| Riociguat for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension: a phase II study. | |
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MedLine Citation:
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PMID: 20530034 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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We assessed the therapeutic potential of riociguat, a novel soluble guanylate cyclase stimulator, in adults with chronic thromboembolic pulmonary hypertension (CTEPH; n = 42) or pulmonary arterial hypertension (PAH; n = 33) in World Health Organization (WHO) functional class II/III. In this 12-week, multicentre, open-label, uncontrolled phase II study, patients received oral riociguat 1.0-2.5 mg t.i.d. titrated according to systemic systolic blood pressure (SBP). Primary end-points were safety and tolerability; pharmacodynamic changes were secondary end-points. Riociguat was generally well tolerated. Asymptomatic hypotension (SBP <90 mmHg) occurred in 11 patients, but blood pressure normalised without dose alteration in nine and after dose reduction in two. Median 6-min walking distance increased in patients with CTEPH (55.0 m from baseline (390 m); p<0.0001) and PAH (57.0 m from baseline (337 m); p<0.0001); patients in functional class II or III and bosentan pre-treated patients showed similar improvements. Pulmonary vascular resistance was significantly reduced by 215 dyn·s·cm(-5) from baseline (709 dyn·s·cm(-5); p<0.0001). 42 (56%) patients were considered to have experienced drug-related adverse events (AEs; 96% mild or moderate). Dyspepsia, headache and hypotension were the most frequent AEs. Study discontinuation because of AEs was 4%. These preliminary data show that riociguat has a favourable safety profile and improves exercise capacity, symptoms and pulmonary haemodynamics in CTEPH and PAH. Randomised controlled trials are underway. |
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Authors:
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H A Ghofrani; M M Hoeper; M Halank; F J Meyer; G Staehler; J Behr; R Ewert; G Weimann; F Grimminger |
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Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't Date: 2010-06-07 |
Journal Detail:
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Title: The European respiratory journal : official journal of the European Society for Clinical Respiratory Physiology Volume: 36 ISSN: 1399-3003 ISO Abbreviation: Eur. Respir. J. Publication Date: 2010 Oct |
Date Detail:
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Created Date: 2010-10-04 Completed Date: 2011-03-10 Revised Date: 2011-04-20 |
Medline Journal Info:
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Nlm Unique ID: 8803460 Medline TA: Eur Respir J Country: Switzerland |
Other Details:
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Languages: eng Pagination: 792-9 Citation Subset: IM |
Affiliation:
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Dept of Internal Medicine, Medical Clinic II/V, University Hospital Giessen and Marburg GmbH, Klinikstrasse 36, 35392 Giessen, Germany. ardeschir.ghofrani@innere.med.uni-giessen.de |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00454558 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Oral Aged Antihypertensive Agents / pharmacology*, therapeutic use Exercise Female Guanylate Cyclase / metabolism Humans Hypertension, Pulmonary / drug therapy* Male Middle Aged Prospective Studies Pyrazoles / pharmacology* Pyrimidines / pharmacology* Thromboembolism / drug therapy* Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Antihypertensive Agents; 0/Pyrazoles; 0/Pyrimidines; 625115-55-1/riociguat; EC 4.6.1.2/Guanylate Cyclase |
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