Study on Long-Term Use and Adherence to Inclisiran, Evolocumab, and Alirocumab for Cardiovascular Diseases in Italy

What this Trial Is About

Researchers are evaluating long-term adherence and persistence to the cholesterol-lowering treatments inclisiran and anti-PCSK9 monoclonal antibodies mAbs including evolocumab and alirocumab in real-world clinical settings. The study focuses on patients with cardiovascular diseases such as atherosclerotic cardiovascular disease and familial hypercholesterolemia. It aims to understand how well patients continue and follow these treatments over time in routine care. Participants are grouped based on the treatment they receive inclisiran injections, evolocumab injections, alirocumab injections, or a combined group receiving either evolocumab or alirocumab. The study tracks treatment use and persistence from the first prescription during the identification period and follows patients for up to 48 months. Data are collected continuously at 3-month intervals after an initial 6-month period. Throughout the study, researchers collect information on medication adherence, persistence, baseline demographics, clinical characteristics, comorbidities, and the timing and number of treatment doses. Assessments occur every 3 months up to 4 years to monitor ongoing use and patterns of these lipid-lowering therapies. This observational study does not involve experimental treatments but observes patient medication use and outcomes in regular clinical practice.

A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab