Abstract
Background: Oral treprostinil (TRE) decreased the risk of adjudicated clinical worsening (CW) compared to placebo (PBO) in FREEDOM-EV (HR 0.74; 95% CI 0.56,0.97; p=0.0391). This prespecified analysis hypothesized that changes in NT-proBNP, World Health Organization Functional Class (FC), Borg dyspnea score (BDS), and 6-minute walk distance (6MWD) would be dose-dependent.
Methods: Participants with pulmonary arterial hypertension (PAH) taking one PAH medication were randomized to TRE or PBO and titrated to 12 mg thrice daily (TID). Results are compared for TRE <3 or ≥3 mg TID vs. a common PBO group at Week 24 (W24). AEs occurring by W24 were included. Missing data were imputed as previously described.
Results: Baseline characteristics were similar. More than half (54%) assigned to TRE reached ≥3 mg TID at W24; median dose was 3.6 mg TID. The ≥3 mg TID group had greater clinical response compared to PBO and <3 mg TID groups. Rate of AEs and discontinuations due to AEs were similar for TRE groups.
Conclusions: Higher TRE dose facilitated greater clinical improvements at W24 in this a priori analysis. Although 6MWD effect with ≥3 mg TID was modest, it was coupled with a significant reduction in BDS. AEs did not appear dose dependent. A dose ≥3 mg TID may be a reasonable initial target in clinical practice.
Footnotes
Cite this article as: European Respiratory Journal 2019; 54: Suppl. 63, PA5462.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2019
