To Investigate Blood Lipid Changes and Safety After Litorvazet® Tablets in Dyslipidemia Patients

Daewoong Pharmaceutical Co. LTD.3,000 enrolled

Overview

This study aims to investigate the lipid-lowering effects and safety of administering Litorvazet tablets (ezetimibe/atorvastatin) over a 24-week period in patients with dyslipidemia scheduled to receive Litorvazet tablets in a real-world clinical setting.

In a real-world clinical setting, Litorvazet® tablets will be administered to patients based on the investigator's medical judgment in accordance with the approved prescribing information (indications, dosage, and administration, precautions for use, etc.). Participants for data collection in this study will be patients diagnosed with dyslipidemia as determined by the judgment of their attending physician. All treatments, including drug administration and clinical laboratory tests conducted after the administration of Litorvazet® tablets, will be carried out based solely on the investigator's (attending physician's) medical judgment and will not be influenced by the patient's participation in the study. Information relevant to this observational study will be collected for up to 24 weeks.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Dyslipidemia

Interventions

Litorvazet Tablet 10/10mgDRUG

Ezetimibe 10 mg + Atorvastatin 10 mg

Litorvazet Tablet10/20mgDRUG

Ezetimibe 10 mg + Atorvastatin 20 mg

Litorvazet Tablet 10/40mgDRUG

Ezetimibe 10 mg + Atorvastatin 40 mg

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female adults aged 19 years or older at the time of the screening visit. * Patients with dyslipidemia who are scheduled to receive Litorvazet® tablets based on the investigator's (treating physician's) medical judgment and in accordance with the approved indications. * Individuals who have voluntarily provided written consent to participate in this study. Exclusion Criteria: * Individuals who meet any contraindications for Litorvazet® tablets as specified in the product labeling: * Those with hypersensitivity to any components of this medication. * Patients with active liver disease or those with persistently elevated serum transaminase levels of unknown cause. * Patients with muscle disorders. * Pregnant women, women who may be pregnant, or breastfeeding mothers. * Women of childbearing potential who are not using appropriate contraceptive methods. * Patients receiving glecaprevir and pibrentasvir. * Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. * Individuals with a history of receiving Litorvazett® tablets prior to participating in this study. * Individuals deemed unsuitable for participation in this observational study by the investigator (treating physician) for reasons beyond those listed above.

Locations (1)

Korea University Anam Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Change in LDL-C Levels Compared to Baseline

Change in LDL-C Levels at Week 24 Compared to Baseline

Time frame: at Week 24

Secondary Outcomes

Changes in LDL-C levels compared to baseline [excluding primary endpoints].

Changes in LDL-C levels at Week 12 compared to baseline \[excluding primary endpoints\].

Time frame: at Week 12

Percentage changes (%) in LDL-C levels compared to baseline [excluding primary endpoints].

Percentage changes (%) in LDL-C levels at Week 12 compared to baseline \[excluding primary endpoints\].

Time frame: at Week 12

Changes in LDL-C levels compared to baseline [excluding primary endpoints].

Changes in LDL-C levels at Week 24 compared to baseline \[excluding primary endpoints\].

Time frame: at Week 24

Percentage changes (%) in LDL-C levels compared to baseline [excluding primary endpoints].

Percentage changes (%) in LDL-C levels at Week 24 compared to baseline \[excluding primary endpoints\].

Time frame: at Week 24

Changes in HDL-C levels compared to baseline

Changes in HDL-C levels at Week 12 compared to baseline.

Time frame: at Week 12

Percentage changes (%) in HDL-C levels compared to baseline

Percentage changes (%) in HDL-C levels at Week 12 compared to baseline.

Time frame: at Week 12

Data from ClinicalTrials.gov

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Changes in HDL-C levels compared to baseline

Changes in HDL-C levels at Week 24 compared to baseline.

Time frame: at Week 24

Percentage changes (%) in HDL-C levels compared to baseline

Percentage changes (%) in HDL-C levels at Week 24 compared to baseline.

Time frame: at Week 24

Changes in Non-HDL-C levels compared to baseline

Changes in Non-HDL-C levels at Week 12 compared to baseline

Time frame: at Week 12

Percentage changes (%) in Non-HDL-C levels compared to baseline

Percentage changes (%) in Non-HDL-C levels at Week 12 compared to baseline

Time frame: at Week 12

Changes in Non-HDL-C levels compared to baseline

Changes in Non-HDL-C levels at Week 24 compared to baseline

Time frame: at Week 24

Percentage changes (%) in Non-HDL-C levels compared to baseline

Percentage changes (%) in Non-HDL-C levels at Week 24 compared to baseline

Time frame: at Week 24

Changes in TG levels compared to baseline

Changes in TG levels at Week 12 compared to baseline.

Time frame: at Week 12

Percentage changes (%) in TG levels compared to baseline

Percentage changes (%) in TG levels at Week 12 compared to baseline.

