Magazine article Drug Topics

Enoxaparin Cleared to Treat DVT at Home, in Hospital

Magazine article Drug Topics

Enoxaparin Cleared to Treat DVT at Home, in Hospital

Article excerpt

Patients with deep-vein thrombosis will now be able to treat themselves at home with a prescription drug. The Food & Drug Administration has cleared Lovenox (enoxaparin sodium, Rhone-Poulenc Rorer) injection for treatment of DVT both at home and in the hospital. In April 1998, enoxaparin received FDA approval as a preventive measure for extended in-home use following surgery (Drug Topics, April 20).

The recent approval makes enoxaparin the first low molecular weight heparin available for inpatient treatment of acute deep-vein thrombosis, with or without pulmonary embolism, as well as outpatient treatment of acute DVT without pulmonary embolism. Both indications require that enoxaparin be administered in conjunction with warfarin sodium, and patients are taught to self-administer the injection subcutaneously at a 1-mg dose twice daily.

DVT is responsible for more than 400,000 hospitalizations each year It can lead to pulmonary embolism, which causes or contributes to some 200,000 deaths annually in the United States. DVT is typically treated with unfractionated heparin, given by continuous intravenous infusion. This requires several days of hospitalization along with routine blood tests to monitor drug activity.

Two clinical trials comparing enoxaparin with unfractionated heparin found enoxaparin equivalent to adjusted-dose, continuousinfusion therapy with unfractionated heparin in preventing recurrent venous thromboembolic disease in patients with acute DVT. The safety profile, including bleeding complications of both enoxaparin once daily and enoxaparin twice daily, was comparable to that of continuous-infusion heparin therapy.

Geno Merli, M.D., FACP, director of internal medicine and vice chairman of primary care at Thomas Jefferson Hospital, Philadelphia, said, "Clinical studies and research on this drug show agents given subcutaneously by a small needle had the same effect and safety as the standard treatment for decades, which is heparin in the hospital setting."

Merli said the currently approved indication "moves a portion of care of this disease process to the home environment," but he stressed that enoxaparin is not intended for home use by every patient who has phlebitis or DVT Rather, it should be used selectively for patients who meet certain criteria for treating patients in the home care environment. …

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