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Title: Combination of Simvastatin and Fenofibrate Reduces Cholesterol and Triglycerides in Diabetics: Presented at ACC

"Combination of Simvastatin and Fenofibrate Reduces Cholesterol and Triglycerides in Diabetics: Presented at ACC"

By Ed Susman NEW ORLEANS, LA -- March 28, 2007 -- The combination of cholesterol-lowering agents simvastatin and fenofibrate enhances the ability to reduce blood lipid levels in patients with diabetes, especially triglycerides, researchers reported here at the 56[^th annual scientific sessions of the American College of Cardiology (ACC).

"We observed an average 52-mg decline in triglycerides when simvastatin was added to baseline treatment with fenofibrate," said Heidi May, MS, epidemiologist, LDS Hospital, University of Utah, Salt Lake City, Utah, United States.

"If the baseline treatment was with simvastatin, the addition of fenofibrate reduced triglycerides 14.1 mg/dL," May said in her poster presentation on March 25^th. The difference between the 2 drugs reached statistical significance at the P = .006 level.

May tested both drugs individually and in combination among 300 patients who demonstrated mixed dyslipidaemia after a 6- to 8-week washout period. Dyslipidaemia was defined as having 2 of 3 criteria: low-density lipoprotein (LDL) >100 mg/dL; triglycerides >200 mg/dL; high-density lipoprotein (HDL) <40 mg/dL.

Patients were randomised to 12 weeks of therapy with one of the following regimens: simvastatin 20 mg; fenofibrate 160 mg; combination of the 2 drugs. After 12 weeks all patients continued on combination therapy for 9 months.

"In this 1-year randomised trial of diabetes patients, combination therapy of simvastatin and fenofibrate was safe, well-tolerated and more effective in positively affecting lipids than either form of monotherapy," May said.

In another example, the cholesterol-lowering efficacy of simvastatin was enhanced by about 10 mg when fenofibrate was co-administrated; the cholesterol lowering effects of fenofibrate was increased by 36 mg when simvastatin was added (P < .0001).

When patients were on simvastatin, the addition of fenofibrate reduced low density lipoprotein 3.2 mg/dL. If patients were taking fenofibrate, the addition of simvastatin reduced low density lipoprotein 33.8 mg/dL (P < .0001).

May said her trial is part of the process that could result in the development of a dual-action treatment against cholesterol.

[Presentation title: The Long-term Safety and Efficacy of Combined Simvastatin and Fenofibrate Therapy in Diabetic Patients With Dyslipidemia: The DIACOR Study. Abstract 1008-125]

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