Back to Search
Start Over
Riociguat for the treatment of chronic thromboembolic pulmonary hypertension: a long-term extension study (CHEST-2).
- Source :
-
The European respiratory journal [Eur Respir J] 2015 May; Vol. 45 (5), pp. 1293-302. Date of Electronic Publication: 2014 Nov 13. - Publication Year :
- 2015
-
Abstract
- 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.<br /> (Copyright ©ERS 2015.)
- Subjects :
- Aged
Antihypertensive Agents therapeutic use
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Exercise Test
Female
Follow-Up Studies
Guanylate Cyclase metabolism
Humans
Male
Middle Aged
Respiratory Function Tests
Risk
Time Factors
Walking
Hypertension, Pulmonary drug therapy
Pyrazoles therapeutic use
Pyrimidines therapeutic use
Thromboembolism drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1399-3003
- Volume :
- 45
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- The European respiratory journal
- Publication Type :
- Academic Journal
- Accession number :
- 25395036
- Full Text :
- https://doi.org/10.1183/09031936.00087114