Interim analysis of REPAIR study of Opsumit shows improved heart function in pulmonary arterial hypertension

Actelion Pharmaceuticals announced an interim analysis from the Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension (REPAIR) study of Opsumit (macitentan) that shows treatment with Opsumit in patients with pulmonary arterial hypertension (PAH) was associated with significant improvements in right ventricular (RV) function including reversal of RV remodeling and reduced pulmonary vascular resistance (PVR). The pre-specified interim analysis including 42 patients with PAH showed significant improvements in both primary endpoints including a 15.2 mL mean increase (p<0.0001) in RV stroke volume (RVSV) and a 37% reduction (p<0.0001) in PVR from baseline at Week 26. RVSV was determined by pulmonary artery flow MRI and PVR was measured by right heart catheterization.

A full evaluation, with focus on RV, was also performed using MRI. The results from the REPAIR interim analysis suggest that treatment with Opsumit is associated with significantly improved RV function as determined by MRI in patients with PAH. In the REPAIR study, the safety profile of Opsumit was consistent with previous clinical trial data. The data are being presented at the American College of Cardiology's 68th Annual Scientific Session.