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

NCT07023445 | Completed

• 1 other identifier: CKJX839D1US01
• Study Type: observational
• Target: 37,688
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerotic Cardiovascular Disease; Familial Hypercholesterolemia

Keywords

Low-density lipoprotein cholesterol; Real-world

Outcome Measures

Primary Outcomes (2)

• Number of Patients per Demographic Category

  Demographics included: * Age group * Gender * Insurance type * Race/ethnicity

  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)

  Baseline

Secondary Outcomes (4)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Patients with ≥1 prescription claims for the index medications in the 12-month prior-index period (exclusive of index date).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 17, 2025
• Study Start: January 20, 2023
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

US (1)