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Safety, Tolerability and Clinical Effects of a Rapid Dose Titration of Subcutaneous Treprostinil Therapy in Pulmonary Arterial Hypertension: A Prospective Multi-Centre Trial
- Source :
- Respiration; international review of thoracic diseases. 92(6)
- Publication Year :
- 2016
-
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 :
- Endothelin Receptor Antagonists
Male
610 Medizin
030204 cardiovascular system & hematology
Infusions, Subcutaneous
0302 clinical medicine
Germany
Medicine
Prospective Studies
Prospective cohort study
Aged, 80 and over
ddc:610
Safety tolerability
Middle Aged
medicine.anatomical_structure
Treatment Outcome
Tolerability
PROSTACYCLIN
EPOPROSTENOL
SURVIVAL
INFUSION
Treprostinil
Pulmonary arterial hypertension
Subcutaneous infusion
Anesthesia
Drug Therapy, Combination
Female
Tricuspid Valve
medicine.drug
Pulmonary and Respiratory Medicine
Adult
medicine.medical_specialty
Combination therapy
Dose titration
Hypertension, Pulmonary
Walk Test
macromolecular substances
Infusion Site
03 medical and health sciences
Pharmacotherapy
Humans
Intensive care medicine
Adverse effect
Antihypertensive Agents
Aged
Dose-Response Relationship, Drug
business.industry
Phosphodiesterase 5 Inhibitors
Epoprostenol
Discontinuation
Clinical trial
Regimen
030228 respiratory system
Vascular resistance
Vascular Resistance
business
Subjects
Details
- ISSN :
- 14230356
- Volume :
- 92
- Issue :
- 6
- Database :
- OpenAIRE
- Journal :
- Respiration; international review of thoracic diseases
- Accession number :
- edsair.doi.dedup.....fd3ecf6b6cef6bdd778785f9ef2a7237