Observational Study of Leqvio Pre-filled Syringe Inclisiran Sodium for Adults with Primary Hypercholesterolemia or Mixed Dyslipidemia

What this Trial Is About

Researchers are observing adults with primary hypercholesterolemia or mixed dyslipidemia who are prescribed Leqvio Pre-filled Syringe inclisiran sodium to assess its safety and effectiveness in routine clinical practice. This is a non-interventional post-marketing surveillance study required by Korean health authorities to monitor patients already receiving this treatment. Participants are adults 18 years or older who have been prescribed Leqvio according to approved guidelines, including those who have not reached LDL-C targets with statins or cannot tolerate statins. There is no treatment allocation or placebo the study enrolls patients who have already started Leqvio treatment. The study will track patients over a period of up to 15 months. Throughout the study, researchers will monitor adverse events and adverse drug reactions and measure changes in LDL cholesterol levels and lipid profiles at baseline, 3, 9, and 15 months. The study will also analyze how patients baseline characteristics and medication use affect outcomes. Participants will provide informed consent, and their safety and treatment responses will be regularly assessed during routine clinical visits.

Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)