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 volunteersQualifiers
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
Case-only
Other
Treatments tested in this trial
Praluent (Alirocumab)
DrugAlirocumab 300 mg injection
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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).
Secondary outcomes
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.
Sponsors and contacts
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