Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFederico II University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients under Bempedoic acid 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 Bempedoic acid as part of routine clinical management of their hyperlipidaemia, based on national reimbursement criteria at the time of enrollment.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • Bempedoic acid

    Drug

    film-coated tablets

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: Subjects with hyperlipidaemia under Bempedoic acid treatment1 intervention

Trial outcomes

Primary outcomes

1

Description of adherence to treatment with Bempedoic acid 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 efficacy of treatment with Bempedoic acid 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
3

Description of persistence to treatment with Bempedoic acid 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

Secondary outcomes

1

Description of safety of treatment with Bempedoic acid 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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