Selexipag for Chronic Thromboembolic Pulmonary Hypertension in Japanese Patients - A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase II Study.
Acetamides
/ adverse effects
Adult
Aged
Antihypertensive Agents
/ adverse effects
Chronic Disease
Double-Blind Method
Female
Humans
Hypertension, Pulmonary
/ complications
Japan
/ epidemiology
Male
Middle Aged
Prognosis
Pulmonary Embolism
/ complications
Pyrazines
/ adverse effects
Receptors, Epoprostenol
/ agonists
Treatment Outcome
Vascular Resistance
/ drug effects
Chronic thromboembolic pulmonary hypertension
Prostacyclin receptor agonist
Pulmonary hemodynamics
Safety
Selexipag
Journal
Circulation journal : official journal of the Japanese Circulation Society
ISSN: 1347-4820
Titre abrégé: Circ J
Pays: Japan
ID NLM: 101137683
Informations de publication
Date de publication:
25 09 2020
25 09 2020
Historique:
pubmed:
4
9
2020
medline:
14
10
2021
entrez:
4
9
2020
Statut:
ppublish
Résumé
Selexipag is an oral prostacyclin receptor (IP receptor) agonist with a non-prostanoid structure. This study examined its efficacy and safety in Japanese patients with non-operated or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH).Methods and Results:This Phase II study was a randomized, double-blind, placebo-controlled parallel-group comparison. The primary endpoint was a change in pulmonary vascular resistance (PVR) from baseline to week 17. The main analysis involved a per-protocol set group of 28 subjects. The change in PVR (mean±SD) after 17 weeks of treatment in the selexipag group was -104±191 dyn·s/cm Selexipag treatment improved pulmonary hemodynamics in Japanese patients with CTEPH, but PVR did not show a significant difference between the selexipag and placebo groups. (Trial registration: JAPIC Clinical Trials Information [JapicCTI-111667]).
Sections du résumé
BACKGROUND
Selexipag is an oral prostacyclin receptor (IP receptor) agonist with a non-prostanoid structure. This study examined its efficacy and safety in Japanese patients with non-operated or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH).Methods and Results:This Phase II study was a randomized, double-blind, placebo-controlled parallel-group comparison. The primary endpoint was a change in pulmonary vascular resistance (PVR) from baseline to week 17. The main analysis involved a per-protocol set group of 28 subjects. The change in PVR (mean±SD) after 17 weeks of treatment in the selexipag group was -104±191 dyn·s/cm
CONCLUSIONS
Selexipag treatment improved pulmonary hemodynamics in Japanese patients with CTEPH, but PVR did not show a significant difference between the selexipag and placebo groups. (Trial registration: JAPIC Clinical Trials Information [JapicCTI-111667]).
Identifiants
pubmed: 32879152
doi: 10.1253/circj.CJ-20-0438
doi:
Substances chimiques
Acetamides
0
Antihypertensive Agents
0
Pyrazines
0
Receptors, Epoprostenol
0
selexipag
5EXC0E384L
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1866-1874Commentaires et corrections
Type : CommentIn