Efficacy and safety of switching to ezetimibe 10 mg/rosuvastatin 2.5 mg in Korean patients with type 2 diabetes mellitus and dyslipidaemia: A multicentre, prospective study (EROICA study)

Abstract

Aims To evaluate the lipid-lowering efficacy, safety, and adherence of switching from moderate- or low-intensity statin monotherapy to ezetimibe 10 mg/rosuvastatin 2.5 mg in Korean patients with type 2 diabetes mellitus (T2DM) and dyslipidaemia. Materials and Methods This multicentre, open-label, single-arm, prospective study enrolled adults with T2DM and LDL-C >= 70 mg/dL despite >= 12 weeks of moderate or low-intensity statin therapy. Participants received ezetimibe 10 mg/rosuvastatin 2.5 mg once daily for 12 weeks. The primary endpoint was the proportion achieving LDL-C <70 mg/dL at Week 12. Secondary endpoints included changes in lipid and glycaemic parameters, subgroup analyses, and safety outcomes. Results Of 639 screened patients, 586 were included in the full analysis set (FAS). At Week 12, 62.3% (95% CI 58.4-66.2) achieved LDL-C <70 mg/dL. Mean LDL-C decreased by 26.0% from 90.9 +/- 17.2 to 67.3 +/- 19.3 mg/dL (p < 0.001). Total cholesterol, non-HDL-C, and apoB decreased significantly (all p < 0.001); HDL-C and triglycerides were unchanged (p = 0.914 and p = 0.393, respectively). HbA1c increased by 0.15 +/- 0.53% and fasting glucose by 3.6 +/- 24.7 mg/dL (both p < 0.001). HOMA-IR decreased by -0.22 +/- 3.09, not significant (p = 0.085). Subgroup analyses showed greater LDL-C reductions in patients with BMI <23 kg/m2, prior low-intensity statin use, or pravastatin therapy, and smaller reductions in those receiving GLP-1 receptor agonists or thiazolidinediones. Adherence averaged 97.5% (97.4%, >= 80%). Among 591 participants, 9.8% had at least one adverse event, mostly mild and not clinically significant. Conclusions Switching to ezetimibe 10 mg/rosuvastatin 2.5 mg achieved substantial LDL-C reductions, high goal attainment, excellent adherence, and good tolerability in Korean T2DM patients with dyslipidaemia.