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Oral Treprostinil is Associated with Improved Survival in FREEDOM-EV and its Open-Label Extension
Ekkehard Grünig1, Franck Rahaghi2, Jean Elwing3
1Thoraxklinik-Heidelberg gGmbH, and German Center for Lung Research (DZL), Heidelberg, Germany.
Oral treprostinil significantly improved survival in patients with pulmonary arterial hypertension (PAH). Patients initially on placebo who switched to oral treprostinil experienced substantial functional gains, demonstrating durable benefits.
Area of Science:
- Cardiology
- Pulmonology
- Pharmacology
Background:
- Pulmonary arterial hypertension (PAH) is a severe condition.
- Oral treprostinil has shown promise in delaying clinical worsening in PAH patients.
- Open-label extension studies provide valuable long-term data on treatment efficacy and survival.
Purpose of the Study:
- To evaluate the impact of oral treprostinil on overall survival in PAH patients.
- To assess functional benefits in patients initially receiving a placebo.
- To determine the durability of treprostinil's benefits.
Main Methods:
- Analysis of data from the FREEDOM-EV trial and its open-label extension (OLE).
- Kaplan-Meier survival analysis and Cox proportional hazards modeling.
- Assessment of functional class, 6-minute walk distance (6MWD), and NT-proBNP levels.
Main Results:
- Initial assignment to oral treprostinil reduced mortality by 9% (HR 0.64, p=0.013).
- Patients switched from placebo to treprostinil showed significant improvements in functional class, 6MWD (+84m), and NT-proBNP (-778 pg/mL).
- High adherence (92%) and sustained benefits were observed in patients continuing treprostinil.
Conclusions:
- Oral treprostinil significantly improves survival in PAH patients.
- Switching to oral treprostinil post-worsening provides substantial functional benefits.
- The positive effects of oral treprostinil are durable and well-tolerated.
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