SERAPHIN

Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome

Patient / Population Intervention / Exposure Comparison Outcome

In 742 patients with pulmonary arterial hypertension, macitentan reduced morbidity and mortality events compared with placebo.

742

Design

Double-blind, event-driven RCT

Endpoint

First morbidity or mortality event

Relevance

ResultHR 0.55 for the primary composite.

Pulido T, et al. N Engl J Med. 2013;369(9):809-818. 10.1056/NEJMoa1213917

Discussion & critique

First PAH trial powered for a long-term morbidity/mortality endpoint rather than 6-minute walk distance — it raised the evidentiary bar for the field.