Clinical trial NCT06507852: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerotic Cardiovascular Disease
Hypercholesterolemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patients who Received Inclisiran Dose 2 and 3 Within Specified Time Intervals
timeFrame: Up to 26 months
Secondary outcomes:
measure: Percentage of Patients Taking Different Concomitant Lipid Lowering Therapy (LLT) at Index Date
timeFrame: Day 1 of Month 6
measure: Percentage of Patients who Received Inclisiran Doses Within Specified Time Intervals
timeFrame: Up to 26 months
measure: Gender
timeFrame: Baseline
measure: Race
timeFrame: Baseline
measure: Smoking Status
timeFrame: Baseline
measure: Physical Activity
timeFrame: Baseline
measure: Prescribing Physician Specialty
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Body Mass Index
timeFrame: Baseline
measure: Blood Pressure
timeFrame: Baseline
measure: Percentage of Male Patients by Age Group
timeFrame: Baseline
measure: Percentage of Female Patients by Age Group
timeFrame: Baseline
measure: Percentage of Patients Categorized by Comorbidities
timeFrame: Baseline
measure: Cholesterol
timeFrame: Baseline
measure: Triglycerides
timeFrame: Baseline
measure: Apolipoprotein B
timeFrame: Baseline
measure: Glycated hemoglobin
timeFrame: Baseline
measure: Lipoprotein(a)
timeFrame: Baseline
measure: Creatinine
timeFrame: Baseline
measure: Alanine Aminotransferase
timeFrame: Baseline
measure: Aspartate Aminotransferase
timeFrame: Baseline
measure: Alkaline phosphatase
timeFrame: Baseline
measure: Percentage of Patients With Procedures
timeFrame: Baseline
measure: Percentage of Atherosclerotic Cardiovascular Disease (ASCVD) Patients Categorized by Qualifying Diagnosis
timeFrame: Baseline
measure: Percentage of ASCVD-risk Equivalent Patients Categorized by Qualifying Criteria
timeFrame: Baseline
measure: Percentage of Patients Categorized by Lipid Lowering Therapies (LLTs) Prior to Index Date
timeFrame: Up to 6 months pre-index date
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: