This was a single-center, retrospective, observational study (non-interventional study with secondary use of data) among patients in a real-world setting. This study used the medical record data from patients in Yiling. Eligible patients who newly initiated inclisiran from 26 January 2022 to 21 August 2023 were included. The retrospective data up to the date of ethics committee approval (April 2024) was collected. The study team collected patient data using an electronic case report form (eCRF) from April 2024 to June 2024.
Study Type
OBSERVATIONAL
Enrollment
600
Novartis
East Hanover, New Jersey, United States
Percentage Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels
Time frame: Baseline, Month 9
Absolute Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels
Time frame: Baseline, Month 9
Change From Baseline to Month 9 in Total Cholesterol Levels
Time frame: Baseline, Month 9
Change From Baseline to Month 9 in Apolipoprotein B Levels
Time frame: Baseline, Month 9
Change From Baseline to Month 9 in non-High Density Lipoprotein Cholesterol Levels
Time frame: Baseline, Month 9
Change From Baseline to Month 9 in Serum Apolipoprotein A1 Levels
Time frame: Baseline, Month 9
Change From Baseline to Month 9 in High Density Lipoprotein Cholesterol Levels
Time frame: Baseline, Month 9
Change From Baseline to Month 9 in Lipoprotein (a) Levels
Time frame: Baseline, Month 9
Change From Baseline to Month 9 in Triglyceride Levels
Time frame: Baseline, Month 9
Number of Patients With at Least two Doses of Inclisiran After the First Injection of Inclisiran
Time frame: Up to 27 months
Number of Patients who Switched at Least Once From Inclisiran to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Monoclonal Antibody Treatment
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Time frame: Up to 27 months
Number of Patients With Changes in Lipid-lowering Therapies (LLTs)
Changes in LLTs included: * LLT dose modification (dose increase, dose decrease). * LLT switches. * Use of new add-on therapy. * LLT interruption. * LLT discontinuation. * Time between first inclisiran injection and subsequent doses.
Time frame: Up to 27 months
Proportion of Days Covered (Adherence) of Inclisiran Over 12 Months
Proportion of Days Covered of inclisiran over 12 months was calculated by the days covered by inclisiran within 12 months divided by 12 months.
Time frame: 12 months
Number of Patients per Demographic Category
Demographic categories included: * Age * Gender * Ethnicity * Smoking history * Alcohol use history
Time frame: Baseline
Number of Patients per Clinical Characteristic Category
Clinical characteristics included: * Family history of hereditary disease * Comorbidities * Medication history * Concomitant medications and/or therapies * Background LLT regimens
Time frame: Baseline
Baseline Lipid Levels
Lipids included, but were not limited to, LDL-C, total cholesterol, apolipoprotein B, non-high density lipoprotein cholesterol, serum apolipoprotein A1, high density lipoprotein cholesterol, lipoprotein (a), and triglycerides.
Time frame: Baseline