About this trial
This study aims to evaluate the long-term adherence and persistence to inclisiran and anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in real-world clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A first ever prescription of injection of inclisiran, evolocumab, or alirocumab during the identification period.
Age ≥18 years at index date.
With at least 12 months data availability prior to index date.
Disqualifiers
None
Trial population
Adult patients in Italy who initiated inclisiran, evolocumab, or alirocumab treatment during the identification period with at least 18 months of follow-up.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Proportion of Days Covered (PDC) With Inclisiran
PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest. Index date is the date of first use of the treatment.
Annual PDC With Inclisiran
PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest.
Persistence With Inclisiran Treatment
Persistence is defined as time to discontinuation by exceeding a pre-specified allowable gap beyond the scheduled time for the next dose/prescription. Index date is the date of first use of the treatment.
Secondary outcomes
PDC With Anti-PCSK9-mAbs
PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest. Index date is the date of first use of the treatment.
Annual PDC With Anti-PCSK9-mAbs
PDC is defined as the number of days with medication supply (covered days) within a period of interest divided by the number of days in the period of interest.
Persistence With Anti-PCSK9-mAb Treatment
Persistence is defined as time to discontinuation by exceeding a pre-specified allowable gap beyond the scheduled time for the next dose/prescription. Index date is the date of first use of the treatment.
Baseline Demographics
Sponsors and contacts
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