Overview
Primary objectives:
- To assess the effectiveness of the PRALUENT® 2 ml SYDNEY auto-injector as measured by the lipid-lowering effect of alirocumab after approx. 12 weeks treatment
- To assess the treatment satisfaction, as well as patient adherence and persistence after approximately 12 weeks of treatment with the PRALUENT® 2 ml SYDNEY auto-injector
Secondary objective:
Safety and tolerability
Description
Study duration per participant is approximately 12 weeks
Eligibility
Inclusion Criteria:
- Primary hypercholesterolaemia (heterozygous familial or non-familial) or mixed dyslipidaemia AND confirmed vascular disease() AND other regular risk factors(*), OR confirmed familial heterozygous hypercholesterolaemia
- Documented maximum dietary and drug lipid-lowering therapy within the last 12 months
- Inadequate reduction of low-density lipoprotein cholesterol (LDL-C) despite maximum possible dietary and lipid-lowering therapy
- The decision of the treating physician to use the PRALUENT® 2 ml SYDNEY auto-injector regardless of study enrolment
- No previous therapy with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor OR prior treatment with a PCSK9 inhibitor every 2 weeks (Q2W) or monthly (Q4W)
- Signed Informed Consent Form
(*) Coronary heart disease (CHD), cerebrovascular manifestation, peripheral arterial
occlusive disease (PAOD)
(**) For cardiovascular events (e.g. diabetes mellitus, renal function glomerular
filtration rate (GFR) < 60 ml/min)
Exclusion Criteria:
- Planned or existing pregnancy, cancer, drug or alcohol abuse, dementia, or general
inability to understand the content of the observational study
- Existing treatment by lipid apheresis
- Age < 18 years
- Contraindications to treatment with alirocumab (PRALUENT®) according to the SmPC
- Current participation in a clinical study
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.