Brand Name: Fragmin
Active Ingredient: dalteparin sodium
Indication: prevention of deep-vein thrombosis (DVT) in patients undergoing hip replacement surgery or abdominal surgery
Company Name: Pharmacia & Upjohn
Fragmin (dalteparin) is a low-molecular-weight heparin marketed by Pharmacia & Upjohn. It has proven to be beneficial in preventing thromboembolic complications in patients undergoing abdominal surgery or hip replacement surgery when administered once before surgery and for a week after the procedure.
How it Works
Fragmin (dalteparin) is a low-molecular-weight heparin with antithrombotic properties. It enhances the inhibition of Factor Xa and thrombin by antithrombin in the blood-clotting cascade. Clotting time is only slightly affected by the drug.
Fragmin (dalteparin): Clinical Study Results
Clinical studies of Fragmin were conducted in patients undergoing abdominal surgery and hip replacement surgery. Two double-blind, randomized controlled clinical trials found Fragmin (dalteparin) to be superior to placebo and as effective as heparin in preventing deep-vein thrombosis (DVT) in patients undergoing abdominal surgery. Only 4.4% of the patients in the Fragmin group experienced a thromboembolic event compared to 17.6% in the placebo group (p-value vs. placebo = 0.008).
The results of a study comparing Fragmin and heparin provided evidence that the two drugs are similar in their abilities to prevent deep-vein thrombosis (DVT). In the Fragmin (dalteparin) and heparin groups, 3.9% and 4.0% of patients, respectively, presented with a thromboembolic event (p-value vs. heparin = 0.74). A third trial was conducted to determine the most effective dose of Fragmin (dalteparin). This study demonstrated 5000 IU daily to be more efficacious than 2500 IU daily, with 9.3% vs. 15.1% of the patients experiencing a thromboembolic incident (p-value = 0.001).
Fragmin (dalteparin) was also tested in patients undergoing hip replacement. An open-label, randomized study compared 5000 IU of Fragmin to the use of warfarin sodium. The incidence of deep-vein thrombosis (DVT) was significantly lower in the Fragmin group, with 14.6% of patients experiencing a thromboembolic event compared to 25.8% of the warfarin sodium group (p = 0.006). A single-center, double-blind study compared Fragmin to heparin. The incidence of proximal deep-vein thrombosis (DVT) was notably lower in the Fragmin group (9.0% vs. 26.1%, p = 0.01), as was the incidence of pulmonary embolism (13.4% vs. 27.5%, p = 0.032).
What the Patient Should Know
The adverse events associated with Fragmin (dalteparin) are hematoma at the injection site and thrombocytopenia.