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Retrospective observational cohort study to compare medication adherence at 12 months between patients in Japan with dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) who newly initiate inclisiran versus those who newly initiate evolocumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exposure group | patients who initiated inclisiran as their first treatment | ||
| control group | patients who initiated evolocumab as their first treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence at 12 months : proportion of days covered (PDC) within a period that the patient is persistent | Adherence is defined using proportion of days covered (PDC) within a period that the patient is persistent: calculated as the number of days covered by the target drug (inclisiran in the exposure group, evolocumab in the control group) during the 12 months follow-up period, divided by 365 days. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with good adherence | Proportion of patients with good adherence at 12 months follow-up period, defined as PDC ≥ 80%. | 12 months |
| Number of patients by demographic category |
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Inclusion Criteria:
The patients are included if they meet all the following criteria:
Exclusion Criteria:
Those with any of the following criteria will be excluded.
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Adult patients with dyslipidemia and/or hypercholesterolemia who initiated treatment with inclisiran or evolocumab in the period after first approval of inclisiran in 22-Nov-2023
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
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| Baseline |
| Time to discontinuation | The date of discontinuation of first treatment drug will be considered as the date of outcome occurrence. | 12 months |
| Proportion of patients receiving LLTs | Proportion of patients receiving LLTs (statin only/ezetimibe only/statin and ezetimibe) during the baseline period and 12 months follow-up period | 12 months |