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Dose-response relationship of oral treprostinil for secondary endpoints in the FREEDOM-EV study

R James White, E Grünig, C Jerjes-Sanchez D, G M Bohns Meyer, T Pulido, P Sepulveda, K Y Wang, C Q Deng, R Grover, D Solum, A Ousmanou, V F Tapson
European Respiratory Journal 2019 54: PA5462; DOI: 10.1183/13993003.congress-2019.PA5462
R James White
1University of Rochester Medical Center, Rochester, United States of America
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  • For correspondence: Jim_White@URMC.Rochester.edu
E Grünig
2University Hospital Heidelberg, Heidelberg, Germany
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C Jerjes-Sanchez D
3Unidad De Inv Clinica En Medicina, Monterrey, Mexico
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G M Bohns Meyer
4Complexo Hospitalar Santa Casa de Porto Alegre, Porto Alegre, Brazil
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T Pulido
5Instituto Nacional de Cardiologia Ignacio Chávez, Mexico City, Mexico
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P Sepulveda
6Hospital San Juan De Dios, University of Chile, Santiago, Chile
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K Y Wang
7Taichung Veterans General Hospital, Taichung, Taiwan
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C Q Deng
8United Therapeutics, Research Triangle Park, United States of America
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R Grover
8United Therapeutics, Research Triangle Park, United States of America
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D Solum
8United Therapeutics, Research Triangle Park, United States of America
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A Ousmanou
8United Therapeutics, Research Triangle Park, United States of America
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V F Tapson
9Cedars Sinai, Los Angeles, United States of America
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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.

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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.

  • Pulmonary hypertension
  • Treatments
  • RCT (Randomized Controlled Trial)

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
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Dose-response relationship of oral treprostinil for secondary endpoints in the FREEDOM-EV study
R James White, E Grünig, C Jerjes-Sanchez D, G M Bohns Meyer, T Pulido, P Sepulveda, K Y Wang, C Q Deng, R Grover, D Solum, A Ousmanou, V F Tapson
European Respiratory Journal Sep 2019, 54 (suppl 63) PA5462; DOI: 10.1183/13993003.congress-2019.PA5462

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Dose-response relationship of oral treprostinil for secondary endpoints in the FREEDOM-EV study
R James White, E Grünig, C Jerjes-Sanchez D, G M Bohns Meyer, T Pulido, P Sepulveda, K Y Wang, C Q Deng, R Grover, D Solum, A Ousmanou, V F Tapson
European Respiratory Journal Sep 2019, 54 (suppl 63) PA5462; DOI: 10.1183/13993003.congress-2019.PA5462
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