Sotatercept improves exercise capacity in pulmonary arterial hypertension
Treatment with sotatercept improved 6-minute walk test distance in patients with pulmonary arterial hypertension on stable background therapy compared with placebo, according to a study.
In this multicenter, double-blind, phase 3 trial, adults with pulmonary arterial hypertension who were receiving stable background therapy were randomly assigned to receive subcutaneous sotatercept (n = 163) or placebo (n = 160) every 3 weeks.
From baseline to week 24, the median change in the 6-minute walk distance was 34.4 m in the sotatercept group and 1.0 m and 1.0 m in the placebo group, with a Hodges-Lehmann estimate difference of 40.8 m (P <0.001).
Secondary endpoints, including multicomponent improvement, change in pulmonary vascular resistance, change in N-terminal pro-B-type natriuretic peptide level, improvement in WHO functional class, time to death or clinical worsening, and French risk score, were scores significantly improved with sotatercept compared with placebo.
Patients in the sotatercept group experienced more frequent epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure than those in the placebo group.
Hoeper MM, Badesch DB, Ghofrani HA, et al; STELLAR Trial Investigators. Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2023;doi: 10.1056/NEJMoa2213558. Epub ahead of print. PMID: 36877098.
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