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Clinical pharmacy and clinical trials (including case series)
Comparing oral rivaroxaban versus standard treatment in the treatment of symptomatic deep vein thrombosis: a patient-reported treatment satisfaction study
  1. S. Cano,
  2. L. Bamber,
  3. D. Lamping,
  4. M. Wang,
  5. M.H. Prins,
  6. R. Bauersachs,
  7. A.S. Gallus,
  8. A.W.A. Lensing
  1. 1Peninsula College of Medicine and Dentistry, Clinical Neurology Research Group, Plymouth, United Kingdom
  2. 2Bayer HealthCare AG, Global Market Access Xarelto, Wuppertal, Germany
  3. 3London School of Hygiene and Tropical Medicine, Department of Health Services Research & Policy, London, United Kingdom
  4. 4Bayer HealthCare Pharmaceuticals Inc, Statistics, Montville NJ, USA
  5. 5Maastricht University Medical Centre, Department of Epidemiology, Maastricht, The Netherlands
  6. 6Max Ratschow Clinic for Angiology, Department of Vascular Medicine, Darmstadt, Germany
  7. 7Flinders Medical Centre, Department of Pathology, Adelaide, Australia
  8. 8Bayer HealthCare, R&D, Wuppertal, Germany

Abstract

Background The EINSTEIN DVT study was a large, open-label, randomised trial comparing rivaroxaban with the standard care (enoxaparin/vitamin K antagonist (VKA)) in patients with acute deep vein thrombosis (DVT) and without symptomatic pulmonary embolism. Rivaroxaban was evaluated for the treatment of DVT in a single-drug approach with a fixed-dose regimen without the need for initial heparinisation, routine laboratory monitoring or dose adjustment.

Purpose To investigate patient-reported treatment satisfaction in a subset of patients from the EINSTEIN DVT study.

Materials and methods More than 1400 patients from seven countries (Canada, France, Germany, Italy, The Netherlands, UK and USA) were requested to complete a new, validated measure of treatment satisfaction: the AntiClot Treatment Scale (ACTS). At scheduled visits throughout treatment (day 15, months 1, 2, 3, 6 and 12) patients completed the ACTS, which consists of two scales: ACTS Burdens (12 items) and ACTS Benefits (3 items). For each scale, higher total scores indicate higher satisfaction. A prespecified repeated-measures regression analysis was used to compare ACTS scores in the intention-to-treat population.

Results Patients reported higher treatment satisfaction in the rivaroxaban group compared with the enoxaparin/VKA group, with higher mean ACTS scores across visits. Mean ACTS Burdens scores were 55.2 versus 52.6 (p<0.0001) in favour of rivaroxaban; a consistent treatment effect over time was observed, with the difference in mean scores ranging from 2.2 at month 2 to 3.2 at month 12. Mean ACTS Benefits scores were 11.7 versus 11.5 (p=0.006), showing an improvement in satisfaction for the rivaroxaban group. There was no difference in mean ACTS Benefits scores at day 15, with the treatment effect for rivaroxaban becoming apparent at month 2 and later.

Conclusions These data show that rivaroxaban provided improved treatment satisfaction for patients with DVT compared with enoxaparin/VKA, particularly in reducing patient-reported anticoagulation burden.

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