Sotatercept for Combined Post- and Pre-capillary Pulmonary Hypertension Associated With Heart Failure: Results from the Phase 2, Randomized, Placebo-Controlled CADENCE Study - PubMed
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- #Clinical Trial
- #Pulmonary Hypertension
- #Heart Failure
- Sotatercept, an activin signalling inhibitor, was evaluated in a phase 2 trial for combined post- and pre-capillary pulmonary hypertension in heart failure with preserved ejection fraction (CpcPH-HFpEF), a condition with no proven therapies.
- In the randomized, placebo-controlled CADENCE study with 164 patients, sotatercept doses of 0.3 mg/kg and 0.7 mg/kg every 3 weeks significantly reduced pulmonary vascular resistance compared to placebo at week 24, with Hodges-Lehmann shift estimates of -1.02 and -0.75 Wood units, respectively.
- The treatment also led to reductions in mean pulmonary arterial pressure and pulmonary arterial wedge pressure, and a modest improvement in 6-minute walk distance for the 0.3 mg/kg dose.
- Common adverse events included increased hemoglobin and diarrhea, but the study provides proof of concept for improved pulmonary and cardiac hemodynamics with sotatercept in CpcPH-HFpEF.