Document Detail


Riociguat for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension: a phase II study.
MedLine Citation:
PMID:  20530034     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2010-06-07
Journal Detail:
Title:  The European respiratory journal     Volume:  36     ISSN:  1399-3003     ISO Abbreviation:  Eur. Respir. J.     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-10-04     Completed Date:  2011-03-10     Revised Date:  2013-05-23    
Medline Journal Info:
Nlm Unique ID:  8803460     Medline TA:  Eur Respir J     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  792-9     Citation Subset:  IM    
Affiliation:
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.:
ClinicalTrials.gov/NCT00454558
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MeSH Terms
Descriptor/Qualifier:
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:
0/Antihypertensive Agents; 0/Pyrazoles; 0/Pyrimidines; 625115-55-1/riociguat; EC 4.6.1.2/Guanylate Cyclase

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