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Amid Lingering Questions, FDA Reprieves LDL Cholesterol–Lowering Medication
Mike Mitka
JAMA. 2009;301(8):813-815.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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After a months-long investigation, the US Food and Drug Administration (FDA) reiterated on January 8 that ezetimibe/simvastatin is an acceptable medication for reducing levels of low-density lipoprotein cholesterol (LDL-C).
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Blockage in a coronary artery sets the stage for myocardial infarction. A study that is scheduled to be completed in 2012 may reveal whether ezetimibe/simvastatin, which lowers levels of low-density lipoprotein cholesterol, reduces cardiovascular death and major cardiovascular events. (Photo credit: GJLP/www.sciencesource.com)
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The agency's review of ezetimibe/simvastatin was prompted when the drug combination's efficacy was questioned based on data released in March 2008 from the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) trial. The study's investigators concluded that the relatively expensive proprietary drug produced greater reductions in levels of LDL-C than did simvastatin alone but resulted in similar changes in arterial intima-media thickness, a surrogate measurement for atherosclerosis progression, a risk factor for cardiovascular disease . . . [Full Text of this Article] CONTROVERSY
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