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Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with hyperlipidaemia under Inclisiran treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inclisiran | Drug | Injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Description of adherence to treatment with Inclisiran in a real-life Italian population | Adherence will be assessed in terms of Medical Possession Ratio (MPR) which is defined as the ratio between the treatment units dispensed during the treatment period and the duration of the treatment period itself. | at 3 months and every 6 months thereafter |
| Description of persistence to treatment with Inclisiran in a real-life Italian population | Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment. | at 3 months and every 6 months thereafter |
| Description of efficacy of treatment with Inclisiran in a real-life Italian population | Efficacy of treatment will be evaluated as a change in the LDL (deltaLDL) value from the start of treatment (percentage and absolute value). The deltaLDL will be calculated as an overall (mean and median value), by type of prevention (primary and secondary), by type of basic therapy, by demographic variables (age, sex, geographic origin, basal LDL levels) and by type of prescriber (hospital or territorial). | at 3 months and every 6 months thereafter |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes patients from Italy, who have received Inclisiran as part of routine clinical management of their hyperlipidaemia, based on national reimbursement criteria, at time of enrollment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federico II University of Naples, Department of Advanced Biomedical Sciences | Recruiting | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C585830 | ALN-PCS |
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| D009750 |
| Nutritional and Metabolic Diseases |