high cardiovascular risk defined as patients with: Documented cardiovascular disease (CVD), clinical or unequivocal on imaging. Documented clinical CVD includes previous acute myocardial infarction, coronary revascularization and other arterial revascularization procedures, stroke and TIA, aortic aneurysm and PAD. Unequivocally documented CVD on imaging includes plaque on coronary angiography or carotid ultrasound; DM with target organ damage or with a major risk factor such as smoking or marked hypercholesterolaemia or marked hypertension.
History of statin intolerance, demonstrated by: trial of ≥2 statins with intolerance of any dose or to increase statin dose above the total maximum doses because of intolerable: Myopathy or myalgia (muscle pain, ache, or weakness without CK elevation), or Myositis (muscle symptoms with increased CK levels), or Rhabdomyolysis (muscle symptoms with marked CK elevation) and Resolution or improvement of symptoms when the statin dose was decreased or discontinued
patients with LDL-C \>55 mg/dL
end-stage renal disease on chronic hemodialysis
Participant is willing and able to give informed consent for participation in the study.
Use of drugs or dietary supplements that can impact on cholesterol value (i.e. progestinic, red yeast rice, niacin \>200 mg/d, lipid-regulating drugs - eg, fibrates or derivatives, ezetimibe, bile-acid sequestrants, stanols, or stanol esters - )
Previous treatment with evolocumab or any other anti-PCSK9 therapy
Inability to provide informed consent or to attend follow-up visits
Unreliability as a study participant based on judgment of investigator's knowledge of the subject (eg, alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, psychosis)
Current enrollment in another investigational device or drug study or \<30 d since ending another investigational device or drug study
serum triglycerides level \> 400 mg/dL at baseline
Pregnancy, breastfeeding, or inadequate birth control in premenopausal female subjects
Laboratory values at screening CK \>3 × ULN; AST or ALT \>2 × ULN
