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

Retrospective Assessment of Inclisiran Adherence, Treatment Patterns, Patient Characteristics, and Effectiveness Among ASCVD Patients With Hypercholesterolemia, ASCVD-risk Equivalent Patients With Hypercholesterolemia and Familial Hypercholesterolemia Patients Prescribed LEQVIO® (Inclisiran) in a Real-world Setting

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia; Atherosclerotic Cardiovascular Disease

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Overall Cohort; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients who Received Inclisiran Dose 2 and 3 Within Specified Time Intervals	Time intervals: Time from Dose 1 to Dose 2: 5 months or less.; Time from Dose 2 to Dose 3:Less than 6 months.Between 6 months and 9 months.Greater than 9 months.	Up to 26 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height		Baseline
Weight		Baseline
Gender		Baseline
Age		Baseline
Race		Baseline
Body Mass Index		Baseline
Triglycerides		Baseline
Apolipoprotein B		Baseline
Percentage of Patients Taking Different Concomitant Lipid Lowering Therapy (LLT) at Index Date	Index date was defined as the date of first administration of inclisiran.	Day 1 of Month 6
Percentage of Patients who Received Inclisiran Doses Within Specified Time Intervals	Time intervals: Time from Dose 1 to Dose 2:Less than 3.5 months.Between 3.5 and 5 months.Greater than 5 months.; Time from Dose 2 to Dose 3:Less than 6 months.Between 6 and 7 months.Between 7 and 8 months.Between 8 and 9 months.Greater than 9 months.	Up to 26 months
Smoking Status	Patient smoker status: Non-smoker; Current smoker; Past smoker; Unknown	Baseline
Physical Activity	Physical activity was classified as intense, light, moderate, or unknown.	Baseline
Prescribing Physician Specialty		Baseline
Blood Pressure	Blood pressure: systolic and diastolic.	Baseline
Percentage of Male Patients by Age Group	Age groups: Less than 15 years old.; 15 to 19 years old.; 20 to 29 years old.; 30 to 39 years old.; 40 to 49 years old.; 50 to 59 years old.; 60 years or older.	Baseline
Percentage of Female Patients by Age Group	Age groups: Less than 15 years old.; 15 to 19 years old.; 20 to 29 years old.; 30 to 39 years old.; 40 to 49 years old.; 50 to 59 years old.; 60 years or older.	Baseline
Percentage of Patients Categorized by Comorbidities		Baseline
Cholesterol	Cholesterol included: Low-density lipoprotein cholesterol.; High-density lipoprotein cholesterol.; Non-high-density lipoprotein cholesterol.; Total cholesterol.	Baseline
Glycated hemoglobin		Baseline
Lipoprotein(a)		Baseline
Creatinine		Baseline
Alanine Aminotransferase		Baseline
Aspartate Aminotransferase		Baseline
Alkaline phosphatase		Baseline
Percentage of Patients With Procedures		Baseline
Percentage of Atherosclerotic Cardiovascular Disease (ASCVD) Patients Categorized by Qualifying Diagnosis	Qualifying diagnoses were coronary artery disease (CAD), peripheral artery disease (PAD), and cerebrovascular disease (CVD).	Baseline
Percentage of ASCVD-risk Equivalent Patients Categorized by Qualifying Criteria	Qualifying Criteria: Type II diabetes mellitus.; Framingham risk score of 20% or greater.; Type I diabetes mellitus of for more than 20 years.	Baseline
Percentage of Patients Categorized by Lipid Lowering Therapies (LLTs) Prior to Index Date	Index date was defined as the date of first administration of inclisiran.	Up to 6 months pre-index date

Collaborators and Investigators

• Sponsor: Novartis
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Actual): July 6, 2023
• Study Completion (Actual): July 6, 2023

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Cardiovascular Diseases; Hypercholesterolemia; Atherosclerosis; Hyperlipoproteinemia Type II
• Other Study ID Numbers: CKJX839A1AT01