Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study.

ABSTRACT:

Background

Following positive results from the Phase III CHEST-1 study in patients with inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), the Phase IIIb CTEPH early access study (EAS) was designed to assess the safety and tolerability of riociguat in real-world clinical practice, as well as to provide patients with early access to riociguat before launch. Riociguat is approved for the treatment of inoperable and persistent/recurrent CTEPH.

Methods

We performed an open-label, uncontrolled, single-arm, early access study in which 300 adult patients with inoperable or persistent/recurrent CTEPH received riociguat adjusted from 1 mg three times daily (tid) to a maximum of 2.5 mg tid. Patients switching from unsatisfactory prior pulmonary a

SUBMITTER: McLaughlin VV 

PROVIDER: S-EPMC5745920 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature