Cytokinetics, Inc. (Nasdaq: CYTK) today announced new data from two additional analyses from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), as well as an analysis of patients hospitalized for heart failure with reduced ejection fraction (HFrEF) from the Get With The Guidelines®-Heart Failure Registry, were presented at the American Heart Association Scientific Sessions 2022 in Chicago, IL.
“An estimated two million people in the U.S. have HFrEF with an EF ≤30%, pointing to a significant unmet need and a high cost burden. Data from GALACTIC-HF show that treatment with omecamtiv mecarbil is not only associated with a reduction in heart failure hospitalizations, but also a correspondingly significant reduction in costs associated with hospitalizations,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “Additionally, in a separate analysis from GALACTIC-HF, we observed that, although women enrolled in the trial had worse quality of life, there were no differences observed in the treatment effect for omecamtiv mecarbil between men and women.”
Reduction in Heart Failure Events for North American Patients Treated with Omecamtiv Mecarbil in GALACTIC-HF Associated with 26.9% Cost Reduction over Three Years
Nihar R. Desai, M.D., MPH, Associate Professor of Medicine, Associate Chief, Cardiovascular Medicine, Yale School of Medicine, Center for Outcomes Research and Evaluation, presented data from an analysis of the healthcare resource use, early benefit and costs of hospitalization for North American patients with heart failure with reduced ejection fraction (HFrEF) treated with omecamtiv mecarbil in GALACTIC-HF. This analysis included 1,090 (78.6%) North American patients from GALACTIC-HF matching the criteria of a subgroup of patients previously identified as being the most likely to benefit from treatment with omecamtiv mecarbil: those with an ejection fraction (EF) ≤30% and who were not receiving digoxin in the presence of atrial fibrillation at baseline. In this subgroup, treatment with omecamtiv mecarbil was associated with a reduction in the risk of the primary composite endpoint of cardiovascular death or first heart failure event (hazard ratio (HR) 0.80; 95% CI 0.68-0.95; p=0.013) and a reduction in the risk of first heart failure event (HR 0.81; 95% CI 0.67-0.98; p=0.027). Treatment with omecamtiv mecarbil also reduced the risk for total heart failure events (HR 0.76; 95% CI 0.61-0.94; p=0.010; absolute risk reduction (ARR) 14.2; number needed to treat (NNT) 7), with 44% fewer heart failure events seen at 30 days (incidence rate ratio (IRR) 0.56, p=0.035), 39% fewer heart failure events at 90 days (IRR 0.61, p=0.005), and 21% fewer heart failure events at 3 years (IRR 0.78, p=0.029), with rising ARR over time. The estimated cost reduction due to heart failure events avoided with omecamtiv mecarbil averaged $420 per patient at 30 days (38% reduction), $928 per patient at 90 days (34% reduction), and $6,052 per patient (26.9% reduction) at 3 years, suggesting that treatment with omecamtiv mecarbil is associated with both a clinical and economic benefit for patients with HFrEF.
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