Riociguat for the treatment of chronic thromboembolic pulmonary hypertension: a long-term extension study (CHEST-2)
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie
PubMed
25395036
DOI
10.1183/09031936.00087114
PII: 09031936.00087114
Knihovny.cz E-zdroje
- MeSH
- antihypertenziva terapeutické užití MeSH
- časové faktory MeSH
- chůze MeSH
- dvojitá slepá metoda MeSH
- guanylátcyklasa metabolismus MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- plicní hypertenze farmakoterapie MeSH
- pyrazoly terapeutické užití MeSH
- pyrimidiny terapeutické užití MeSH
- respirační funkční testy MeSH
- riziko MeSH
- rozvrh dávkování léků MeSH
- senioři MeSH
- tromboembolie farmakoterapie MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- zátěžový test MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- antihypertenziva MeSH
- guanylátcyklasa MeSH
- pyrazoly MeSH
- pyrimidiny MeSH
- riociguat MeSH Prohlížeč
Riociguat is a soluble guanylate cyclase stimulator approved for the treatment of inoperable and persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH). In the 16-week CHEST-1 study, riociguat showed a favourable benefit-risk profile and improved several clinically relevant end-points in patients with CTEPH. The CHEST-2 open-label extension evaluated the long-term safety and efficacy of riociguat. Eligible patients from CHEST-1 received riociguat individually adjusted up to a maximum dose of 2.5 mg three times daily. The primary objective was the safety and tolerability of riociguat; exploratory efficacy end-points included 6-min walking distance (6MWD) and World Health Organization (WHO) functional class (FC). Overall, 237 patients entered CHEST-2 and 211 (89%) were ongoing at this interim analysis (March 2013). The safety profile of riociguat in CHEST-2 was similar to CHEST-1, with no new safety signals. Improvements in 6MWD and WHO FC observed in CHEST-1 persisted for up to 1 year in CHEST-2. In the observed population at 1 year, mean±sd 6MWD had changed by +51±62 m (n=172) versus CHEST-1 baseline (n=237), and WHO FC had improved/stabilised/worsened in 47/50/3% of patients (n=176) versus CHEST-1 baseline (n=236). Long-term riociguat had a favourable benefit-risk profile and apparently showed sustained benefits in exercise and functional capacity for up to 1 year.
Global Clinical Development Bayer HealthCare Pharmaceuticals Barcelona Spain
Global Clinical Development Bayer HealthCare Pharmaceuticals Wuppertal Germany
Kerckhoff Heart and Lung Center Bad Nauheim Germany
University of Giessen and Marburg Lung Center
University of Giessen and Marburg Lung Center Dept of Medicine Imperial College London London UK
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