Patterns of Inclisiran Use in the Real World: An Analysis of US Databases

Completed

• Conditions: Atherosclerotic Cardiovascular Disease; Familial Hypercholesterolemia

• Registration Number: NCT07023445
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-20
• Primary Completion: 2024-06-28
• Study Completion: 2024-06-28
• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37688

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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%.

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States