Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan

Study Overview
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Brief Summary
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The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.

Detailed Description
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The objectives of study are to 1) determine the incidence of adverse events and adverse drug reactions among patients receiving evolocumab for up to 2 years, and 2) identify and describe patient characteristics (e.g. demographics, medical history) associated with the safety and effectiveness of evolocumab therapy for the patients with Familial Hypercholesterolemia (Heterozygous or Homozygous) and Hypercholesterolemia in Japan

Official Title
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Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab (AMG 145) in Japan

Conditions
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Hypercholesterolemia, Familial Hypercholesterolemia

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients for whom evolocumab is prescribed at participating medical institutions in accordance with the approved Japan prescribing information (i.e., those with Familial Hypercholesterolemia (Heterozygous or Homozygous and Hypercholesterolemia who have high risk factors for cardiovascular event and do not respond sufficiently to HMGCoA reductase inhibitor (statin) for hypercholesterolemia). Exclusion Criteria: No exclusion criteria are applied.
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 |
| --- | --- |
| Evolocumab exposed<br>Patients for whom evolocumab is prescribed. Dosage, period (start/end date), frequency of injection (Every 2 weeks (Q2W), Every 4 weeks (Q4W)), drug withdrawal (Yes or No, date, reason) and injection site (upper arm, abdomen, thigh) of evolocumab will be collected. | Other: No intervention<br>* No intervention; observation of routine medical care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events and adverse drug reactions | The incidence of adverse events and drug reactions will be described using the same units (events per 1000 person-years). Adverse events (including seriousness and causal relations to drug or device), inclusive of reaction at local injection sites, and other safety information (e.g. overdose, lack of effectiveness, pregnancy and lactation with or without adverse event) will be described. | 2 years | 
| Laboratory values for LDL-C |  | 2 years | 
| Laboratory values for HDL-C |  | 2 years | 
| Laboratory values for total cholesterol |  | 2 years | 
| Laboratory values for triglycerides |  | 2 years | 
| Laboratory values for Apolipoprotein (Apo) A1 | This will be measured if feasible. | 2 years | 
| Laboratory values for Apolipoprotein (Apo) Apo B | This will be measured if feasible. | 2 years | 
| Laboratory values for Apolipoprotein (Apo) Apo E | This will be measured if feasible. | 2 years | 
| Laboratory values for lipoprotein(a) | This will be measured if feasible. | 2 years |