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Ezetimibe May Improve Cholesterol in High-Risk Groups: Presented at ENDO
By Mike Fillon
NEW ORLEANS, LA -- June 22, 2004 -- A new drug with cholesterol-lowering properties significantly lowers cholesterol level when added to commonly used cholesterol-lowering statin drugs in people who are at highest risk for developing heart problems and diabetes.
These results were reported here June 19th in a clinical oral session at the 86th Annual Meeting of The Endocrine Society.
Margo A. Denke, MD, Associate Professor of Internal Medicine, University of Texas Health Science Center, San Antonio, and colleagues presented the results of the Ezetimibe Added to Statin Effectiveness (EASE) trial, a large, randomized, clinical study that examined the effectiveness of a new drug, ezetimibe, combined with cholesterol-lowering statin drugs to modify lipid levels.
Ezetimibe is in a new class of lipid lowering drug that inhibits the absorption of cholesterol from the intestine.
Dr. Denke said patients with diabetes or metabolic syndrome are at increased risk for coronary heart disease compared to the general population. Despite often having normal or slightly elevated levels of low-density lipoprotein (LDL) cholesterol, patients with diabetes mellitus and metabolic syndrome may have abnormal levels of high density lipoprotein (HDL) cholesterol, triglycerides (TG) and intermediate triglyceride-rich lipoproteins, which imparts an increased risk for coronary heart disease (CHD).
The EASE trial included 3030 patients who were not at the recommended LDL cholesterol goal. More than one third of patients had diabetes and nearly two-thirds met the criteria for metabolic syndrome.
About two thirds of the study group added a 10 mg dose of ezetimibe to their current statin therapy and the remainder of the subjects received placebo. Of the patients using statins, approximately 40% took atorvastatin, 29% simvastatin, 22% pravastatin, and 10% other. All patients were evaluated after 6 weeks of ezetimibe treatment.
An additional subset of patients from the two groups met the criteria for metabolic dyslipidemia characterized by both low HDL-C and elevated TG and at least one other characteristic of metabolic syndrome.
In the patient groups, the addition of ezetimibe to ongoing statin therapy significantly reduced LDL-C levels by 26% to 28%, compared with a 2% to 3% reduction for patients treated with placebo. Dr. Denke says these changes were consistent with the degree of LDL-C lowering obtained in the overall population.
"Furthermore, the addition of ezetimibe to ongoing statin therapy significantly improved numerous other lipoprotein measures, including HDL-C and triglycerides in the diabetic, metabolic syndrome, and metabolic dyslipidemia patients," Dr. Denke said. "Treatment was also well tolerated with a safety profile comparable to statin alone."
The study was sponsored by Merck/Schering Plough Pharmaceuticals.
[Presentation title: "Ezetimibe Added to Statin Therapy Reduces LDL-C, TG and Non-HDL-C and Improves HDL-C in Patients with Diabetes and Metabolic Syndrome." Abstract #OR53-4]
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