Health TrialsbyHealthPanel

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

ConditionHypercholesterolemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFederico II University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients under PCSK9 inhibitor treatment.

Disqualifiers

Age < 18 years o > 80 years;

Patients who refuse to participate and to sign informed consent.

Trial population

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.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • Repatha (evolocumab); Praluent (alirocumab)

    Drug

    Dosage form: Injection

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: Group 11 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
every 6 months
2

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.

Time frame
every 6 months
3

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).

Time frame
every 6 months

Secondary outcomes

1

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.

Time frame
every 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Federico II University

Lead sponsor

Source ClinicalTrials.gov
Apply now