Clinical trial NCT07023445: Patterns of Inclisiran Use in the Real World: An Analysis of US Databases
Official title: Patterns of Inclisiran Use in the Real World: A Retrospective Analysis of US Databases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerotic Cardiovascular Disease
Familial Hypercholesterolemia
Keywords: Low-density lipoprotein cholesterol
Real-world
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 37688
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of Patients per Demographic Category
timeFrame: Baseline
measure: Number of Patients per Clinical Characteristic Category
timeFrame: Baseline
Secondary outcomes:
measure: Change From Baseline in LDL-C Levels
timeFrame: From Baseline up to 1 year
measure: Number of Patients who Achieved a Reduction of 50% or more in LDL-C Levels After Initiating Treatment
timeFrame: Up to 1 year
measure: Number of Patients who Achieved LDL-C Levels Below 70 Milligrams per Deciliter (mg/dL) and 55 mg/dL After Initiating Treatment
timeFrame: Up to 1 year
measure: Medication Adherence
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: