Efficacy of Generic Formation of Ezetimibe in Patients with High Cardiovascular Risk Receiving High-Potency Statin

Abstract

Background: Ezetimibe has been recommended to add on statin therapy when maximally tolerated statin cannot achieve low-density lipoprotein cholesterol (LDL-C) target. However, the safety and efficacy of generic formulation of ezetimibe has rarely been reported. Objective: To examine efficacy of branded generic ezetimibe in patients with high cardiovascular risk receiving high-potency statin. Materials and Methods: The present study was a prospective cohort study in adult patients with high cardiovascular risk receiving atorvastatin 40 mg/day, but the LDL-C level was still higher than 70 mg/dL. Branded generic ezetimibe 10 mg once daily (MiBEAZ™) was added on the highpotency statin therapy as a combination treatment. Lipid parameters were evaluated three months after ezetimibe treatment. Results: Of the 61 patients, mean age was 62.4±11.5 years, and 33 (54.1%), were male. Coronary artery disease was reported in 58 patients or 95.1%. The median baseline of LDL-C was 95.0 mg/dL (IQR 79.5, 108.5). At 3-month follow-up, total cholesterol and LDL-C levels were significantly decreased by branded generic ezetimibe add-on therapy. The relative change of LDL-C reduction was 26.3% (IQR –38.8, –11.1, p<0.001). The LDL-C target under 70 mg/dL was attained in 60% of the patients. Triglyceride and high-density lipoprotein cholesterol levels remained unchanged. After ezetimibe medication, there were no differences in renal or hepatic function. Conclusion: The authors demonstrated that branded generic ezetimibe significantly reduced levels of LDL-C in high cardiovascular risk patients with uncontrolled LDL-C level despite the high-potency statin treatment. There was no concern regarding safety issues with the branded generic ezetimibe add-on therapy. Keywords: Low-density lipoprotein cholesterol; Generic ezetimibe; Lipid-lowering; Dyslipidemia