Hypercholesterolemia
Conditions
Brief summary
Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.
Interventions
DRUGRepatha (evolocumab); Praluent (alirocumab)
Dosage form: Injection
Sponsors
Federico II University
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Description of adherence of treatment with PCSK9 inhibitors in a real-life Italian population. | every 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. | every 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. | every 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
| Measure | Time frame | Description |
|---|---|---|
| Description of adherence, efficacy and safety of treatment with PCSK9 inhibitors in a real-life Italian population general and divided into subgroups. | every 6 months | Safety will be evaluated in terms of adverse reactions or intolerance to the drug. |
Countries
Italy
Contacts
CONTACTPasquale Perrone Filardi, MD
Outcome results
None listed