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.