Jane S. Ricciuti, RPh, MS

Disclosures

January 23, 2004

In This Article

Anticoagulants

Fragmin
(dalteparin sodium) Injection

Manufacturer: Pharmacia & Upjohn

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 12/10/03)

NEW Indication: This supplemental new drug application is approved for the use of Fragmin (dalteparin sodium) injection for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.

Dosing: Dalteparin 5000 IU administered subcutaneously once daily. Duration of clinical trials ranged from 12-14 days.

Clinical Summary: In a double-blind, multicenter, randomized, placebo-controlled clinical trial, general medical patients with severely restricted mobility who were at risk of venous thromboembolism were randomized to receive either dalteparin 5000 IU or placebo subcutaneously once daily during days 1-14 of the study. The primary end point was evaluated at day 21, and the follow-up period was up to day 90. Patients had an acute medical condition requiring a projected hospital stay of at least 4 days, and were confined to bed during waking hours.

A total of 3681 patients were enrolled and treated: 1848 received dalteparin and 1833 received placebo. The primary efficacy end point was defined as at least 1 of the following within days 1-21 of the study: asymptomatic DVT (diagnosed by compression ultrasound), a confirmed symptomatic DVT, a confirmed pulmonary embolism, or sudden death.

Dalteparin demonstrated a reduced incidence of thromboembolic events, including verified DVT, by day 21; 2.45% incidence of a thromboembolic event in dalteparin treated patients vs 4.76% incidence in placebo patients. The prophylactic effect was sustained through day 90.

Fragmin (dalteparin sodium) Injection Labeling

Fragmin (dalteparin sodium) Injection

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