Detail
Article
Online article
FT
Medvik - BMC
  • Something wrong with this record ?

Long-Term Treatment With Subcutaneous Treprostinil in Patients With Severe Inoperable Chronic Thromboembolic Pulmonary Hypertension in the Multimodal Therapy Era (Data From CTREPH Study Open Label Extension)

P. Jansa, R. Sadushi-Kolici, N. Skoro-Sajer, G. Kopec, I. Simkova, R. Steringer-Mascherbauer, B. Salobir, J. Lindner, IM. Lang

. 2025 ; 15 (2) : e70080. [pub] 20250427

Status not-indexed Language English Country United States

Document type Journal Article

Persistent link   https://www.medvik.cz/link/bmc25014480

The aim of the open label extension (OLE) of CTREPH study was to characterize multimodal treatment in patients with severe inoperable CTEPH, to describe long-term subcutaneous (SC) treprostinil safety and tolerability, and to evaluate change in functional class and exercise capacity over 24 months since completion of the blinded phase of CTREPH. The target population in the OLE consisted of patients who completed 24 weeks of blinded treatment with either high-dose treprostinil of around 30 ng/kg/min (former high-dose group), or low-dose treprostinil of around 3 ng/kg/min (former low-dose group) in the CTREPH study. From the start of OLE, treprostinil dose and any additional therapy were chosen according to the standard of care and physician's discretion. Out of 47 enrolled patients, 20 patients received other PH drugs during OLE and 17 patients underwent at least 1 BPA session. Number of treprostinil-related AEs was substantially higher in the former low-dose group in comparison to the former high-dose group. Related AEs were also more frequent during the first 6 months of the preceding blinded trial than over 24 months of OLE, especially infusion site pain and all local infusion site reactions. No new safety signal was detected. Evaluated clinical outcomes show sustained benefit from long-term treprostinil treatment. Long-term SC treprostinil is a safe and effective component of multimodal treatment for patients with severe CTEPH. Patients who tolerate treprostinil after initiation are likely to continue tolerating it over time, with the clinical benefit maintained over 24 months.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc25014480
003      
CZ-PrNML
005      
20250905141409.0
007      
ta
008      
250701s2025 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1002/pul2.70080 $2 doi
035    __
$a (PubMed)40291433
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Jansa, Pavel $u Clinical Department of Cardiology and Angiology, 2nd Department of Medicine General University Hospital Prague Czech Republic $1 https://orcid.org/0000000237117064 $7 jo2008427138
245    10
$a Long-Term Treatment With Subcutaneous Treprostinil in Patients With Severe Inoperable Chronic Thromboembolic Pulmonary Hypertension in the Multimodal Therapy Era (Data From CTREPH Study Open Label Extension) / $c P. Jansa, R. Sadushi-Kolici, N. Skoro-Sajer, G. Kopec, I. Simkova, R. Steringer-Mascherbauer, B. Salobir, J. Lindner, IM. Lang
520    9_
$a The aim of the open label extension (OLE) of CTREPH study was to characterize multimodal treatment in patients with severe inoperable CTEPH, to describe long-term subcutaneous (SC) treprostinil safety and tolerability, and to evaluate change in functional class and exercise capacity over 24 months since completion of the blinded phase of CTREPH. The target population in the OLE consisted of patients who completed 24 weeks of blinded treatment with either high-dose treprostinil of around 30 ng/kg/min (former high-dose group), or low-dose treprostinil of around 3 ng/kg/min (former low-dose group) in the CTREPH study. From the start of OLE, treprostinil dose and any additional therapy were chosen according to the standard of care and physician's discretion. Out of 47 enrolled patients, 20 patients received other PH drugs during OLE and 17 patients underwent at least 1 BPA session. Number of treprostinil-related AEs was substantially higher in the former low-dose group in comparison to the former high-dose group. Related AEs were also more frequent during the first 6 months of the preceding blinded trial than over 24 months of OLE, especially infusion site pain and all local infusion site reactions. No new safety signal was detected. Evaluated clinical outcomes show sustained benefit from long-term treprostinil treatment. Long-term SC treprostinil is a safe and effective component of multimodal treatment for patients with severe CTEPH. Patients who tolerate treprostinil after initiation are likely to continue tolerating it over time, with the clinical benefit maintained over 24 months.
590    __
$a NEINDEXOVÁNO
655    _2
$a časopisecké články $7 D016428
700    1_
$a Sadushi-Kolici, Roela $u Department of Internal Medicine II, Division of Cardiology Medical University of Vienna Vienna Austria
700    1_
$a Skoro-Sajer, Nika $u Department of Internal Medicine II, Division of Cardiology Medical University of Vienna Vienna Austria
700    1_
$a Kopec, Grzegorz $u Department of Cardiac and Vascular Diseases St. John Paul II Hospital Krakow Poland $u Department of Cardiac and Vascular Diseases, Pulmonary Circulation Centre Jagiellonian University Medical College Krakow Poland
700    1_
$a Simkova, Iveta $u Department of Cardiology and Angiology of Medical Faculty, National Institute of Cardiovascular Diseases Slovak Medical University Bratislava Slovakia
700    1_
$a Steringer-Mascherbauer, Regina $u Department of Internal Medicine II Ordensklinikum Linz Elisabethinen Linz Austria
700    1_
$a Salobir, Barbara $u Department of Pulmonary Diseases and Allergy Ljubljana University Medical Centre Ljubljana Slovenia
700    1_
$a Lindner, Jaroslav $u 2nd Department of Surgery - Department of Cardiovascular Surgery General University Hospital Prague Czech Republic
700    1_
$a Lang, Irene M $u Department of Internal Medicine II, Division of Cardiology Medical University of Vienna Vienna Austria $1 https://orcid.org/0000000304852692
773    0_
$w MED00200184 $t Pulmonary circulation $x 2045-8932 $g Roč. 15, č. 2 (2025), s. e70080
856    41
$u https://pubmed.ncbi.nlm.nih.gov/40291433 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20250701 $b ABA008
991    __
$a 20250905141357 $b ABA008
999    __
$a ok $b bmc $g 2388097 $s 1251600
BAS    __
$a 3
BAS    __
$a PreBMC-PubMed-not-MEDLINE
BMC    __
$a 2025 $b 15 $c 2 $d e70080 $e 20250427 $i 2045-8932 $m Pulmonary circulation $n Pulm Circ $x MED00200184
LZP    __
$a Pubmed-20250701
Back

Find record

Citation metrics

Archiving options