Safety, Tolerability and Clinical Effects of a Rapid Dose Titration of Subcutaneous Treprostinil Therapy in Pulmonary Arterial Hypertension: A Prospective Multi-Centre Trial

被引：12

作者：

Gruenig, Ekkehard ^{[1
]}

Benjamin, Nicola ^{[1
]}

Lange, Tobias J. ^{[2
]}

Krueger, Ulrich ^{[3
]}

Klose, Hans ^{[4
]}

Neurohr, Claus ^{[5
]}

Wilkens, Heinrike ^{[6
]}

Halank, Michael ^{[7
]}

Seyfarth, Hans-Juergen ^{[8
]}

Held, Matthias

Traube, Andrew ^{[10
]}

Pernow, Michelle ^{[9
,10
]}

Grover, E. Robert ^{[10
]}

Egenlauf, Benjamin ^{[1
]}

Gerhardt, Felix ^{[11
,12
]}

Viethen, Thomas ^{[11
,12
]}

Rosenkranz, Stephan ^{[11
,12
]}

机构：

[1] Heidelberg Univ, Thorax Clin, Ctr Pulm Hypertens, Rontgenstr 1, DE-69126 Heidelberg, Germany

[2] Univ Med Ctr Regensburg, Dept Internal Med 2, Regensburg, Germany

[3] Hosp Niederrhein, Dept Cardiol, Duisburg, Germany

[4] Univ Hamburg, Dept Pneumol, Hamburg, Germany

[5] Univ Munich, Dept Pneumol, Munich, Germany

[6] Univ Homburg, Dept Pneumol, Homburg, Germany

[7] Univ Dresden, Dept Pneumol, Dresden, Germany

[8] Univ Leipzig, Dept Pneumol, Leipzig, Germany

[9] Mission Med Hosp, Ctr Pulm Hypertens & Pulm Vasc Dis, Dept Internal Med, Wurzburg, Germany

[10] United Therapeut Europe Ltd, Chertsey, England

[11] Univ Hosp Cologne, Dept Cardiol, Cologne, Germany

[12] Univ Cologne, CCRC, Cologne, Germany

来源：

RESPIRATION | 2016年 / 92卷 / 06期

关键词：

Treprostinil; Pulmonary arterial hypertension; Subcutaneous infusion; PROSTACYCLIN; EPOPROSTENOL; SURVIVAL; INFUSION;

D O I：

10.1159/000450759

中图分类号：

R56 [呼吸系及胸部疾病];

学科分类号：

摘要：

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.

引用

页码：362 / 370

页数：9

共 41 条

[41] A phase II prospective, randomized, double-blind, placebo-controlled multi-centre clinical trial to assess the safety of 0.005% estriol vaginal gel in hormone receptor-positive postmenopausal women with early stage breast cancer in treatment with aromatase inhibitors (AIs) in the adjuvant setting - Initial safety results
Sanchez Rovira, P.
Gil Gil, M.
Presa Lorita, J.
Suarez Almarza, J.
Nieto Magro, C.
[J]. EUROPEAN JOURNAL OF CANCER, 2016, 57 : S44 - S44

← 1 2 3 4 5 →