Primary Hypercholesterolemia or Mixed Dyslipidemia
Investigational drug(s) / intervention(s)
Inclisiran
Inclisiran: There is no treatment allocation. Patients administered Leqvio by prescription that have started before inclusion of the patient into the study will be enrolled.
Study summary
This non-interventional study is a mandatory regular Post Marketing Surveillance(rPMS) granted by the Korean health authorities, and is conducted to assess the effectiveness and safety of Leqvio® Pre-filled Syringe(inclisiran sodium) in routine clinical practice for the approved indications (primary hypercholesterolemia or mixed dyslipidemia).
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria:
If a subject meets all of the following criteria, he/she can participate in this study:
1. Adult patients(18 years or older) who have hypercholesterolemia or mixed dyslipidemia and are prescribed Leqvio® Pre-filled Syringe(inclisiran sodium) according to domestically approved product information in real clinical practice
2. Patients who are unable to reach LDL-C target with maximum tolerated dose of statin, or patients with statin intolerance
3. Patients who provided consent to participate in the study(informed consent form)
Exclusion Criteria:
A subjects who meets any of the following criteria cannot participate in this study:
1. Contraindications in accordance with domestic prescribing information
2. Patients participating in clinical trials of other investigational drugs
3. Patients who do not provide consent to participate in the study
Primary outcome measure(s)
Incidences of adverse events/adverse drug reactions (AEs/ADRs) — up to 15 months Cumulative incidences of AEs, ADRs, SAEs, Serious ADR(SADRs), Unexpected AEs, and Unexpected ADRs due to Leqvio® Pre-filled Syringe(inclisiran sodium) during the observation period \["The term "unexpected" means that it is not listed in the domestic labeling(according to health authority regulations)\]
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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