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
NCT Number: NCT06507852
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Atherosclerotic Cardiovascular Disease|Hypercholesterolemia
Sponsor: Novartis
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 95
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-03
Completion Date: 2023-07-06
Locations: Novartis, East Hanover, New Jersey, 07936, United States

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.

Primary Outcome Measures: 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: 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|Gender, Baseline|Race, Baseline|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|Age, Baseline|Weight, Baseline|Height, Baseline|Body Mass Index, 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|Triglycerides, Baseline|Apolipoprotein B, 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