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Göteborgs universitets publikationer

Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement

Författare och institution:
Bengt I. Eriksson (Institutionen för kliniska vetenskaper, sektionen för anestesi, biomaterial och ortopedi); L. Borris (-); O. E. Dahl (-); S. Haas (-); M. V. Huisman (-); A. K. Kakkar (-); F. Misselwitz (-); P. Kalebo (-)
Publicerad i:
J Thromb Haemost, 4 ( 1 ) s. 121-8
1538-7933 (Print)
Artikel, refereegranskad vetenskaplig
Sammanfattning (abstract):
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.
Ämne (baseras på Högskoleverkets indelning av forskningsämnen):
Klinisk medicin ->
Kirurgi ->
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
Postens nummer:
Posten skapad:
2007-07-10 08:59
Posten ändrad:
2007-08-31 11:22

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