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Efficacy and Safety Profile: Treatment of Venous Thromboembolism (VTE)

Lindmarker P et al. Thromb Haemost. 1994;72:186-1901

Study Design:

An open, multicentre, randomised, controlled trial designed to monitor the efficacy and safety of Fragmin compared to UFH in the treatment of venographically confirmed DVT. Once DVT was suspected, UFH could be administered (IV bolus 5,000 IU UFH, followed by an IV infusion 800-1700 IU/hour for a maximum of 24 hours.) During the randomized phase (6-9 days, until INR 2.0-3.0 for 2 consecutive days) the Fragmin cohort received 200 IU/kg SC daily (up to a maximum single daily dose of 18,000 IU) ; the UFH cohort received UFH by infusion, adjusted to maintain aPTT.
Both groups received warfarin on the day of venography  and it was continued for a minimum of 3 months.

Primary endpoint:

Change in Marder scores between venograms obtained before and after treatment. The second venogram (final assessment) was carried out as soon as practical following discontinuation of Fragmin/UFH.

Study Results:

Efficacy: In 94% of Fragmin patients and 92% of UFH patients, the Marder score was improved or unchanged.

Safety: During the trial, there were no reports of a major bleeding occurrence in either group. Minor bleeding was reported in 4 Fragmin patients and 2 UFH patients, out of a total of 196 study participants

Conclusion:

Once daily subcutaneous Fragmin injection has been demonstrated to be no less effective than continuous intravenous infusion of UFH in the treatment of DVT, when assessed by Marder score.

Treatment of VTE

Fragmin Tolerability

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PP-PFE-GBR-2688. December 2020

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