If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  New Heparin Allows Surgeons To Determine Dose Based On Patient's Weight ST. DAVIDS, Pa. -- June 2, 1997 -- A new low molecular weight heparin (LMWH) --Normiflo(R) (ardeparin sodium-injection) -- has received clearance for marketing by the U.S. Food and Drug Administration (FDA) for prevention of deep venous thrombosis (DVT) which may lead to pulmonary embolism (PE) following knee replacement surgery The new drug, according to its makers, Wyeth-Ayerst Laboratories, differs from other agents in its class by allowing the orthopedic surgeon to determine dosing based on a patient’s weight. Venous thromboembolic disease includes DVT, the formation of blood clots following surgery, and its complications such as PE, which can be sudden and fatal. This new dosing method eliminates the need for daily dosage adjustments and routine coagulation laboratory monitoring. All other drugs in the category are administered with a fixed dose. "Each patient undergoing knee replacement surgery is different. It seems logical that smaller patients may require less drug, and larger patients more drug," said Philip de Vane, M.D., Assistant Vice President, Clinical Affairs, Medical Affairs Department for Wyeth-Ayerst Laboratories. "Weight-based dosing offers another choice in DVT prophylaxis -- a choice that allows the surgeon to individualize the dose according to a patient’s body weight to achieve a constant plasma level of anti-Xa activity (the conversion of coagulation factor X to Xa)." Low molecular weight heparins In recognition of the safety and efficacy of LMWH agents, the most recent Consensus Conference of the American College of Chest Physicians (ACCP) reported several recent studies that demonstrated LMWH efficacy to be superior to warfarin therapy for DVT/PE prophylaxis following knee replacement surgery, a procedure that puts patients at high risk of developing the condition. Previously the ACCP had endorsed the anticoagulant warfarin for DVT/PE. Clinical trial results In a pivotal study reported in the Journal of Bone and Joint Surgery (1994: 76A, 1174-85), dosing regimens of Normiflo were compared with warfarin ( Coumadin(R); DuPont Merck) for preventing DVT in a subset comprising elective knee replacement surgery patients. Normiflo treatment was begun postoperatively. Normiflo (50 anti-Xa units/kg) administered twice daily (every 12 hours) was found to be more effective than warfarin (initial dose of 6 mg preoperatively, 4 mg postoperatively; then adjusted to INR 2.0 to 3.0) in preventing venous thromboembolism. The investigators concluded that ardeparin sodium administered twice daily was significantly more effective than warfarin and that the two regimens had comparable safety profiles.
|
