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The Lancet Publishes PREVAIL Study Results Showing Lovenox,Superiority Over Unfractionated Heparin for Reducing the Risk of,Venous ThromboEmbolism in Patients With Acute Ischemic Stroke

Risk of Having a Venous ThromboEmbolism (VTE) is Reduced by a Significant 43% in Acute Ischemic Stroke Patients Treated With Clexane(R) / Lovenox(R)

BRIDGEWATER, N.J., April 20, 2007 /PRNewswire-FirstCall/ -- Sanofi-aventis announced the publication of the PREVAIL (Prevention of VTE after Acute Ischemic Stroke with LMWH Enoxaparin) trial in the April 21st issue of The Lancet. The results of the trial showed that once daily administration of Clexane(R) / Lovenox(R) (enoxaparin sodium injection) 40 mg was more effective than UnFractionated Heparin (UFH) 5000 IU twice a day for the prevention of VTE in patients who suffered an acute ischemic stroke, a group of medically- ill patients at an increased risk for developing VTE.

Among medically-ill patients, stroke patients are at an increased risk for developing VTE. Without VTE prophylaxis, up to 75% of patients with hemiplegia following stroke develop Deep-Vein Thrombosis (DVT) and 20% develop Pulmonary Embolism (PE).

PREVAIL study showed a significant 43% relative risk reduction in VTE events was observed with Clexane(R) / Lovenox(R) vs. UFH for the primary efficacy endpoint, the composite of symptomatic or asymptomatic DVT, symptomatic and/or fatal PE during the treatment period (10.2 % vs. 18.1%; p= 0.0001).

Importantly, the reduction in VTE risk was also observed in patients presenting with different levels of ischemic stroke severity, without significant difference in clinically important bleedings as well.

The significant reduction of VTE risk with Clexane(R) / Lovenox(R) versus UFH was maintained when therapy was initiated within 24 hours or 24 hours-48 hours after stroke onset.

The incidence of the composite of symptomatic intracranial and major extracranial haemorrhage was small with no difference between groups (enoxaparin 1.3%, UFH 0.7%; p=0.2275). No difference was observed for symptomatic intracranial haemorrhage betwe
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