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November 16, 2005Blood

YM150, an Oral Direct Factor Xa Inhibitor, as Prophylaxis for Venous Thromboembolism in Patients with Elective Primary Hip Replacement Surgery. A Dose Escalation Study.

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Why the study?

Does YM150 prevent venous thromboembolism in patients undergoing elective primary hip replacement surgery?

Population

n=174 patients undergoing elective primary hip replacement surgery

Comparison

YM150 3, 10, 30 or 60 mg once daily starting… vs Subcutaneous enoxaparin 40 mg once daily…

Design

RCT, randomized, open-label with blinded evaluation of all outcomes by an…

Follow-up

7-10 days

Authors

BEBengt I. ErikssonKarolinska InstitutetATAlexander G.G. TurpieMcMaster UniversityMLMichael R. LassenUniversity of Copenhagen

Discussion

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Implication

Supports YM150 30-60 mg daily for VTE prophylaxis after hip replacement; confirms dose-dependent efficacy versus enoxaparin in RCT.

Structured PICO

Does YM150 prevent venous thromboembolism in patients undergoing elective primary hip replacement surgery?

P
Population
n=174 patients undergoing elective primary hip replacement surgery
I
Intervention
YM150 (oral direct factor Xa inhibitor) 3, 10, 30 or 60 mg once daily starting 6-10 h after surgery for 7-10 days
C
Comparator
Subcutaneous enoxaparin 40 mg once daily starting 12 h before surgery for 7-10 days
O
Outcome
Safety (major and/or clinically relevant non-major bleeding) and efficacy (venous thromboembolism detected by mandatory bilateral venography on the last treatment day and/or symptomatic VTE)composite

Oral YM150 at doses of 10 to 60 mg once daily is safe and effective for VTE prophylaxis after primary hip replacement surgery, showing a significant dose-related reduction in VTE.

Cite This Study

Eriksson et al. (2005) studied this question.

synapsesocial.com/papers/6a84b40a2cc9708cfc15b034https://doi.org/10.1182/blood.v106.11.1865.1865
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Once Daily YM150, an Oral Direct Factor Xa Inhibitor, for Prevention of Venous Thromboembolism in Patients Undergoing Elective Primary Hip Replacement.2007 · 7 citations
  2. 2YM150, An Oral Direct Inhibitor of Factor Xa, Demonstrated a Predictable and Dose-Proportional Pharmacokinetic/Pharmacodynamic Profile After Single and Multiple Dosing: Results From Three Studies2010 · 16 citations
  3. 3A Phase II Study of the Safety and Efficacy of a Novel Oral fXa Inhibitor (LY517717) for the Prevention of Venous Thromboembolism Following TKR or THR.2005 · 27 citations
  4. 4Prevention of Venous Thromboembolism after Total Hip Replacement with Once-Daily BAY 59-7939 - An Oral, Direct Factor Xa Inhibitor.2005 · 11 citations
  5. 5Oral direct factor Xa inhibition with edoxaban for thromboprophylaxis after elective total hip replacement2010 · 146 citations