Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia
Conditions
Keywords
Low-density lipoprotein cholesterol, Real-world
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a first claim for inclisiran within the identification period. * Patients without a claim for inclisiran and with a first alirocumab claim or first evolocumab claim within the identification period. * Patients with 12 months of continuous enrollment (CE) before index, inclusive of index date. Additional inclusion criteria for secondary outcome measures: * Patients with at least 6-month or 12-month CE period post-index. * Patients with continuous use of the index medications. * Patients with available low-density lipoprotein cholesterol (LDL-C) measurements at baseline and after treatment initiation.
Exclusion criteria
• Patients with ≥1 prescription claims for the index medications in the 12-month prior-index period (exclusive of index date).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients per Demographic Category | Baseline | Demographics included: * Age group * Gender * Insurance type * Race/ethnicity |
| Number of Patients per Clinical Characteristic Category | Baseline | Clinical characteristics included: * Body mass index * Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis * Familial Hypercholesterolemia (FH) diagnosis * Comorbidities * Type of lipid lowering therapy (LLT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | Up to 1 year | 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%. |
Countries
United States
Outcome results
None listed