EASE研究
Ezetimibe Add-on to Statin Therapy for Effectiveness Trial
Presented at
American College of Cardiology
Scientific Sessions 2004
Presented by Dr. Thomas Pearson
EASE Trial
Endpoints (6 weeks):
Percent change from baseline in LDL cholesterol in the
overall population and by NCEP ATP III CHD risk category
EASE Trial
Presented at ACC Scientific Sessions 2004
3,030 Patients with low-density lipoprotein (LDL) cholesterol exceeding National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III goals.
Randomized, double-blind, multicenter
Ezetimibe
n=2,020
Placebo
n=1,010
Treatment
Added to a dose of any statin (40% atorvastatin,
29% simvastatin, 22% pravastatin, 10% other)
Reduction in Triglycerides
p<0.001
Presented at ACC Scientific Sessions 2004
EASE Trial
A large proportion of patients in the trial had diabetes (38.4%) and metabolic syndrome by NCEP ATP III criteria (60%).
Baseline LDL levels were 129 mg/dl in the overall population, 123 mg/dl in the coronary heart disease (CHD) or CHD risk equivalent group, 147 mg/dl in the multiple risk factors group, and 167 mg/dl in the <2 risk factors group.
The ezetimibe arm had a larger reduction in triglycerides and a larger increase in high-density lipoprotein (HDL) levels.
Ezetimibe
Placebo
mg/dl
Increase in
High-Density Lipoprotein (HDL)
p<0.001
Ezetimibe
Placebo
Reduction in LDL
p<0.001
Presented at ACC Scientific Sessions 2004
EASE Trial
In the overall study population, a larger percent change from baseline in LDL levels occurred in the ezetimibe arm versus placebo.
The follow-up LDL level in the ezetimibe arm was 95 mg/dl.
A larger percentage of patients in the ezetimibe arm reached target LDL goals.
Results were similar across the different statin brands and by the prespecified subgroups of age group, gender, and diabetes status.
Ezetimibe
Placebo
Reached Target
LDL Goals
p<0.001
mg/dl
Ezetimibe
Placebo
Reduction in LDL
p<0.001
Presented at ACC Scientific Sessions 2004
EASE Trial
Reached Target LDL Goals
p<0.001
mg/dl
Similar results were observed in the CHD/CHD risk equivalent subgroup, the multiple risk factor subgroup, and the <2 CHD risk factor subgroup.
There were no increases in the frequency of alanine aminotransferase (ALT) ≥3 times upper limit of normal (ULN) (0.4% for ezetimibe vs. 0.2% for placebo), aspartate aminotransferase (AST) ≥3 times ULN (0.2% vs. 0.1%), or creatine kinase (CK) ≥10 times ULN (0 in both groups).
CHD/CHD Equivalent
Multiple Risk Factor
<2 CHD Risk Factor
CHD/CHD Equivalent
Multiple Risk Factor
<2 CHD Risk Factor
Among patients with LDL cholesterol exceeding NCEP ATP III goals and on statin therapy, additional treatment with ezetimibe was associated with a larger reduction in LDL cholesterol and a greater number of patients meeting LDL target goals compared with placebo, with no additional safety issues.
The 23% larger reduction in LDL levels was higher than the 6-8% reduction usually observed by doubling the statin dose.
The present trial adds to the growing body of studies showing an added benefit with ezetimibe in addition to statin therapy. Earlier trials used a selected statin rather than any statin, as in the present trial, which represents a "real-world" evaluation regarding the use of concomitant ezetimibe therapy.
EASE Trial