Pharmacia starts new study of LMWH drug

Pharmacia has initiated a new large-scale clinical trial of its lowmolecular weight heparin Fragmin (dalteparin sodium injection) for the prophylaxis of venous thromboembolism in general medical patients who are at significant risk.

The firm maintains that the study, called PREVENT (Prospective Evaluation of Dalteparin Efficacy for Prevention of VTE in Immobilized Patients Trial) will differ from prior LMWH trials in this setting because it will utilize the most clinically-relevant endpoints of deep vein thrombosis, pulmonary embolism and sudden death. For the first time in a LMWH trial, symptomatic and asymptomatic proximal DVT will be diagnosed, primarily using compression ultrasonography.

PREVENT will enroll more than 3,000 patients and compare Fragmin (5,000 International Units/day for up to 14 days) with placebo. It is scheduled to run for nine months' follow-up, with results expected in the fourth quarter of 2002.