Efficacy and safety of the oral direct factorXa inhibitor apixaban for symptomatic deep vein thrombosis. The Botticelli DVT dose-ranging study

H. Buller; D. Deitchman; M. Prins; A. Segers; R.I. Baker

doi:10.1111/j.1538-7836.2008.03054.x

Back

Efficacy and safety of the oral direct factorXa inhibitor apixaban for symptomatic deep vein thrombosis. The Botticelli DVT dose-ranging study

Journal article

Peer reviewed

Efficacy and safety of the oral direct factorXa inhibitor apixaban for symptomatic deep vein thrombosis. The Botticelli DVT dose-ranging study

H. Buller, D. Deitchman, M. Prins, A. Segers and R.I. Baker

Journal of Thrombosis and Haemostasis, Vol.6(8), pp.1313-1318

2008

DOI: https://doi.org/10.1111/j.1538-7836.2008.03054.x

Files and links (1)

url

Free to Read *No subscription requiredView

Abstract

BACKGROUND: Apixaban, an oral potent reversible direct inhibitor of activated factor X, has shown promise in the prevention of venous thromboembolism following major orthopedic surgery. We conducted a dose-ranging study in patients with deep vein thrombosis. METHODS: Consecutive patients with symptomatic deep vein thrombosis were included and randomized to receive 84-91 days of apixaban 5 mg twice-daily, 10 mg twice-daily, or 20 mg once-daily, or low molecular weight heparin (LMWH) followed by a vitamin K antagonist (VKA). The primary efficacy outcome was the composite of symptomatic recurrent venous thromboembolism and asymptomatic deterioration of bilateral compression ultrasound or perfusion lung scan. The principal safety outcome was the composite of major and clinically relevant, non-major bleeding. RESULTS: The mean age of the 520 included patients was 59 years, and 62% were male. The primary outcome occurred in 17 of the 358 apixaban-treated patients [4.7%, 95% confidence interval (CI) 2.8-7.5%] and in five of the 118 LMWH/VKA-treated patients (4.2%, 95% CI 1.4-9.6%) who were evaluable. The incidence in all three apixaban groups was low and comparable without evidence of a dose response. The principal safety outcome occurred in 28 (7.3%) of the 385 apixaban-treated patients and in 10 (7.9%) of the 126 LMWH/VKA-treated patients. No dose response for apixaban was observed. CONCLUSION: These observations warrant further evaluation of apixaban in phase III studies. The attractive fixed-dose regimen of this compound may meet the demand to simplify anticoagulant treatment in patients with established venous thromboembolism.

Details

Title: Efficacy and safety of the oral direct factorXa inhibitor apixaban for symptomatic deep vein thrombosis. The Botticelli DVT dose-ranging study
Authors/Creators: H. Buller (Author/Creator) - University of Amsterdam
D. Deitchman (Author/Creator) - University of Amsterdam
M. Prins (Author/Creator) - Bristol-Myers Squibb (Germany)
A. Segers (Author/Creator) - Maastricht University
R.I. Baker (Author/Creator)
Publication Details: Journal of Thrombosis and Haemostasis, Vol.6(8), pp.1313-1318
Publisher: Wiley-Blackwell
Identifiers: 991005542751207891
Copyright: © 1999 - 2017 John Wiley & Sons, Inc.
Murdoch Affiliation: Institute for Immunology and Infectious Diseases
Language: English
Resource Type: Journal article
Additional Information: Murdoch University authors made contribution to this work as part of the Botticelli Investigators Writing Committee.

UN Sustainable Development Goals (SDGs)

This output has contributed to the advancement of the following goals:

Source: InCites

Metrics

25 Record Views

219 Times Cited - Web of Science

InCites Highlights

These are selected metrics from InCites Benchmarking & Analytics tool, related to this output

Collaboration types: Industry collaboration; Domestic collaboration; International collaboration
Citation topics: 1 Clinical & Life Sciences; 1.94 Cardiac Arrhythmia; 1.94.95 Atrial Fibrillation Management
Web Of Science research areas: Hematology; Peripheral Vascular Disease
ESI research areas: Clinical Medicine