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AstraZeneca's Crestor approved in US for prevention of cardiovascular disease
 
 
 
 
February 08, 2010, by Mark Todoruk, www.firstwordplus.com
 
The FDA granted expanded approval to AstraZeneca's Crestor (rosuvastatin) on Monday for the prevention of cardiovascular disease "to reduce the risk of stroke, heart attack, and the risk of arterial revascularization procedures in individuals who have no clinically evident heart disease but are at an increased risk of heart disease."
 
Crestor can be used by men aged 50 years or over, or by women aged 60 years or over, who have an elevated C-reactive protein measure and at least one other cardiovascular risk factor. The agency also noted that "this is the first time Crestor has been approved for use in the prevention of heart disease in individuals with 'normal' LDL cholesterol levels and no clinically evident heart disease."

 
The approval was based on results from the JUPITER trial, which demonstrated that Crestor significantly reduced the risk of heart attack, stroke and certain other cardiovascular events by 44 percent, compared to placebo, in people with normal cholesterol levels who had elevated levels of C-reactive protein.
 
JUPITER Study Reports Reducing hsCRP & LDL to Low Levels with ... Mar 29, 2009 ... "In healthy men and women starting rosuvastatin therapy in theJUPITER trial, achievement of target concentrations of LDL cholesterol less ... www.natap.org/2009/HIV/033109_03.htm
 
"an inflammatory biomarker that is independently associated with cardiovascular risk. C-Reactive Protein, Statins, and Cardiovascular Risk: What Can ... JUPITER (Justification for the Use of Statins in Primary Prevention: An ... JUPITERparticipants were at even lower risk than those in the prior primary ... www.natap.org/2009/HIV/051809_01.htm
 
FDA advisory panel votes in favor of broadened rosuvastatin ... In JUPITER, age was the lone cardiovascular risk factor, in addition to ... The 27% increase in risk of diabetes observed in JUPITER is likely real, ... www.natap.org/2009/newsUpdates/121709_07.htm
 
Sales of Crestor totalled $4.5 billion in 2009.
 
Reference Articles
 
US FDA approves new indication for Crestor - (AstraZeneca)
 
AstraZeneca?s Crestor cleared to prevent heart attacks, stroke - (Bloomberg)
 
AstraZeneca wins FDA approval to market Crestor to patients with healthy cholesterol - (Chicago Tribune)
 
Crestor and the JUPITER trial - (FDA)
 
US clears wider use of AstraZeneca cholesterol drug - (Forexyard)
 
FDA approves wider use for cholesterol-lowering drug Crestor - (Morningstar)
 
 
 
 
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