Ezetimibe/Simvastatin a Novel Way for Type 2’s to Reduce CVD Risk

According to a new study, Type 2 diabetes patients are at increased risk for cardiovascular disease (CVD), yet a novel therapy employing the use of ezetimibe/simvastatin offers this patient population the option of lowering not only LDL-C, but also non-HDL-C, apo-B, and hs-CRP.

The VYTAL study was a multi-center, randomized, double-blind, 6-week study in a total of 1,229 T2DM patients with hypercholesterolemia. The patients had their diabetes treated with drugs and/or insulin, or controlled by diet alone.

Using logistic regression, head researcher Dr. Weinstock and colleagues assessed the percentage of patients who reached recommended levels of LDL-C, non-HDL-C, apo-B, and hs-CRP when subjected to treatment with ezetimibe/simvastatin (E/S) versus atorvastatin (A).

The patients in the VYTAL study were assigned either to the usual starting dose of E/S (10/20 mg) or A (10 or 20 mg), given once daily for the whole duration of the study, or to the next highest doses of E/S (10/40 mg) or A (40 mg).

For all dose levels, significantly higher proportions of type 2 patients treated with E/S compared to patients on the A arm attained individual LDL-C levels <70 mg/dL (59.7% vs 21.5%, P <.001 at starting dose), non-HdL-C levels <100 mg/dL (43.9% vs 16.3%, P <.001 at starting dose), apo-B levels <90 mg/dL (63.2% vs 34.2%, P <.001 at starting dose). At all doses, the percentages of patients reaching <2 mg/L hs-CRP levels were comparable, said researchers.

Regarding the safety of the two treatments, of the 494 patients treated with E/S, only 20 patients (4%) experienced drug-related adverse events, compared to 30 patients (4.1%) in the A-treated arm.

Interestingly, when taking into account the percent of patients attaining both LDL-C levels <70 mg/dL and hs-CRP levels <2 mg/L, the data shows a significantly higher proportion: 30.9% patients in the E/S arm vs 11.5% in the A-treated arm (P <.001 at starting dose), said Dr. Weinstock.

Lead investigator Ruth S. Weinstock, MD, PhD, Professor of Medicine, SUNY Upstate Medical and Veterans Affairs Medical Center, Syracuse, New York, presented a post-hoc analysis of the data from the VYTAL study in a poster presentation on Oct. 6, 2007 at the XVI International Symposium on Drugs Affecting Lipid Metabolism (DALM).
[Presentation title: Effect of Ezetimibe/simvastatin verus Atorvastin on Attainment of Optional Recommended Levels of LDL-C, Apo-B, non-HDL-C, and hs-CRP in Type 2 Diabetes Patients: the VYTAL Study. Abstract 323]