No difference between simvastatin and Vytorin ENHANCE trial shows

January 17, 2008

Study results show no difference between simvastatin and Vytorin

Results of the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) study appear to indicate no benefit from the combination of ezetimibe (Zetia, Merck/Schering-Plough) and simvastatin (sold together as Vytorin, Merck/Schering-Plough) over simvastatin alone, as measured by carotid artery thickness. The study involved 720 patients and showed Vytorin lowered LDL cholesterol levels by 58% versus 41% with simvastatin alone, but, interestingly, the average thickness of the carotid artery plaque increased 0.0111mm in patients taking Vytorin compared with 0.0058 mm in patients taking simvastatin. Commenting on the findings, the American College of Cardiology (ACC) warned that clinical decisions should not be made on the basis of the ENHANCE study alone, and noted that this was an imaging study and not a clinical outcome trial. Final decisions should not be made until the complete study results are presented, which will take place in March 2008 at the ACC Scientific Session. Until then, ACC recommends that ezetimibe remain a reasonable option for patients who are currently on a high-dose statin but have not reached their lipid goals.

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