Vericiguat veilig en goed verdraagbaar bij verergerd HFrEF — VERINA

INTRODUCTION: Patients with heart failure (HF) with reduced ejection fraction (HFrEF) remain at high risk of cardiovascular (CV) death and hospitalization following a worsening heart-failure event. Data on vericiguat, a prescription oral medication used to treat symptomatic chronic HF, in adult Indian patients are limited. METHODS: Adults with chronic HFrEF and a worsening heart-failure event were enrolled in a prospective, multicenter, open-label, single-arm phase IV study design. Participants received vericiguat in addition to foundational medical therapy (FMT) and were followed for approximately 48 weeks. The primary endpoint was CV death or first hospitalization for HF. Secondary endpoints included CV death, first hospitalization for HF, all-cause death or first hospitalization for HF, all-cause death and safety outcomes. RESULTS: Of 231 patients who underwent screening, 205 received vericiguat and comprised the safety analysis set; of these, 203 patients constituted the full analysis set. The mean age of participants was 58 years. Baseline use of angiotensin receptor-neprilysin inhibitors and sodium-glucose cotransporter-2 inhibitors was 52.7% and 75.6%, respectively. At week 48, Kaplan-Meier (KM) estimates were 10.1% for the primary endpoint, 3.3% for CV death, 9.1% for first hospitalization for HF, 11.5% for all-cause death or first hospitalization for HF, and 5.9% for all-cause death. Attainment of the target dose was 91.6%, with 69.5% of participants reaching and maintaining 10 mg by week 4. Study drug-related adverse events (AEs) were reported in 3.4% of participants, and treatment-emergent AEs requiring discontinuation in 2.0% of participants. CONCLUSION: In Indian patients with worsening HFrEF, high target-dose attainment and no new safety signals were observed during 48 weeks of vericiguat treatment. TRIAL REGISTRATION: Clinical Trials Registry-India: CTRI/2022/11/047636.