Hypercholesterolemia
Conditions
Brief summary
Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population
Interventions
DRUGInclisiran
Injection
Sponsors
Federico II University
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients under Inclisiran 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 to treatment with Inclisiran in a real-life Italian population | at 3 months and every 6 months thereafter | 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 to treatment with Inclisiran in a real-life Italian population | at 3 months and every 6 months thereafter | Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment. |
| Description of efficacy of treatment with Inclisiran in a real-life Italian population | at 3 months and every 6 months thereafter | 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 basic therapy, by demographic variables (age, sex, geographic origin, basal LDL levels) and by type of prescriber (hospital or territorial). |
Countries
Italy
Outcome results
None listed