Research Article: Oral Treprostinil is Associated with Improved Survival in FREEDOM-EV and its Open-Label Extension
Abstract:
In the event-driven FREEDOM-EV trial, oral treprostinil delayed clinical worsening in patients with pulmonary arterial hypertension (PAH). Open-label extension studies offer additional data about tolerability, efficacy, and survival, especially for those initially assigned placebo. The aim of the current study was to determine if oral treprostinil changed survival when considering the parent and extension study, if treprostinil provides functional benefits for participants initially assigned to placebo, and if the benefits observed for those treated with treprostinil were durable.
Introduction:
Pulmonary arterial hypertension (PAH) is a rare but progressive and often fatal lung vascular disease, and while therapy options have greatly expanded, evidence to guide clinicians in choosing specific drugs remains sparse [1]. Historically, data from open-label extensions supplemented the primary efficacy data [2,3,4], assessing durability for those initially assigned active and any benefit for those initially assigned placebo (PBO). Three times daily oral treprostinil (TRE) was shown to reduce the risk of…
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