Martin H Prins1, Luke Bamber2, Stefan J Cano3, Maria Y Wang4, Petra Erkens5, Rupert Bauersachs6, Anthonie W A Lensing7. 1. Maastricht University Medical Centre, 6200 MD Maastricht, The Netherlands. Electronic address: mh.prins@maastrichtuniversity.nl. 2. Bayer Pharma AG, Wuppertal, Aprather Weg 18a, 42096 Wuppertal, Germany. Electronic address: luke.bamber@bayer.com. 3. Peninsula College of Medicine and Dentistry, Plymouth, PL6 8BU, UK. Electronic address: stefan.cano@pms.ac.uk. 4. Bayer HealthCare, Montville, NJ, 13342, USA. Electronic address: maria.wang@bayer.com. 5. Maastricht University Medical Centre, 6200 MD Maastricht, The Netherlands. 6. Max Ratschow Clinic for Angiology, Grafenstraße 9, 64283 Darmstadt, Germany. Electronic address: rupert.bauersachs@klinikum-darmstadt.de. 7. Bayer Pharma AG, Wuppertal, Aprather Weg 18a, 42096 Wuppertal, Germany. Electronic address: anthonie.lensing@bayer.com.
Abstract
INTRODUCTION:Rivaroxaban is an oral, direct Factor Xa inhibitor, approved for the treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT) and the secondary prevention of recurrent PE and DVT as a fixed-dose, monotherapy regimen that does not require initial heparinisation, routine coagulation monitoring or dose adjustment. Approval in this indication was supported by results from EINSTEIN PE, a large, randomised, open-label study that compared rivaroxaban with enoxaparin/vitamin K antagonist (VKA) therapy in patients with acute symptomatic PE with or without DVT. MATERIALS AND METHODS: Patient-reported treatment satisfaction was evaluated in a predefined subanalysis of EINSTEIN PE to enable monitoring and optimisation of patient-reported outcomes and, therefore, patient compliance. As part of EINSTEIN PE, 2,397 patients in seven countries were asked to complete a validated measure of treatment satisfaction, the Anti-Clot Treatment Scale (ACTS) throughout the duration of treatment (up to 12 months). RESULTS: Patients reported greater satisfaction in the rivaroxaban treatment arm as compared with the enoxaparin/VKA treatment arm. Treatment with rivaroxaban was reported as being significantly less burdensome than enoxaparin/VKA therapy, and the benefits of treatment were significantly greater. CONCLUSION:Rivaroxaban treatment resulted in improved treatment satisfaction compared with enoxaparin/VKA in PE patients, particularly in reducing patient-reported anticoagulation burden.
RCT Entities:
INTRODUCTION:Rivaroxaban is an oral, direct Factor Xa inhibitor, approved for the treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT) and the secondary prevention of recurrent PE and DVT as a fixed-dose, monotherapy regimen that does not require initial heparinisation, routine coagulation monitoring or dose adjustment. Approval in this indication was supported by results from EINSTEIN PE, a large, randomised, open-label study that compared rivaroxaban with enoxaparin/vitamin K antagonist (VKA) therapy in patients with acute symptomatic PE with or without DVT. MATERIALS AND METHODS:Patient-reported treatment satisfaction was evaluated in a predefined subanalysis of EINSTEIN PE to enable monitoring and optimisation of patient-reported outcomes and, therefore, patient compliance. As part of EINSTEIN PE, 2,397 patients in seven countries were asked to complete a validated measure of treatment satisfaction, the Anti-Clot Treatment Scale (ACTS) throughout the duration of treatment (up to 12 months). RESULTS:Patients reported greater satisfaction in the rivaroxaban treatment arm as compared with the enoxaparin/VKA treatment arm. Treatment with rivaroxaban was reported as being significantly less burdensome than enoxaparin/VKA therapy, and the benefits of treatment were significantly greater. CONCLUSION:Rivaroxaban treatment resulted in improved treatment satisfaction compared with enoxaparin/VKA in PE patients, particularly in reducing patient-reported anticoagulation burden.
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