Efficacy and Safety of Pitavastatin/Ezetimibe in Dyslipidemia Patients With Metabolic Syndrome: An Observational Study

This is a multi-center, open-label, prospective observational study designed to collect real-world evidence on the efficacy and safety of Pitavastatin/Ezetimibe tablets (2/10 mg and 4/10 mg). The study population consists of adult patients with dyslipidemia who satisfy the criteria for metabolic syndrome.

Key study procedures and objectives include:

Treatment: Participants who are prescribed Pitavastatin/Ezetimibe tablets as part of their routine care will be enrolled. No experimental intervention or forced treatment allocation will be performed.

Efficacy Evaluation: The primary endpoint is the percentage change in LDL-C levels from baseline (Visit 1) to 24 weeks (Visit 2). Secondary endpoints include changes in other lipid parameters (Total Cholesterol, Triglycerides, HDL-C, non-HDL-C, Apo B) and the percentage of patients reaching their target LDL-C levels at 24 and 48 weeks.

Safety Evaluation: All adverse events (AEs) and serious adverse events (SAEs) will be recorded and analyzed to assess the safety profile of the study drug in this specific patient population.

Duration: Each participant will be observed for a total of 48 weeks, with visits occurring at baseline, 24 weeks, and 48 weeks.

The results of this study are expected to provide clinical insights into the long-term management of dyslipidemia in patients with multiple metabolic risk factors using a pitavastatin/ezetimibe combination.

Inclusion criteria

• Age 19 years old at the time of written informed consent
• Subjects diagnosed with dyslipidemia and metabolic syndrome
• Subjects who had no treatment history with lipid regulators within 4 weeks prior to Visit1 or who had insufficient therapeutic effects from 8 weeks of treatment with lipid regulators using the same dosage and administration
• Subjects who meet the following LDL-C levels according to the classification of cardiovascular disease risk groups* at Visit 1 or who are planned to be treated with Pitavastatin/Ezetimibe Tablets based on the judgment of the investigator
• Subjects who voluntarily sign the informed consent form for study participation

Exclusion criteria

• Individuals for whom Pitavastatin/Ezetimibe Tablets is contraindicated as specified in the label's Precautions for Use
• Individuals who were treated with other investigational products (IP) or investigational devices within 4 weeks prior to participation in the present study or who are expected to have such treatment during the present study
• Individuals who are considered to have difficulty participating in the study for other reasons based on the judgment of the investigator