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Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Subjects with hyperlipidaemia under PCSK9 inhibitors treatment (Repatha/Praulent). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repatha (evolocumab); Praluent (alirocumab) | Drug | Dosage form: Injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Description of adherence of treatment with PCSK9 inhibitors 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. MPR will be calculated as overall MPR (mean and median value), MPR by type of prevention (primary and secondary), MPR by type of antiPCSK9 inhibitor (alirocumab vs. evolocumab), MPR by type of background therapy (statin yes, statin no) , MPR by demographic variables (age, sex, geographic origin, basal LDL levels), MPR by type of prescriber (hospital or territorial). | every 6 months |
| Description of persistence of treatment with PCSK9 inhibitors in a real-life Italian population. | Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment. | every 6 months |
| Description of efficacy of treatment with PCSK9 inhibitors 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 antiPCSK9 inhibitor (alirocumab vs. evolocumab), by type of basic therapy (statin yes, statin no), by demographic variables (age, sex, geographic origin, basal LDL levels), by type of prescriber (hospital or territorial). | every 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Description of adherence, efficacy and safety of treatment with PCSK9 inhibitors in a real-life Italian population general and divided into subgroups. | Safety will be evaluated in terms of adverse reactions or intolerance to the drug. | every 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes patients from Italy, who have received PCSK9 inhibitor as part of routine clinical management of their hyperlipidaemia for at least 6 months at time of enrollment, based on national reimbursement criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pasquale Perrone Filardi, MD | Contact | +390817462224 | fpperron@unina.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedali dell'Ovest Vicentino | Recruiting | Arzignano | 36071 | Italy |
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| University of Bari Aldo Moro | Recruiting | Bari | 70121 | Italy |
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| University of Campania Luigi Vanvitelli | Recruiting | Caserta | 81100 | Italy |
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| University Magna Graecia of Catanzaro | Recruiting | Catanzaro | 88100 | Italy |
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| Presidio Ospedaliero Maria SS Addolorata | Recruiting | Eboli | 84025 | Italy |
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| Policlinico Riuniti Foggia | Recruiting | Foggia | 71122 | Italy |
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| Università degli Studi di Genova | Recruiting | Genova | 16126 | Italy |
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| Ospedale di Lecce | Recruiting | Lecce | 73100 | Italy |
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| Università degli Studi di Messina | Recruiting | Messina | 98122 | Italy |
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| Policlinico di Milano Ospedale Maggiore - Fondazione IRCCS Ca' Granda | Recruiting | Milan | 20122 | Italy |
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| ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | 20162 | Italy |
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| AORN dei Colli - Ospedale monaldi | Recruiting | Naples | 80131 | Italy |
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| Federico II University of Naples, Department of Advanced Biomedical Sciences | Recruiting | Naples | 80131 | Italy |
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| Federico II University of Naples, Department of Translational Medical Sciences | Recruiting | Naples | 80131 | Italy |
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| University of Naples Federico II, Department of Clinical Medicine and Surgery | Recruiting | Naples | 80131 | Italy |
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| Azienda Ospedaliero-Universitaria "Maggiore della Carità" | Recruiting | Novara | 28100 | Italy |
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| Azienda Ospedaliero-Univeristaria di Parma | Recruiting | Parma | 43126 | Italy |
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| Presidio Ospedaliero Pescara | Recruiting | Pescara | 65124 | Italy |
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| Ospedale di Rivoli | Recruiting | Rivoli | 10098 | Italy |
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| Policlinico Tor Vergata | Recruiting | Roma | 00133 | Italy |
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| Azienda Ospedaliera San Camillo-Forlanini | Recruiting | Roma | 00152 | Italy |
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| Policlinico Casilino | Recruiting | Roma | 00169 | Italy |
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| Sapienza University of Rome | Withdrawn | Roma | 00185 | Italy |
| Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona | Recruiting | Salerno | 84131 | Italy |
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| Ospedale SS Annunziata A.O.U. | Recruiting | Sassari | 07100 | Italy |
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| University of Siena | Recruiting | Siena | 53100 | Italy |
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| Azienda Ospedaliera Ordine Mauriziano Torino | Recruiting | Torino | 10128 | Italy |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C577155 | evolocumab |
| C571059 | alirocumab |
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