Efficacy and Safety of Baroezet Tablet in Korean Patients With Dyslipidemia: A Prospective Observational Study

This study is a prospective, non-interventional, multi-center observational study conducted in Korea to evaluate the efficacy and safety of Baroezet Tablet 1/10 mg (Pitavastatin calcium/Ezetimibe) in patients with dyslipidemia in routine clinical practice.

Eligible patients aged 19 years or older who require treatment with Baroezet Tablet will be enrolled after providing written informed consent. Treatment decisions, including dosage and duration, will be made at the discretion of the treating physician in accordance with approved labeling.

Data will be collected at baseline, approximately 12 weeks, and 24 weeks, based on routine clinical visits. The primary efficacy endpoint is the percent change in LDL-C from baseline to 24 weeks. Secondary endpoints include changes in lipid parameters (TC, TG, HDL-C, non-HDL-C), HbA1c, and achievement of LDL-C targets according to risk categories.

Safety will be assessed by monitoring adverse events and laboratory abnormalities, including liver enzymes and creatine kinase levels.

Approximately 15,000 patients will be enrolled across multiple centers in Korea.

Inclusion criteria

• Adults aged ≥19 years
• Patients diagnosed with dyslipidemia
• Patients who require treatment with Baroezet Tablet
• Patients who provide written informed consent

Exclusion criteria

• Hypersensitivity to study drug components
• Active liver disease
• Pregnant or breastfeeding women
• Patients considered inappropriate by investigator