Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy

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 alirocumab 300 mg in a real-life Italian population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

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 alirocumab 300mg as part of routine clinical management of their hyperlipidaemia at time of enrollment, based on national reimbursement criteria.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • Praluent (Alirocumab)

    Drug

    Alirocumab 300 mg injection

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: Subjects with hyperlipidaemia under Alirocumab 300 mg treatment.1 intervention

Trial outcomes

Primary outcomes

1

Description of adherence of treatment with alirocumab 300mg 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.

Time frame
6-12-24-36 months
2

Description of persistence of treatment with alirocumab 300mg in a real-life Italian population.

Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.

Time frame
6-12-24-36 months
3

Description of efficacy of treatment with alirocumab 300mg 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).

Time frame
6-12-24-36 months

Secondary outcomes

1

Description of safety of treatment with alirocumab 300mg in a real-life Italian population.

Safety will be evaluated in terms of adverse reactions or intolerance to the drug.

Time frame
6-12-24-36 months

Other outcomes

Sponsors and contacts

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