Potential Applicability of Omecamtiv Mecarbil to Patients Hospitalized for Worsening Heart Failure.

In the Global Approach to Lowering Adverse Cardiac Outcomes through Improving Contractility in Heart Failure (GALACTIC-HF) trial, omecamtiv mecarbil (OM), a selective cardiac myosin activator, reduced the risk of cardiovascular death or heart failure (HF) event (defined as a hospitalization or urgent visit for HF) in patients with chronic HF and left ventricular ejection fraction (LVEF) ≤ 35%, with prespecified secondary analyses suggesting a larger treatment benefit as baseline LVEF decreased. 1 Teerlink JR Diaz R Felker GM McMurray JJV Metra M Solomon SD Adams KF Anand I Arias-Mendoza A Biering-Sørensen T Böhm M Bonderman D Cleland JGF Corbalan R Crespo-Leiro MG Dahlström U Echeverria LE Fang JC Filippatos G Fonseca C Goncalvesova E Goudev AR Howlett JG Lanfear DE Li J Lund M Macdonald P Mareev V Momomura SI O'Meara E Parkhomenko A Ponikowski P Ramires FJA Serpytis P Sliwa K Spinar J Suter TM Tomcsányi J Vandekerckhove H Vinereanu D Voors AA Yilmaz MB Zannad F Sharpsten L Legg JC Varin C Honarpour N Abbasi SA Malik FI Kurtz CE GALACTIC-HF InvestigatorsCardiac myosin activation with omecamtiv mecarbil in systolic heart failure. N Engl J Med. 2021; 384: 105-116 Crossref PubMed Scopus (315) Google Scholar However, despite the GALACTIC-HF trial meeting the primary efficacy end point and identifying no significant safety concerns with OM, the US Food and Drug Administration rejected an initial application for drug approval, stating that an additional clinical trial was required to establish substantial evidence of OM effectiveness with benefits that outweigh the risks. Although the future of OM drug approval in the United States and worldwide remains unclear, understanding the applicability of the GALACTIC-HF eligibility criteria to patients hospitalized for HF with reduced ejection fraction (HFrEF) may inform the use and anticipated impact of OM should regulatory approval occur. The present study aimed to examine the proportion and characteristics of patients hospitalized for worsening HFrEF in clinical practice who may be potential candidates for OM and treatment eligibility in the subset of patients with severely reduced LVEF ≤ 30%.