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Oral, direct Factor...
Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement
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- Eriksson, Bengt I., 1946 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences
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Borris, L. (författare)
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Dahl, O. E. (författare)
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visa fler...
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Haas, S. (författare)
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Huisman, M. V. (författare)
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Kakkar, A. K. (författare)
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Misselwitz, F. (författare)
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Kalebo, P. (författare)
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visa färre...
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(creator_code:org_t)
- 2006
- 2006
- Engelska.
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Ingår i: J Thromb Haemost. - 1538-7933. ; 4:1, s. 121-8
- Relaterad länk:
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https://gup.ub.gu.se...
Abstract
Ämnesord
Stäng
- BACKGROUND: Joint replacement surgery is an appropriate model for dose-ranging studies investigating new anticoagulants. OBJECTIVES: To assess the efficacy and safety of a novel, oral, direct factor Xa (FXa) inhibitor--BAY 59-7939--relative to enoxaparin in patients undergoing elective total hip replacement. METHODS: In this double-blind, double-dummy, dose-ranging study, patients were randomized to oral BAY 59-7939 (2.5, 5, 10, 20, or 30 mg b.i.d.), starting 6-8 h after surgery, or s.c. enoxaparin 40 mg once daily, starting on the evening before surgery. Treatment was continued until mandatory bilateral venography was performed 5-9 days after surgery. RESULTS: Of 706 patients treated, 548 were eligible for the primary efficacy analysis. The primary efficacy endpoint was the incidence of any deep vein thrombosis, non-fatal pulmonary embolism, and all-cause mortality; rates were 15%, 14%, 12%, 18%, and 7% for BAY 59-7939 2.5, 5, 10, 20, and 30 mg b.i.d., respectively, compared with 17% for enoxaparin. The primary efficacy analysis did not demonstrate any significant trend in dose-response relationship for BAY 59-7939. The primary safety endpoint was major, postoperative bleeding; there was a significant increase in the frequency of events with increasing doses of BAY 59-7939 (P = 0.045), but no significant differences between individual BAY 59-7939 doses and enoxaparin. CONCLUSIONS: When efficacy and safety were considered together, the oral, direct FXa inhibitor BAY 59-7939, at 2.5-10 mg b.i.d., compared favorably with enoxaparin for the prevention of venous thromboembolism in patients undergoing elective total hip replacement.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
Nyckelord
- Adult
- Aged
- Aged
- 80 and over
- Anticoagulants/*administration & dosage/adverse effects
- Arthroplasty
- Replacement
- Hip/*adverse effects/methods
- Dose-Response Relationship
- Drug
- Double-Blind Method
- Enoxaparin/administration & dosage
- Factor Xa/*antagonists & inhibitors
- Female
- Hemorrhage/chemically induced
- Humans
- Male
- Middle Aged
- Morpholines/administration & dosage/adverse effects
- Postoperative Complications/prevention & control
- Pulmonary Embolism/drug therapy/prevention & control
- Thiophenes/administration & dosage/adverse effects
- Thromboembolism/drug therapy/prevention & control
- Venous Thrombosis/drug therapy/mortality/*prevention & control
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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