Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inclisiran Cohort | Adult patients who first received inclisiran between 01 October 2023 and 30 June 2024. | ||
| PCSK9 mAbs Cohort | Adult patients who first received PCSK9 mAbs between 01 October 2023 and 30 June 2024. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline | From Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in LDL-C From Baseline | From Baseline to 3, 9, and 12 months | |
| Absolute Change in LDL-C From Baseline | From Baseline to 3, 6, 9, and 12 months | |
Not provided
Inclusion criteria:
• First received inclisiran or any PCSK9 mAbs during the indexing period.
Exclusion criteria:
Not provided
Not provided
Not provided
Chinese adults with hypercholesterolemia or mixed dyslipidemia who used either inclisiran or PCSK9 mAb for the first time between October 1, 2023 and June 30, 2024, and whose EHRs were in one of three regional EHR databases.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
Not provided
| Label | URL |
|---|---|
| Link to study results | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Proportion of Days Covered (PDC) |
PDC: (number of days covered by medication over 12 months/365 days) x 100% |
| 12 months |
| Proportion of Patients who Remained (Persistence) on Medication | 12 months |
| Number of Inclisiran Injections | 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). | 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). | From Baseline to 3, 6, 9, and 12 months |
| Number of Patients by Demographic Category | Demographics include smoking history and alcohol history. | 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. | 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. | 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. | Baseline, Month 6, Month 9, Month 12 |
| D009750 |
| Nutritional and Metabolic Diseases |