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Efficacy and Safety Profile: Thromboprophylaxis in Bedridden Medical Patients

(with medical conditions including, but not limited to: congestive cardiac failure (NYHA class III or IV), acute respiratory failure or acute infection, who also have a predisposing risk factor for venous thromboembolism such as age over 75 years, obesity, cancer or previous history of VTE.)

Leizorovicz A et al. Circulation 2004;110:874–8791.

Study Design:

An international, multicentre, randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of Fragmin for the prevention of venous thromboembolism (VTE) in acutely ill medical patients (N=3,706). Patients were assigned to receive either s.c. Fragmin (5,000 IU o.d.; n=1,518) or placebo (n=1,473) for 14 days and were followed up for 90 days.

Primary endpoint: 

Incidence of VTE by Day 21.

Secondary endpoints:

Mortality by Days 14, 21 and 90; symptomatic deep vein thrombosis (DVT) or asymptomatic DVT at Day 21; major and minor bleeding; drug-related allergic reactions; thrombocytopenia by Day 21; symptomatic VTE at Day 90.

Results:

Patients treated with Fragmin had a lower incidence of VTE at Day 21 compared with patients treated with placebo (2.77% vs. 4.96%, P=0.0015). This observed benefit was maintained at 90 days. The incidence of proximal DVT by Day 21 was lower among patients receiving Fragmin than those receiving placebo (symptomatic: 0.11% vs 0.40%; asymptomatic: 1.79% vs. 3.65%). 2 placebo and no Fragmin patients had fatal pulmonary embolism ( PE) by Day 21. There was no significant difference in mortality between both groups at 14, 21 or 90 days. Patients treated with Fragmin had a higher incidence of major bleeding than patients treated with placebo (0.49% vs. 0.16%, P=0.15).

Conclusion:

Fragmin reduced clinically important VTE with a low risk of bleeding in acutely ill medical patients.

Kucher et al. Arch Intern Med 2005;165:341–3452.

Study Design:

Retrospective analysis of the PREVENT trial to determine if fixed rather than weight-based dosages of Fragmin are as effective and safe for the prevention of VTE in obese and elderly medical patients. Obese patients (n=1,118) and elderly patients (n=1,226) received either Fragmin (5,000 IU, o.d.) or placebo.

Primary endpoint:

Symptomatic VTE, fatal PE, sudden death or asymptomatic proximal DVT by Day 21.

Results:

In obese patients, primary end point incidence was higher in those treated with placebo rather than Fragmin (4.3% vs. 2.8%), however, no difference was observed between obese and non-obese patients who reached the primary endpoint receiving either treatment. In elderly patients (≥ 75 years old), primary end point incidence was higher in those treated with placebo rather than Fragmin (8.0% vs. 4.2%). The incidence of PE and DVT was higher in elderly patients compared to younger patients; this was the case in both the Fragmin and placebo groups.

Fragmin did not increase incidence of major bleeding events by Day 21 in obese (0% vs. 0.7% placebo; P=0.99) and in elderly (1.1% vs. 0.7% placebo; P=0.12) patients.

Conclusion:

A fixed dose of Fragmin (5,000 IU, o.d.) was as effective in VTE prevention at Day 21 in obese vs. non-obese and in elderly vs. younger hospitalised patients. With respect to safety, no significant differences in mortality or major bleeding were observed between Fragmin and placebo treated patients, in both the obese and elderly subgroups.

Bedridden Thromboprophylaxis

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PP-PFE-GBR-2688. December 2020

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