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- Title
Safety, Tolerability and Clinical Effects of a Rapid Dose Titration of Subcutaneous Treprostinil Therapy in Pulmonary Arterial Hypertension: A Prospective Multi-Centre Trial.
- Authors
Grünig, Ekkehard; Benjamin, Nicola; Lange, Tobias J.; Krueger, Ulrich; Klose, Hans; Neurohr, Claus; Wilkens, Heinrike; Halank, Michael; Seyfarth, Hans-Jürgen; Held, Matthias; Traube, andrew; Pernow, Michelle; Grover, E. Robert; Egenlauf, Benjamin; Gerhardt, Felix; Viethen, Thomas; Rosenkranz, Stephan
- 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.
- Subjects
PREVENTION of drug side effects; SUBCUTANEOUS injections; PULMONARY hypertension; VASODILATORS; VOLUMETRIC analysis; TREATMENT effectiveness; PHARMACODYNAMICS
- Publication
Respiration, 2016, Vol 92, Issue 6, p362
- ISSN
0025-7931
- Publication type
Article
- DOI
10.1159/000450759