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The objective of this study is to evaluate LDL-C reduction over time among individuals initiating alirocumab 150 mg compared with inclisiran in routine clinical practice. The study will leverage observational data reflective of routine care and apply contemporary methods in target trial emulation and causal inference to estimate comparative treatment effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alirocumab 150 mg | Participants initiating alirocumab 150 mg were included. |
| |
| Inclisiran | Participants receiving Inclisiran were included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alirocumab 150 mg | Drug | The study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage Reduction in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline Over the 60 to 450 Days Follow-up | From baseline through 60 to 450 days of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Number of Days With Low-Density Lipoprotein Cholesterol (LDL-C) Less Than 70 mg/dL (1.8 mmol/L) | Total number of days during which a participant's LDL-C level will remain below 70 mg/dL (1.8 mmol/L) will be reported. | From baseline through 60 to 450 days of follow-up |
| Variation in Low-Density Lipoprotein Cholesterol (LDL-C) levels Observed Within the Same Participant |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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Adults (>= 18 years) initiating alirocumab 150 mg or inclisiran among adults eligible for proprotein convertase subtilisin/kexin type 9 (PCSK9) -targeting therapy in routine practice: from January 2016 to July 2024.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi | Bridgewater | New Jersey | 08807 | United States |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| Inclisiran | Drug | The study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice. |
|
Within-participant variability in low-density lipoprotein cholesterol (LDL-C) levels will be summarized using the mid-95% range. |
| From baseline through 60 to 450 days of follow-up |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C571059 | alirocumab |
| C585830 | ALN-PCS |
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