Riociguat for the treatment of pulmonary arterial hypertension
Open accessAbstract
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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Pulmonary vascular health is intimately tied to effective NO bioactivity.
“Given that most efficacious therapies for the treatment of PH involve targeting of NO signaling[48,49], it is clear that pulmonary vascular health is intimately tied to effective NO bioactivity.”
From Enterosalivary nitrate metabolism and the microbiome: Intersection of microbial metabolism, nitric oxide and diet in cardiac and pulmonary vascular health (2017) · cites this paper as [49]
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Soluble Guanylate Cyclase Stimulators in Pulmonary Hypertension
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Self-citationPathophysiology and new advances in pulmonary hypertension
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The molecular targets of approved treatments for pulmonary arterial hypertension
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Self-citationSotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension
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Self-citationCombination therapy: the future of management for idiopathic pulmonary fibrosis?
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Temporal trends in pulmonary arterial hypertension: results from the COMPERA registry
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Self-citationThe Fifth World Symposium on Pulmonary Hypertension
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Self-citationLong-term safety and efficacy of imatinib in pulmonary arterial hypertension
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Self-citationStructure and Activation of Soluble Guanylyl Cyclase, the Nitric Oxide Sensor
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Pulmonary hypertension and its management in patients undergoing non‐cardiac surgery
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Congenital diaphragmatic hernia-associated pulmonary hypertension
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The cGMP Signaling Pathway as a Therapeutic Target in Heart Failure With Preserved Ejection Fraction
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Rationale and Design of The SOluble guanylate Cyclase StimulatoR in HeArT FailurE Studies (SOCRATES)
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Treatment of pulmonary arterial hypertension: recent progress and a look to the future
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Self-citationMechanisms and treatment of pulmonary arterial hypertension
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Evaluation of Macitentan in Patients With Eisenmenger Syndrome
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Self-citationThe importance of patient perspectives in pulmonary hypertension
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Self-citationPhenotypic Consequences of a Genetic Predisposition to Enhanced Nitric Oxide Signaling
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Effects of sotatercept on haemodynamics and right heart function: analysis of the STELLAR trial
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Self-citationThe Nitric Oxide Pathway in Pulmonary Vascular Disease
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Treatment of pulmonary hypertension
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Novel sGC Stimulators and sGC Activators for the Treatment of Heart Failure
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Congenital diaphragmatic hernia-associated pulmonary hypertension
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Pulmonary Hypertension in Congenital Heart Disease
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Self-citation
- 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
- 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
- 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 · 2012: 1
- 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 › 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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