Healthcare Industry News: sanofi-aventis
News Release - December 12, 2006
New Study Shows Clexane(R) / Lovenox(R) (Enoxaparin Sodium Injection) is More Effective Than Unfractionated Heparin (UFH) for Preventing the Risk of Venous Thromboembolism (VTE) in Patients With Acute Ischemic StrokeThe PREVAIL Study Showed That in Acute Ischemic Stroke Patients Treated With Clexane® / Lovenox®, the Risk of Having a VTE was Lowered by a Significant 43% With no Significant Increase in Clinically Important Bleedings When Compared to UFH
ORLANDO, Florida, December 12 (HSMN NewsFeed) --sanofi-aventis announced today that the results of the PREVAIL (Prevention of VTE after Acute Ischemic Stroke with LMWH Enoxaparin) study presented at the 48th American Society of Hematology (ASH) annual meeting in Orlando demonstrated a significant 43% reduction in venous thromboembolism (VTE) events with enoxaparin vs. unfractionated heparin (UFH) in medically-ill patients who suffered an acute ischemic stroke.
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)[1,2].
The primary efficacy endpoint of the study was the composite of symptomatic or asymptomatic DVT, and/or symptomatic or fatal PE during the treatment period.
The significant 43% relative risk reduction in VTE events observed with enoxaparin vs. UFH for the primary efficacy endpoint (10.2 % vs. 18.1%; p=0.0001) was associated with a consistent reduction in proximal DVT by 53% (4.5% vs. 9.6%; p=0.0003).
There was no significant difference in clinically important bleedings (1.3% vs. 0.7%, p=0.20), corresponding to the combination of both symptomatic intracranial bleeding, the most serious complication, and major extracranial bleeding.
The reduction in VTE risk was also observed in patients presenting with different levels of stroke severity, with no significant difference in clinically important bleedings.
"Balancing the benefits of lowering the risk of VTE while minimizing the risk of bleeding is a very important element in choosing prophylactic regimens for this particularly fragile patient population, as it combines the usual factors of VTE in addition to the stroke context," said Dr. David Sherman, Professor in the Division of Neurology in the Department of Medicine at the University of Texas Health Science Center (UTHSC) in San Antonio, and principal investigator of the study. "PREVAIL showed that enoxaparin, when compared to UFH, had a superior efficacy with no significant increase in clinically important bleedings. These data provide new evidence that suggests enoxaparin can be used as VTE prophylaxis in this high risk population".
About Venous Thromboembolism (VTE)
Venous thromboembolism is a general term used to describe the formation of a blood clot (thrombus) that blocks a vessel. This may occur in any part of the venous system, but the most common manifestations are deep-vein thrombosis (DVT), usually in the leg, and pulmonary embolism (PE).
VTE is also a common complication among individuals who have experienced an acute ischemic stroke (AIS).
PREVAIL trial is the first large-scale, multinational, prospective, randomized study which enrolled 1,762 ischemic stroke patients (stratified by NIH Stroke Scale Score) in over 15 countries.
Patients confirmed with an acute ischemic stroke, were randomized within 48 hours of stroke symptoms to receive enoxaparin daily 40 mg SC or UFH 5000 IU SC Q 12 treatment for 10 days +/- 4 days with a follow up period of 90 days and stratified by NIH Stroke Scale Score (severe greater than or equal to 14 and less severe <14).
The primary efficacy endpoint was the composite of symptomatic or asymptomatic DVT, symptomatic ad / or fatal PE during the treatment period. The primary safety endpoints included symptomatic intracranial bleeding, major extracranial bleeding and all-cause mortality.
Enoxaparin is an anticoagulant of the low molecular weight heparin (LMWH) class. Its clinical applications are linked to its antithrombotic properties. It is used to inhibit clot formation in venous or arterial vessels to avoid potential acute or chronic complications of venous or arterial thrombosis such as pulmonary embolism, myocardial infarction or death of cardiovascular origin. As with all anticoagulants, the most frequently reported side effect for enoxaparin is bleeding. Clinical indications for enoxaparin may vary from one country to another.
sanofi-aventis is the world's third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY ).
1. McCarthy ST, Turner J. Low-dose subcutaneous heparin in the prevention of deep-vein thrombosis and pulmonary emboli following acute stroke. Age Ageing 1986; 15: 84-8
2. McCarthy ST, Turner JJ, Robertson D, Hawkey CJ, Macey DJ. Low-dose heparin as a prophylaxis against deep-vein thrombosis after acute stroke. Lancet 1977: 2: 800-1.
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