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Fragmin approved for prevention of deep vein thrombosis
Bridgewater, NJ-based Pharmacia & Upjohn recently announced that the Food and Drug Administration (FDA) has approved its low molecular weight heparin, Fragmin (dalteparin sodium injection), for the prevention of deep vein thrombosis following hip replacement surgery.
Administered once daily, Fragmin was shown to significantly lower the risk of deep vein thrombosis that can lead to pulmonary embolism following patients undergoing hip replacement surgery.
Results from the study
In one prospective, randomized multicenter Phase III study that compared Fragmin with warfarin (Coumadin) in 382 patients who had elective total hip replacements, Fragmin lowered the incidence of total deep vein thrombosis to 14.6%, vs. 25.8% for patients receiving warfarin.
In a second study, Fragmin was compared to unfractionated sodium heparin (standard heparin) in 123 patients who had elective total hip replacements. The incidence of total deep vein thrombosis was lower in patients receiving Fragmin (30%), compared with those receiving heparin (42%).
Although statistically insignificant, Framan did prove superior to standard heparin in lowering the incidence of proximal deep vein thrombosis (9.5% vs. 30%). Fragmin was administered once a day; standard heparin was given three times daily.
Fragmin can be given to patients as a subcutaneous once-daily dose; standard heparin is often administered up to three times daily. Fragmin injection is available in packs of 10 single-dose prefilled syringes in two strengths, 2,500 IU and 5,000 IU, as well as a 95,000 IU multidose vial.
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