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Indications & Efficacy > Hip Replacement Surgery
ARIXTRA Cut VTE* by More Than Half vs Enoxaparin Sodium After Hip Replacement Surgery
In a large-scale clinical trial of more than 2,300 patients, ARIXTRA was proven to reduce the risk of venous thromboembolism (VTE) vs enoxaparin sodium by 56%. For the purpose of this study, hip replacement surgery was defined as primary elective total hip replacement surgery or a revision of at least one component of a previously implanted total hip prosthesis.
Study Characteristics
- Patient population: 2,309 patients randomized into the study
- Hip Replacement Surgery Study design: Randomized, multicenter,
double-blind clinical trial in patients undergoing hip replacement surgery
- Duration of thromboprophylaxis: 5 to 9 days
- Primary efficacy outcome: VTE up to day 11, defined as DVT detected by mandatory bilateral venography, documented symptomatic DVT, or documented symptomatic PE
Incidence of major bleeding was 4.1% (47/1,140) for ARIXTRA
and 2.8% (32/1,133) for enoxaparin (P = NS)†
In another clinical study where Lovenox® was given 30
mg twice daily initiated 12 to 24 hours post-op, ARIXTRA reduced VTE*
by 26% (48/787 for ARIXTRA vs 66/797 for enoxaparin sodium; P =
.10 [NS]) following hip replacement surgery.
ARIXTRA Cut Proximal DVT‡ by 72% vs Enoxaparin Sodium Following Hip Replacement Surgery
In another clinical study where Lovenox was given 30 mg twice daily initiated 12 to 24 hours post-op, incidence of proximal DVT‡ was 1.7% (14/816) for ARIXTRA vs 1.2% (10/830) for enoxaparin sodium (P = NS) following hip replacement surgery.
*VTE, the primary endpoint, was a composite of documented
DVT and/or documented symptomatic PE reported up to day 11.
†Bleeding leading to reoperation; nonfatal bleeding involving a critical
organ;
fatal bleeding; or bleeding index >2. Bleeding index was defined
as the number of whole blood or packed red blood cell (PRBC) units transfused
+ [(prebleeding)-(postbleeding)] hemoglobin (g/dL) values.
‡DVT involving popliteal or more proximal veins
reported up to day 11.
If you have additional questions regarding ARIXTRA,
please call us
Please see Important Safety Information and complete Prescribing Information, including BOXED WARNING regarding epidural and spinal hematomas.
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Synthetically engineered to target only Factor Xa. Click here.
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© 1997-2009 GlaxoSmithKline. All Rights Reserved.