Sotatercept for Combined Post- and Pre-capillary Pulmonary Hypertension Associated With Heart Failure
Results from the Phase 2, Randomized, Placebo-Controlled CADENCE Study
In this phase 2, placebo-controlled trial (n=164), sotatercept lowered pulmonary vascular resistance at week 24 in patients with combined post- and pre-capillary pulmonary hypertension associated with HFpEF. The median placebo-adjusted decline was largest in the 0.3 mg/kg arm. Until now no proven therapy existed for this CpcPH–HFpEF population, which involves remodeling in both the heart and pulmonary vasculature.
Summary
Background: Combined post- and pre-capillary pulmonary hypertension in heart failure with preserved ejection fraction (CpcPH–HFpEF) involves remodeling in both the heart and pulmonary vasculature. Despite significant mortality, there are no proven therapies.Methods: In this multicenter, randomized, placebo-controlled, phase 2 trial, adults received sotatercept (0.3 or 0.7 mg/kg) or placebo every 3 weeks. The primary end point was change in pulmonary vascular resistance at week 24. Hodges–Lehmann shift estimates described placebo-adjusted changes.Results: 164 patients were randomized 54:55:55 to sotatercept 0.3 mg/kg, 0.7 mg/kg, and placebo, and baseline median pulmonary vascular resistance was 5.2 (interquartile range [IQR] 4.0–6.9) Wood units. The median change from baseline in pulmonary vascular resistance at week 24 was –0.67 Wood units in the sotatercept 0.3 mg/kg group, –0.33 Wood units in the sotatercept 0.7 mg/kg group, and 0.26 Wood units in the placebo group. The Hodges–Lehman
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