Clinical research
Effectiveness and tolerability of ezetimibe co-administered with statins versus statin dose-doubling in high-risk patients with persistent hyperlipidemia: The EZE(STAT)2 trial
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Submission date: 2010-07-20
Final revision date: 2010-12-24
Acceptance date: 2010-12-28
Online publication date: 2011-11-08
Publication date: 2011-10-30
Arch Med Sci 2011;7(5):766–775
Introduction : When a standard dose of statins fails to achieve lipid control in patients at high risk for coronary artery disease (CAD), increasing the statin dosage or co-administration of additional agents is recommended. The aim of this study was to compare the safety and lipid-lowering efficacy of doubling the standard statin dose (STAT2) to that of co-administering ezetimibe 10 mg/day (EZE + statin) in Canadian patients at high CAD risk with persistent hyper­li­pi­demia upon statin treatment.
Material and methods : Six-week, open-label, randomized, multicentre study. The primary outcome was the change in plasma LDL-C and secondary measures included the change in additional lipid parameters. Safety was assessed with the incidence of emergent adverse events (AEs).
Results : Eight hundred eighty-five patients (EZE + statin, n = 586; STAT2, n = 299) completed the study. The mean (SD) percent change in low-density lipoprotein cholesterol (LDL-C) was – 30.9% (18.2) for the EZE + statin group and –18.4% (19.0) for the STAT2 group (p = 0.001). Percent and absolute decreases in total cholesterol (TC), triglycerides and the TC to high-density lipoprotein cholesterol ratio (TC/HDL-C) were significantly greater for the EZE + statin group (p = 0.001). After 6 weeks of treatment, 70% of the patients in the EZE + statin group and 48% of patients in the STAT2 group (OR = 2.45, p < 0.001) achieved target LDL-C levels of < 2.5 mmol/l. Incidence of AEs was similar between groups, with the exception of a higher incidence of muscle disorders in the STAT2 group.
Conclusions : In patients at high CAD risk who are above the LDL-C target while on statin monotherapy, co-administration of ezetimibe is well tolerated and more effective in improving the lipid profile compared to doubling the existing statin dose.