Evaluation of Dyslipidemia Management After Statin and Ezetimibe Complex Treatment

Real World Data Observational Study to Evaluate the Management Status of Dyslipidemia Following Administration of Statin and Ezetimibe Complex Treatment Patient in the Medical Situation by Classification of Medical Institutions in KOREA

This study is a large-scale, prospective, multi-site, and non-interventional observational study to observe the change and safety of dyslipidemia management status when administering statin+etimib complex drugs in patients with dyslipidemia.

Study Overview

• Status: Active, not recruiting
• Conditions: Dyslipidemias
• Intervention / Treatment: Drug: Statin+Ezetimibe compound

Detailed Description

All treatments, including drug administration and laboratory tests performed after administration of statin+etimib complex, are performed by the researcher's medical judgment regardless of the subject's participation in the study, and the information to be confirmed in this observational study is collected up to 24 weeks.

Data collection will begin after the date of signing the research contract, and the follow-up period for each study subject is from the registration date (Visit 1) to the 24th week (Visit 3).

To evaluate subjects' clinical performance in real world, we collect demographic information and medical treatment based on patient's medical records, previous dyslipidemia drug administration information, blood lipid tests and liver function tests conducted at the start date of statin+etimib compound administration and subsequent 24 weeks (± 8 weeks). In the case of safety-related information, such as abnormal cases, data shall be collected at any time during the 24-week follow-up period if there is a visit by the study subject according to daily treatment.

• Study Type: Observational
• Enrollment (Estimated): 18000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

In order to assume the amount of LDL-C change at 24 weeks compared to the base value, the clinical trial results of the test subjects with similar underlying diseases that can be currently referred to were used.

Description

Inclusion Criteria:

1. Adult men and women aged 19 or older as of the time of the registered visit (Visit 1)
2. Patients with dyslipidemia who are planning to administer statin+ezetimib complex or who are administering dyslipidemia complex according to the researcher's medical judgment based on the permission of statin+ezetimib complex
3. A person who can understand the information provided to him or her and voluntarily sign a written consent form

Exclusion Criteria:

1. Patients who overreact to the main ingredients or components of the drug in the study
2. Patients with active liver disease or patients with continuously high serum aminotransferase levels with unknown cause
3. Patients with muscle disease.
4. Pregnant women or pregnant women and nursing mothers
5. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion
6. A person who is not permitted by administration of statin+etimib complex or who falls under prohibition of administration
7. In addition to the above, a person who has determined that the researcher is not suitable for participation in this observation study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment group; statin+ezetimibe compound	Drug: Statin+Ezetimibe compound; Crezet Tablet, Litorvazet Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate and amount of change in LDL-C (measured LDL-C and calculated LDL-C)	Rate and amount of change in LDL-C (measured LDL-C and calculated LDL-C) at 24 weeks compared to baseline	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-C change rate and amount	LDL-C change rate and amount at 12 weeks compared to baseline	12 weeks
Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC)	Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC) at 12 weeks compared to baseline	12 weeks
Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC)	Rate and amount of change in lipid variables (Non-HDL-C, HDL-C, TG, TC) at 24 weeks compared to baseline	24 weeks
Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate)	Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate) at 12 weeks compared to baseline	12 weeks
Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate)	Changes in ALT (Alanine Transaminase), AST (Aspartate Transaminase), and e-GFR (Estimated Glomerular Filtration Rate) at 24 weeks compared to baseline	24 weeks

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: JinWon Kim, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Ezetimibe
• Other Study ID Numbers: DWLC_RWE02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not Yet decided

Drug and device information, study documents

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