Bosentan for patients with chronic thromboembolic pulmonary hypertension |
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| Authors: | Fabio Giuseppe Vassallo Metka Kodric Cleante Scarduelli Sergio Harari Alfredo Potena Angelo Scarda Marco Piattella Roberto Cassandro Marco Confalonieri |
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| Affiliation: | 1. Department of Pneumology, University Hospital of Trieste, Trieste, Italy;2. Pneumology Unit, Hospital of Bozzolo-Mantova, Mantova, Italy;3. Department of Pneumology, Hospital S.Giuseppe, Milan, Italy;4. Respiratory Unit, Arcispedale S.Anna, Ferrara, Italy;1. Department of Respiratory Medicine, Hannover Medical School and German Centre for Lung Research (DZL), Hannover 30623, Germany;2. Department of Pneumology, VU University Medical Center, Amsterdam, Netherlands;1. Department of Cardiac Surgery, the Prince Charles Hospital, Brisbane, Qld, Australia;2. Queensland Centre for Lung Transplantation and Vascular Disease, The Prince Charles Hospital, Brisbane, Qld, Australia;3. Adult Intensive Care Unit, The Prince Charles Hospital, Brisbane, Qld, Australia;1. Department of Respirology, Graduate School of Medicine, Chiba University, Chiba 260-8670, Japan;2. Department of Advanced Medicine in Pulmonary Hypertension, Graduate School of Medicine, Chiba University, Chiba 260-8670, Japan;1. Abteilung für Kardiologie, Klinikum Oldenburg, European Medical School Oldenburg-Groningen, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany;2. Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany;3. Klinik für Innere Medizin IV, Klinik für Nephrologie und Hypertensiologie, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany;4. Department of Chemistry and ABCRF, University College Cork, Western Road, Cork, Ireland;5. Department of Human Biology, Maastricht University, Maastricht, The Netherlands;6. Institute for Clinical Chemistry and Clinical Pharmacology, University Clinics Bonn, Germany;1. Department of Research and Education, CIRO, Horn, The Netherlands;2. Department of Respiratory Medicine, Zuyderland, Heerlen, The Netherlands;3. Department of Respiratory Medicine, Zuyderland, Sittard-Geleen, The Netherlands;4. Department of Medical Psychology and Department of Pulmonary Diseases, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands;5. Boehringer Ingelheim, Alkmaar, The Netherlands;6. Department of Family Medicine, CAPHRI School of Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands;7. Department of Respiratory Medicine, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands;8. Centre of Expertise for Palliative Care, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands |
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| Abstract: | BackgroundChronic thromboembolic pulmonary hypertension (CTEPH) is a progressive disease leading to worsening functional status and reduced survival for those patients who cannot undergo pulmonary endarterectomy (PEA). Pharmacotherapy with novel drugs for pulmonary hypertension may be useful in treating patients who are poor candidates for surgery, but there are still few clinical data on medical therapy for CTEPH.The aim of this prospective open-label, multicenter, study is to compare the efficacy of 1-year bosentan treatment to standard drugs in nonoperated patients with CTEPH.Patients and methodsThirty-four nonoperated patients with CTEPH were enrolled. Functional assessment included 6 minute walk test (6MWT), Borg index, WHO classification, arterial blood gases and echocardiography systolic pulmonary artery pressure (sPAP). Seventeen patients received bosentan (62.5 mg bid for 4 weeks and then 125 mg bid); 17 patients were treated with standard therapy alone.ResultsAt admission sPAP was 76.18 +/? 5.96 mmHg in bosentan group and 71.48 +/? 3.71 mmHg in controls, paO2 64.68 +/? 2.25 mmHg in bosentan group, and 59.52 +/? 2.05 mmHg in controls, 6MWT 297.53 +/? 34.25 mt in bosentan group, and 268.47 +/? 36.54 mt in controls. After 12 months there were significant differences between the groups in the 6MWT (+ 57.24 +/? 22.21 m vs ? 73.13 +/? 21.23 m, p < 0.001), dyspnoea index (Borg score 4.29 +/? 0.49 vs 7.06 +/? 0.32, p < 0.001) and oxygenation (paO2 65.93 +/? 3.76 mmHg vs 48.48 +/? 1.31 mmHg, p < 0.001). The sPAP was stable after 12 months of bosentan (76.18 +/? 5.96 mmHg vs 71.00 +/? 5.41 mmHg, p = 0.221) in contrast to controls (71.48 +/? 3.71 mmHg vs 80.44 +/? 4.70 mmHg, p = 0.029).ConclusionThe data of this open-label study in nonoperated CTEPH patients suggest an improvement in functional outcomes adding Bosentan to diuretics and oral anticoagulants. No improvement was observed using only standard drugs after 1-year. |
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