A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorNovartis Pharmaceuticals

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

5,995 Participants
are grouped into 4 trial groups
Group A: Inclisiran Cohort
Group B: Evolocumab Cohort
Group C: Alirocumab Cohort
Group D: Pooled Anti-PCSK9-mAb Cohort

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months
2

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.

Time frame
0-12 months, 12-24 months, 24-48 months
3

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.

Time frame
6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months

Secondary outcomes

1

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.

Time frame
6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months
2

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.

Time frame
0-12 months, 12-24 months, 24-48 months
3

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.

Time frame
6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months
4

Baseline Demographics

Time frame
Baseline

Other outcomes

Sponsors and contacts

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