Atherosclerotic Cardiovascular Disease, Cardiovascular Diseases, Hypercholesterolemia, Familial
Conditions
Keywords
Real-world, Retrospective, Adherence, Persistence, Long-term, PCSK9i
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
• Patients who received either evolocumab or alirocumab as their index study drug and who were dispensed the other anti-PCSK9-mAb (alirocumab and evolocumab respectively) before the identification period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Days Covered (PDC) With Inclisiran | 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months | 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 | 0-12 months, 12-24 months, 24-48 months | 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 | 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months | 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
| Measure | Time frame | Description |
|---|---|---|
| PDC With Anti-PCSK9-mAbs | 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months | 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 | 0-12 months, 12-24 months, 24-48 months | 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 | 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months | 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 | Baseline | — |
| Baseline Clinical Characteristics: Number of Patients by Diagnosis | Baseline | Diagnoses include primary hypercholesterolemia, mixed dyslipidemia, homozygous familial hypercholesterolemia, and atherosclerotic cardiovascular disease (ASCVD) where available. |
| Baseline Clinical Characteristics: Number of Patients by Comorbidity | Baseline | — |
| Baseline Clinical Characteristics: Charlson Comorbidity Index (CCI) Score | Baseline | 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). |
| PDC With Lipid Lowering Therapies (LLTs) at Baseline | 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. |
| Number of Patients by LLTs Received | Every 3 months from baseline through index date until the end of follow-up, assessed up to 48 months | Treatment patterns of LLT use. Index date is the date of first use of the treatment. |
| Number and Percentage of Patients Receiving Each of the Inclisiran Doses | From index date until the end of follow-up, assessed up to 48 months | Index date is the date of first use of the treatment. |
| Time Between Inclisiran Doses | From index date until the end of follow-up, assessed up to 48 months | Index date is the date of first use of the treatment. |
| Number of Anti-PCSK9-mAb Prescriptions | From index date until the end of follow-up, assessed up to 48 months | Index date is the date of first use of the treatment. |
| Time Between Anti-PCSK9-mAb Prescriptions | From index date until the end of follow-up, assessed up to 48 months | Index date is the date of first use of the treatment. |
| Association Between Treatment Adherence and Baseline Characteristics per Cohort | Baseline, up to 48 months | 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. |
| Association Between Treatment Persistence and Baseline Characteristics per Cohort | Baseline, up to 48 months | 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. |
Countries
Switzerland
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed