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

Recruiting

• Conditions: Hypercholesterolemia
• Interventions: Drug: Repatha (evolocumab); Praluent (alirocumab)

• Registration Number: NCT05430828
• Lead Sponsor: Federico II University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-07
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-03-07
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Repatha (evolocumab); Praluent (alirocumab)	Subjects with hyperlipidaemia under PCSK9 inhibitors treatment (Repatha/Praulent).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (27)

Ospedali dell'Ovest Vicentino; 🇮🇹 Arzignano, Italy

University of Bari Aldo Moro; 🇮🇹 Bari, Italy

Università degli Studi di Genova; 🇮🇹 Genova, Italy

University of Campania Luigi Vanvitelli; 🇮🇹 Caserta, Italy

Policlinico di Milano Ospedale Maggiore - Fondazione IRCCS Ca' Granda; 🇮🇹 Milano, Italy

Federico II University of Naples, Department of Advanced Biomedical Sciences; 🇮🇹 Napoli, Italy

Presidio Ospedaliero Maria SS Addolorata; 🇮🇹 Eboli, Italy

Policlinico Riuniti Foggia; 🇮🇹 Foggia, Italy

Ospedale di Lecce; 🇮🇹 Lecce, Italy

Azienda Ospedaliero-Universitaria "Maggiore della Carità"; 🇮🇹 Novara, Italy

Federico II University of Naples, Department of Translational Medical Sciences; 🇮🇹 Napoli, Italy

Ospedale di Rivoli; 🇮🇹 Rivoli, Italy

Policlinico Casilino; 🇮🇹 Roma, Italy

Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona; 🇮🇹 Salerno, Italy

Sapienza University of Rome; 🇮🇹 Roma, Italy

Ospedale SS Annunziata A.O.U.; 🇮🇹 Sassari, Italy

University of Siena; 🇮🇹 Siena, Italy

University Magna Graecia of Catanzaro; 🇮🇹 Catanzaro, Italy

University of Naples Federico II, Department of Clinical Medicine and Surgery; 🇮🇹 Napoli, Italy

Azienda Ospedaliera Ordine Mauriziano Torino; 🇮🇹 Torino, Italy

Università degli Studi di Messina; 🇮🇹 Messina, Italy

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milano, Italy

AORN dei Colli - Ospedale monaldi; 🇮🇹 Napoli, Italy

Azienda Ospedaliero-Univeristaria di Parma; 🇮🇹 Parma, Italy

Presidio Ospedaliero Pescara; 🇮🇹 Pescara, Italy

Policlinico Tor Vergata; 🇮🇹 Roma, Italy

Azienda Ospedaliera San Camillo-Forlanini; 🇮🇹 Roma, Italy