Familial Hypercholesterolemia, Hypercholesterolemia
Conditions
Brief summary
The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.
Detailed description
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
Interventions
OTHERNo intervention
No intervention; observation of routine medical care
Sponsors
Amgen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events and adverse drug reactions | 2 years | 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. |
| 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 | 2 years | This will be measured if feasible. |
| Laboratory values for Apolipoprotein (Apo) Apo B | 2 years | This will be measured if feasible. |
| Laboratory values for Apolipoprotein (Apo) Apo E | 2 years | This will be measured if feasible. |
| Laboratory values for lipoprotein(a) | 2 years | This will be measured if feasible. |
Countries
Japan
Outcome results
None listed