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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

EXCLAIM is the First International Study to Show That Extended Thromboprophylaxis Reduces VTE Risk in Acutely-ill Medical Patients With a Statistically Significant 44%

PARIS, July 8, 2007 /PRNewswire-FirstCall/ --Sanofi-aventis announced today the results of the EXCLAIM (EXtended CLinical prophylaxis in Acutely Ill Medical patients) study, which showed the benefit of extended prophylaxis in acutely ill medical patients with reduced mobility by demonstrating the superiority of 5 weeks course of prophylaxis with Clexane(R)/Lovenox(R) compared to 10 days regimen with a statistically significant 44% reduction in venous thromboembolism (VTE) events (Deep Vein Thrombosis and / or Pulmonary Embolism). The findings were presented at the XXIst ISTH Congress (International Society on Thrombosis and Haemostasis) in Geneva, Switzerland.

Acutely ill medical patients are at high risk of VTE. The benefit of thromboprophylaxis with enoxaparin (10 plus or minus 4 days) has already been demonstrated in this patient population and is considered as the standard regimen(1). Nonetheless clinical practice suggests that the risk of VTE may continue beyond 10 days(1) particularly in patients with reduced mobility. The efficacy and safety of extended prophylaxis in this medical population had never been assessed although it has been demonstrated for several high-risk surgical patient populations(2,3) and therefore recommended by international guidelines(4).

The objective of 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 rate. The primary efficacy endpoint was the incidence of asymptomatic deep-vein thrombosis (DVT), symptomatic DVT, symptomatic pulmonary embolism (PE), or fatal PE during the double-blind period.

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