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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inclisiran Cohort | Chinese adult patients who received at least one treatment with inclisiran. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels | Baseline, Month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels | Baseline, Month 9 | |
| Change From Baseline to Month 9 in Total Cholesterol Levels | Baseline, Month 9 | |
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Inclusion criteria:
Exclusion criteria:
• Participated in any blinded interventional clinical studies anytime during the study period.
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This was a retrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Change From Baseline to Month 9 in Apolipoprotein B Levels |
| Baseline, Month 9 |
| Change From Baseline to Month 9 in non-High Density Lipoprotein Cholesterol Levels | Baseline, Month 9 |
| Change From Baseline to Month 9 in Serum Apolipoprotein A1 Levels | Baseline, Month 9 |
| Change From Baseline to Month 9 in High Density Lipoprotein Cholesterol Levels | Baseline, Month 9 |
| Change From Baseline to Month 9 in Lipoprotein (a) Levels | Baseline, Month 9 |
| Change From Baseline to Month 9 in Triglyceride Levels | Baseline, Month 9 |
| Number of Patients With at Least two Doses of Inclisiran After the First Injection of Inclisiran | 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 | Up to 27 months |
| Number of Patients With Changes in Lipid-lowering Therapies (LLTs) | Changes in LLTs included:
| 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. | 12 months |
| Number of Patients per Demographic Category | Demographic categories included:
| Baseline |
| Number of Patients per Clinical Characteristic Category | Clinical characteristics included:
| 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. | Baseline |
| D009750 |
| Nutritional and Metabolic Diseases |