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This was a retrospective observational cohort study of patients who initiated inclisiran, alirocumab, or evolocumab in a real-world setting in the United States. The study used data extracted from three databases: (1) open and closed claims from Komodo's Healthcare map and electronic medical records (EMRs) from outpatient clinics affiliated with (2) Healix and (3) Metro Infusion Centers.
The study period spanned from 01 January 2021 to the latest date of the available data for each database. Index date was defined as the date of the first claim for inclisiran, alirocumab, or evolocumab within the patient identification period. The 12-month period prior to the index date (including the index date) was the baseline period. Follow-up spanned from the index date up to patient disenrollment, death, or the end of the study period, whichever came first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inclisiran Cohort | Patients with a prescription or claim for inclisiran. | ||
| Alirocumab Cohort | Patients with a prescription or claim for alirocumab. | ||
| Evolocumab Cohort | Patients with a prescription or claim for evolocumab. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients per Demographic Category | Demographics included:
| Baseline |
| Number of Patients per Clinical Characteristic Category | Clinical characteristics included:
| Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in LDL-C Levels | From Baseline up to 1 year | |
| Number of Patients who Achieved a Reduction of 50% or more in LDL-C Levels After Initiating Treatment | Up to 1 year | |
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Inclusion Criteria:
Additional inclusion criteria for secondary outcome measures:
Exclusion criteria:
• Patients with ≥1 prescription claims for the index medications in the 12-month prior-index period (exclusive of index date).
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This was a retrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Number of Patients who Achieved LDL-C Levels Below 70 Milligrams per Deciliter (mg/dL) and 55 mg/dL After Initiating Treatment |
| Up to 1 year |
| Medication Adherence | Adherence was defined using proportion of days covered (PDC) within a period that the patient was persistent: the number of days covered by the prescription fills divided by the number of days between the first fill of the medication during the identification period (index date) and the end of the observational period. A patient was classified as having poor adherence if the calculated PDC was below 80%. | Up to 1 year |
| D008052 |
| Lipid Metabolism, Inborn Errors |
| 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 |