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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inclisiran Cohort | Patients receiving inclisiran injection(s). | ||
| Evolocumab Cohort | Patients receiving evolocumab injection(s). | ||
| Alirocumab Cohort | Patients receiving alirocumab injection(s). | ||
| Pooled Anti-PCSK9-mAb Cohort | Patients receiving anti-PCSK9-mAbs either evolocumab or alirocumab. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months |
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Inclusion criteria:
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.
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Adult patients in Italy who initiated inclisiran, evolocumab, or alirocumab treatment during the identification period with at least 18 months of follow-up.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D008052 | Lipid Metabolism, Inborn Errors |
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| 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. | 0-12 months, 12-24 months, 24-48 months |
| 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. | 6 months after index date and every 3 months thereafter until the end of follow-up, assessed up to 48 months |
| Baseline Demographics | 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. | Baseline |
| Baseline Clinical Characteristics: Number of Patients by Comorbidity | 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). | 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. | Baseline |
| Number of Patients by LLTs Received | Treatment patterns of LLT use. Index date is the date of first use of the treatment. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, up to 48 months |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |