generics at affordable cost.
- Sacubitril/valsartan revolutionized the HF management with significant improvement in ejection fraction translating into improvement in clinical symptoms.
- Contrary to western counterparts, Indian population has low SBP, low BMI, thus the dose of sacubitril/valsartan is the key to minimize chance of hypotension. We found that, 50 mg BD of sacubitril/valsartan is the most suitable dose for Indian population with good tolerability profile.
