Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy

Study Overview
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Brief Summary
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Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.

Official Title
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Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Repatha (evolocumab); Praluent (alirocumab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients under PCSK9 inhibitor treatment. Exclusion Criteria: Age < 18 years o > 80 years; Patients who refuse to participate and to sign informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Subjects with hyperlipidaemia under PCSK9 inhibitors treatment (Repatha/Praulent). | Drug: Repatha (evolocumab); Praluent (alirocumab)<br>* Dosage form: Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 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. | 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). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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. | 6 months |