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

Daewoong Pharmaceutical

Status

Completed

Conditions

Dyslipidemia

Treatments

Drug: Litorvazet Tablet 10/10mg

Drug: Litorvazet Tablet10/20mg

Drug: Litorvazet Tablet 10/40mg

Study type

Observational

Funder types

Industry

Identifiers

NCT06866509

DWLTV_OS_01

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,000 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.