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Ezetimibe Plus Simvastatin Effective Treatment for Diabetics with Increased LDL-Cholesterol Levels: Presented at ADA

By Jill Stein

ORLANDO, FL -- June 7, 2004 -- Ezetimibe plus simvastatin helps diabetics achieve their target low-density lipoprotein (LDL) cholesterol levels more effectively than statins alone, researchers announced here on June 6^th at the 64^th Scientific Sessions of the American Diabetes Association (ADA).

Ezetimibe inhibits intestinal absorption of both dietary and biliary cholesterol without affecting uptake of triglycerides or fat-soluble vitamins.

James McKenney, MD, National Clinical Research, Inc., Richmond, Virginia, reported the results of a study that assessed whether ezetimibe co-administered with simvastatin would be more effective than simvastatin alone in helping diabetics achieve their LDL-cholesterol goals.

"The incidence of coronary heart disease [CHD] among diabetic patients is two to four times that of nondiabetics," Dr. McKenney noted. Both the ADA and National Cholesterol Education Program (NCEP) guidelines recommend that diabetes be classified and managed as a coronary heart disease risk equivalent with a target LDL-cholesterol level of less than 100 mg/dL.

"Statins are the drugs of choice to treat hypercholesterolemia in diabetic patients, however, many diabetics on statin therapy fail to reach their LDL-cholesterol target," he said.

Roughly 700 participants in the present trial satisfied the NCEP criteria for CHD/CHD equivalent and had an LDL-cholesterol level that was 130 mg/dL or greater.

Subjects were randomized to 23 weeks of daily treatment with simvastatin 20 mg, ezetimibe 10mg plus simvastatin 10 mg; ezetimibe 10mg plus simvastatin 20 mg; ezetimibe 10mg plus simvastatin 40 mg.

Patients were evaluated for LDL levels at weeks 6, 12, and/or 18 and the simvastatin dose was doubled up to 80 mg in patients who did not reach target levels.

The primary efficacy measure was the percentage of patients who reached their goal at 5 weeks.

Results showed that more patients treated with combination therapy reached their LDL goal level (P <.001) than did patients treated with simvastatin alone at 23 weeks (P <.001). This was the case in both diabetics and nondiabetics. After controlling for baseline differences, goal attainment rates among diabetics and nondiabetics were not statistically different (P >.20).

Ezetimibe plus simvastatin at any dose resulted in significantly greater percent decrease in LDL-cholesterol level than did simvastatin 20 mg alone. Patients treated with ezetimibe required fewer simvastatin dose titrations and used lower doses of simvastatin to achieve LDL-cholesterol levels less than 100 mg/dL than did patients on simvastatin alone.

Diabetic patients tolerated the combination of ezetimibe and simvastatin and had favourable safety outcomes that were similar to those seen in nondiabetics.

"Overall, the results show that therapy with ezetimibe/simvastatin coadministration -- a treatment strategy that provides dual inhibition of both the synthesis and intestinal absorption of cholesterol -- may help patients reach LDL-cholesterol goals with fewer titrations and using lower simvastatin doses," Dr. McKenney said.

The study was sponsored by Merck/Schering-Plough Pharmaceuticals.


[Presentation title: "LDL-Cholesterol Goal Attainment among Patients with Diabetes Mellitus Treated with Ezetimibe Plus Simvastatin Coadministration Versus Simvastatin

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