Efficacy and safety of ralinepag, a novel oral IP agonist, in PAH patients on mono or dual background therapy: results from a phase 2 randomised, parallel group, placebo-controlled trial.
Eur Respir J
; 54(4)2019 10.
Article
en En
| MEDLINE
| ID: mdl-31391223
ABSTRACT
PURPOSE:
This phase 2 study was designed to assess the efficacy, safety and tolerability of immediate-release orally administered ralinepag, a selective, non-prostanoid prostacyclin receptor agonist with a 24-h terminal half-life, compared to placebo in adult patients with symptomatic pulmonary arterial hypertension (PAH).METHODS:
61 PAH patients who were receiving standard care, including mono or dual PAH-targeted background therapy were randomised 21 to ralinepag (n=40) or placebo (n=21). The starting dose of ralinepag was 10â µg twice daily. Dosage was then up-titrated as tolerated over the course of the 9-week dose-titration period, to a maximum total daily dose of 600â µg (300â µg twice daily). The primary efficacy end-point was the absolute change in pulmonary vascular resistance (PVR) from baseline to week 22. Additional end-points included percentage change in PVR from baseline, other haemodynamic parameters, 6-min walk distance (6MWD) and safety and tolerability.RESULTS:
Ralinepag significantly decreased PVR by 163.9â dyn·s·cm-5 compared to an increase of 0.7â dyn·s·cm-5 with placebo (p=0.02); the least-squares mean change from baseline PVR was -29.8% compared with placebo (p=0.03). 6MWD increased from baseline by 36.2â m with ralinepag and 29.4â m with placebo (p=0.90). Serious adverse events occurred in 10% of ralinepag patients and 29% of placebo patients. Study discontinuations occurred in 13% of ralinepag patients and 10% of placebo patients.SUMMARY:
Ralinepag reduced PVR compared with placebo in PAH patients on mono (41%) or dual combination (59%) background therapy.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Resistencia Vascular
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Carbamatos
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Activadores de Enzimas
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Receptores de Epoprostenol
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Inhibidores de Fosfodiesterasa 5
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Antagonistas de los Receptores de Endotelina
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Prueba de Paso
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Hipertensión Arterial Pulmonar
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Acetatos
Tipo de estudio:
Clinical_trials
Límite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Eur Respir J
Año:
2019
Tipo del documento:
Article
País de afiliación:
Estados Unidos