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

Novartis

Status: Completed

Conditions: Cardiovascular Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT07214857

CKJX839D1US03

Details and patient eligibility

About

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.

Enrollment: 1,385 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

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

Trial design

1,385 participants in 3 patient groups

Secondary Prevention Population

Description:

Patients with known ASCVD who met the secondary prevention population eligibility criteria.

High-risk Primary Prevention Population

Description:

Patients without known ASCVD who met the high-risk primary prevention population eligibility criteria.

Diabetes Population

Description:

Patients with diabetes who met the diabetes population eligibility criteria.