Lessons from the BEAT Trial: Implications for Inhaled Treprostinil
Abstract
Abstract Background Combination therapy is recommended for pulmonary arterial hypertension (PAH), part of which generally includes prostanoids, which affect both the vascular tone and vessel remodeling seen in PAH. This study tested whether a dual prostacyclin treatment strategy (oral esuberaprost + inhaled treprostinil and oral background PAH therapies) would provide additional clinical benefit. Methods 271 World Health Organization functional class (FC) III/IV patients with PAH received placebo or 28.4 µg oral esuberaprost 4 times daily, in addition to newly initiated or ongoing inhaled treprostinil and background therapies. Results There was no difference between treatment groups in time to clinical worsening (primary endpoint); 49 (36.0%) patients on esuberaprost and 51 (37.8%) on placebo had a clinical worsening event. No favorable esuberaprost treatment effects were observed for the secondary or exploratory endpoints (6-minute walk distance [6MWD], Borg dyspnea score, and N-terminal pro-brain natriuretic peptide [NT-proBNP]). There were 21 all-cause deaths (esuberaprost: 8 [5.9%]; placebo: 13 [9.6%]). Post hoc exploratory analyses to investigate the effect of inhaled treprostinil on treprostinil-naïve patients (n = 151) found that the addition of inhaled treprostinil resulted in improvements in multiple components of risk status, NT-proBNP, and 6MWD from screening through week 52, irrespective of background therapy. Notably, these improvements were also seen in…
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