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Postoperative Melag...
Postoperative Melagatran/Ximelagatran for the Prevention of Venous Thromboembolism following Major Elective Orthopaedic Surgery : Effects of Timing of First Dose and Risk Factors for Thromboembolism and Bleeding Complications on Efficacy and Safety
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Dahl, O. E. (författare)
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- Eriksson, Bengt I., 1946 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för de kirurgiska disciplinerna, Avdelningen för ortopedi,Institute of Surgical Sciences, Department of Orthopaedics
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Agnelli, G. (författare)
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visa fler...
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Cohen, A. T. (författare)
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Mouret, P. (författare)
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Rosencher, N. (författare)
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Panfilov, S. (författare)
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Bylock, A. (författare)
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Andersson, M. (författare)
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visa färre...
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(creator_code:org_t)
- 2005
- 2005
- Engelska.
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Ingår i: Clin Drug Investig. - 1173-2563. ; 25:1, s. 65-77
- Relaterad länk:
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https://gup.ub.gu.se...
Abstract
Ämnesord
Stäng
- OBJECTIVES: To examine the influence of timing of postoperative initiation of subcutaneous melagatran followed by oral ximelagatran, and of risk factors for venous thromboembolism (VTE; including deep vein thrombosis [DVT] and pulmonary embolism [PE]) and bleeding complications, on the efficacy and safety of this regimen, compared with preoperative enoxaparin sodium, following total hip replacement (THR) or total knee replacement (TKR) surgery. DESIGN: Statistical analyses of efficacy and safety in subgroups of the METHRO III intention-to-treat population. MAIN OUTCOME MEASURES: Main efficacy outcome measures were major VTE (proximal DVT, PE or VTE-related death) and total VTE (distal or proximal DVT, fatal or non-fatal PE). The main safety outcome measures were blood transfusion, severe bleeding events, blood loss, bleeding-related adverse events and need for reoperation. RESULTS: In the combined THR and TKR population, melagatran initiated 4 - <8 hours postoperatively was non-inferior to enoxaparin sodium with respect to the risks of total VTE (absolute risk reduction [ARR] 0; 95% confidence interval [CI] -4.4, 4.4) and major VTE (ARR -0.63; 95% CI -2.94, 1.67). The rate of major VTE was unaffected by the different risk factors. In the combined THR and TKR population, blood transfusion requirements were lower with melagatran/ximelagatran than enoxaparin sodium (odds ratio 0.83; 95% CI 0.71, 0.96; p = 0.016). CONCLUSIONS: Melagatran/ximelagatran initiated 4 - <8 hours postoperatively provided a comparable level of protection against total and major VTE to preoperative enoxaparin sodium. Major VTE rates and safety were consistent across different patient subgroups. Subcutaneous melagatran followed by fixed-dose oral ximelagatran offers an alternative to the standard European low molecular-weight heparin regimen in a wide range of patients.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
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