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Clinical Trials and Lipid Guidelines for Type II Diabetes

Medical College of Georgia, Augusta.

The management of dyslipidemia in adults with diabetes is receiving more attention. However, there is a paucity of large, prospective, randomized outcome trials designed for diabetic patients. Diabetic dyslipidemia is characterized by an increase in triglyceride levels, low high-density lipoprotein (HDL) cholesterol concentrations, and small, dense low-density lipoprotein (LDL) particles. The treatment goals include an LDL cholesterol less than 100 mg/dL, triglyceride level less than 150 mg/dL, and an HDL greater than 40 mg/dL for men and more than 50 mg/dL for women. In the Diabetic Atherosclerosis Intervention Study, fenofibrate resulted in a 42% less increase in the percent stenosis, as assessed by quantitative coronary arteriography. The Heart Protection Study documented the unambiguous benefit of simvastatin in reducing all-cause mortality among 5963 diabetic patients. The Lescol Intervention Prevention Study observed a reduction in major adverse cardiac events in diabetics undergoing percutaneous intervention who received fluvastatin. The Veterans Affairs HDL Cholesterol Intervention Trial reported a reduction in major coronary events among 627 diabetic patients with low HDL cholesterol who sustained a myocardial infarction. The Fenofibrate Intervention and Event Lowering in Diabetics (FIELD) Trial (n = 9795), the Action to Control Cardiovascular Risk in Diabetes (ACCORD, n = 10,000), the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non Insulin Dependent Diabetes Mellitus (ASPEN, n = 2421), and the Collaborative Atorvastatin Diabetes Study (CARDS, n = 2140) will provide the prospective outcome data that are needed for the management of patients. Combination drug therapy will be necessary to achieve treatment goals. Careful monitoring will be required to avoid myositis and hepatotoxicity.

Key Words: Diabetes mellitus • hyperlipidemia • randomized trials • review

Address for reprints: L. Michael Prisant, MD, Director of Hypertension and Clinical Pharmacology, Medical College of Georgia, 1120 Fifteenth Street, BI-5084, Augusta, GA 30912.

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