SIMVASTATIN &ATORVASTATIN IN PT W/ TYPE II DIABETES MELLITUS &HYPER

Wake Forest University, Winston Salem NC

Investigators

Linked publications & trials

Abstract

Patients with type 2 diabetes mellitus commonly have hypercholesterolemia (elevated cholesterol) due to abnormalities with the breakdown and synthesis of cholesterol. LDL (bad) cholesterol levels are frequently higher in diabetics and may lead to the high morbidity and mortality rates associated with diabetics with cardiovascular disease. Several drugs are available for clinical use in the United States to reduce cholesterol. Atorvastatin is one such drug, but because it is one of the newest, there is much less clinical data available on it for objective evaluation. This study will provide more clinical data on atorvastatin and compare its efficacy and tolerability to simvastatin, another FDA approved medication for hypercholesterolemia. In this open label, randomized, dose response study, patients will be washed out of any prior lipid (fat) lowering therapy for at least 6 weeks and placed on a lipid (fat) lowering diet for 4 weeks prior to receiving study drug. After the washout period, patients will be randomized to 18 weeks of drug treatment with increasing doses of simvastatin (20 mg to 40 mg to 80 mg) 80 mg of simvastatin is considered to be an experimental dose or atorvastatin (10 mg to 20 mg to 40 mg). The doses will be increased at 6 week intervals and total patient participation is for 22 weeks. The main objective is to compare the percentage LDL (bad) cholesterol reduction from baseline in patients with type 2 diabetes and elevated cholesterol treated with either 20 mg simvastatin or 10 mg atorvastatin. Subjects (Patients) are seen in clinic on an out patient basis.