Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement
| Autor: | Eriksson, B. I., Borris, L., Dahl, O. E., Haas, S., Huisman, M. V., Kakkar, A. K., Misselwitz, F., Kalebo, P., Breyer, H. -G., Bounameaux, H., Leizorovicz, A., Angeras, U., Falk, A., Prins, M., Zachrisson, B., Eriksson, H., Sandgren, G., Wallin, J., Engel, A., Hochreiter, J., Niessner, H., Driesen, R., Horlyck, E., Jorgensen, P. S., Lassen, M., Delecroix, M., Hayek, E., Le Pelley, E., Birkner, W., Fritsche, H. -M., Gunther, K. -P., Halder, A., Kleinfeld, F., Kurth, A., Mouret, P., Brenner, B., Dekel, S., Halperin, N., Martinovich, U., Ageno, W., Fraschini, G., Lodigiani, C., Parise, P., Silingardi, M., Slappendel, R., van der Vis, H., Verburg, A., Aarseth, O., Hovick, O., Hovind, H., Bednarek, A., Blancha, J., Kwiatkowski, K., Mazurkiewicz, S., Niedzwiedski, T., Skowronski, J., Castellet, E., Gomar, F., Granero, X., Peidro, L., Edshage, B., Lind, S., Wykman, A., Cohen, A. |
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| Rok vydání: | 2006 |
| Předmět: |
Male
medicine.drug_mechanism_of_action medicine.medical_treatment Deep vein Arthroplasty Replacement Hip Knee replacement law.invention Postoperative Complications Randomized controlled trial Rivaroxaban law Aged 80 and over Venous Thrombosis medicine.diagnostic_test Total hip replacement Hematology Middle Aged Thrombosis Pulmonary embolism Direct Factor Xa inhibitor medicine.anatomical_structure Anesthesia Female Venous thromboembolism medicine.drug Adult medicine.medical_specialty Morpholines Factor Xa Inhibitor Venography Hemorrhage Thiophenes Oral anticoagulant Prophylaxis Double-Blind Method Thromboembolism medicine Humans Enoxaparin Aged Dose-Response Relationship Drug business.industry Anticoagulants medicine.disease Surgery business Pulmonary Embolism Factor Xa Inhibitors |
| Zdroj: | Journal of thrombosis and haemostasis : JTH. 4(1) |
| ISSN: | 1538-7933 |
| Popis: | Summary. 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. |
| Databáze: | OpenAIRE |
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