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A new oral direct t...
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
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- Eriksson, Bengt I., 1946 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för de kirurgiska disciplinerna, Avdelningen för ortopedi,Institute of Surgical Sciences, Department of Orthopaedics
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Dahl, O. E. (author)
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Buller, H. R. (author)
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Hettiarachchi, R. (author)
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Rosencher, N. (author)
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Bravo, M. L. (author)
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Ahnfelt, L. (author)
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Piovella, F. (author)
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Stangier, J. (author)
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Kalebo, P. (author)
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Reilly, P. (author)
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(creator_code:org_t)
- 2005
- 2005
- English.
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In: J Thromb Haemost. - 1538-7933. ; 3:1, s. 103-11
- Related links:
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https://gup.ub.gu.se...
Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
Keyword
- 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
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Eriksson, Bengt ...
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Dahl, O. E.
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Buller, H. R.
-
Hettiarachchi, R ...
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Rosencher, N.
-
Bravo, M. L.
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show more...
-
Ahnfelt, L.
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Piovella, F.
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Stangier, J.
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Kalebo, P.
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Reilly, P.
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Surgery
- Articles in the publication
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J Thromb Haemost
- By the university
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University of Gothenburg