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.
Study Type
OBSERVATIONAL
Enrollment
37,688
Novartis
East Hanover, New Jersey, United States
Number of Patients per Demographic Category
Demographics included: * Age group * Gender * Insurance type * Race/ethnicity
Time frame: Baseline
Number of Patients per Clinical Characteristic Category
Clinical characteristics included: * Body mass index * Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis * Familial Hypercholesterolemia (FH) diagnosis * Comorbidities * Type of lipid lowering therapy (LLT)
Time frame: Baseline
Change From Baseline in LDL-C Levels
Time frame: From Baseline up to 1 year
Number of Patients who Achieved a Reduction of 50% or more in LDL-C Levels After Initiating Treatment
Time frame: 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
Time frame: 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%.
Time frame: Up to 1 year
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