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Enoxaparin Given at Home for Deep Vein Thrombosis More Efficacious and Less Expensive than Unfractionated Heparin Given in Hospital: Presented at ASH

By Bruce Sylvester

PHILADELPHIA, PA -- December 11, 2002 -- Treatment of symptomatic deep-vein thrombosis (DVT) with once-daily enoxaparin at home is as safe, more effective and less expensive than treatment with unfractionated heparin (UFH) in the hospital, researchers report.

"This is the first study to use and compare these regimens using one dose a day," said Beng Chong, MD, investigator and professor of medicine at St. George Hospital, University of New South Wales School of Medicine, in Sydney, Australia. "It was much more convenient than in a prior study where they used twice-daily dosing at home and in the hospital. This is particularly important if you have to send a nurse to a patient's home to administer a drug. It is also clearly less expensive and more efficacious to use enoxaparin."

The research was presented here this week at the annual meeting of the American Society of Hematology.

Dr. Chong's team enrolled subjects with lower extremity symptomatic DVT confirmed by venogram/ultrasonogram in a prospective, multicentre, open, randomized, controlled study designed to compare the efficacy and safety of once-daily enoxaparin treatment at home with continuous unfractionated heparin (UFH) infusion in hospital for the treatment of DVT.

The subjects received for at least five days either 1.5 mg/kg enoxaparin (150 patients) once daily subcutaneously at home or continuous infusion with UFH (148 patients) in hospital. The researchers administered warfarin to all subjects at baseline and for the next three months.

The investigators used Australian cost data to evaluate the treatment regimens (direct and indirect cost). They assessed efficacy endpoints (including recurrent symptomatic DVT and pulmonary embolism) up to 24 weeks following treatment, confirming efficacies with venography/ultrasonography and ventilation/perfusion lung scanning.

Safety end-points included bleeding and other adverse events. The investigators also accounted for the direct costs of drugs during hospital and post-hospitalization, physician visits, administration time, hospital admission/readmission and emergency services. They estimated indirect costs based on productivity loss for employed and unemployed patients.

The recurrence rate of DVT in evaluable patients was enoxaparin 1.6 percent (2/125) and UFH 7.3 percent (8/110, p=0.049). The incidence of pulmonary embolism in evaluable patients was enoxaparin 0.0 percent (0/125) and UFH 3.7 percent (4/107, p=0.044). The incidence of major bleeding was enoxaparin 0.0 percent and UFH 2.0 percent (p=non-significant). The incidence of all bleeding events was enoxaparin 10.0 percent, and UFH 13.5 percent, (p=non-significant).

The total direct costs in Australian dollars were $1363 for enoxaparin and $4058 for UFH. The total indirect costs were $1678 for enoxaparin and $1569 for UFH. The total costs were $3041 for enoxaparin and $5627 for UFH.

"The main cost drivers were costs associated with hospital admission ($258 for enoxaparin and $2495 for UFH) and hospital readmission ($512 for enoxaparin and $1104 for UFH). Treatment with enoxaparin once daily at home led to an average direct cost saving of $2695 per patient. When indirect costs related to productivity loss were taken into account, the total cost saving was $2586 per patient," the authors reported.

Dr. Chong also noted that, "We've had extreme difficulty getting nurses to patients twice a day. So the results of this study imply potential changes in patterns of treatment as well as comparing for costs."

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