Vericiguat appears to reduce the risk of the composite end point of death due to cardiovascular causes or hospitalization for heart failure (HF) in symptomatic chronic heart failure patients, according to results from the VICTORIA trial.
In this phase 3 trial, the safety and efficacy of vericiguat, a novel, orally administered, soluble guanylate cyclase stimulator, were assessed in patients with heart failure and reduced ejection fraction (HFrEF) following a worsening event. Patients included in the randomized, double-blind, placebo-controlled trial were required to have chronic heart failure (New York Heart Association class II, III, or IV) as well as an ejection fraction of <45%.
In addition to guideline-based therapy, patients (N=5050) received either vericiguat (target dose: 10mg once daily) or placebo. The primary end point of the study was a composite of death due to cardiovascular causes or first HF hospitalization.
Results of the study showed that vericiguat, in combination with other HF therapies, reduced the risk for the composite end point compared with placebo. The authors reported that 35.5% (897/2526) of patients who received vericiguat experienced a primary-outcome event compared with 38.5% (972/2524) of placebo patients (hazard ratio [HR], 0.90; 95% CI, 0.82-0.98; P =.02) over a median of 10.8 months.
“The 10% relative difference between the groups in the primary composite outcome in this high-risk population at a median follow-up of 10.8 months translated into an absolute event-rate reduction of 4.2 events per 100 patient-years,” the authors explained, adding that “Based on this absolute risk reduction, the number needed to treat with vericiguat for 1 year to prevent a primary-outcome event is approximately 24 patients.”
Findings of the study also revealed that the incidence rates for serious adverse events were similar for patients who received vericiguat compared with those who received placebo (32.8% vs 34.8%, respectively). The analysis did indicate, however, that a larger number of vericiguat patients experienced symptomatic hypotension as well as syncope vs placebo (symptomatic hypotension: 9.1% vs 7.9%, respectively; P =.12; syncope: 4.0% vs 3.5%, respectively; P =.30).
“For this group of chronic heart failure patients at high risk for future events, vericiguat has the potential to provide a significant addition to usual guideline-based treatment,” said Paul W. Armstrong, MD, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, the study’s lead author. “We are pleased with the observed absolute risk reduction and are hopeful that this result may open up a new avenue for appropriate patients and a possible path for future discovery in cardiovascular heart disease.”
Armstrong, P et al; for the VICTORIA Study Group. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. New England Journal of Medicine. DOI: 10.1056/NEJMoa1915928