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3. Prevention of venous thromboembolism with an oral factor Xa inhibitor, YM150, after total hip arthroplasty. A dose finding study (ONYX-2)

Author

Eriksson, Bi, Turpie, Ag, Lassen, Mr, Prins, Mh, Agnelli, G, Kälebo, P, Wetherill, G, Wilpshaar, Jw, Meems, L, Paireddy, A, Wall, M, Hermus, G, Willems, M, Zachrisson, B, Wallin, J, Eriksson, H, Sandgren, G, Angerås, U, Falk, A, Bergqvist, D, Gallus, A, Tijssen, Jg, Pessayre, D, Grohs, Jg, Nogler, M, Wurnig, C, Gavrankapetanovic, I, Maric, V, Pavic, V, Deniger, J, Kofránek, I, Pink, M, Pink, T, Hölmich, P, Mejdahl, S, Mikkelsen, S, Leppilahti, J, Pesola, M, Fink, B, Göbel, F, Graichen, H, Halder, Am, Kienapfel, H, Kurth, A, Ferrousis, I, Macheras, G, D'Angelo, A, Baudo, F, Borghi, B, Della Rocca, G, Fanelli, G, Grappiolo, G, Grossi, P, Piovella, F, Silingardi, M, Spotorno, L, Baurovskis, A, Keselis, J, Peredistijs, A, Kocius, M, Smailys, A, Buciuto, R, Hedlund, T, Talsnes, O, Bednarek, A, Blacha, J, Kwiatkowski, K, Niedzwiedzki, T, Skowronski, Jc, Wojciechowski, P, Dryagin, V, Ivanov, P, Kopenkin, S, Kuropatkin, G, Lapshinov, E, Levin, G, Linnik, S, Medvedev, A, Nikolaev, V, Safronov, A, Sergeev, S, Harhaji, V, Kecojevic, V, Mitkovic, M, Nedeljkovic, R, Ristic, B, Stosic, P, Todorovic, P, Hlavác, M, Oslanec, D, Alonso Aguirre MA, Casa Pantoja, V, Cruz Pardos, A, Díaz Almodovar JL, Gomar Sancho, F, Otero Fernández, R, Valle Ortiz MJ, Vilanova Vázquez JL, Ahnfelt, L, Andersson, C, Petersson, Lg, Ponzer, S., Eriksson BI., Turpie AG., Lassen MR., Prins MH., Agnelli G., Kalebo P., Wetherill G., Wilpshaar JW., Meems L., ONYX-2 study group, Borghi B., ACS - Amsterdam Cardiovascular Sciences, Cardiology, Epidemiologie, MUMC+: KIO Kemta (9), and RS: CAPHRI School for Public Health and Primary Care

Subjects
Time Factors, total hip arthroplasty, Arthroplasty, Replacement, Hip, Deep vein, medicine.medical_treatment, Administration, Oral, direct factor Xa inhibitor, law.invention, chemistry.chemical_compound, Randomized controlled trial, oral anticoagulant, law, Stroke, Aged, 80 and over, medicine.diagnostic_test, Incidence, Darexaban, Hematology, Middle Aged, Thrombosis, Treatment Outcome, medicine.anatomical_structure, Elective Surgical Procedures, Anesthesia, prophylaxis, Adult, medicine.medical_specialty, Acute coronary syndrome, venous thromboembolism, Venography, Postoperative Hemorrhage, Risk Assessment, Young Adult, direct factor Xa inibhitor, YN150, oral thromboprophylaxis, flebography, arthroplasty, Double-Blind Method, Fibrinolytic Agents, medicine, Humans, cardiovascular diseases, Enoxaparin, Aged, Dose-Response Relationship, Drug, business.industry, Phlebography, medicine.disease, Arthroplasty, Surgery, Logistic Models, chemistry, YM150, business, Factor Xa Inhibitors
Abstract

Summary. Background: Anticoagulant prophylaxis substantially reduces the risk of venous thromboembolism (VTE) after major orthopedic surgery. The direct factor Xa inhibitor YM150 is currently under investigation for the prevention of VTE, stroke and ischemic vascular events in patients after orthopedic surgery, with atrial fibrillation and with acute coronary syndrome, respectively. Objectives: To investigate the efficacy and safety of YM150 for the prevention of VTE following elective total hip arthroplasty. Patients/methods: Patients were randomized to postoperative, once-daily, oral YM150 (5, 10, 30, 60 or 120 mg) (double-blind) or preoperative subcutaneous (open label) enoxaparin (40 mg) for 5 weeks. The primary efficacy endpoint comprised VTE diagnosed by mandatory bilateral venography or verified symptomatic deep vein thrombosis (DVT) plus all deaths up to 9 days after surgery. The primary safety outcome was major bleeding up to 9 days after surgery. Results: Primary efficacy endpoint: of 1017 patients randomized, 960 patients were evaluable for safety and 729 patients for efficacy. A dose-related decrease in VTE incidence from YM150 5 to 60 mg (P = 0.0005) and from 5 to120 mg (P = 0.0002) was found. The VTE incidence was 27.4%, 31.7%, 19.3%, 13.3% and 14.5% for 5, 10, 30, 60 and 120 mg YM150, respectively, and 18.9% for enoxaparin. Primary safety endpoint: there was one major bleed with YM150 (60 mg) and one with enoxaparin. Conclusions: The oral direct FXa inhibitor YM150 demonstrated a significant dose response regarding efficacy. Doses from 30 to 120 mg had comparable efficacy to enoxaparin, without compromising safety regarding major bleeding events.

Published
2010
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4. Deoxyhypusine hydrolase from Plasmodium vivax, the neglected human malaria parasite: molecular cloning, expression and functional activity

Author

Anyi, V., Pink, M., Schmitz-Spanke, S., Von Koschtizky, I., Zhao, K. H., Langer, B., and Kaiser, A.

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Primaquine, a 4-aminoquinoline, is the only drug which cures the dormant hypnozoites of persistant liver stages from P. vivax. Increasing resistance needs the discovery of alternative pathways as drug targets to develop novel drug entities. Deoxyhypusine hydroxylase (DOHH) completes hypusine biosynthesis[for full text, please go to the a.m. URL], 10th Malaria Meeting

Published
2013
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5. Die Rolle von Clathrin in der Pathogenese der Endokrinen Orbitopathie (EO)

Author

Meyer zu Hörste, M, Ströher, E, Berchner-Pfannschmidt, U, Schmitz-Spanke, S, Pink, M, Göthert, JR, Fischer, JW, Gulbins, E, and Eckstein, AK

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Hintergrund: Bei der Endokrinen Orbitopathie (EO) kommt es im Rahmen der lokalen entzündlichen Autoimmunreaktion in der Orbita zur verstärkten Adipogenese und Proliferation der Orbitafibroblasten, zur massiv gesteigerten Produktion von Extrazellulärmatrix, und infolge dessen zur Volumenzunahme[for full text, please go to the a.m. URL], 174. Versammlung des Vereins Rheinisch-Westfälischer Augenärzte

Published
2012
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