Time frame: at Week 12

Changes in TG levels compared to baseline

Changes in TG levels at Week 24 compared to baseline

Time frame: at Week 24

Percentage changes (%) in TG levels compared to baseline

Percentage changes (%) in TG levels at Week 24 compared to baseline

Time frame: at Week 24

Changes in TC levels compared to baseline

Changes in TC levels at Week 12 compared to baseline

Time frame: at Week 12

Percentage changes (%) in TC levels compared to baseline

Percentage changes (%) in TC levels at Week 12 compared to baseline

Time frame: at Week 12

Changes in TC levels compared to baseline

Changes in TC levels at Week 24 compared to baseline

Time frame: at Week 24

Percentage changes (%) in TC levels compared to baseline

Percentage changes (%) in TC levels at Week 24 compared to baseline

Time frame: at Week 24

Changes in ALT levels compared to baseline

Changes in ALT levels at Week 12 compared to baseline

Time frame: at Week 12

Changes in AST levels compared to baseline

Changes in AST levels at Week 12 compared to baseline

Time frame: at Week 12

Percentage changes (%) in ALT levels compared to baseline

Percentage changes (%) in ALT levels at Week 12 compared to baseline

Time frame: at Week 12

Percentage changes (%) in AST levels compared to baseline

Percentage changes (%) in AST levels at Week 12 compared to baseline

Time frame: at Week 12

Changes in ALT levels compared to baseline

Changes in ALT levels at Week 24 compared to baseline

Time frame: at Week 24

Changes in AST levels compared to baseline

Changes in AST levels at Week 24 compared to baseline

Time frame: at Week 24

Percentage changes (%) in ALT levels compared to baseline

Percentage changes (%) in ALT levels at Week 24 compared to baseline

Time frame: at Week 24

Percentage changes (%) in AST levels compared to baseline

Percentage changes (%) in AST levels at Week 24 compared to baseline

Time frame: at Week 24

Changes in systolic blood pressure compared to baseline

Changes in systolic blood pressure at Week 12 compared to baseline

Time frame: at Week 12

Changes in diastolic blood pressure compared to baseline

Changes in diastolic blood pressure at Week 12 compared to baseline

Time frame: at Week 12

Percentage changes (%) in systolic blood pressure compared to baseline

Percentage changes (%) in systolic blood pressure at Week 12 compared to baseline

Time frame: at Week 12

Percentage changes (%) in diastolic blood pressure compared to baseline

Percentage changes (%) in diastolic blood pressure at Week 12 compared to baseline

Time frame: at Week 12

Changes in systolic blood pressure compared to baseline

Changes in systolic blood pressure at Week 24 compared to baseline

Time frame: at Week 24

Changes in diastolic blood pressure compared to baseline

Changes in diastolic blood pressure at Week 24 compared to baseline

Time frame: at Week 24

Percentage changes (%) in systolic blood pressure compared to baseline

Percentage changes (%) in systolic blood pressure at Week 24 compared to baseline

Time frame: at Week 24

Percentage changes (%) in diastolic blood pressure compared to baseline

Percentage changes (%) in diastolic blood pressure at Week 24 compared to baseline

Time frame: at Week 24

Changes in HbA1c levels compared to baseline

Changes in HbA1c levels at Week 12 compared to baseline

Time frame: at Week 12

Percentage changes (%) in HbA1c levels compared to baseline

Percentage changes (%) in HbA1c levels at Week 12 compared to baseline

Time frame: at Week 12

Changes in HbA1c levels compared to baseline

Changes in HbA1c levels at Week 24 compared to baseline

Time frame: at Week 24

Percentage changes (%) in HbA1c levels compared to baseline

Percentage changes (%) in HbA1c levels at Week 24 compared to baseline

Time frame: at Week 24

Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels

Changes in LDL-C levels at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels

Time frame: at Week 12

Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels

Goal attainment rates at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels

Time frame: at Week 12

Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels

Changes in LDL-C levels at Week 24 in patients who did not achieve their therapeutic targets based on baseline risk levels

Time frame: at Week 24

Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels

Goal attainment rates at Week 24 in patients who did not achieve their therapeutic targets based on baseline risk levels

Time frame: at Week 24

Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels

Changes in LDL-C levels at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels

Time frame: at Week 12

Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels

Goal maintenance rates at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels

Time frame: at Week 12

Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels

Changes in LDL-C levels at Week 24 in patients who achieved their therapeutic targets based on baseline risk levels

Time frame: at Week 24

Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels

Goal maintenance rates at Week 24 in patients who achieved their therapeutic targets based on baseline risk levels

Time frame: at Week 24

Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Changes in LDL-C levels at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Time frame: at Week 12

Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Goal maintenance rates at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Time frame: at Week 12

Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Changes in LDL-C levels at Week 24 in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Time frame: at Week 24

Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Goal maintenance rates at Week 24 in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Time frame: at Week 24

Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Changes in LDL-C levels at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Time frame: at Week 12

Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Goal attainment rates at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Time frame: at Week 12

Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Changes in LDL-C levels at Week 24 in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Time frame: at Week 24

Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Goal attainment rates at Week 24 in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment

Time frame: at Week 24