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.
Study Type
OBSERVATIONAL
Enrollment
5,995
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
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
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
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
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
Persistence With Anti-PCSK9-mAb Treatment
Novartis Pharmaceuticals
CONTACT
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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
Baseline Demographics
Time frame: Baseline
Baseline Clinical Characteristics: Number of Patients by Diagnosis
Diagnoses include primary hypercholesterolemia, mixed dyslipidemia, homozygous familial hypercholesterolemia, and atherosclerotic cardiovascular disease (ASCVD) where available.
Time frame: Baseline
Baseline Clinical Characteristics: Number of Patients by Comorbidity
Time frame: Baseline
Baseline Clinical Characteristics: Charlson Comorbidity Index (CCI) Score
CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be categorized as low (0-1) and high (≥2).
Time frame: Baseline
PDC With Lipid Lowering Therapies (LLTs) at Baseline
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: Baseline
Number of Patients by LLTs Received
Treatment patterns of LLT use. Index date is the date of first use of the treatment.
Time frame: Every 3 months from baseline through index date until the end of follow-up, assessed up to 48 months
Number and Percentage of Patients Receiving Each of the Inclisiran Doses
Index date is the date of first use of the treatment.
Time frame: From index date until the end of follow-up, assessed up to 48 months
Time Between Inclisiran Doses
Index date is the date of first use of the treatment.
Time frame: From index date until the end of follow-up, assessed up to 48 months
Number of Anti-PCSK9-mAb Prescriptions
Index date is the date of first use of the treatment.
Time frame: From index date until the end of follow-up, assessed up to 48 months
Time Between Anti-PCSK9-mAb Prescriptions
Index date is the date of first use of the treatment.
Time frame: From index date until the end of follow-up, assessed up to 48 months
Association Between Treatment Adherence and Baseline Characteristics per Cohort
Multivariable regression models will be used to examine how baseline characteristics could be associated with treatment adherence per cohort. Baseline characteristics may include age, sex, diagnosis, cardiovascular events, comorbidities, adherence to LLTs, and number of medications received at index and post-index.
Time frame: Baseline, up to 48 months
Association Between Treatment Persistence and Baseline Characteristics per Cohort
Cox proportional hazards models will be used to examine how baseline characteristics could be associated with treatment persistence per cohort. Baseline characteristics may include age, sex, diagnosis, cardiovascular events, comorbidities, adherence to LLTs, and number of medications received at index and post-index.
Time frame: Baseline, up to 48 months