Time to clinical improvement: an appropriate surrogate endpoint for pulmonary arterial hypertension medication trials.

ABSTRACT:

Background

Many retrospective studies suggest that risk improvement may be a suitable efficacy surrogate endpoint for pulmonary arterial hypertension (PAH) medication trials. This prospective multicenter study assessed the efficacy of domestic ambrisentan in Chinese PAH patients and observed risk improvement and time to clinical improvement (TTCI) under ambrisentan treatment.

Methods

Eligible patients with PAH were enrolled for a 24-week treatment with ambrisentan. The primary efficacy endpoint was 6-min walk distance (Δ6MWD). The exploratory endpoints were risk improvement and TTCI, defined as the time from initiation of treatment to the first occurrence of risk improvement.

Results

A total of 83 subjects were enrolled. After ambrisentan treatment, Δ6MWD was signific

SUBMITTER: Wang A 

PROVIDER: S-EPMC10291317 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature