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November 16, 2005Blood

A 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.

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Key result

LY517717 at 100-150 mg is non-inferior to enoxaparin for VTE prevention after knee or hip replacement.

  • n=511

Why the study?

Does LY517717 prevent venous thromboembolism in patients undergoing total knee or hip replacement compared to enoxaparin?

Population

511 patients undergoing total knee replacement (TKR) or total hip replacement (THR).

Comparison

LY517717 at doses of 25, 50, 75, 100, 125 or 150… vs Enoxaparin 40 mg SC once daily for 6-10 doses.

Design

RCT, randomized, double-blind, double-dummy

Follow-up

30 days (±7)

Authors

GAGiancarlo AgnelliVascular MedicineSHSylvia HaasVascular MedicineKKKathryn A. KruegerUniversität Hamburg

Discussion

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Implication

Supports oral LY517717 for VTE prophylaxis after knee/hip replacement; confirms non-inferiority to enoxaparin in RCT.

Study Design

Type

RCT (n=511)

Blinding

double-blind, double-dummy

Randomization

randomized

Structured PICO

Does LY517717 prevent venous thromboembolism in patients undergoing total knee or hip replacement compared to enoxaparin?

P
Population
511 patients undergoing total knee or hip replacement, randomized to receive oral LY517717 or enoxaparin for 6-10 doses to prevent VTE.
I
Intervention
LY517717 (oral direct fXa inhibitor) at doses of 25, 50, 75, 100, 125 or 150 mg once daily for 6-10 doses.
C
Comparator
Enoxaparin 40 mg SC once daily for 6-10 doses.
O
Outcome
Combined VTE endpoint (DVT detected by mandatory venography and symptomatic DVT and PE events) through day 30 (±7).composite

LY517717 at doses of 100-150 mg is safe and non-inferior to enoxaparin for VTE prophylaxis after major orthopedic surgery.

Cite This Study

Agnelli et al. (2005) conducted an RCT in venous thromboembolism (n=511). LY517717 vs. enoxaparin 40 mg SC once daily was evaluated on combined VTE endpoint (DVT detected by mandatory venography and symptomatic DVT and PE events). LY517717 at 100, 125, and 150 mg was non-inferior to enoxaparin for preventing VTE after knee or hip replacement (90% CI upper limits for absolute differences 0.13, 0.05, and 0.01).

synapsesocial.com/papers/6aa39ed7229fb590e7c613f2https://doi.org/10.1182/blood.v106.11.278.278
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Also Consider

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

  1. 1An Adaptive-Design Dose-Ranging Study of PD 0348292, a New Oral Factor Xa Inhibitor, for Thromboprophylaxis after Total Knee Replacement Surgery.2008 · 13 citations
  2. 2Once Daily YM150, an Oral Direct Factor Xa Inhibitor, for Prevention of Venous Thromboembolism in Patients Undergoing Elective Primary Hip Replacement.2007 · 7 citations
  3. 3Prevention of Venous Thromboembolism after Total Hip Replacement with Once-Daily BAY 59-7939 - An Oral, Direct Factor Xa Inhibitor.2005 · 11 citations
  4. 4YM150, an Oral Direct Factor Xa Inhibitor, as Prophylaxis for Venous Thromboembolism in Patients with Elective Primary Hip Replacement Surgery. A Dose Escalation Study.2005 · 22 citations
  5. 5A dose-finding study with TAK-442, an oral factor Xa inhibitor, in patients undergoing elective total knee replacement surgery2010 · 32 citations