Chart Review of Repatha® in Subjects With Hyperlipidaemia

Study Overview
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Brief Summary
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Review of clinical characteristics of patients who are prescribed Repatha® and how their treatment is managed.

Official Title
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Observational Serial Chart Review of Repatha® Use in European Subjects With Hyperlipidaemia

Conditions
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Hypercholesterolaemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (>18 years) Provided informed consent Initiated on Repatha® at physician's discretion, after 1st August 2015 Received at least one dose of Repatha® Exclusion Criteria: Enrolled in an interventional study of PCSK9 inhibitor within 12 weeks prior to initiation of Repatha® Received commercially available PCSK9 inhibitor within 12 weeks prior to initiation of Repatha®

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Group 1<br>To describe the clinical characteristics of subjects at initiation of Repatha® (up to 2000 subjects). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of clinical characteristics of subjects initiated on Repatha® | Age at initiation of Repatha®, Gender Familial hypercholesterolaemia status Diabetic status, Cardiovascular history History of statin intolerance | Study day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe LDL-C and other cholesterol values over time | Detail all cholesterol assessments recorded during the observation period (Total Cholesterol, LDL-C, HDL-C, Non-HDL-C and Triglycerides). | Up to 26 weeks prior to the first dose of Repatha®, up to 30 months post first dose of Repatha® | 
| Describe Repatha® dose over time | Record Repatha® dose in mg | From the first dose of Repatha® up to 30 months post first dose | 
| Describe use of other lipid-modifying therapies | Describe lipid-modifying therapies over time, type, dose and dose frequency during the observation period | From the first dose of Repatha® up to 30 months post first dose | 
| Describe Physician visits | Collection of all primary and secondary healthcare visit dates and classification as to cardiovascular and non-cardiovascular. | From the first dose of Repatha® up to 30 months post first dose | 
| Describe hospitalizations | Detail all hospitalizations from enrolment to end of study | From the first dose of Repatha® up to 30 months post first dose | 
| Describe Repatha® dose frequency over time | Record dose frequency (Q2W, QM) | From the first dose of Repatha® up to 30 months post first dose | 
| Describe Repatha® administrative device use over time | Record Repatha® administration device details, personal injector, autoinjector or pre-filled syringe throughout the observation period | From the first dose of Repatha® up to 30 months post first dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypercholesterolaemia, lipid-lowering therapies