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Göteborgs universitets publikationer

Dabigatran Etexilate: Pivotal Trials for Venous Thromboembolism Prophylaxis After Hip or Knee Arthroplasty

Författare och institution:
Bengt I. Eriksson (Institutionen för kliniska vetenskaper, sektionen för anestesi, biomaterial och ortopedi); R. Friedman (-)
Publicerad i:
Clinical and Applied Thrombosis/Hemostasis, 15 ( 1S ) s. 25S-31S
Artikel, refereegranskad vetenskaplig
Sammanfattning (abstract):
Dabigatran etexilate, an oral direct thrombin inhibitor, was investigated in 3 large phase III trials for the prevention of venous thromboembolism (VTE) after total hip arthroplasty (RE-NOVATE, N = 3494) or total knee arthroplasty (RE-MODEL, N = 2076 and RE-MOBILIZE, N = 2615). RE-NOVATE and RE-MODEL were conducted mainly in Europe, and RE-MOBILIZE was conducted predominantly in the United States and Canada. This review discusses the results of these trials. In all 3 trials, 2 doses, 220 mg and 150 mg once daily, were compared with enoxaparin. Both RE-MODEL and RE-NOVATE demonstrated noninferiority for the primary outcome (a composite of total VTE events and all-cause mortality), P = .0003 and P < .0001, respectively, for these trials. In 2008, these data formed the basis for European and Canadian approval. While RE-MOBILIZE did not demonstrate noninferiority for the primary outcome (25.3% for enoxaparin vs 31.1% for 220 mg, risk difference +5.8%, 95% CI, 0.8-10.8; P = .02 and 33.7% for 150 mg, risk difference +8.4%, 95% CI, 3.4-13.3; P = .0009), both treatments were similar for the secondary composite outcome (major VTE plus VTE-related mortality; 3.4% with 220 mg, 3.0% with 150 mg, and 2.2% with enoxaparin) and symptomatic deep vein thrombosis (0.8%, 0.7%, and 0.6%). There were no differences in the bleeding rates, hepatic enzyme elevations, or acute coronary syndrome events between the 2 treatments. With the practical advantages of once-daily oral dosing, dabigatran etexilate can be considered an attractive alternative to conventional thromboprophylaxis regimens in patients undergoing elective total hip and knee arthroplasty.
Ämne (baseras på Högskoleverkets indelning av forskningsämnen):
Klinisk medicin ->
Kirurgi ->
Postens nummer:
Posten skapad:
2010-01-13 14:08
Posten ändrad:
2012-08-09 08:57

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