RCT | Sotatercept improves exercise capacity in patients with pulmonary arterial hypertension

Summary: This multicenter, double-blind randomized trial involved 323 adults with Pulmonary Arterial Hypertension (PAH) who were randomized to receive either subcutaneous sotatercept or placebo every three weeks for 24 weeks.

The primary endpoint was the change from baseline in the 6-minute walk distance. Sotatercept demonstrated a greater improvement in exercise capacity compared to placebo and improved secondary endpoints, including pulmonary vascular resistance and WHO functional class.

Adverse events were more common in the sotatercept group and included epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure.

Article: Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries:

STELLAR, ‘Impressive’ Results With Novel Drug Sotatercept in PAH – TCTMD

A Study of Sotaterceptin Combination With Background Therapy for the Treatment of Pulmonary Arterial Hypertension – STELLAR – American College of Cardiology