November 20, 2009Blood
Phase II Dose-Finding Study with TAK-442, An Oral Factor Xa Inhibitor, in Patients Undergoing Elective Knee Arthroplasty.
Key result
TAK-442 at total daily doses of 40 to 160 mg had similar efficacy to enoxaparin (primary endpoint incidence 10.6%-28.8% across doses vs 14.9%) for thromboprophylaxis after total knee arthroplasty.
Why the study?
Does TAK-442 reduce the composite of all-cause mortality, DVT, and PE in patients undergoing elective knee arthroplasty compared to enoxaparin?
Population
1038 males and females 18 years of age or older undergoing elective unilateral total knee arthroplasty.
Comparison
TAK-442 40 or 80 mg oral once daily, or 10, 20… vs Enoxaparin 30 mg subcutaneous twice daily for 10…
Design
RCT, randomly assigned to 1 of 7 treatment groups, Enoxaparin was given…
Follow-up
30 days after the last dose of study drug
Authors
Discussion
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Implication
Supports oral factor Xa inhibition as alternative to enoxaparin post-TKA; confirms comparable efficacy in RCT.
Study Design
Type
RCT (n=1,038)
Blinding
Double-blind for TAK-442, open-label for enoxaparin
Randomization
randomly assigned
Multicenter
Yes
Structured PICO
Does TAK-442 reduce the composite of all-cause mortality, DVT, and PE in patients undergoing elective knee arthroplasty compared to enoxaparin?
P
Population
1,038 adults undergoing elective unilateral total knee arthroplasty, treated with TAK-442 or enoxaparin for 10 days and followed for 30 days.
I
Intervention
TAK-442 40 or 80 mg oral once daily, or 10, 20, 40, or 80 mg oral twice daily for 10 days (first dose 6-8 hours postoperatively).
C
Comparator
Enoxaparin 30 mg subcutaneous twice daily for 10 days (first dose 12-24 hours postoperatively).
O
Outcome
Composite of all-cause mortality, symptomatic and asymptomatic DVT, and pulmonary embolism (PE).composite
In patients undergoing total knee replacement, the oral factor Xa inhibitor TAK-442 at daily doses of 40 to 160 mg demonstrated similar efficacy and safety to enoxaparin.
Cite This Study
Weitz et al. (2009) conducted an RCT in elective unilateral total knee arthroplasty (n=1,038). TAK-442 vs. enoxaparin 30 mg BID was evaluated on composite of all-cause mortality, symptomatic and asymptomatic DVT, and pulmonary embolism (PE). TAK-442 at total daily doses of 40 to 160 mg had similar efficacy to enoxaparin (primary endpoint incidence 10.6%-28.8% across doses vs 14.9%) for thromboprophylaxis after total knee arthroplasty.