Patterns of Inclisiran Use in the Real World: An Analysis of US Databases
Completed
Conditions studied: Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia
In brief
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.
Key facts
- Study ID
- NCT07023445
- Run by
- Novartis Pharmaceuticals
- People needed
- 37688
- Starts
- 2023-01-20
- Expected to finish
- 2024-06-28
- Last updated by the study team
- 2025-06-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
- 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.
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).
Where it is running
- Novartis — East Hanover, New Jersey, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.