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

Novartis95 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Atherosclerotic Cardiovascular Disease Hypercholesterolemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Outcomes

Primary Outcomes

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.

Time frame: Up to 26 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: Up to 26 months

Gender

Time frame: Baseline

Race

Time frame: Baseline

Smoking Status

Patient smoker status: * Non-smoker * Current smoker * Past smoker * Unknown

Time frame: Baseline

Physical Activity

Physical activity was classified as intense, light, moderate, or unknown.

Time frame: Baseline

Prescribing Physician Specialty

Time frame: Baseline

Age

Time frame: Baseline

Weight

Time frame: Baseline

Height

Time frame: Baseline

Body Mass Index

Time frame: Baseline

Blood Pressure

Blood pressure: systolic and diastolic.

Time frame: 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.

Time frame: 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.

Time frame: Baseline

Percentage of Patients Categorized by Comorbidities

Time frame: Baseline

Cholesterol

Cholesterol included: * Low-density lipoprotein cholesterol. * High-density lipoprotein cholesterol. * Non-high-density lipoprotein cholesterol. * Total cholesterol.

Time frame: Baseline

Triglycerides

Time frame: Baseline

Apolipoprotein B

Time frame: Baseline

Glycated hemoglobin

Time frame: Baseline

Lipoprotein(a)

Time frame: Baseline

Creatinine

Time frame: Baseline

Alanine Aminotransferase

Time frame: Baseline

Aspartate Aminotransferase

Time frame: Baseline

Alkaline phosphatase

Time frame: Baseline

Percentage of Patients With Procedures

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: Up to 6 months pre-index date