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
- Conditions
- HypercholesterolemiaAtherosclerotic Cardiovascular Disease
- Registration Number
- NCT06507852
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- 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.
• None.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Patients who Received Inclisiran Dose 2 and 3 Within Specified Time Intervals Up to 26 months 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.
- Secondary Outcome Measures
Name Time Method Blood Pressure Baseline Blood pressure: systolic and diastolic.
Prescribing Physician Specialty Baseline Body Mass Index Baseline Lipoprotein(a) Baseline Creatinine Baseline Alanine Aminotransferase Baseline Aspartate Aminotransferase Baseline Alkaline phosphatase Baseline Percentage of Patients who Received Inclisiran Doses Within Specified Time Intervals Up to 26 months 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.Physical Activity Baseline Physical activity was classified as intense, light, moderate, or unknown.
Age Baseline Glycated hemoglobin Baseline Percentage of Atherosclerotic Cardiovascular Disease (ASCVD) Patients Categorized by Qualifying Diagnosis Baseline Qualifying diagnoses were coronary artery disease (CAD), peripheral artery disease (PAD), and cerebrovascular disease (CVD).
Height Baseline Gender Baseline Race Baseline Smoking Status Baseline Patient smoker status:
* Non-smoker
* Current smoker
* Past smoker
* UnknownPercentage of Female Patients by Age Group Baseline 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.Percentage of Patients Categorized by Comorbidities Baseline Cholesterol Baseline Cholesterol included:
* Low-density lipoprotein cholesterol.
* High-density lipoprotein cholesterol.
* Non-high-density lipoprotein cholesterol.
* Total cholesterol.Apolipoprotein B Baseline Percentage of ASCVD-risk Equivalent Patients Categorized by Qualifying Criteria Baseline Qualifying Criteria:
* Type II diabetes mellitus.
* Framingham risk score of 20% or greater.
* Type I diabetes mellitus of for more than 20 years.Percentage of Patients Categorized by Lipid Lowering Therapies (LLTs) Prior to Index Date Up to 6 months pre-index date Index date was defined as the date of first administration of inclisiran.
Percentage of Patients Taking Different Concomitant Lipid Lowering Therapy (LLT) at Index Date Day 1 of Month 6 Index date was defined as the date of first administration of inclisiran.
Weight Baseline Percentage of Male Patients by Age Group Baseline 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.Triglycerides Baseline Percentage of Patients With Procedures Baseline
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States