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Ezetimibe Helps Achieve LDL- Cholesterol Goals in Hypercholesterolemics With or Without Diabetes: Presented at IDF

By Jill Stein

PARIS, FRANCE -- August 26, 2003 -- Use of ezetimibe can be extremely helpful in high-risk hypercholesterolaemic patients with or without type 2 diabetes who fail to achieve their low- density lipoprotein (LDL)-cholesterol goals with statin monotherapy.


Results show that the strategy can significantly decrease LDL-cholesterol and help patients achieve their target LDL-cholesterol, according to research reported on August 25^th at the Eighteenth International Diabetes Federation Congress (IDF).

Dr. Leon Simons, with St. Vincent's Hospital in New South Wales, Australia, presented the results of an analysis of 769 hypercholesterolaemic patients, with or without diabetes, who were already on statin monotherapy and later randomised to 8 weeks' therapy with placebo or ezetimibe, 10 mg/d.

"The incidence of coronary heart disease among patients with type 2 diabetes is 2 to 4 times that of individuals without diabetes," Dr. Simons said. "The increased risk of coronary heart disease is due, at least in part, to the dyslipidaemia associated with this condition. Statins are the drugs of choice to treat hypercholesterolaemia in patients with type 2 diabetes, however many patients with diabetes fail to reach accepted LDL-cholesterol goals."

Ezetimibe is a novel cholesterol absorption inhibitor that has a complementary mechanism of action to statins, which inhibit cholesterol synthesis in the liver, he continued. Ezetimibe blocks the transport of dietary and biliary cholesterol across the intestinal wall without affecting absorption of bile acids, fatty acids, fat-soluble vitamins, or triglycerides.

Dr. Simons' group believed that the co-administration of ezetimibe with statins may offer superior LDL-cholesterol -lowering efficacy to statin alone.

Subjects in the trial were 18 years of age or older and had been on a stable dose of a statin for at least 6 months, and had an LDL-cholesterol that exceeded the recommended target level for their National Cholesterol Education Panel (NCEP) coronary heart disease risk category. Triglyceride levels in all participants were less than 3.96 mmol/L.

In the present analysis, high-risk patients with coronary heart disease and/or type 2 diabetes (with an LDL-cholesterol goal of less than or equal to 2.6 mmol/L) were divided into two groups depending on whether or not they had type 2 diabetes.

Of patients with a baseline LDL-cholesterol greater than 2.6 mmol/L, more type 2 diabetics than non-type 2 diabetics reached LDL-cholesterol goal than on statin plus ezetimibe. However, the adjusted odds of reaching the therapeutic target on statin plus ezetimibe versus statin plus placebo were not significantly different for the two subgroups. l

The effects of the cholesterol absorption inhibitor on lipids were consistent between patients with and without type 2 diabetes.

Haemoglobin A 1 C levels remained stable for all type 2 diabetic patients at about 7.0 % during treatment.

The statin/ezetimibe combination was well tolerated.

"Our results show that the co-administration of ezetimibe with statins, a treatment strategy that affects both cholesterol absorption and synthesis, offers a new therapeutic option for patients with type 2 diabetes who require additional LDL-cholesterol reductions," Dr. Simons said.

The study was funded by Merck Research Laboratories in Rahway, New Jersey.


[Study title: Effects of ezetmibe added to on-going statin therapy on LDL-C goal attainment in high risk hypercholesterolemic patients with or without type 2 diabetes mellitus. Abstract 1028]

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