Cited by 1,346Pulmonary Hypertension Research and TreatmentsVascular Anomalies and TreatmentsHeart Failure Treatment and Management

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Riociguat for the Treatment of Pulmonary Arterial Hypertension

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Ghofrani, Hossein-Ardeschir, Galiè, Nazzareno, Grimminger, Friedrich, Grünig, Ekkehard, Humbert, Marc, Jing, Zhi-Cheng, Keogh, Anne M., Langleben, David, Kilama, Michael Ochan, Fritsch, Arno, Neuser, Dieter, Rubin, Lewis J.·2013·New England Journal of Medicine

DOI 10.1056/nejmoa1209655

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Abstract

Background Riociguat, a soluble guanylate cyclase stimulator, has been shown in a phase 2 trial to be beneficial in the treatment of pulmonary arterial hypertension. Methods In this phase 3, double-blind study, we randomly assigned 443 patients with symptomatic pulmonary arterial hypertension to receive placebo, riociguat in individually adjusted doses of up to 2.5 mg three times daily (2.5 mg-maximum group), or riociguat in individually adjusted doses that were capped at 1.5 mg three times daily (1.5 mg-maximum group). The 1.5 mg-maximum group was included for exploratory purposes, and the data from that group were analyzed descriptively. Patients who were receiving no other treatment for pulmonary arterial hypertension and patients who were receiving endothelin-receptor antagonists or (nonintravenous) prostanoids were eligible. The primary end point was the change from baseline to the end of week 12 in the distance walked in 6 minutes. Secondary end points included the change in pulmonary vascular resistance, N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, World Health Organization (WHO) functional class, time to clinical worsening, score on the Borg dyspnea scale, quality-of-life variables, and safety. Results By week 12, the 6-minute walk distance had increased by a mean of 30 m in the 2.5 mg-maximum group and had decreased by a mean of 6 m in the placebo group (least-squares mean difference, 36 m; 95% confidence interval, 20 to 52; P Conclusions Riociguat si…

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Authors: Ghofrani, H.-A., Galiè, N., Grimminger, F., Grünig, E., Humbert, M., Jing, Z.-C., Keogh, A. M., Langleben, D., Kilama, M. O., Fritsch, A., Neuser, D., & Rubin, L. J.
Affiliations: Justus-Liebig-Universität Gießen (DE)
University of Bologna (IT)
University Hospital Heidelberg (DE)
Université Paris-Sud (FR)
Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
St Vincent's Hospital Sydney (AU)
Jewish General Hospital (CA)
Bayer (Italy) (IT)
Bayer (Germany) (DE)
University of California San Diego (US)
ORCID: Ghofrani, Hossein-Ardeschir
Galiè, Nazzareno
Grimminger, Friedrich
Grünig, Ekkehard
Humbert, Marc
Jing, Zhi-Cheng
Keogh, Anne M.
Langleben, David
Rubin, Lewis J.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2013-07-25
Volume: 369
Issue: 4
Pages: 330-340
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1209655
OpenAlex: W2107011819
Cited by: 1,346
References: 26
Citations by year: 2026: 52 · 2025: 70 · 2024: 75 · 2023: 90 · 2022: 98 · 2021: 112 · 2020: 93 · 2019: 85 · 2018: 92 · 2017: 115 · 2016: 145 · 2015: 152 · 2014: 128 · 2013: 32
FWCI: 124.09
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Pulmonary Hypertension Research and Treatments
Health Sciences › Medicine › Genetics (clinical) › Vascular Anomalies and Treatments
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
Keywords: riociguat, pulmonary arterial hypertension, soluble guanylate cyclase stimulator, 6-minute walk distance, pulmonary vascular resistance, NT-proBNP, WHO functional class, dyspnea, endothelin receptor antagonists, prostanoids, dose adjustment, syncope, exercise capacity, quality of life, drug safety, drug efficacy
MeSH terms: Adult, Aged, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Hypertension, Pulmonary, Male, Middle Aged, Peptide Fragments, Prostaglandins, Pyrazoles, Pyrimidines, Quality of Life, Vascular Resistance, Walking, Exercise Tolerance, Natriuretic Peptide, Brain, Endothelin Receptor Antagonists

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Riociguat for the Treatment of Pulmonary Arterial Hypertension

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