Study Procedures
Patients who met eligibility criteria and, after receiving
a 6-ml test placebo injection, agreed to
undergo a regimen of monthly subcutaneous injections
for a year entered a run-in period of 4 to
12 weeks, during which open-label background
lipid-lowering therapy was administered (Fig. S1
and S2 in the Supplementary Appendix). All patients
were counseled on the components of the
Therapeutic Lifestyle Changes diet, as outlined
by the Adult Treatment Panel III (ATP III) of the
National Cholesterol Education Program.11 On
the basis of the screening LDL cholesterol level,
previous use of statin therapy, and cardiovascular
risk (as determined by the ATP-III guidelines), we
assigned all patients to one of four lipid-lowering
regimens: diet alone, diet with 10 mg of atorvastatin
daily, diet with 80 mg of atorvastatin daily,
or diet with 80 mg of atorvastatin plus 10 mg of
ezetimibe daily.