Antithrombin alfa in hereditary antithrombin deficient patients: A phase 3 study of prophylactic intravenous administration in high risk situations
| Autor: | Mario von Depka, Bernard Boneu, Johan Frieling, Marie Helene Horellou, R. Campbell Tait, Don W. Shaffer, Laura J. Bonfiglio, Robert Klamroth, Carl-Erik Dempfle, Andreas Tiede, John Lazarchick, Andrew D Mumford, C. Shiach, Jacqueline Conard, Francesco Baudo, Sam Schulman |
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| Rok vydání: | 2008 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Arthroplasty Replacement Hip Mammaplasty Deep vein Antithrombins Drug Administration Schedule Blood Coagulation Disorders Inherited hemic and lymphatic diseases Internal medicine medicine Coagulopathy Humans Prospective Studies cardiovascular diseases Elective surgery Infusions Intravenous Blood Coagulation Aged Venous Thrombosis Ultrasonography Doppler Duplex Cesarean Section Heparin business.industry Antithrombin Anticoagulants Phlebography Hematology Middle Aged Delivery Obstetric medicine.disease Thrombosis Recombinant Proteins United States Surgery Europe Venous thrombosis Treatment Outcome ATryn medicine.anatomical_structure Female business medicine.drug |
| Zdroj: | Thrombosis and Haemostasis. 99:616-622 |
| ISSN: | 2567-689X 0340-6245 |
| Popis: | SummaryDuring surgery and childbirth, patients with hereditary antithrombin (AT) deficiency are at high risk for thrombosis,and heparin prophylaxis may not be sufficiently efficacious. In these patients, exogenous AT may be used in association with heparin. A recombinant human AT (generic name: antithrombin alfa) has been developed. This multi-center study assessed the efficacy and safety of prophylactic intravenous administration of antithrombin alfa to hereditaryAT deficient patients in high risk situations, including elective surgery, childbirth, or cesarean section. Antithrombin alfa was administered prior to and during the high risk period for restoration and maintenance of AT activity at 100% of normal. Heparin, low-molecular-weight heparin, and/or vitamin K antagonists were used according to standard of care. The primary efficacy endpoint was the incidence of acute deep vein thrombosis (DVT) from baseline up to day 30 post dosing as assessed by independent central review of duplex ultrasonograms and/or venograms. Safety was assessed based on adverse events (AEs) and laboratory evaluations. Five surgical and nine obstetrical hereditary AT deficiency patients received antithrombin alfa for a mean period of seven days.No clinically overt DVT occurred. Central review of ultrasonograms identified signs of acute DVT in two out of 13 evaluable patients. No antithrombin alfa-related AEs were reported. No patient developed anti-antithrombin alfa antibodies. In conclusion, this study suggests that antithrombin alfa is a safe and effective alternative to human plasma-derived AT for treating hereditary AT deficiency patients at high risk for thromboembolic events. |
| Databáze: | OpenAIRE |
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