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Completed

NCT Number: NCT07023445

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

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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Key information

Conditions

Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Familial Hypercholesterolemia Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Number of Patients per Demographic Category

    Time frame: Baseline

    Demographics included:

    • Age group
    • Gender
    • Insurance type
    • Race/ethnicity

  2. Number of Patients per Clinical Characteristic Category

    Time frame: Baseline

    Clinical characteristics included:

    • Body mass index
    • Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis
    • Familial Hypercholesterolemia (FH) diagnosis
    • Comorbidities
    • Type of lipid lowering therapy (LLT)

Secondary outcomes

  1. Change From Baseline in LDL-C Levels

    Time frame: From Baseline up to 1 year

  2. Number of Patients who Achieved a Reduction of 50% or more in LDL-C Levels After Initiating Treatment

    Time frame: Up to 1 year

  3. 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

  4. Medication Adherence

    Time frame: 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%.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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