Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study |
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| Authors: | Vallerie V McLaughlin Pavel Jansa Jens E Nielsen-Kudsk Michael Halank Gérald Simonneau Ekkehard Grünig Silvia Ulrich Stephan Rosenkranz Miguel A Gómez Sánchez Tomás Pulido Joanna Pepke-Zaba Joan Albert Barberá Marius M Hoeper Jean-Luc Vachiéry Irene Lang Francine Carvalho Christian Meier Katharina Mueller Sylvia Nikkho Andrea M D’Armini |
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| Institution: | 1.University of Michigan Health System,Ann Arbor,USA;2.Cardiology and Angiology Department, General University Hospital,Prague,Czech Republic;3.Department of Cardiological Medicine,Aarhus University,Aarhus,Denmark;4.University Hospital Dresden,Dresden,Germany;5.H?pital Bicêtre, Université Paris-Sud, Laboratoire d’Excellence en Recherche sur le Médicament et Innovation Thérapeutique, and INSERM Unité 999,Paris,France;6.Thoraxclinic,University Hospital Heidelberg,Heidelberg,Germany;7.Clinic of Pulmonology,University Hospital Zurich,Zurich,Switzerland;8.Department III of Internal Medicine,Cologne University Heart Center,Cologne,Germany;9.Unidad de I. Cardiaca e Hipertensión Pulmonar,Hospital Universitario 12 de Octubre,Madrid,Spain;10.Instituto Nacional de Cardiología,Mexico City,Mexico;11.National Pulmonary Vascular Diseases Unit, Papworth Hospital,Cambridge,UK;12.Department of Pulmonary Medicine, Hospital Clínic-IDIBAPS,University of Barcelona, and Biomedical Research Networking Center on Respiratory Diseases,Madrid,Spain;13.Clinic for Respiratory Medicine, Hannover Medical School,Hannover,Germany;14.Département de Cardiologie, H?pital Erasme,Université Libre de Bruxelles,Brussels,Belgium;15.Allgemeines Krankenhaus der Stadt Wien,Medizinische Universit?t Wien,Wien,Austria;16.Global Development,S?o Paulo,Brazil;17.Global Medical Affairs,Berlin,Germany;18.Bayer AG,Wuppertal,Germany;19.Global Clinical Development,Berlin,Germany;20.Division of Cardiothoracic Surgery, Foundation “IRCCS Policlinico San Matteo”,University of Pavia School of Medicine,Pavia,Italy |
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| Abstract: | BackgroundFollowing positive results from the Phase III CHEST-1 study in patients with inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), the Phase IIIb CTEPH early access study (EAS) was designed to assess the safety and tolerability of riociguat in real-world clinical practice, as well as to provide patients with early access to riociguat before launch. Riociguat is approved for the treatment of inoperable and persistent/recurrent CTEPH.MethodsWe performed an open-label, uncontrolled, single-arm, early access study in which 300 adult patients with inoperable or persistent/recurrent CTEPH received riociguat adjusted from 1 mg three times daily (tid) to a maximum of 2.5 mg tid. Patients switching from unsatisfactory prior pulmonary arterial hypertension (PAH)-targeted therapy (n =?84) underwent a washout period of at least 3 days before initiating riociguat. The primary aim was to assess the safety and tolerability of riociguat, with World Health Organization functional class and 6-min walking distance (6MWD) as exploratory efficacy endpoints.ResultsIn total, 262 patients (87%) completed study treatment and entered the safety follow-up (median treatment duration 47 weeks). Adverse events were reported in 273 patients (91%). The most frequently reported serious adverse events were syncope (6%), right ventricular failure (3%), and pneumonia (2%). There were five deaths, none of which was considered related to study medication. The safety and tolerability of riociguat was similar in patients switched from other PAH-targeted therapies and those who were treatment naïve. In patients with data available, mean?±?standard deviation 6MWD had increased by 33?±?42 m at Week 12 with no clinically relevant differences between the switched and treatment-naïve subgroups.ConclusionsRiociguat was well tolerated in patients with CTEPH who were treatment naïve, and in those who were switched from other PAH-targeted therapies. No new safety signals were observed.Trial registrationClinicalTrials.org NCT01784562. Registered February 4, 2013. |
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