Hypercholesterolemia, Mixed Dyslipidemia
Conditions
Keywords
Inclisiran, PCSK9 mAb, Low density lipoprotein cholesterol, Adherence, Real-world, Meta-analysis
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• First received inclisiran or any PCSK9 mAbs during the indexing period.
Exclusion criteria
* Participated in any interventional or observational study of inclisiran or PCSK9 mAbs anytime during the study period. * In the inclisiran cohort, the first inclisiran injection was during the index period, and patients were treated with PCSK9 mAbs within 3 months prior to first inclisiran.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline | From Baseline to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Proportion of Days Covered (PDC) | 12 months | PDC: (number of days covered by medication over 12 months/365 days) x 100% |
| 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 | From Baseline to 3, 6, 9, and 12 months | 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). |
| Absolute Change in Other Lipids and Lipoproteins From Baseline | From Baseline to 3, 6, 9, and 12 months | 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). |
| Number of Patients by Demographic Category | Baseline | Demographics include smoking history and alcohol history. |
| Number of Patients by Clinical Characteristic | Baseline | Clinical characteristics include previous lipid-lowering drugs, type of diagnosis, family history of familial hypercholesterolemia, comorbidities, and statin intolerance. |
| LDL-C Measures of Variability - Standard Deviation | Baseline, Month 6, Month 9, Month 12 | 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. |
| LDL-C Measures of Variability - Correlation of Variation | Baseline, Month 6, Month 9, Month 12 | 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. |
Countries
United States
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed