Riociguat for pulmonary arterial hypertension associated with congenital heart disease.
Heart
; 101(22): 1792-9, 2015 Nov.
Article
em En
| MEDLINE
| ID: mdl-26135803
ABSTRACT
OBJECTIVE:
The Pulmonary Arterial hyperTENsion sGC-stimulator Trial-1 (PATENT-1) was a randomised, double-blind, placebo-controlled phase III trial evaluating riociguat in patients with pulmonary arterial hypertension (PAH). PATENT-2 was an open-label long-term extension to PATENT-1. Here, we explore the efficacy and safety of riociguat in the subgroup of patients with persistent/recurrent PAH after correction of congenital heart disease (PAH-CHD) from the PATENT studies.METHODS:
In PATENT-1, patients received riociguat (maximum 2.5 or 1.5â mg three times daily) or placebo for 12â weeks; efficacy assessments included change from baseline to study end in 6-min walking distance (6MWD; primary), pulmonary vascular resistance (PVR), N-terminal of the prohormone of brain natriuretic peptide (NT-proBNP), WHO functional class (WHO FC) and time to clinical worsening. In PATENT-2, eligible patients from PATENT-1 received long-term riociguat (maximum 2.5â mg three times daily); the primary assessment was safety and tolerability. All PAH-CHD patients had a corrected cardiac defect.RESULTS:
In PATENT-1, riociguat increased mean±SD 6MWD from baseline to week 12 by 39±60â m in patients with PAH-CHD versus 0±42â m for placebo. Riociguat also improved several secondary variables versus placebo, including PVR (-250±410 vs -66±632â dyn·s/cm(5)), NT-proBNP (-164±317 vs -46±697â pg/mL) and WHO FC (21%/79%/0% vs 8%/83%/8% improved/stabilised/worsened). One patient experienced clinical worsening (riociguat 1.5â mg group). Riociguat was well tolerated. In PATENT-2, riociguat showed sustained efficacy and tolerability in patients with PAH-CHD at 2â years.CONCLUSIONS:
Riociguat was well tolerated in patients with PAH-CHD and improved clinical outcomes including 6MWD, PVR, WHO FC and NT-proBNP. TRIAL REGISTRATION NUMBER The clinical trials numbers are NCT00810693 for PATENT-1 and NCT00863681 for PATENT-2.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pirazóis
/
Pirimidinas
/
Cardiopatias Congênitas
/
Hipertensão Pulmonar
/
Anti-Hipertensivos
Tipo de estudo:
Clinical_trials
/
Risk_factors_studies
Limite:
Adult
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Heart
Assunto da revista:
CARDIOLOGIA
Ano de publicação:
2015
Tipo de documento:
Article
País de afiliação:
Alemanha