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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.
Respiration. 2016; 92(6):362-370.R

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.

Authors+Show Affiliations

Centre for Pulmonary Hypertension, Thorax Clinic at the University of Heidelberg, Heidelberg, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

27784026

Citation

Grünig, Ekkehard, et al. "Safety, Tolerability and Clinical Effects of a Rapid Dose Titration of Subcutaneous Treprostinil Therapy in Pulmonary Arterial Hypertension: a Prospective Multi-Centre Trial." Respiration; International Review of Thoracic Diseases, vol. 92, no. 6, 2016, pp. 362-370.
Grünig E, Benjamin N, Lange TJ, et al. Safety, Tolerability and Clinical Effects of a Rapid Dose Titration of Subcutaneous Treprostinil Therapy in Pulmonary Arterial Hypertension: A Prospective Multi-Centre Trial. Respiration. 2016;92(6):362-370.
Grünig, E., Benjamin, N., Lange, T. J., Krueger, U., Klose, H., Neurohr, C., Wilkens, H., Halank, M., Seyfarth, H. J., Held, M., Traube, A., Pernow, M., Grover, E. R., Egenlauf, B., Gerhardt, F., Viethen, T., & Rosenkranz, S. (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; International Review of Thoracic Diseases, 92(6), 362-370.
Grünig E, et al. Safety, Tolerability and Clinical Effects of a Rapid Dose Titration of Subcutaneous Treprostinil Therapy in Pulmonary Arterial Hypertension: a Prospective Multi-Centre Trial. Respiration. 2016;92(6):362-370. PubMed PMID: 27784026.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety, Tolerability and Clinical Effects of a Rapid Dose Titration of Subcutaneous Treprostinil Therapy in Pulmonary Arterial Hypertension: A Prospective Multi-Centre Trial. AU - Grünig,Ekkehard, AU - Benjamin,Nicola, AU - Lange,Tobias J, AU - Krueger,Ulrich, AU - Klose,Hans, AU - Neurohr,Claus, AU - Wilkens,Heinrike, AU - Halank,Michael, AU - Seyfarth,Hans-Jürgen, AU - Held,Matthias, AU - Traube,Andrew, AU - Pernow,Michelle, AU - Grover,E Robert, AU - Egenlauf,Benjamin, AU - Gerhardt,Felix, AU - Viethen,Thomas, AU - Rosenkranz,Stephan, Y1 - 2016/10/27/ PY - 2016/08/13/received PY - 2016/09/13/accepted PY - 2016/10/27/pubmed PY - 2017/9/20/medline PY - 2016/10/27/entrez SP - 362 EP - 370 JF - Respiration; international review of thoracic diseases JO - Respiration VL - 92 IS - 6 N2 - 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. SN - 1423-0356 UR - https://www.unboundmedicine.com/medline/citation/27784026/Safety_Tolerability_and_Clinical_Effects_of_a_Rapid_Dose_Titration_of_Subcutaneous_Treprostinil_Therapy_in_Pulmonary_Arterial_Hypertension:_A_Prospective_Multi_Centre_Trial_ L2 - https://www.karger.com?DOI=10.1159/000450759 DB - PRIME DP - Unbound Medicine ER -