Low-Density Lipoprotein Cholesterol Reduction With Alirocumab 150 mg Versus Inclisiran in Individuals Initiating Therapy in Routine Clinical Practice

Sanofi996 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

996

Conditions

Atherosclerotic Cardiovascular Disease

Interventions

Alirocumab 150 mgDRUG

The study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

InclisiranDRUG

The study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants initiating alirocumab 150 mg or inclisiran. * Participants with at least once LDL-C measurement during 365 days before index. * Participants who continuously enrolled in medical and pharmacy benefits for at least 365 days pre index. Exclusion Criteria: * Participants with unknown sex, geographic region, or insurance type, and age \< 18 years at index. * Participants with exposure to evolocumab before index. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Locations (1)

Sanofi

Bridgewater, New Jersey, United States

Outcomes

Primary Outcomes

Mean Percentage Reduction in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline Over the 60 to 450 Days Follow-up

Time frame: From baseline through 60 to 450 days of follow-up

Secondary Outcomes

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.

Time frame: From baseline through 60 to 450 days of follow-up

Variation in Low-Density Lipoprotein Cholesterol (LDL-C) levels Observed Within the Same Participant

Within-participant variability in low-density lipoprotein cholesterol (LDL-C) levels will be summarized using the mid-95% range.

Time frame: From baseline through 60 to 450 days of follow-up

Data from ClinicalTrials.gov

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