A real-world study assessing the dosage pattern and demographics of patients with HFrEF initiated on ARNi in India: the ADD ARNI study
P B Jayagopal, A Pande, S Kamal, S Mittal, S Shrivastava, S Mukhopadhay, S Chintamani, A Mehta, M Shah, R Iyer, A Sugumaran, S Sawant, M SenthilnathanAbstract
Background
Angiotensin Receptor Neprilysin inhibitor (ARNi) is one of the four pillars for management of heart failure with reduced ejection fraction (HFrEF). There is paucity of Indian data on the use of ARNi in the real-world settings.
Purpose
The aim of this study was to assess the dosage pattern and treatment persistence with ARNi in HFrEF patients.
Methods
This was a real-world, multicenter, prospective, observational study conducted in India, that included patients with HFrEF. ARNi was added to their ongoing regimen and patients were followed up after 3 months.
Results
ADD ARNI evaluated dosage patterns and demographic characteristics of heart failure patients with reduced ejection fraction (HFrEF) initiated on angiotensin receptor neprilysin inhibitor (ARNi) therapy across 145 centers in India. A total of 2,302 ARNi-naïve patients (mean age: 58 years; 70% male) with NYHA class II–IV and LVEF <40% were enrolled and followed for 12 weeks. Baseline comorbidities included hypertension (77.9%), diabetes (66.2%), and coronary artery disease (61%). At initiation, 66.9% received 50 mg BID ARNi, while 17.5% received 100 mg BID; by study end, the proportion on 100 mg BID increased significantly to 24.4% (p=0.001). Various drugs use optimization was observed, with increased MRA use (48.9% to 55%, p=0.001) and reduced diuretic use (57.3% to 46.4%, p=0.001). Clinical outcomes demonstrated significant improvement in NYHA class, with 16.9% achieving class I at follow-up, and mean LVEF rising from 33.8% to 44.5% (p=0.001). NT-proBNP levels decreased markedly (1800.8 to 700.5 pg/mL, p=0.001). Safety analysis revealed low adverse event incidence (1%), primarily hypotension and cough. These findings support ARNi therapy as effective and well-tolerated in real-world Indian HFrEF patients, with notable improvements in functional status and cardiac biomarkers.
Conclusion
In this large, real-world Indian cohort of HFrEF patients, initiation of ARNi therapy over a 12-week period was associated with meaningful improvements in cardiac function, functional status, and reductions in NT-proBNP. Dose optimization and improved adherence to guideline-directed therapy were observed, with minimal adverse events, supporting the effectiveness and tolerability of ARNi in routine clinical practice. However longer duration follow-up data is needed to assess future outcomes, adherence and safety related parameters to strengthen the outcomes shown in this study.