Atherosclerotic Cardiovascular Disease, Hypercholesterolemia
Conditions
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.
Interventions
None listed
Sponsors
Novartis
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Gender | Baseline | — |
| Race | Baseline | — |
| Smoking Status | Baseline | Patient smoker status: * Non-smoker * Current smoker * Past smoker * Unknown |
| Physical Activity | Baseline | Physical activity was classified as intense, light, moderate, or unknown. |
| Prescribing Physician Specialty | Baseline | — |
| Age | Baseline | — |
| Weight | Baseline | — |
| Height | Baseline | — |
| Body Mass Index | Baseline | — |
| Blood Pressure | Baseline | Blood pressure: systolic and diastolic. |
| 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. |
| Percentage 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. |
| 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 | Baseline | Qualifying diagnoses were coronary artery disease (CAD), peripheral artery disease (PAD), and cerebrovascular disease (CVD). |
| 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. |
Countries
United States
Outcome results
None listed