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

A Prospective, Multicenter, Non-Interventional Observational Study to Investigate Changes in Blood Lipid Levels and Safety Following Administration of Litorvazet® Tablets in Patients With Dyslipidemia

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: Litorvazet Tablet 10/10mg; Drug: Litorvazet Tablet10/20mg; Drug: Litorvazet Tablet 10/40mg

Detailed Description

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 (Actual): 3000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

To estimate LDL-C changes at Week 24 in a dyslipidemia population on Ezetimibe/Atorvastatin, clinical trial data from participants with similar baseline conditions were used. The standard deviation (SD) of LDL-C changes ranged from 23.57 to 38.91 mg/dL in two studies, and a pooled SD was calculated.

With a 20% dropout rate, 3,000 participants (2,400 evaluable) were included. Assuming an SD of 33 mg/dL for LDL-C changes, a two-sided 95% confidence interval with a 1.32 mg/dL margin of error was generated. Including the dropout rate, a total of 3,000 participants were selected.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients With Dyslipidemia	Drug: Litorvazet Tablet 10/10mg; Ezetimibe 10 mg + Atorvastatin 10 mg; Drug: Litorvazet Tablet10/20mg; Ezetimibe 10 mg + Atorvastatin 20 mg; Drug: Litorvazet Tablet 10/40mg; Ezetimibe 10 mg + Atorvastatin 40 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LDL-C Levels Compared to Baseline	Change in LDL-C Levels at Week 24 Compared to Baseline	at Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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].	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].	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].	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].	at Week 24
Changes in HDL-C levels compared to baseline	Changes in HDL-C levels at Week 12 compared to baseline.	at Week 12
Percentage changes (%) in HDL-C levels compared to baseline	Percentage changes (%) in HDL-C levels at Week 12 compared to baseline.	at Week 12
Changes in HDL-C levels compared to baseline	Changes in HDL-C levels at Week 24 compared to baseline.	at Week 24
Percentage changes (%) in HDL-C levels compared to baseline	Percentage changes (%) in HDL-C levels at Week 24 compared to baseline.	at Week 24
Changes in Non-HDL-C levels compared to baseline	Changes in Non-HDL-C levels at Week 12 compared to baseline	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	at Week 12
Changes in Non-HDL-C levels compared to baseline	Changes in Non-HDL-C levels at Week 24 compared to baseline	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	at Week 24
Changes in TG levels compared to baseline	Changes in TG levels at Week 12 compared to baseline.	at Week 12
Percentage changes (%) in TG levels compared to baseline	Percentage changes (%) in TG levels at Week 12 compared to baseline.	at Week 12
Changes in TG levels compared to baseline	Changes in TG levels at Week 24 compared to baseline	at Week 24
Percentage changes (%) in TG levels compared to baseline	Percentage changes (%) in TG levels at Week 24 compared to baseline	at Week 24
Changes in TC levels compared to baseline	Changes in TC levels at Week 12 compared to baseline	at Week 12
Percentage changes (%) in TC levels compared to baseline	Percentage changes (%) in TC levels at Week 12 compared to baseline	at Week 12
Changes in TC levels compared to baseline	Changes in TC levels at Week 24 compared to baseline	at Week 24
Percentage changes (%) in TC levels compared to baseline	Percentage changes (%) in TC levels at Week 24 compared to baseline	at Week 24
Changes in ALT levels compared to baseline	Changes in ALT levels at Week 12 compared to baseline	at Week 12
Changes in AST levels compared to baseline	Changes in AST levels at Week 12 compared to baseline	at Week 12
Percentage changes (%) in ALT levels compared to baseline	Percentage changes (%) in ALT levels at Week 12 compared to baseline	at Week 12
Percentage changes (%) in AST levels compared to baseline	Percentage changes (%) in AST levels at Week 12 compared to baseline	at Week 12
Changes in ALT levels compared to baseline	Changes in ALT levels at Week 24 compared to baseline	at Week 24
Changes in AST levels compared to baseline	Changes in AST levels at Week 24 compared to baseline	at Week 24
Percentage changes (%) in ALT levels compared to baseline	Percentage changes (%) in ALT levels at Week 24 compared to baseline	at Week 24
Percentage changes (%) in AST levels compared to baseline	Percentage changes (%) in AST levels at Week 24 compared to baseline	at Week 24
Changes in systolic blood pressure compared to baseline	Changes in systolic blood pressure at Week 12 compared to baseline	at Week 12
Changes in diastolic blood pressure compared to baseline	Changes in diastolic blood pressure at Week 12 compared to baseline	at Week 12
Percentage changes (%) in systolic blood pressure compared to baseline	Percentage changes (%) in systolic blood pressure at Week 12 compared to baseline	at Week 12
Percentage changes (%) in diastolic blood pressure compared to baseline	Percentage changes (%) in diastolic blood pressure at Week 12 compared to baseline	at Week 12
Changes in systolic blood pressure compared to baseline	Changes in systolic blood pressure at Week 24 compared to baseline	at Week 24
Changes in diastolic blood pressure compared to baseline	Changes in diastolic blood pressure at Week 24 compared to baseline	at Week 24
Percentage changes (%) in systolic blood pressure compared to baseline	Percentage changes (%) in systolic blood pressure at Week 24 compared to baseline	at Week 24
Percentage changes (%) in diastolic blood pressure compared to baseline	Percentage changes (%) in diastolic blood pressure at Week 24 compared to baseline	at Week 24
Changes in HbA1c levels compared to baseline	Changes in HbA1c levels at Week 12 compared to baseline	at Week 12
Percentage changes (%) in HbA1c levels compared to baseline	Percentage changes (%) in HbA1c levels at Week 12 compared to baseline	at Week 12
Changes in HbA1c levels compared to baseline	Changes in HbA1c levels at Week 24 compared to baseline	at Week 24
Percentage changes (%) in HbA1c levels compared to baseline	Percentage changes (%) in HbA1c levels at Week 24 compared to baseline	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	at Week 24

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Sung-Mi Park, Dr., Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: DWLTV_OS_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No