A Real-world Study of Inclisiran Adherence, Treatment Patterns, Patient Characteristics, and Effectiveness in ASCVD Patients With Hypercholesterolemia, ASCVD-risk Equivalent Patients With Hypercholesterolemia and Familial Hypercholesterolemia

Novartis

Status: Completed

Conditions: Atherosclerotic Cardiovascular Disease; Hypercholesterolemia

Study type: Observational

Funder types: Industry

Identifiers

NCT06507852

CKJX839A1AT01

Details and patient eligibility

About

This was a descriptive, non-interventional, retrospective cohort study among patients with atherosclerotic cardiovascular disease (ASCVD) and hypercholesterolemia, ASCVD-risk equivalent (ASCVD-RE) or familial hypercholesterolemia (FH) administered inclisiran in a real-world setting in Austria.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who were 18 years or older.
• Signed informed consent was obtained.
• Patients who received at least one inclisiran injection in the identification period.
• Patients with at least one diagnosis of ASCVD, ASCVD-RE or FH diagnosis prior to index date.
• Patients with at least one low-density lipoprotein cholesterol (LDL-C) measurement of 70 milligrams per deciliter (mg/dL) or greater, within 6 months prior to index date.

ASCVD was defined as previous diagnosis of coronary artery disease (CAD), peripheral artery disease (PAD) or cerebrovascular disease (CVD).

ASCVD-RE was defined as: no previous diagnosis of ASCVD at any time on the patient chart and they met at least one of the following criteria:

• Diagnosis of type II diabetes mellitus (T2DM).
• Diagnosis of type I diabetes mellitus (T1DM) of long duration (greater than 20 years).
• 10-year risk of 20% or greater by Framingham risk score.

Exclusion criteria

• None.

Trial design

95 participants in 1 patient group

Overall Cohort

Description:

Adult patients with ASCVD and hypercholesterolemia, ASCVD-RE with hypercholesterolemia, or FH, who were prescribed inclisiran in a real-world setting as per clinical practice and according to the label in Austria.