Gruenig, Ekkehard and Benjamin, Nicola and Lange, Tobias J. and Krueger, Ulrich and Klose, Hans and Neurohr, Claus and Wilkens, Heinrike and Halank, Michael and Seyfarth, Hans-Juergen and Held, Matthias and Traube, Andrew and Pernow, Michelle and Grover, E. Robert and Egenlauf, Benjamin and Gerhardt, Felix and Viethen, Thomas and Rosenkranz, Stephan (2016) Safety, Tolerability and Clinical Effects of a Rapid Dose Titration of Subcutaneous Treprostinil Therapy in Pulmonary Arterial Hypertension: A Prospective Multi-Centre Trial. RESPIRATION, 92 (6). pp. 362-370. ISSN 0025-7931, 1423-0356
Full text not available from this repository. (Request a copy)Abstract
Background: Subcutaneous treprostinil has dose-dependent beneficial effects in patients with severe pulmonary arterial hypertension, but adverse effects like infusion site pain can lead to treatment discontinuation. Objectives: The objective of this study was to evaluate safety, tolerability and clinical effects of a rapid up-titration dosing regimen of subcutaneous treprostinil using proactive infusion site pain management. Methods: Effects of rapid up-titration dosing regimen on tolerability and clinical parameters were evaluated in this 16-week, open-label multi-centre study. Results: Thirty-nine patients with idiopathic or heritable pulmonary arterial hypertension on stable treatment with oral pulmonary arterial hypertension-approved drugs (90% on dual combination therapy) were included. Patients achieved a median treprostinil dosage of 35.7 ng/kg/min after 16 weeks. A good overall safety profile was demonstrated with 3 patients (8%) withdrawing due to infusion site pain, which occurred in 97% of patients. After 16 weeks, median 6-min walking distance, cardiac index, pulmonary vascular resistance, and tricuspid annular plane systolic excursion improved. Conclusions: Rapid up-titration of subcutaneous treprostinil was well tolerated, achieving a clinically effective dose associated with improvement of exercise capacity and haemodynamics after 16 weeks. A rapid dose titration regimen and proactive infusion site pain management may improve the handling of this therapy and contribute to better treatment outcome. (C) 2016 S. Karger AG, Basel.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PROSTACYCLIN; EPOPROSTENOL; SURVIVAL; INFUSION; Treprostinil; Pulmonary arterial hypertension; Subcutaneous infusion |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 13 Mar 2019 14:15 |
| Last Modified: | 13 Mar 2019 14:15 |
| URI: | https://pred.uni-regensburg.de/id/eprint/2616 |
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