Safety and tolerability of transition from inhaled treprostinil to oral selexipag in pulmonary arterial hypertension: Results from the TRANSIT-1 study.
Acetamides
/ administration & dosage
Administration, Inhalation
Administration, Oral
Antihypertensive Agents
/ administration & dosage
Dose-Response Relationship, Drug
Drug Substitution
Drug Tolerance
Epoprostenol
/ administration & dosage
Female
Follow-Up Studies
Humans
Male
Middle Aged
Prodrugs
Prospective Studies
Pulmonary Arterial Hypertension
/ drug therapy
Pulmonary Wedge Pressure
/ physiology
Pyrazines
/ administration & dosage
Treatment Outcome
inhaled treprostinil
prostacyclin-pathway targeting therapy
pulmonary arterial hypertension
selexipag
treatment transition
Journal
The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation
ISSN: 1557-3117
Titre abrégé: J Heart Lung Transplant
Pays: United States
ID NLM: 9102703
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
received:
26
04
2018
revised:
28
08
2018
accepted:
05
09
2018
pubmed:
6
11
2018
medline:
26
12
2019
entrez:
5
11
2018
Statut:
ppublish
Résumé
A long-term trial showed that the oral prostacyclin (PGl Patients receiving non-prostanoid oral PAH therapy and inhaled treprostinil at stable doses, in World Health Organization Functional Class II/III, with 6-minute walk distance ≥ 300 meters were enrolled. The 16-week main treatment period included downtitration of inhaled treprostinil over 8 weeks and parallel uptitration of selexipag over 12 weeks. Sustained treatment transition at Week 16 was defined as (1) receiving selexipag at Week 16; (2) no selexipag interruption(s) totaling ≥ 8 days; and (3) no inhaled treprostinil or other prostanoids after Week 8. Clinical parameters and patient-reported treatment satisfaction outcomes were assessed at Week 16. All 34 enrolled patients completed the study. At Week 16, 32 patients (94.1%) had stopped inhaled treprostinil and were receiving selexipag. Twenty-eight patients (82.4%) met all criteria for sustained treatment transition. During the study, 3 patients discontinued selexipag due to adverse events. Overall, most adverse events were typical of prostanoid therapies and started during the uptitration phase. In general, patients remained clinically stable throughout treatment and reported improved convenience. Transition to oral selexipag from inhaled treprostinil in PAH patients was successful and well tolerated in most patients, and associated with greater convenience. NCT02471183.
Sections du résumé
BACKGROUND
A long-term trial showed that the oral prostacyclin (PGl
METHODS
Patients receiving non-prostanoid oral PAH therapy and inhaled treprostinil at stable doses, in World Health Organization Functional Class II/III, with 6-minute walk distance ≥ 300 meters were enrolled. The 16-week main treatment period included downtitration of inhaled treprostinil over 8 weeks and parallel uptitration of selexipag over 12 weeks. Sustained treatment transition at Week 16 was defined as (1) receiving selexipag at Week 16; (2) no selexipag interruption(s) totaling ≥ 8 days; and (3) no inhaled treprostinil or other prostanoids after Week 8. Clinical parameters and patient-reported treatment satisfaction outcomes were assessed at Week 16.
RESULTS
All 34 enrolled patients completed the study. At Week 16, 32 patients (94.1%) had stopped inhaled treprostinil and were receiving selexipag. Twenty-eight patients (82.4%) met all criteria for sustained treatment transition. During the study, 3 patients discontinued selexipag due to adverse events. Overall, most adverse events were typical of prostanoid therapies and started during the uptitration phase. In general, patients remained clinically stable throughout treatment and reported improved convenience.
CONCLUSIONS
Transition to oral selexipag from inhaled treprostinil in PAH patients was successful and well tolerated in most patients, and associated with greater convenience.
CLINICAL TRIAL NUMBER
NCT02471183.
Identifiants
pubmed: 30391194
pii: S1053-2498(18)31644-9
doi: 10.1016/j.healun.2018.09.003
pii:
doi:
Substances chimiques
Acetamides
0
Antihypertensive Agents
0
Prodrugs
0
Pyrazines
0
selexipag
5EXC0E384L
Epoprostenol
DCR9Z582X0
treprostinil
RUM6K67ESG
Banques de données
ClinicalTrials.gov
['NCT02471183']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
43-50Subventions
Organisme : NHLBI NIH HHS
ID : K23 HL105784
Pays : United States
Informations de copyright
Copyright © 2018. Published by Elsevier Inc.