Retrospective, non-interventional database study for the evaluation of real-world drug use patterns, clinical characteristics and clinical outcomes in patients initiated on Vericiguat in India

Vericiguat is a first in class soluble guanylate cyclase (sGC) stimulator that is indicated for reducing the risk of cardiovascular death and hospitalization for heart failure (HF) in adults who have symptomatic chronic heart failure or in adults with an ejection fraction of less than 45% who have recently been hospitalized for heart failure, that has been approved by the U.S. Food & Drug Administration (FDA) in January 2021 and approved in India in February 2022. On the basis of the VICTORIA trial, Vericiguat is specifically recognized for the management of Worsening Heart Failure (WHF) in recent guidelines for heart failure with reduced ejection fraction (HFrEF). The recommended starting dose of Vericiguat is 2.5 mg orally once daily with food which is to be doubled approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient.[¹,²,³] Vericiguat enhances the cyclic guanosine monophosphate (GMP) pathway by directly stimulating soluble guanylate cyclase through a binding site independent of nitric oxide, and it sensitizes soluble guanylate cyclase to endogenous nitric oxide by stabilizing nitric oxide binding to the binding site. The nitric oxide-sGC-cGMP pathway is important in the development and progression of heart failure but is relatively unexplored. No other disease-modifying heart failure drugs act on this pathway. HF with reduced ejection fraction (HFrEF) is the most prevalent type of HF in India, as seen in the recent Trivandrum HF registry. The in-hospital mortality and all-cause mortality rate is higher in patients with HFrEF. HF leads to 1.8 million hospitalizations each year in India. According to the Manipal Heart Failure Registry (MHFR), the average length of a hospital stay for HF during the initial admission is 5.3 ± 2.9 days and the average overall cost per patient is 1.3 Lakh INR. Although chronic HF management has improved significantly, heart failure remains a progressive clinical syndrome with a poor prognosis, leading to millions of hospitalizations worldwide. Although there is currently a limited real-world data on usage of Vericiguat, discussing the early initiation of Vericiguat in different patient profiles with worsening HF can assist clinicians in managing these patients effectively. Identifying diverse patient profiles that would benefit from Vericiguat therapy is essential. Currently vericiguat is approved in India for the management of worsening heart failure in patients with chronic HFrEF with left ventricular ejection fraction (LVEF) <45%. This retrospective data analysis will help generate insights and inform clinicians on clinical characteristics of patients initiated on Vericiguat, drug utilization patterns and the initial outcomes observed in real world setting. The study’s results will help health care professionals (HCP’s) identify right patient profiles for Vericiguat initiation, leading to optimal management of WHF, thereby reducing HF hospitalization and mortality.