AT-TARGET-IT: Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
Study Details
Study Description
Brief Summary
Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1 Subjects with hyperlipidaemia under PCSK9 inhibitors treatment (Repatha/Praulent). |
Drug: Repatha (evolocumab); Praluent (alirocumab)
Dosage form: Injection
|
Outcome Measures
Primary Outcome Measures
- Description of adherence of treatment with PCSK9 inhibitors in a real-life Italian population. [6 months]
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).
- Description of persistence of treatment with PCSK9 inhibitors in a real-life Italian population. [6 months]
Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.
- Description of efficacy of treatment with PCSK9 inhibitors in a real-life Italian population. [6 months]
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).
Secondary Outcome Measures
- Description of adherence, efficacy and safety of treatment with PCSK9 inhibitors in a real-life Italian population general and divided into subgroups. [6 months]
Safety will be evaluated in terms of adverse reactions or intolerance to the drug.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients under PCSK9 inhibitor treatment for at least 6 months prior to enrollment.
Exclusion Criteria:
-
Age < 18 years or > 80 years;
-
Hypersensitivity to the active substance or to any of the excipients;
-
Advanced Kidney Disease (eGFR < 30 ml/min/1.73m2);
-
Severe hepatic insufficiency (Child-Pugh C);
-
Pregnancy and breastfeeding;
-
Terminal illness (cancer, AIDS, etc.);
-
History of alcohol, drug or medication abuse;
-
Any condition that could put the patient at risk by participating in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Bari Aldo Moro | Bari | Italy | 70121 | |
| 2 | University of Campania Luigi Vanvitelli | Caserta | Italy | 81100 | |
| 3 | University Magna Graecia of Catanzaro | Catanzaro | Italy | 88100 | |
| 4 | Presidio Ospedaliero Maria SS Addolorata | Eboli | Italy | 84025 | |
| 5 | Policlinico Riuniti Foggia | Foggia | Italy | 71122 | |
| 6 | ASST Grande Ospedale Metropolitano Niguarda | Milano | Italy | 20162 | |
| 7 | Federico II University of Naples | Napoli | Italy | 80131 | |
| 8 | Presidio Ospedaliero Pescara | Pescara | Italy | 65124 | |
| 9 | Ospedale di Rivoli | Rivoli | Italy | 10098 |
Sponsors and Collaborators
- Federico II University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 264/20