Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study

Eligible participants with screening central laboratory low-density lipoprotein cholesterol
(LDL-C) values ≥ 75 mg/dL (1.9 mmol/L) were instructed to follow National Cholesterol
Education Program (NCEP) Adult Treatment Panel III (ATP) Therapeutic Lifestyle Changes (TLC)
diet and were assigned to 1 of the following 4 background lipid-lowering therapies for a
4-week stabilization period based upon their screening LDL-C and its distance from the
individual's required goal as stipulated by their NCEP ATP III risk category:

1. no drug therapy required - diet alone

2. low dose drug therapy required - diet plus atorvastatin 10 mg orally (PO) once daily
(QD)

3. high dose drug therapy required - diet plus atorvastatin 80 mg PO QD

4. maximal drug therapy required - diet plus atorvastatin 80 mg PO QD plus ezetimibe 10 mg
PO QD.

If the participant met entry criteria at the end of the lipid stabilization period they were
randomized 2:1 to receive evolocumab 420 mg or placebo subcutaneously once a month for 52
weeks in addition to their background therapy.

Inclusion Criteria:

- Subject has provided informed consent.

- Fasting LDL-C ≥ 75 mg/dL and meeting the following LDL-C values on background
lipid-lowering therapy:

- < 100 mg/dL for subjects with diagnosed coronary heart disease (CHD) or CHD risk
equivalent

- < 130 mg/dL for subjects without diagnosed CHD or CHD risk equivalent

- OR on maximal background lipid-lowering therapy defined as atorvastatin 80 mg PO
QD and ezetimibe 10 mg PO QD

- Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

- New York Heart Association (NYHA) II-IV heart failure, or last known left ventricular
ejection fraction < 30%

- Uncontrolled cardiac arrhythmia

- Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI),
coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization,
type 1 diabetes, newly diagnosed or poorly controlled type 2 diabetes

- Uncontrolled hypertension