Safety, tolerability and clinical effects of a rapid dose titration of subcutaneous treprostinil therapy in pulmonary arterial hypertension: a prospective multi-centre trial

<b><i>Background:</i></b> 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. <b><i>Objectives:</i></b&...

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Main Authors:	Grünig, Ekkehard (Author) , Benjamin, Nicola (Author) , Lange, Tobias J. (Author) , Krueger, Ulrich (Author) , Klose, Hans (Author) , Neurohr, Claus (Author) , Wilkens, Heinrike (Author) , Halank, Michael (Author) , Seyfarth, Hans-Jürgen (Author) , Held, Matthias (Author) , Traube, Andrew (Author) , Pernow, Michelle (Author) , Grover, E. Robert (Author) , Egenlauf, Benjamin (Author) , Gerhardt, Felix (Author) , Viethen, Thomas (Author) , Rosenkranz, Stephan (Author)
Format:	Article (Journal)
Language:	English
Published:	August 13, 2016
In:	Respiration Year: 2016, Volume: 92, Issue: 6, Pages: 362-370
ISSN:	1423-0356
DOI:	10.1159/000450759
Online Access:	Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1159/000450759 Verlag, lizenzpflichtig, Volltext: https://www.karger.com/Article/FullText/450759
Author Notes:	Ekkehard Grünig, Nicola Benjamin, Tobias J. Lange, Ulrich Krueger, Hans Klose, Claus Neurohr, Heinrike Wilkens, Michael Halank, Hans-Jürgen Seyfarth, Matthias Held, Andrew Traube, Michelle Pernow, E. Robert Grover, Benjamin Egenlauf, Felix Gerhardt, Thomas Viethen, Stephan Rosenkranz

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Summary:	<b><i>Background:</i></b> 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. <b><i>Objectives:</i></b> 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. <b><i>Methods:</i></b> Effects of rapid up-titration dosing regimen on tolerability and clinical parameters were evaluated in this 16-week, open-label multi-centre study. <b><i>Results:</i></b> 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. <b><i>Conclusions:</i></b> 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.
Item Description:	Gesehen am 14.08.2020
Physical Description:	Online Resource
ISSN:	1423-0356
DOI:	10.1159/000450759