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A new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial

Författare och institution:
Bengt I. Eriksson (Institutionen för de kirurgiska disciplinerna, Avdelningen för ortopedi); O. E. Dahl (-); H. R. Buller (-); R. Hettiarachchi (-); N. Rosencher (-); M. L. Bravo (-); L. Ahnfelt (-); F. Piovella (-); J. Stangier (-); P. Kalebo (-); P. Reilly (-)
Publicerad i:
J Thromb Haemost, 3 ( 1 ) s. 103-11
1538-7933 (Print)
Artikel, refereegranskad vetenskaplig
Sammanfattning (abstract):
BACKGROUND: Dabigatran etexilate is an oral direct thrombin inhibitor undergoing evaluation for the prevention of venous thromboembolism (VTE) following orthopedic surgery. METHODS: In a multicenter, parallel-group, double-blind study, 1973 patients undergoing total hip or knee replacement were randomized to 6-10 days of oral dabigatran etexilate (50, 150 mg twice daily, 300 mg once daily, 225 mg twice daily), starting 1-4 h after surgery, or subcutaneous enoxaparin (40 mg once daily) starting 12 h prior to surgery. The primary efficacy outcome was the incidence of VTE (detected by bilateral venography or symptomatic events) during treatment. RESULTS: Of the 1949 treated patients, 1464 (75%) patients were evaluable for the efficacy analysis. VTE occurred in 28.5%, 17.4%, 16.6%, 13.1% and 24% of patients assigned to dabigatran etexilate 50, 150 mg twice daily, 300 mg once daily, 225 mg twice daily and enoxaparin, respectively. A significant dose-dependent decrease in VTE occurred with increasing doses of dabigatran etexilate (P < 0.0001). Compared with enoxaparin, VTE was significantly lower in patients receiving 150 mg twice daily [odds ratio (OR) 0.65, P = 0.04], 300 mg once daily (OR 0.61, P = 0.02) and 225 mg twice daily (OR 0.47, P = 0.0007). Compared with enoxaparin, major bleeding was significantly lower with 50 mg twice daily (0.3% vs. 2.0%, P = 0.047) but elevated with higher doses, nearly reaching statistical significance with the 300 mg once-daily dose (4.7%, P = 0.051). CONCLUSIONS: Oral administration of dabigatran etexilate, commenced early in the postoperative period, was effective and safe across a range of doses. Further optimization of the efficacy/safety balance will be addressed in future studies.
Ämne (baseras på Högskoleverkets indelning av forskningsämnen):
Klinisk medicin ->
Kirurgi ->
Administration, Oral, Adult, Aged, Aged, 80 and over, Anticoagulants/*pharmacology, Arthroplasty, Replacement, Hip/*adverse effects, Arthroplasty, Replacement, Knee/*adverse effects, Benzimidazoles/*chemistry/*pharmacology, Dose-Response Relationship, Drug, Double-Blind Method, Enoxaparin/*pharmacology, Female, Humans, Male, Middle Aged, Odds Ratio, Postoperative Complications, Postoperative Period, Pyridines/*chemistry/*pharmacology, Regression Analysis, Thrombin/*antagonists & inhibitors, Thromboembolism/*prevention & control
Postens nummer:
Posten skapad:
2007-07-10 09:16
Posten ändrad:
2007-08-31 11:39

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