To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Lovenox Effective in the Treatment of Deep Vein Thrombosis URL: http://www.pslgroup.com/dg/6952.htm Doctor's Guide March 14, 1996
HAMILTON, Ontario-March 14, 1996 -- Results of a clinical trial published in this week's issue of The New England Journal of Medicine show that patients with potentially life-threatening blood clots can treat themselves safely and effectively in their own homes with a drug in a unique class of antithrombotics known as low molecular weight heparin (LMWH). The study showed that treatment with Lovenox(R) (enoxaparin sodium) eliminates the need for hospitalization or greatly reduces hospital stays, increasing patient convenience and potentially saving substantial health-care costs. In the 500-patient Canadian study, Lovenox, an injectable LMWH, was used to treat patients with acute proximal deep vein thrombosis (DVT) in the home setting, and was compared to standard intravenous heparin administered in the hospital. "The results of this trial confirm that low molecular weight heparin is beneficial for home use," said Mark N. Levine, M.D., lead author of the study and CEO of the Hamilton Regional Cancer Centre. "Because of its unique pharmacological properties and more predictable anticoagulant response, low molecular weight heparin such as enoxaparin has the advantage of allowing DVT to be treated in the home setting rather than in the hospital." In the study, patients with acute proximal DVT were randomly assigned to intravenous standard heparin in the hospital or Lovenox 1 mg/kg injected subcutaneously every 12 hours. The latter drug was administered primarily at home, either by the patient or a family member. The study design allowed outpatients receiving LMWH to go home immediately and hospitalized patients receiving LMWH to be discharged early. The mean number of days in the hospital for the LMWH group was only 1.1 days compared to 6.5 days for the standard heparin group; 120 LMWH patients were never hospitalized. "The demonstration that low molecular weight heparin can be given safely and with effectiveness at home in a large number of patients with proximal DVT constitutes a major advance because it both increases patient convenience and reduces health costs," said Jack Hirsh, M.D., clinical investigator and director of Hamilton Civic Hospitals Research Centre. "Given the increasing concern of government and society with steeply rising health-care costs, it is important to capitalize not only on the efficacy of these new agents, but also on their potential to be administered in less expensive settings." Most Common, Preventable Cause of Hospital Death DVT is the formation of blood clots in the deep veins of the leg, a serious and potentially fatal complication of hospitalization for illness, including orthopedic surgery, major surgery, cancer, heart disease or paralysis due to trauma or stroke. Clinical risk factors for DVT include advanced age, prolonged immobility, cancer, prior venous thromboembolism, obesity and varicose veins. DVT is a major cause of life-threatening pulmonary emboli, which occur when a clot fragments, then circulates and lodges in the lungs, a condition that can lead to sudden death. Venous thromboembolic disease is responsible for more than 400,000 hospitalizations and up to 200,000 deaths each year in the United States. According to the American College of Chest Physicians, DVT may be the most common preventable cause of hospital death. Usually, patients with deep vein thrombi which extend above the knee (proximal DVT) are treated initially in the hospital with standard heparin administered by continuous intravenous infusion for five to seven days. Hospitalization is necessary because standard heparin must be administered intravenously and produces a variable anticoagulant response among patients, therefore its dosage must be monitored closely by a laboratory test. Unlike other antithrombotic agents, Lovenox offers unique advantages for use in the home setting in that it requires no daily blood monitoring, eliminating the need and cost of laboratory testing, and can be self-administered easily. Lovenox is the first LMWH introduced in both Canada and the United States. Lovenox, also known as Clexane(R) in some European countries, is derived from the depolymerization of heparin, the parent anticoagulant molecule. Hamilton Civic Hospitals has more than 4,000 employees and 730 beds on two sites. Areas of emphasis include: cancer, cardiac disease, community hospital services, orthopedic joint reconstruction, multiple trauma and burns, neurosciences, vascular disease and women's health. Hamilton Civic Hospitals has made a strong commitment to research and is internationally known for its research endeavors. It also plays a key role with McMaster University's Faculty of Health Sciences and Mohawk College in the education of health professionals. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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