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Evaluation of adherence, persistence and efficacy of treatment with alirocumab 300 mg in a real-life Italian population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with hyperlipidaemia under Alirocumab 300 mg treatment. | Subjects with hyperlipidaemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Praluent (Alirocumab) | Drug | Alirocumab 300 mg injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Description of adherence of treatment with alirocumab 300mg 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. | 6-12-24-36 months |
| Description of persistence of treatment with alirocumab 300mg in a real-life Italian population. | Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment. | 6-12-24-36 months |
| Description of efficacy of treatment with alirocumab 300mg 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). | 6-12-24-36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Description of safety of treatment with alirocumab 300mg in a real-life Italian population. | Safety will be evaluated in terms of adverse reactions or intolerance to the drug. | 6-12-24-36 months |
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Inclusion Criteria:
- Patients under alirocumab 300mg treatment.
Exclusion Criteria:
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The study population includes patients from Italy, who have received alirocumab 300mg as part of routine clinical management of their hyperlipidaemia at time of enrollment, based on national reimbursement criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pasquale Perrone Filardi | Contact | +390817462224 | fpperron@unina.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federico II University of Naples, Department of Advanced Biomedical Sciences | Recruiting | Naples | Napoli | 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 |
|---|---|
| C571059 | alirocumab |
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| D009750 |
| Nutritional and Metabolic Diseases |