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Oral, direct Factor...
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Eriksson, Bengt I.,1946Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences
(författare)
Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement
- Artikel/kapitelEngelska2006
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LIBRIS-ID:oai:gup.ub.gu.se/43930
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https://gup.ub.gu.se/publication/43930URI
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Ämneskategori:art swepub-publicationtype
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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 och genrebeteckningar
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MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Kirurgi hsv//swe
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MEDICAL AND HEALTH SCIENCES Clinical Medicine Surgery hsv//eng
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Adult
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Aged
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Aged
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80 and over
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Anticoagulants/*administration & dosage/adverse effects
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Arthroplasty
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Replacement
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Hip/*adverse effects/methods
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Dose-Response Relationship
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Drug
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Double-Blind Method
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Enoxaparin/administration & dosage
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Factor Xa/*antagonists & inhibitors
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Female
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Hemorrhage/chemically induced
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Humans
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Male
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Middle Aged
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Morpholines/administration & dosage/adverse effects
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Postoperative Complications/prevention & control
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Pulmonary Embolism/drug therapy/prevention & control
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Thiophenes/administration & dosage/adverse effects
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Thromboembolism/drug therapy/prevention & control
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Venous Thrombosis/drug therapy/mortality/*prevention & control
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Borris, L.
(författare)
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Dahl, O. E.
(författare)
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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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Göteborgs universitetInstitutionen för kliniska vetenskaper
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:J Thromb Haemost4:1, s. 121-81538-7933
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