Hypercholesterolaemia
Conditions
Keywords
hypercholesterolaemia, lipid-lowering therapies
Brief summary
Review of clinical characteristics of patients who are prescribed Repatha® and how their treatment is managed.
Interventions
None listed
Sponsors
Amgen
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Description of clinical characteristics of subjects initiated on Repatha® | Study day 1 | Age at initiation of Repatha®, Gender Familial hypercholesterolaemia status Diabetic status, Cardiovascular history History of statin intolerance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe Repatha® dose over time | From the first dose of Repatha® up to 30 months post first dose | Record Repatha® dose in mg |
| Describe use of other lipid-modifying therapies | From the first dose of Repatha® up to 30 months post first dose | Describe lipid-modifying therapies over time, type, dose and dose frequency during the observation period |
| Describe Physician visits | From the first dose of Repatha® up to 30 months post first dose | Collection of all primary and secondary healthcare visit dates and classification as to cardiovascular and non-cardiovascular. |
| Describe LDL-C and other cholesterol values over time | Up to 26 weeks prior to the first dose of Repatha®, up to 30 months post first dose of Repatha® | Detail all cholesterol assessments recorded during the observation period (Total Cholesterol, LDL-C, HDL-C, Non-HDL-C and Triglycerides). |
| Describe Repatha® dose frequency over time | From the first dose of Repatha® up to 30 months post first dose | Record dose frequency (Q2W, QM) |
| Describe Repatha® administrative device use over time | From the first dose of Repatha® up to 30 months post first dose | Record Repatha® administration device details, personal injector, autoinjector or pre-filled syringe throughout the observation period |
| Describe hospitalizations | From the first dose of Repatha® up to 30 months post first dose | Detail all hospitalizations from enrolment to end of study |
Countries
Austria, Belgium, Bulgaria, Czechia, Germany, Greece, Italy, Portugal, Slovakia, Spain, Sweden, Switzerland
Outcome results
None listed