The efficacy of statin monotherapy uptitration versus switching to ezetimibe/simvastatin: results of the EASEGO study

• Published in: Current medical research and opinion 2008-03, Vol.24 (3), p.685-694
• Main Authors: Roeters van Lennep, Henk W. O., Liem, An Ho, Dunselman, Peter H. J. M., Dallinga-Thie, Geesje M., Zwinderman, Aeilko H., Wouter Jukema, J.
• Format: Article
• Language: English
• Subjects: Aged; Anticholesteremic Agents - administration & dosage; Anticholesteremic Agents - adverse effects; Anticholesteremic Agents - therapeutic use; Atorvastatin; Atorvastatin Calcium; Azetidines - administration & dosage; Azetidines - adverse effects; Azetidines - therapeutic use; Cardiovascular disease; Cholesterol, LDL - blood; Cholesterol, LDL - drug effects; Coronary Artery Disease - drug therapy; Diabetes Mellitus, Type 2 - blood; Drug Therapy, Combination; Ezetimibe; Female; Heptanoic Acids - administration & dosage; Heptanoic Acids - adverse effects; Heptanoic Acids - therapeutic use; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; LDL-C lowering; LDL-subfractions; Male; Middle Aged; Prospective Studies; Pyrroles - administration & dosage; Pyrroles - adverse effects; Pyrroles - therapeutic use; Simvastatin; Simvastatin - administration & dosage; Simvastatin - adverse effects; Simvastatin - therapeutic use; Treatment Outcome
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/030079908X273273

ABSTRACT Objective: To assess the incremental low-density lipoprotein-cholesterol (LDL-C) lowering efficacy of doubling the statin dose or switching to the ezetimibe/simvastatin 10/20 mg combination tablet (EZE/SIMVA) in patients on simvastatin 20 mg or atorvastatin 10 mg not at LDL-C target < 2.5 mmol/L. Study design and methods: Patients with documented coronary heart disease (CHD) and/or type 2 diabetes (DM2) with LDL-C ≥ 2.5 and < 5.0 mmol/L despite treatment with atorvastatin 10 mg or simvastatin 20 mg were randomized to (1) double statin dose or (2) switch to ezetimibe/simvastatin 10/20, according to a PROBE study design. LDL-C, lipoprotein subfractions and safety data were assessed during the study. Results: 119 of 178 (67%) patients in the EZE/SIMVA group and 49 of 189 (26%) in the doubling statin group reached target LDL-C < 2.5 mmol/L. The odds ratio of success for EZE/SIMVA versus doubling statin treatment in reaching the LDL-C target of < 2.5 mmol/L was 5.7 (95% CI: 3.7-9.0, p < 0.0001). A reduction in total cholesterol (TC), total/high density lipoprotein (HDL) cholesterol ratio and apolipoprotein B was observed in both groups, but this reduction was significantly more pronounced in the EZE/SIMVA group as compared with the doubling statin dose group. Treatment was well tolerated and no difference was observed between the two groups with regard to adverse effects. Conclusions: In CHD/DM2 patients treated with simvastatin or atorvastatin with LDL-C persistently ≥ 2.5 mmol/L, switching to the EZE/SIMVA was more effective in attaining the LDL-C target of < 2.5 mmol/L than doubling the statin dose.