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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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“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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Guidelines for the diagnosis and treatment of pulmonary hypertension
Galiè, N., Hoeper, M. M., Humbert, M. J. C., Torbicki, A., Vachiéry, J., Barberà, J. A., Beghetti, M., Corris, P. A., Gaine, S., Gibbs, J. S. R., et al. (2009) · European Heart Journal · doi:10.1093/eurheartj/ehp297 · Cited by 3,853
Self-citationBosentan Therapy for Pulmonary Arterial Hypertension
Rubin, L. J., Badesch, D. B., Barst, R. J., Galiè, N., Black, C. M., KEOGH, A. M., Pulido, T., Frost, A., Roux, S., Leconte, I., et al. (2002) · New England Journal of Medicine · doi:10.1056/nejmoa012212 · Cited by 2,718
Self-citationBarst, R. J., Rubin, L. J., Long, W. A., McGoon, M. D., Rich, S., Badesch, D. B., Groves, B. Μ., Tapson, V. F., Bourge, R. C., Brundage, B. H., et al. (1996) · New England Journal of Medicine · doi:10.1056/nejm199602013340504 · Cited by 2,688
Self-citationSildenafil Citrate Therapy for Pulmonary Arterial Hypertension
Galiè, N., Ghofrani, H. A., Torbicki, A., Barst, R. J., Rubin, L. J., Badesch, D. B., Fleming, T. R., Parpia, T., Burgess, G., Branzi, A., et al. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa050010 · Cited by 2,466
Self-citationACCF/AHA 2009 Expert Consensus Document on Pulmonary Hypertension
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Self-citationInhaled Iloprost for Severe Pulmonary Hypertension
Olschewski, H., Simonneau, G., Galiè, N., HIGENBOTTAM, T. W., Naeije, R., Rubin, L. J., Nikkho, S. M., Speich, R., Hoeper, M. M., Behr, J., et al. (2002) · New England Journal of Medicine · doi:10.1056/nejmoa020204 · Cited by 1,783
Self-citationRiociguat for the Treatment of Chronic Thromboembolic Pulmonary Hypertension
Ghofrani, H. A., D’Armini, A. M., Grimminger, F., Hoeper, M. M., Jansa, P., Kim, N. H., Mayer, E., Simonneau, G., Wilkins, M. R., Fritsch, A., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1209657 · Cited by 1,393
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Self-citationTadalafil Therapy for Pulmonary Arterial Hypertension
Galiè, N., Brundage, B. H., Ghofrani, H. A., Oudiz, R. J., Simonneau, G., Safdar, Z., Shapiro, S., White, R. J., Chan, M., Beardsworth, A., et al. (2009) · Circulation · doi:10.1161/circulationaha.108.839274 · Cited by 1,096
Self-citationAmbrisentan for the Treatment of Pulmonary Arterial Hypertension
Galiè, N., Olschewski, H., Oudiz, R. J., Torres, F., Frost, A., Ghofrani, H. A., Badesch, D. B., McGoon, M. D., McLaughlin, V. V., Roecker, E. B., et al. (2008) · Circulation · doi:10.1161/circulationaha.107.742510 · Cited by 1,077
Self-citationMechanisms of disease: pulmonary arterial hypertension
SCHERMULY, R. T., Ghofrani, H. A., Wilkins, M. R., & Grimminger, F. (2011) · Nature Reviews Cardiology · doi:10.1038/nrcardio.2011.87 · Cited by 818
Self-citationA meta-analysis of randomized controlled trials in pulmonary arterial hypertension
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Self-citationSoluble Guanylate Cyclase as an Emerging Therapeutic Target in Cardiopulmonary Disease
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Self-citationExpression and function of soluble guanylate cyclase in pulmonary arterial hypertension
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Clinical worsening in trials of pulmonary arterial hypertension: results and implications
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2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension
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Self-citation2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension
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Self-citation2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension
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Self-citation2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension
Humbert, M. J. C., Kovács, G., Hoeper, M. M., Badagliacca, R., Berger, R. M. F., Brida, M., Carlsen, J., Coats, A. J. S., Subías, P. E., Ferrari, P., et al. (2022) · European Respiratory Journal · doi:10.1183/13993003.00879-2022 · Cited by 2,388
Self-citationInitial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
Galiè, N., Barberà, J. A., Frost, A., Ghofrani, H. A., Hoeper, M. M., McLaughlin, V. V., Peacock, A. J., Simonneau, G., Vachiéry, J., Grünig, E., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1413687 · Cited by 1,182
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Metadata
- 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
- 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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