Study to Assess the Real World Effectiveness of Inclisiran in Chinese Adult Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Prior treatment

• Treatment with monoclonal antibodies directed towards PCSK9 within 90 days before first visit (V1)
• Participation in any cardiovascular clinical trial, concurrent or within the last 30 days of the baseline
• Treatment with monoclonal antibodies directed towards PCSK9 during research period

Other illness

• Severe hepatic impairment (Child-Pugh class C)
• Hypersensitivity to the active substance or to any of the excipients of inclisiran solution
  • SoC Historical Cohort Patients meeting any of the following criteria are not eligible for inclusion in this study.
• Severe hepatic impairment (Child-Pugh class C)

Lab values

• Severe renal impairment (eGFR ≤ 30 mL/min), and/or on hemodialysis
• Severe renal impairment, (eGFR ≤ 30 mL/min), and/or on hemodialysis

Other

• Inclisiran Cohort Patients meeting any of the following criteria are not eligible for inclusion in this study.
• Females who are pregnant or nursing, or who are preparing for pregnancy
• Participation in any cardiovascular clinical trial during research period
• Females who are pregnant or nursing during research period

• Inclisiran Cohort Patients eligible for inclusion in this study must meet all of the following criteria.
• Confirmed diagnosis of primary hypercholesterolemia or mixed dyslipidemia
• Age ≥ 18 years at baseline
• Initiated treatment with inclisiran according to the decision of both physician and patient
• Signed informed consent(s) must be obtained prior to participation in the study
  • SoC Historical Cohort Patients eligible for inclusion in this study must meet all of the following criteria.
• Confirmed diagnosis of primary hypercholesterolemia or mixed dyslipidemia, with which reference to LDL-C \> 70 mg/dL (1.8 mmol/L)
• Age ≥ 18 years
• Compliance with the standard lipid-lowering therapy, which is defined as a change from prior lipid-lowering therapy to an optimal lipid-lowering regimen, with the date of compliance with standard lipid-lowering therapy after January 1, 2017 as the index date
• With available LDL-C test at baseline, which is defined as the closest LDL-C test to the index date within 6 months prior to the index date
• With available LDL-C test on D90 (90±60 days) or D330 (330±90 days) after the index date