Universität zu Köln

Gruenig, Ekkehard, Benjamin, Nicola, Lange, Tobias J., Krueger, Ulrich, Klose, Hans, Neurohr, Claus, Wilkens, Heinrike, Halank, Michael, Seyfarth, Hans-Juergen, Held, Matthias, Traube, Andrew, Pernow, Michelle, Grover, E. Robert, Egenlauf, Benjamin ORCID: 0000-0003-2466-1420, Gerhardt, Felix, 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). S. 362 - 371. BASEL: KARGER. ISSN 1423-0356

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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:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Gruenig, Ekkehard UNSPECIFIED UNSPECIFIED UNSPECIFIED Benjamin, Nicola UNSPECIFIED UNSPECIFIED UNSPECIFIED Lange, Tobias J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Krueger, Ulrich UNSPECIFIED UNSPECIFIED UNSPECIFIED Klose, Hans UNSPECIFIED UNSPECIFIED UNSPECIFIED Neurohr, Claus UNSPECIFIED UNSPECIFIED UNSPECIFIED Wilkens, Heinrike UNSPECIFIED UNSPECIFIED UNSPECIFIED Halank, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Seyfarth, Hans-Juergen UNSPECIFIED UNSPECIFIED UNSPECIFIED Held, Matthias UNSPECIFIED UNSPECIFIED UNSPECIFIED Traube, Andrew UNSPECIFIED UNSPECIFIED UNSPECIFIED Pernow, Michelle UNSPECIFIED UNSPECIFIED UNSPECIFIED Grover, E. Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED Egenlauf, Benjamin UNSPECIFIED orcid.org/0000-0003-2466-1420 UNSPECIFIED Gerhardt, Felix UNSPECIFIED UNSPECIFIED UNSPECIFIED Viethen, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Rosenkranz, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-293383
DOI:	10.1159/000450759
Journal or Publication Title:	Respiration
Volume:	92
Number:	6
Page Range:	S. 362 - 371
Date:	2016
Publisher:	KARGER
Place of Publication:	BASEL
ISSN:	1423-0356
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PROSTACYCLIN; EPOPROSTENOL; SURVIVAL; INFUSION Multiple languages Respiratory System Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/29338