Source: Diabetes Care
Effects of combined ezetimibe and simvastatin therapy as compared to simvastatin alone in patients with type 2 diabetes: a prospective, randomized, double-blind, clinical trial
Ruggenenti P, Cattaneo D, Rota S, Iliev I, Parvanova A, Diadei O, Ene-Iordache B, Ferrari S, Bossi AC, Trevisan R, Belviso A, Remuzzi G, for the Ezetimibe and Simvastatin in dyslipidemia of Diabetes (ESD) Study Group;
Diabetes Care (Jun 2010)
Abstract
Objective: To assess the effects of inhibited gastrointestinal cholesterol absorption in statin-treated dyslipidemic patients.
Research Design and Methods: In a multi-center, prospective, randomized, double-blind, placebo-controlled trial we primarily compared by ANCOVA the effect of 2-month ezetimibe (10 mg/day) or placebo therapy on low-density-lipoprotein (LDL) cholesterol serum levels in 108 type 2 diabetes patients with albuminuria<200 mug/min and total cholesterol concentrations>135 mg/dL despite simvastatin treatment (40 mg/day)
Results: Unlike placebo, ezetimibe decreased LDL cholesterol from 99+/-31 to 66+/-22 mg/dL, total cholesterol from 162+/-36 to 124+/-30 mg/dL and apolipoprotein B from 83+/-22 to 64+/-18 mg/dL (p<0.0001 for all changes vs placebo). Seventy-two and 17% of patients on ezetimibe or placebo achieved LDL levels<70 mg/dL, respectively (p<0.0001). Treatment was well tolerated.
Conclusions: Adding ezetimibe to simvastatin therapy helps improving pro-atherogenic lipoprotein profile in type 2 diabetes patients who fail to reach recommended lipid targets with statin therapy alone.
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