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Subcutaneous Dalteparin Superior to Oral Anticoagulants in Reducing Risk of Venous Thromboembolism in Cancer Patients
New England Journal of Medicine (NEJM)
07/11/2003
By Joene Hendry
Subcutaneous dalteparin, a low-molecular weight heparin, was more effective in reducing the risk of thromboembolism without increasing the risk of bleeding than an oral anticoagulant in cancer patients with acute venous thromboembolism according to findings from a multi-centre, randomised, open-label trial.
Mark N. Levine, MD, of Henderson Hospital, Hamilton, Ontario, Canada, and colleagues compared daily subcutaneous dalteparin (1 month at 200 IU/kilogram of body weight then 5 months at 150 IU/kilogram of body weight) or the same dalteparin dosage for 5 to 7 days followed by 5 months of oral warfarin or acenocoumarol to a target international normalised ratio of 2.5.
A total of 676 patients were equally assigned to the dalteparin and the oral anticoagulant groups for 6 months. The patients had similar baseline characteristics between groups. Ninety percent had solid tumours while 67% had metastatic disease.
During the study period, 27 patients taking dalteparin compared with 53 patients in the oral anticoagulant group had recurrent venous thromboembolism. This conferred a 9% probability of recurrent thromboembolism at 6 months for the dalteparin group compared with a 17% probability for those in the oral anticoagulant group. No significant difference in the rate of major bleeding or in any bleeding was seen between treatment groups.
Among those taking subcutaneous dalteparin the mortality rate at 6 months was 39% compared with a mortality rate of 41% at 6 months for those taking oral anticoagulants.
Dr. Levine's group notes that, "Long-term self-injection of dalteparin was acceptable to our patients." The researchers conclude, "the risk of symptomatic, recurrent thromboembolism among patients with active cancer is significantly lower with dalteparin therapy than with oral anticoagulant therapy."
N Engl J Med 2003;349:146-53.
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