Brand Name Drug: Innohep
Active Ingredient Drug: tinzaparin sodium
Indication: Treatment of deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium
Company Name: DuPont Pharmaceuticals Company
Availability: Approved by FDA on July 14, 2000
Blood clots in the veins, especially in the legs, are a common and very serious problem that affects some 5 million Americans each year. Such deep vein thrombosis (DVT) can lead to pulmonary embolism (a blood clot that travels to the lungs), which develops in about 500,000 people each year and is fatal in some 50,000 of them. DVT accounts for nearly 800,000 hospitalizations each year.
Physicians treating patients with deep vein thrombosis now have another drug in their arsenal, one that can be given only once a day: Innohep (tinzaparin). The drug, a “low-molecular-weight” heparin manufactured by DuPont Pharmaceuticals Company, was approved by the FDA on July 14, 2000 for the treatment of DVT with or without pulmonary embolism when given with warfarin sodium, another anticlotting drug.
Innohep: Clinical Study Results
In once clinical trial, Innohep was compared to unfractionated (conventional) heparin, the most commonly used anticlotting drug, in 435 hospitalized patients with deep vein thrombosis. Innohep was just as effective as standard heparin therapy in the prevention of recurrent DVT and pulmonary embolism. The death rate among patients who received Innohep was 4.6% (10 patients), compared to 9.6% with heparin (21 patients).
Simonneau and colleagues studied 612 patients with pulmonary embolism who received either Innohep or unfractionated heparin. Innohep was found to be equivalent in effectiveness as conventional heparin in these patients, and the risk of major bleeding (a potential side effect of treatment) was similar between the two patient groups.
What You Should Know
The most common side effect in controlled clinical trials evaluating Innohep for deep vein thrombosis treatment was bleeding; however, the incidence of major bleeding was low (0.8% of 519 patients treated with Innohep compared to 2.7% of 524 patients treated with conventional heparin). Like other anticlotting drugs, Innohep should be used with caution in patients with an increased risk of bleeding.