The purpose of this study was to describe the effectiveness of inclisiran and proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in the real-world setting in China. Data for this study was obtained from three regional electronic health record (rEHR) databases and included patients who met the enrollment requirements during the study identification period (October 1, 2023 to June 30, 2024) who had used either inclisiran or PCSK9 mAb for the first time. The retrospective data up to the date of ethics committee (EC) approval was extracted from multiple rEHR databases to generate study-specific datasets supporting this study on respective secure data analysis platforms. Due to the requirements of data security policies, the patient-level data from rEHR databases could not be transferred out of the secure platform. Thus, independent analysis based on data from each of the three databases was performed separately and meta-analysis was conducted to integrate one result of all independent data analyses.
Study Type
OBSERVATIONAL
Enrollment
11,991
Novartis
East Hanover, New Jersey, United States
Percentage Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline
Time frame: From Baseline to 6 months
Percentage Change in LDL-C From Baseline
Time frame: From Baseline to 3, 9, and 12 months
Absolute Change in LDL-C From Baseline
Time frame: From Baseline to 3, 6, 9, and 12 months
Proportion of Days Covered (PDC)
PDC: (number of days covered by medication over 12 months/365 days) x 100%
Time frame: 12 months
Proportion of Patients who Remained (Persistence) on Medication
Time frame: 12 months
Number of Inclisiran Injections
Time frame: 12 months
Percentage Change in Other Lipids and Lipoproteins From Baseline
Other lipids and lipoproteins include total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), lipoprotein (a) (Lp \[a\]), serum apolipoproteins A1 (Apo A1), apolipoproteins B (Apo B), non-HDL-C, and triglyceride (TG).
Time frame: From Baseline to 3, 6, 9, and 12 months
Absolute Change in Other Lipids and Lipoproteins From Baseline
Other lipids and lipoproteins include total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), lipoprotein (a) (Lp \[a\]), serum apolipoproteins A1 (Apo A1), apolipoproteins B (Apo B), non-HDL-C, and triglyceride (TG).
Time frame: From Baseline to 3, 6, 9, and 12 months
Number of Patients by Demographic Category
Demographics include smoking history and alcohol history.
Time frame: Baseline
Number of Patients by Clinical Characteristic
Clinical characteristics include previous lipid-lowering drugs, type of diagnosis, family history of familial hypercholesterolemia, comorbidities, and statin intolerance.
Time frame: Baseline
LDL-C Measures of Variability - Standard Deviation
LDL-C variability from Baseline to 6 months, 9 months, and 12 months was assessed using two measures of variability: standard deviation and coefficients of variation.
Time frame: Baseline, Month 6, Month 9, Month 12
LDL-C Measures of Variability - Correlation of Variation
LDL-C variability from Baseline to 6 months, 9 months, and 12 months was assessed using two measures of variability: standard deviation and coefficients of variation.
Time frame: Baseline, Month 6, Month 9, Month 12
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