Riociguat for the treatment of pulmonary arterial hypertension associated with connective tissue disease: results from PATENT-1 and PATENT-2.
Ann Rheum Dis
; 76(2): 422-426, 2017 Feb.
Article
en En
| MEDLINE
| ID: mdl-27457511
ABSTRACT
BACKGROUND:
The 12-week, phase III Pulmonary Arterial hyperTENsion sGC-stimulator Trial (PATENT)-1 study investigated riociguat in patients with pulmonary arterial hypertension (PAH). Here, we present a prospectively planned analysis of the safety and efficacy of riociguat in the subgroup of patients with PAH associated with connective tissue disease (PAH-CTD).METHODS:
Patients with PAH-CTD were further classified post hoc as having PAH associated with systemic sclerosis or PAH-other defined CTD. In PATENT-1, patients received riociguat (maximum 2.5 or 1.5â mg three times daily) or placebo. Efficacy endpoints included change from baseline in 6-minute walking distance (6MWD; primary endpoint), haemodynamics and WHO functional class (WHO FC). In the long-term extension PATENT-2, patients received riociguat (maximum 2.5â mg three times daily); the primary endpoint was safety and tolerability.RESULTS:
In patients with PAH-CTD, riociguat increased mean 6MWD, WHO FC, pulmonary vascular resistance and cardiac index. Improvements in 6MWD and WHO FC persisted at 2â years. Two-year survival of patients with PAH-CTD was the same as for idiopathic PAH (93%). Riociguat had a similar safety profile in patients with PAH-CTD to that of the overall population.CONCLUSIONS:
Riociguat was well tolerated and associated with positive trends in 6MWD and other endpoints that were sustained at 2â years in patients with PAH-CTD. TRIAL REGISTRATION NUMBERS PATENT-1 (NCT00810693), PATENT-2 (NCT00863681).Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Pirazoles
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Pirimidinas
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Esclerodermia Sistémica
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Hipertensión Pulmonar
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Antihipertensivos
Tipo de estudio:
Clinical_trials
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Etiology_studies
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Risk_factors_studies
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:
Ann Rheum Dis
Año:
2017
Tipo del documento:
Article
País de afiliación:
Francia