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

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Novartis

Status

Completed

Conditions

Atherosclerotic Cardiovascular Disease
Familial Hypercholesterolemia

Study type

Observational

Funder types

Industry

Identifiers

NCT07023445
CKJX839D1US01

Details and patient eligibility

About

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.

Enrollment

37,688 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

37,688 participants in 3 patient groups

Inclisiran Cohort
Description:
Patients with a prescription or claim for inclisiran.
Alirocumab Cohort
Description:
Patients with a prescription or claim for alirocumab.
Evolocumab Cohort
Description:
Patients with a prescription or claim for evolocumab.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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