Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578)

Inclusion Criteria:

• Genotype-confirmed heterozygous familial hypercholesterolemia with writtendocumentation of the genetic diagnosis at the time of screening and LDL-C >=210mg/dL (5.43 mmol/L), or clinical diagnosis of heterozygous familialhypercholesterolemia, defined as LDL-C >=210 mg/dL (5.43 mmol/L) and at least one ofthe following:

• tendinous xanthoma

• child <18 years of age with hypercholesterolemia (LDL-C >159 mg/dL (4.11mmol/L)

• has a sibling with hypercholesterolemia (LDL-C >190 mg/dL [4.91 mmol/L]) andtendinous xanthoma

• family history with an LDL-C value distribution pattern compatible withdominant autosomal transmission and at least one relative presenting fastingtotal cholesterol values >348 mg/dL (9.0 mmol/L) after exclusion of secondarycauses of dyslipidemia

• LDL-C >=210 mg/dL (5.43 mmol/L) 1 week before randomization

• plasma triglyceride level <=400 mg/dL (4.52 mmol/L)

Exclusion Criteria:

• pregnancy or any other situation, condition, or illness that, in the opinion of theinvestigator, may interfere with optimal participation in the study

• presence of an apolipoprotein B gene mutation with confirmed absence of an LDLreceptor mutation in either allele

• undergoing LDL-apheresis or plasma apheresis

• unsuitable plaque or artery morphology

• use of certain drugs, foods, or other agents known to alter cholesterol levels or tocause pharmacokinetic interactions with either ezetimibe or simvastatin