GALACTIC-HF was a global double-blind, placebo-controlled randomized trial including more than 8,000 recently hospitalized patients at multiple centers that showed modest benefits in the overall HF population.
The post-hoc analysis looked at the subgroup of patients with severe HF, defined as New York Heart Association symptom class II-IV and left ventricular ejection fraction of 35% or less.
"We found that OM had clinically important benefits in (these) patients," Dr. G. Michael Felker of Duke Clinical Research Institute in Durham told Reuters Health by email. "These findings were perhaps not surprising given the mechanism of action of OM - i.e., improvement in systolic performance, which might be expected to provide more benefit in patients with more severe HF."
"These data, which used readily available markers of HF severity - ejection fraction, NYHA class, and recent HF hospitalization - will help clinicians identify those patients most likely to experience a substantial clinical benefit from OM," he said.
"We have not seen any signal in GALACTIC that there is a differential effect by race or ethnicity," he added, "so we would not expect different results in a different patient population."
As reported in JAMA Cardiology, the post-hoc analysis included 2,258 patients (mean age, 64; 79% men) randomized to OM or placebo, and compared results in participants with and without severe HF.
The primary end point was time to first HF event or CV death. Secondary end points included time to CV death and safety and tolerability.
Patients randomized to OM had a significant benefit (20% relative risk reduction) for the primary end point (hazard ratio, 0.80), whereas those without severe HF did not (HR, 0.99).
Results were similar for CV death: HRs for patients with or without severe HF were 0.88 versus 1.10. OM was well tolerated in those with severe disease, with no significant changes in blood pressure, kidney function, or potassium level compared with placebo.
A sensitivity analysis of OM benefits in patients who met all three severe HF criteria showed that a 20% relative risk reduction in the primary end point in the context of high baseline risk translated to an absolute risk reduction of 8.3 events per 100 patient-years (34.3 events per 100 patient-years for OM group vs. 42.6 events for placebo).
The authors conclude, "These data support a potential role of omecamtiv mecarbil therapy among patients for whom current treatment options are limited."
JAMA Cardiology Section Editor Dr. Gregg Fonarow of the David Geffen School of Medicine, University of California, Los Angeles, commented in an email to Reuters Health, "This is a cohort of HF patients at high risk despite use of other established medical therapies. This analysis defines a group of patients that while currently classified as Stage C, may be better described as being Stage C2."
"Should OM become FDA-approved, this analysis has provided useful guidance as to which HF patients would be best targeted for treatment," he said. "Additional studies of this agent in patients with severe HF, including in more race/ethnically diverse populations, would also be useful."
The GALACTIC-HF trial was funded by Amgen, Cytokinetics, and Servier Laboratories. Dr. Felker and many coauthors have received funds from one or more of these companies, as has Dr. Fonarow.
SOURCE: https://bit.ly/3B8teCB and https://bit.ly/3vqKXDT JAMA Cardiology, online October 13, 2021.
By Marilynn Larkin
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