Latebreakers: LMWH given nod for new indication

May 21, 2007

Dalteparin (Fragmin, Pfizer/Eisai) can now be used to reduce the recurrence of venous thromboembolism (VTE) in patients with cancer.

Dalteparin (Fragmin, Pfizer/Eisai) can now be used to reduce the recurrence of venous thromboembolism (VTE) in patients with cancer. The new approval was based on results of the CLOT study, which evaluated the efficacy and safety of the drug as compared with warfarin in reducing deep vein thrombosis (DVT) and pulmonary embolism (PE) in cancer patients. About half as many patients in the group receiving dalteparin (daily for six months) experienced at least one episode of DVT or PE compared with those treated with dalteparin for five to seven days, followed by warfarin for six months. Mortality rates were similar among the two study groups at the conclusion of the study. The group receiving daily dalteparin had a higher incidence of major bleeding, elevations of liver enzymes, and thrombocytopenia. Dalteparin was previously approved for prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, as well as for prevention of DVT that may progress to PE.

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