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Kliniske studier vedrørende akut og kronisk tromboembolisk sygdom

A Study of Flexible Dosage in Extended PE/DVT Treatment

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EINSTEIN CHOICE:
A Study of Xarelto® with a Flexible Choice of Dosage for Extended Treatment of Recurrent VTE

Objective

  • To compare the efficacy and safety profile of 20 mg OD or 10 mg OD Xarelto doses with aspirin for extended treatment of recurrent VTE, in patients who had been treated for 6–12 months with an anticoagulant therapy1

Study Design

  • EINSTEIN CHOICE is a randomised, double-blind, active-controlled, event-driven, superiority, Phase 3 study1
  • The primary efficacy outcome was symptomatic, recurrent, fatal or non-fatal VTE, and the principal safety outcome was major bleeding1
einstein choice study design

* ≤7 days of treatment interruption prior to randomisation. † Patients randomised after the requisite number of primary efficacy outcomes was reached were treated for ≥6 months.

Patients’ Clinical Characteristics

einstein-choice-patients-clinical-characteristics

Key Findings

  • Efficacy
    • Both 10 mg OD and 20 mg OD Xarelto doses significantly reduced the risk of recurrent VTE vs aspirin‡,1
  • Safety
    • Both 10 mg OD and 20 mg OD Xarelto doses demonstrated a low risk of major bleeding, similar to aspirin‡,1
    • Overall rates of major and clinically relevant non-major bleeding were similar between both Xarelto doses and aspirin‡,1

DVT, deep vein thrombosis; OD, once daily; PE, pulmonary embolism; VTE, venous thromboembolism.
‡ For VTE extended treatment.

 

PP-XAR-ALL-1816-1

Referencer

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Senest opdateret: 02/2020