title: Assessing the impact of dabigatran and warfarin on health-related quality of life: results from an RE-LY sub-study.
abstract: BACKGROUND
  Anticoagulation is recommended in patients with atrial fibrillation (AF) to prevent strokes. Vitamin K antagonists, such as warfarin, are associated with numerous practical limitations--frequent anticoagulation monitoring, lifestyle and dietary restrictions--that complicate patient management and may impact health-related quality of life (HRQoL). This study derived HRQoL estimates for AF patients receiving warfarin or dabigatran etexilate (dabigatran), a new oral anticoagulant not requiring anticoagulation monitoring, during one year of stable treatment, i.e. in the absence of outcome events, such as strokes or major bleedings.
  
  
  METHODS
  Changes in HRQoL over time and between treatments were assessed using the EQ-5D (utility and Visual Analogue Scale (VAS) scores) at baseline, 3 and 12 months in a sub-group of 1435 patients participating in the RE-LY trial. RE-LY was a phase III study that compared the safety and efficacy of warfarin, dabigatran 150 mg bid and dabigatran 110 mg bid for stroke prevention in patients with AF.
  
  
  RESULTS
  Utilities ranged from 0.805 (dabigatran 150 mg bid) to 0.811 (dabigatran 110 mg bid) at baseline, and did not change over the one year observation period. No differences between the dabigatran groups and warfarin were statistically significant except for the dabigatran 150 mg bid group at 3 months. Similarly, none of the within-group or between-group differences in VAS scores were statistically significant.
  
  
  CONCLUSIONS
  Over the course of one year, all anticoagulated patients without outcome events (e.g. strokes or major bleedings) had stable HRQoL. Scores between dabigatran and warfarin were comparable, which was unexpected given the known complexities of warfarin treatment.
authors.affiliation: Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany.
authors.forename: B U
authors.initials: BU
authors.lastname: Monz
authors.forename: S J
authors.initials: SJ
authors.lastname: Connolly
authors.forename: M
authors.initials: M
authors.lastname: Korhonen
authors.forename: H
authors.initials: H
authors.lastname: Noack
authors.forename: J
authors.initials: J
authors.lastname: Pooley
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D000991:Antithrombins / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy*; D001562:Benzimidazoles / Q000627:therapeutic use*; D000069604:Dabigatran; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011788:Quality of Life; D014859:Warfarin / Q000627:therapeutic use*; D015091:beta-Alanine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D001562:Benzimidazoles; D015091:beta-Alanine; D014859:Warfarin; D000069604:Dabigatran
keywords: Atrial fibrillation; Dabigatran; Health-related quality of life; Oral anticoagulation; Warfarin