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

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic 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

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

Treatment and study plan

Primary outcomes

Estimated Number of US Patients Eligible for Inclisiran Treatment

Time frame: 10 years
Estimated Number of Preventable Cardiovascular Events Over 10-years of Inclisiran Treatment

Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Oct 9, 2025
Registry last updated: Oct 9, 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.

Published trials that share one or more normalized conditions with this study.

Completed