Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector

Study Overview
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Brief Summary
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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

Detailed Description
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Study duration per participant is approximately 12 weeks

Official Title
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Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector (MARS-NIS)

Conditions
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Primary Hypercholesterolaemia and Mixed Dyslipidaemia, Atherosclerotic Cardiovascular Disease

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Patients for whom the treating physician has decided to initiate lipid-lowering treatment with the PRALUENT® 2 ml SYDNEY auto-injector, irrespective of participation in the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C) |  | from baseline to week 12 | 
| Percent change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C) |  | from baseline to week 12 | 
| Treatment acceptance assessed using the Injection Treatment Acceptance Questionnaire (ITAQ) |  | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 12 weeks | 
| Number of quality defects assessed using product complaints |  | up to 12 weeks |