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New Study Shows That Extending Prophylaxis With Clexane / Lovenox,(enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10,Days for Reducing the Risk of Venous Thromboembolism (VTE) in,Acutely ill Medical Patients With Reduced Mobility

ng the standard of care of patients at high risk for VTE and it further establishes enoxaparin as a reference treatment for VTE prophylaxis in acutely ill medical patients".

About EXCLAIM

The EXCLAIM trial is the first international, multicenter, prospective, randomized, double-blind, placebo-controlled study. It enrolled 5,105 acutely-ill patients with recent reduced mobility in 20 countries, comparing extended-duration (28 plus or minus 4 days) venous thromboembolism (VTE) prophylaxis with enoxaparin, a low-molecular-weight heparin (LMWH) with the standard regimen of enoxaparin (10 plus or minus 4 days) for the prophylaxis of VTE.

Patients recently immobilized for up to 3 days with level 1 mobility (total bed rest or sedentary patients) or with level 2 mobility (with bathroom privileges) with age > 75 years or history of VTE or diagnosis of cancer and predefined acute medical illness were randomized to received enoxaparin 40 mg subcutaneously once daily for 10 plus or minus 4 days and were then randomized to receive the same enoxaparin regimen or placebo for an additional 28 plus or minus 4 days.

The steering committee followed the Data Safety Monitoring Board (DSMB) suggestion that in addition to level 1 mobility patients to re-define the inclusion criteria by adding on level 2 mobility patients inclusion criteria : Age >75 years, or prior VTE or diagnosed cancer.

The objective of the Exclaim study was to assess the superiority of enoxaparin prophylaxis given for 28 plus or minus 4 days versus placebo, both following an initial treatment with enoxaparin for 10 plus or minus 4 days, to reduce VTE events

The primary efficacy endpoint was the incidence of asymptomatic deep-vein thrombosis (DVT) detected by routine standardized ultrasonography, symptomatic DVT, symptomatic pulmonary embolism (PE), or fatal PE during the double-blind period. Secondary efficacy endpoints include the incidence of VTE at 3 months and the incidenc
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