Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F15%3A00059493" target="_blank" >RIV/00023001:_____/15:00059493 - isvavai.cz</a>

Result on the web

<a href="http://erj.ersjournals.com/content/46/2/405.full.pdf+html" target="_blank" >http://erj.ersjournals.com/content/46/2/405.full.pdf+html</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1183/13993003.02044-2014" target="_blank" >10.1183/13993003.02044-2014</a>

Result language

angličtina

Original language name

Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension

Original language description

The safety and efficacy of adding bosentan to sildenafil in pulmonary arterial hypertension (PAH) patients was investigated. In this prospective, double-blind, event-driven trial, symptomatic PAH patients receiving stable sildenafil (}= 20 mg three times daily) for }= 3 months were randomised (1: 1) to placebo or bosentan (125 mg twice daily). The composite primary end-point was the time to the first morbidity/mortality event, defined as all-cause death, hospitalisation for PAH worsening or intravenous prostanoid initiation, atrial septostomy, lung transplant, or PAH worsening. Secondary/exploratory end-points included change in 6-min walk distance and World Health Organization functional class at 16 weeks, change in N-terminal pro-brain natriuretic peptide (NT-proBNP) over time, and all-cause death. Overall, 334 PAH patients were randomised to placebo (n=175) or bosentan (n=159). A primary end-point event occurred in 51.4% of patients randomised to placebo and 42.8% to bosentan (hazard ratio 0.83, 97.31% CI 0.58-1.19; p=0.2508). The mean between-treatment difference in 6-min walk distance at 16 weeks was + 21.8 m (95% CI + 5.9-37.8 m; p=0.0106). Except for NT-proBNP, no difference was observed for any other end-point. The safety profile of bosentan added to sildenafil was consistent with the known bosentan safety profile. In COMPASS-2, adding bosentan to stable sildenafil therapy was not superior to sildenafil monotherapy in delaying the time to the first morbidity/mortality event.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FA - Cardiovascular diseases including cardio-surgery

OECD FORD branch

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Project

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Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2015

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

European respiratory journal

ISSN

0903-1936

e-ISSN

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Volume of the periodical

46

Issue of the periodical within the volume

2

Country of publishing house

GB - UNITED KINGDOM

Number of pages

9

Pages from-to

405-413

UT code for WoS article

000358795800017

EID of the result in the Scopus database

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