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
Summary
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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