Add-on ezetimibe helps achieve lipid targets in Type 2 diabetics
MedWire News: Adding ezetimibe to simvastatin therapy helps diabetes patients reach their lipid targets, a randomized, controlled trial has found.
The authors suggest that add-on ezetimibe is a useful treatment in diabetes patients with persistent dyslipidemia and may help avoid the tolerability issues associated with simply increasing the statin dose.
The Ezetimibe and Simvastatin in Dyslipidemia of Diabetes (ESD) trial was a multicenter, double-blind, placebo-controlled trial performed in Italy.
The participants were 108 patients with Type 2 diabetes, albuminuria <200 µg/min, and total cholesterol levels >135 mg/dl (3.49 mmol/l) despite treatment with simvastatin 40 mg/day.
They were randomly assigned to receive ezetimibe 10 mg/day or placebo, in addition to simvastatin therapy, for 2 months.
At the end of the study, ezetimibe-treated patients showed significant improvements in a range of lipoproteins, whereas there were no changes in placebo-treated patients.
Specifically, in the ezetimibe group, mean levels of low-density lipoprotein (LDL) cholesterol fell by 30.9% (from 99 to 66 mg/dl; 2.56 to 1.71 mmol/l), total cholesterol fell by 21.6% (from 162 to 124 mg/dl; 4.19 to 3.21 mmol/l), and apolipoprotein B fell by 19.6% (from 83 to 64 mg/dl).
Accordingly, ezetimibe-treated patients were significantly more likely than placebo-treated patients to achieve LDL levels below 70 mg/dl (1.81 mmol/l), at 72% versus 17%, as is currently recommended for people with diabetes.
Furthermore, combination treatment with ezetimibe and simvastatin was well-tolerated, with no significant adverse changes in clinical, metabolic, renal, or other safety parameters.
Writing in the journal Diabetes Care, Giuseppe Remuzzi (Mario Negri Institute for Pharmacological Research, Bergamo, Italy) and fellow investigators say that, in Type 2 diabetes patients with persistent dyslipidemia despite statin therapy, add-on ezetimibe "significantly ameliorated the lipid profile" and "increased by four-fold the proportion of patients achieving the LDL target."
They conclude: "Adding ezetimibe to simvastatin therapy helps improve the pro-atherogenic lipoprotein profile in Type 2 diabetic patients while avoiding the drawbacks of maximizing statin doses."
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By Joanna Lyford