The US Food and Drug Administration (FDA) has approved a new indication for dalteparin sodium injection (Fragmin), for the extended treatment of symptomatic venous thromboembolism (VTE) [proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)] to reduce the recurrence of VTE in patients with cancer. Dalteparin is the first low-molecular-weight heparin (LMWH) approved in the US for the extended treatment of recurrent VTE in patients with cancer.
"Cancer treatments and the disease itself put this patient population at significantly higher risk than noncancer patients for developing DVT or PE," said Frederick Rickles, md, clinical professor of medicine at George Washington University Medical Center, Washington, DC.
The FDA approval is based on data from the CLOT study, which evaluated the safety and efficacy of dalteparin in reducing the recurrence of DVT/PE in patients with cancer, compared to an oral anticoagulant. Patients diagnosed with acute DVT, PE, or both were randomized into two groups of 338 patients each. One group received dalteparin for 6 months. The other group received dalteparin for 5 to 7 days, followed by warfarin for 6 months.
The CLOT study showed that, during a 6-month period, nearly twice as many patients (53) treated with warfarin experienced at least one episode of DVT or PE compared to those treated with a once-daily administration of dalteparin (27). Most of the difference occurred during the first month of treatment. The benefit was maintained over the 6-month study period.