Singapore, May 12, 2008: Merck and Schering-Plough have jointly released the results of ENHANCE (Ezetimibe aNd simvastatin in Hypercholesterolemia enhANces atherosClerosis rEgression), an imaging trial in 720 patients with heterozygous familial hypercholesterolemia (HeFH).
The results were presented at the 57th annual scientific sessions of the American College of Cardiology and also were published on-line in The New England Journal of Medicine.
HeFH is a rare genetic condition that causes very high levels of LDL “bad" cholesterol and greatly increases the risk for premature coronary artery disease
A company release said that despite the fact that ezetimibe/simvastatin 10/80 mg (VYTORIN) significantly lowered LDL "bad" cholesterol more than simvastatin 80 mg alone, there was no significant difference between treatment with ezetimibe/simvastatin and simvastatin alone on the pre-specified primary endpoint, a change in the thickness of carotid artery walls over two years as measured by ultrasound. There also were no significant differences between treatment with ezetimibe/simvastatin and simvastatin on the four pre-specified key secondary endpoints: percent of patients manifesting regression in the average carotid artery intima-media thickness (CA IMT); proportion of patients developing new carotid artery plaques >1.3 mm; changes in the average maximum CA IMT; and changes in the average CA IMT plus in the average common femoral artery IMT.
“LDL cholesterol remains the primary target of lipid-modifying therapy and physicians should continue to lower patients' elevated LDL cholesterol and get their patients to their goals based on guidelines," said Michael Davidson, professor, director of preventive cardiology, The University of Chicago, Pritzker School of Medicine.
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