Selexipag for Chronic Thromboembolic Pulmonary Hypertension in Japanese Patientsã- A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase II Study.
Circ J
; 84(10): 1866-1874, 2020 09 25.
Article
em En
| MEDLINE
| ID: mdl-32879152
ABSTRACT
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).MethodsâandâResults:
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/cm5, whereas that in the placebo group was 26±180 dyn·s/cm5. Thus, the treatment effect after 17 weeks of selexipag treatment was calculated as -130±189 dyn·s/cm5(P=0.1553). Although the primary endpoint was not met, for the group not concomitantly using a pulmonary vasodilator the PVR in the selexipag group was significantly decreased compared with placebo group (P=0.0364). The selexipag group also showed improvement in total pulmonary resistance and cardiac index.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]).Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Embolia Pulmonar
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Pirazinas
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Hipertensão Pulmonar
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Acetamidas
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Anti-Hipertensivos
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article