Implementing the EXPEDITE parenteral induction protocol: Rapid parenteral treprostinil titration and transition to oral treprostinil.

Autor:	Kingrey JF; Integris Baptist NZTI Oklahoma City Oklahoma USA., Miller CE; Piedmont Healthcare Atlanta Georgia USA., Franco V; The Ohio State University Wexner Medical Center Columbus Ohio USA., Smith JS; The Ohio State University Wexner Medical Center Columbus Ohio USA., Zolty R; University of Nebraska Medical Center Omaha Nebraska USA., Oudiz RJ; Lundquist Institute at Harbor-UCLA Medical Center Torrance California USA., Elwing JM; University of Cincinnati College of Medicine Cincinnati Ohio USA., Huston JH; UPMC Presbyterian Pittsburgh Pittsburgh Pennsylvania USA., Melendres-Groves L; University of New Mexico School of Medicine Albuquerque New Mexico USA., Ravichandran A; Ascension St. Vincent Indianapolis Indiana USA., Balasubramanian V; Valley Advanced Lung Diseases Institute Fresno California USA., Wu B; United Therapeutics Corporation Research Triangle Park North Carolina USA., Hwang S; United Therapeutics Corporation Research Triangle Park North Carolina USA., Seaman S; United Therapeutics Corporation Research Triangle Park North Carolina USA., Broderick M; United Therapeutics Corporation Research Triangle Park North Carolina USA., Rahaghi FF; Cleveland Clinic Florida Weston Florida USA.
Jazyk:	angličtina
Zdroj:	Pulmonary circulation [Pulm Circ] 2023 Jul 25; Vol. 13 (3), pp. e12255. Date of Electronic Publication: 2023 Jul 25 (Print Publication: 2023).
DOI:	10.1002/pul2.12255
Abstrakt:	Treprostinil is a prostacyclin analogue that targets multiple cellular receptors to treat pulmonary arterial hypertension (PAH). In certain scenarios, patients may require aggressive treprostinil titration. Several studies have demonstrated that higher doses of treprostinil lead to greater clinical benefit. Data supports successful transitions from parenteral to oral treprostinil; however, administration routes, transition duration, and transition setting vary in the real-world. The EXPEDITE clinical trial (NCT03497689) prospectively studied whether rapid parenteral treprostinil induction can be used to achieve high doses of oral treprostinil (total daily dose: ≥12 mg) in prostacyclin naïve PAH patients. Parenteral prostacyclin induction may be more appropriate for patients who need to reach therapeutic dosing more urgently than longer titration durations reported with conventional de novo oral treprostinil initiation. This summary provides strategies utilized in EXPEDITE. Parenteral treprostinil was initiated at 2 ng/kg/min intravenously or subcutaneously; clinicians determined the frequency and dose increment of up-titration. Two distinct transition schedules from parenteral to oral treprostinil were employed: rapid cross-titration in an inpatient setting (median: 2 days) or gradual cross-titration in an outpatient setting (median: 5 days). Patient status was closely monitored after transition; oral treprostinil dose was titrated to clinical effect and tolerability. Factors considered when individualizing dosing strategies included parenteral and oral treprostinil target doses, nursing support, patient education, medication counseling and adverse events management. EXPEDITE demonstrated the time to a therapeutic dose of oral treprostinil is significantly shorter when utilizing a short-term parenteral induction strategy and may be suitable for patients requiring aggressive titration of oral treprostinil. Competing Interests: J. F. Kingrey is part of the speaker bureau for United Therapeutics, Bayer pharmaceuticals, and Janssen Pharmaceuticals, attends advisory boards for United Therapeutics, Bayer, and Janssen, consults for United Therapeutics, Bayer, Janssen, and conducts research for United Therapeutics, Janssen, Acceleron, Gossamer Bio. C. E. Miller is part of the speaker bureau for United Therapeutics, Janssen, and Bayer, attends advisory boards for United Therapeutics and Janssen, consults for United Therapeutics, and conducts clinical research for United Therapeutics, Janssen, Bayer, and Insmed. J. S. Smith serves as a speaker for and has received research funds from Bayer and United Therapeutics. V. Franco has served on advisory boards for United Therapeutics and has supported research for United Therapeutics, Merck, Acceleron, Johnson and Johnson, Respira, Aerovate, Cereno, and Abbott. R. Zolty has received payments for consulting on behalf of United Therapeutics, Bayer, and Janssen/Johnson and Johnson. R. J. Oudiz has received grants from Acceleron/Merck, Gossamer Bio, Insmed, Janssen, and United Therapeutics and honoraria/speaker fees from Merck, Janssen, and United Therapeutics. J. M. Elwing consults for United Therapeutics, Altavant, Aerovate, Bayer, Gossamer Bio, Liquida, and Merck and has received research support and grants from Janssen, United Therapeutics, Liquidia, Phase Bio, Gossamer Bio, Bayer, Acceleron, Altavant, Aerovate, Tenax, and Pharmosa. J. H. Huston has conducted clinical trials for Acceleron, CardiolRx, and Aadi Bioscience. L. Melendres‐Groves has received honoraria and/or fees for consultancy and advisory committees for United Therapeutics Corporation outside of submitted works. A. Ravichandran reports personal fees from United Therapeutics, Bayer, and Actelion outside the submitted work. V. Balasubramanian serves as a consultant for United Therapeutics. B. Wu, S. Hwang, S. Seaman, and M. Broderick are paid employees of United Therapeutics. F. F. Rahaghi has consulted for United Therapeutics, Janssen PH, Merck, and Altavant; served as a speaker for United Therapeutics, Janssen PH, and Bayer; and received research funding from Janssen, Bayer, Merck, Gossamer, and Bellerophon. (© 2023 The Authors. Pulmonary Circulation published by Wiley Periodicals LLC on behalf of the Pulmonary Vascular Research Institute.)
Databáze:	MEDLINE
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