Real-world dosing characteristics and utilization of parenteral treprostinil in the outpatient setting.

Autor: Balasubramanian VP; Division of Pulmonary and Critical Care Medicine University of California, San Francisco Fresno California USA., Safdar Z; Division of Pulmonary Critical Care Medicine and Sleep Houston Methodist Lung Center Houston Texas USA.; Weill Cornell College of Medicine Houston Texas USA., Sketch MR; United Therapeutics Corporation Research Triangle Park North Carolina USA., Broderick M; United Therapeutics Corporation Research Triangle Park North Carolina USA., Nelsen AC; United Therapeutics Corporation Research Triangle Park North Carolina USA., Lee D; United Therapeutics Corporation Research Triangle Park North Carolina USA.; Department of Statistics North Carolina State University Raleigh North Carolina USA., Melendres-Groves L; Division of Pulmonary, Critical Care and Sleep Medicine University of New Mexico Albuquerque New Mexico USA.
Jazyk: angličtina
Zdroj: Pulmonary circulation [Pulm Circ] 2022 Jan 12; Vol. 12 (1), pp. e12016. Date of Electronic Publication: 2022 Jan 12 (Print Publication: 2022).
DOI: 10.1002/pul2.12016
Abstrakt: Real-world dosing and titration of parenteral (subcutaneous, SC; intravenous, IV) prostacyclin, a mainstay of pulmonary arterial hypertension (PAH) treatment, is not always consistent with prescribing information or randomized trials and has yet to be adequately characterized. The current study describes real-world outpatient dosing and titration patterns over time, in PAH patients initiated on SC or IV treprostinil. A longitudinal, cross-sectional analysis of medication shipment records from US specialty pharmacy services between 2009 and 2018 was conducted to determine dosing and titration patterns of SC or IV treprostinil in the outpatient setting beginning with the patient's first shipment. The sample for analysis included shipment records for 2647 patients (IV = 1040, SC = 1607). Although more patients were started on SC treprostinil than IV, median initial outpatient IV treprostinil dose (11 ng/kg/min at month on therapy one [MOT1]) was consistently and statistically significantly higher than initial outpatient SC dose (7.5 ng/kg/min at MOT1; p  < 0.01). However, the SC treprostinil dose acceleration rate (DAR) was more aggressive from MOT1 to MOT6, MOT12, and MOT24, leading to a higher dose achieved at later timepoints. All between-group DAR differences were statistically significant ( p  < 0.001). This study provides evidence that real-world prescribing patterns of parenteral treprostinil in the outpatient setting differs from dosing described in pivotal trials, with important differences between SC and IV administration. Although initial outpatient IV treprostinil dosing was higher, SC titration was accelerated more aggressively and a higher dose was achieved by MOT3 suggesting that factors specific to SC administration (e.g., site pain) may not limit dosing and titration as previously thought.
Competing Interests: Lana Melendres‐Groves has received honoraria and/or fees for consultancy and advisory committees from United Therapeutics Corporation, outside of the submitted work; Zeenat Safdar has received honoraria and/or fees for consultancy and advisory committees from United Therapeutics Corporation, Bayer Pharmaceuticals, Actelion Pharmaceuticals, Boehringer Ingelheim, and Genentech, outside the submitted work. Margaret R. Sketch, Meredith Broderick, and Andrew C. Nelsen are employees of United Therapeutics Corporation. Dasom Lee has nothing to disclose. Vijay P. Balasubramanian has received research support, honoraria, and/or fees for consultancy and an advisory committee from United Therapeutics Corporation, speaker bureau, and advisory committee honoraria and/or fees from Bayer Pharmaceuticals, and speaker bureau honoraria and/or fees from Boehringer Ingelheim, outside the submitted work.
(© 2021 The Authors. Pulmonary Circulation published by John Wiley & Sons Ltd on behalf of Pulmonary Vascular Research Institute.)
Databáze: MEDLINE
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