Abstract

BackgroundLowering cholesterol levels decreases the risk of atherosclerotic diseases. Effective ways to stably reduce LDL-C level are warranted in type 2 diabetic patients, a high-risk population for CVD, with various anti-diabetic therapeutic background. The RESEARCH study focuses on LDL-C reduction in this population along with modifications of the lipid profiles. We evaluated long-term ezetimibe add-on therapy in T2DM patients with hypercholesterolemia.MethodsIn a randomized, multicenter, open-label, prospective study, a total of 109 T2DM patients not attaining LDL-C target value despite first-line dose statin (10 mg of atorvastatin or 1 mg of pitavastatin) therapy in Japan were recruited. We investigated the difference in cholesterol lowering effect between ezetimibe (10 mg) add-on statin (EAT) group and double-dose statin (DST) group. Changes of parameters related to atherosclerotic event risks were assessed.ResultsThe reduction of LDL-C was larger in the EAT group (28.3%) than in the DST group (9.2%) at 52 weeks as well as the primary endpoint of 12 weeks. EAT achieved significant lower levels of TC and apo B, respectively. Both treatments attained significant reduction in sd-LDL-C or hsCRP on this long-term basis. Notably, sd-LDL-C in EAT reduced as low as 36.1 ± 14.9 mg/dl to reach near the threshold (35.0 mg/dl) for atherosclerosis with significantly higher achievement rate (55.6%) than DST treatment. Simultaneously, hsCRP reduction by EAT attained as low value as 0.52 ± 0.43 mg/l.ConclusionsIn the present 52-week long-term period, ezetimibe add-on therapy showed a robust advantage in lowering LDL-C and in attaining target LDL-C values compared with the doubling of statin dose. Moreover, it’s meaningful that sd-LDL, powerfully atherogenic lipoprotein, exhibited prominent decrease consistently prominently by ezetimibe add-on therapy. DM patients with hypercholesterolemia are at high risk for CAD, and adding ezetimibe onto usual-dose statin treatment in Japan has been suggested as the first-line therapy for those DM patients who failed to attain the target LDL-C value (UMIN000002593).

Highlights

  • IntroductionEffective ways to stably reduce LDL-C level are warranted in type 2 diabetic patients, a high-risk population for CVD, with various anti-diabetic therapeutic background

  • Lowering cholesterol levels decreases the risk of atherosclerotic diseases

  • No significant differences were found between the groups in coronary risks or laboratory data, while slight but significant differences were observed in the levels of non-high-density lipoprotein cholesterol (HDL-C), apo-B, and sd-LDL

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Summary

Introduction

Effective ways to stably reduce LDL-C level are warranted in type 2 diabetic patients, a high-risk population for CVD, with various anti-diabetic therapeutic background. Cardiovascular disease remains the leading cause of morbidity and mortality for patients with type 2 diabetes in spite of the multi-factorial interventions recently introduced to control CVD risk factors [1, 2]. Lipid reduction by 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor (statin) therapy plays an essential therapeutic role for type 2 diabetes, but it still fails to frequently attain the target LDL-C level. The addition of ezetimibe to standard therapy with statin inhibits two sources of cholesterol, which improves the profiles of triglyceride-rich lipoproteins in type 2 diabetes and reduces LDL-C to a degree unattainable by either agent alone

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