Dose-escalation study of rivaroxaban (BAY 59-7939)--anoral, dire

REGULAR ARTICLE

Dose-escalation study of rivaroxaban

(BAY 59-7939) – an oral, direct Factor Xa inhibitor –

for the prevention of venous thromboembolism in

patients undergoing total hip replacement

Bengt I. Eriksson

a,

⁎

, Lars C. Borris

b

, Ola E. Dahl

c

, Sylvia Haas

d

Menno V. Huisman

Department of Orthopaedics, Sahlgrenska University Hospital/Östra, SU/Östra sjukhuset, SE-41685 Goteborg,

Sweden

b

Department of Orthopaedics, Aarhus University Hospital, Aarhus, Denmark

c

Thrombosis Research Institute, London, UK

d

Institute of Experimental Oncology and Therapy Research, TUM, Munich, Germany

e

Department of General Internal Medicine and Endocrinology, Leiden University Medical Center, Leiden, The Netherlands

Received 27 October 2006; received in revised form 22 December 2006; accepted 28 December 2006

Available online 12 February 2007

Introduction: Rivaroxaban (BAY 59-7939) is a novel, oral, direct Factor Xa inhibitor in

clinical development for the prevention of thromboembolic disorders. The aim of this

study was to demo nstra te proof- of-p rinci ple for r ivarox aban. Materials and methods: This

was an open-label, dose-escalation study to assess the efficacy and safety of rivaroxaban,

relative to enoxaparin, for the prevention of venous thromboembolism (VTE) after total

Hip replacement surgery;

Oral anticoagulant;

Factor Xa inhibitors;

BAY 59-7939

Abbreviations: VTE, venous thromboembolism; DVT, deep vein thrombosis; PE, pulmonary embolism; LMWH, low molecular weight

; bid, twice daily; od, once daily ; ITT, intention-to-treat; PP, per-protocol; ALT, alanine aminotransferase; AST, aspartate

; ULN, upper limit of normal.