Potential Eligibility and Estimated Preventable Cardiovascular Disease Events From Inclisiran Treatment in the United States

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07214857

Enrollment

1385

Registered

2025-10-09

Start date

2024-03-29

Completion date

2024-10-09

Last updated

2025-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

Prevention, Inclisiran, Statins, Diabetes

Brief summary

The aim of this study was to estimate the number of United States (US) adults with and without prior atherosclerotic cardiovascular disease (ASCVD) and diabetes who may be eligible for inclisiran based on US National Health and Nutrition Examination Survey (NHANES) data and inclisiran eligibility criteria from ongoing clinical trials as well as to estimate the number of preventable ASCVD events based on expected risk reductions from the degree of low-density lipoprotein cholesterol (LDL-C) lowering expected from inclisiran. This study used data from the US NHANES 2011-2020 surveys. NHANES is a national survey which collects medical history, laboratory, and medication information from participants of all ages.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Aged 18 years of age or older * Elevated LDL-C despite statin therapy * Other inclusion criteria per ongoing inclisiran clinical trials

Design outcomes

Primary

Measure	Time frame
Estimated Number of US Patients Eligible for Inclisiran Treatment	10 years
Estimated Number of Preventable Cardiovascular Events Over 10-years of Inclisiran Treatment	10 years

Countries

United States

Outcome results