Results of Macitentan in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension　- A Prospective, Multicenter, Open-Label, Single-Arm, Phase 3 Study.

ABSTRACT: Background: Macitentan, an endothelin-receptor antagonist, is approved in Japan for the treatment of pulmonary arterial hypertension (PAH). This study evaluated the use of macitentan for chronic thromboembolic pulmonary hypertension (CTEPH) in Japanese patients. Methods and Results: This open-label single-arm Phase 3 study evaluated the efficacy and safety of oral macitentan 10 mg (once daily) in Japanese CTEPH patients. The study was prematurely discontinued due to the sponsor's decision to not develop macitentan 10 mg further for the indication of CTEPH (unrelated to safety concerns). Of the 9 patients enrolled in the study, 4 completed 24 weeks of treatment. The mean (±SD) ratio of pulmonary vascular resistance (PVR) at Week 16 to baseline was 71.9±34.3%. The

SUBMITTER: Sakurai S 

PROVIDER: S-EPMC8258181 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature