Omecamtiv mecarbil reduces CV death among patients with severe systolic heart failure: JAMA
Heart failure with reduced ejection fraction is a progressive clinical syndrome, and many patients' condition worsen over time despite treatment.
Omecamtiv mecarbil is a classic, selective cardiac myosin activator, also known as a cardiac myotrope. It is known to improve cardiac function in patients with heart failure with a reduced ejection fraction however its effect on cardiovascular outcomes is unknown.
A randomized clinical study by G. Michael Felker, MD, MHS and team revealed that Omecamtiv mecarbil may be a treatment option to reduce heart failure events in patients with severe systolic heart failure.
Omecamtiv mecarbil therapy provided a clinically meaningful reduction in the composite end point of time to first Heart Failure (HF) event or Cardio Vascular (CV) death among patients with severe HF.
The findings of the study are published in JAMA Cardiology.
The objective of the study was to evaluate the efficacy and safety of omecamtiv mecarbil for the treatment of patients with severe heart failure (HF) enrolled in the GALACTIC-HF randomized clinical trial.
The study was global double-blind, placebo-controlled phase 3 randomized clinical trial that was conducted at multiple centers between January 2017 and August 2020. Patients with symptomatic HF (defined as New York Heart Association symptom class II-IV) and left ventricular ejection fraction of 35% or less were randomized to receive omecamtiv mecarbil or placebo and followed up for a median of 21.8 months. Severe HF was defined as the presence of all of the following criteria: New York Heart Association symptom class III to IV, left ventricular ejection fraction of 30% or less, and hospitalization for HF within the previous 6 months.
The results of the study were
• A total of 8232 patients enrolled in the GALACTIC-HF clinical trial, out of 2258 patients met the specified criteria for severe HF. 1106 patients were randomized to the omecamtiv mecarbil group and 1152 to the placebo group.
• Patients with severe HF who received omecamtiv mecarbil experienced a significant treatment benefit for the primary end point, whereas patients without severe HF had no significant treatment benefit.
• CV death, the results were similar (HR for patients with vs without severe HF: 0.88 [95% CI, 0.75-1.03] vs 1.10 [95% CI, 0.97-1.25]; P = .03 for interaction.
• Omecamtiv mecarbil therapy was well tolerated in patients with severe HF, with no significant changes in blood pressure, kidney function, or potassium level compared with placebo.
Dr Felker, and team concluded that "In this post hoc analysis of data from the GALACTIC-HF clinical trial, omecamtiv mecarbil therapy may have provided a clinically meaningful reduction in the composite end point of time to first HF event or CV death among patients with severe HF. These data support a potential role of omecamtiv mecarbil therapy among patients for whom current treatment options are limited."
Reference:
Felker GM, Solomon SD, Claggett B, et al. Assessment of Omecamtiv Mecarbil for the Treatment of Patients With Severe Heart Failure: A Post Hoc Analysis of Data From the GALACTIC-HF Randomized Clinical Trial. JAMA Cardiol. Published online October 13, 2021. doi:10.1001/jamacardio.2021.4027
