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Medical News & Perspectives
February 25, 2009

Amid Lingering Questions, FDA Reprieves LDL Cholesterol–Lowering Medication

JAMA. 2009;301(8):813-815. doi:10.1001/jama.2009.196

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).

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 (Kastelein JJP et al. N Engl J Med. 2008;358[14]:1431-1443).