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This study is a prospective, non-interventional, multi-center observational study to evaluate the efficacy and safety of Baroezet Tablet 1/10 mg in Korean patients with dyslipidemia in real-world clinical practice.
Patients who are prescribed Baroezet Tablet according to the physician's clinical judgment will be followed for approximately 24 weeks. The study will assess changes in lipid profiles, including LDL-C, as well as safety outcomes such as adverse events.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baroezet Treatment Group | Patients with dyslipidemia who are prescribed Baroezet Tablet 1/10 mg according to routine clinical practice will be observed for approximately 24 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in LDL-C from Baseline to Week 24 | Percent change in LDL-C levels from baseline to approximately 24 weeks after treatment initiation. | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in LDL-C at Week 12 | Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to approximately 12 weeks after treatment initiation. | Baseline to Week 12 |
| Percent Change in Total Cholesterol (TC) |
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Inclusion Criteria:
Exclusion Criteria:
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This study will enroll adult patients aged 19 years or older who are diagnosed with dyslipidemia in routine clinical practice in Korea. Eligible patients are those who require treatment with Baroezet Tablet 1/10 mg based on the physician's clinical judgment and provide written informed consent.
Patients will be recruited from multiple centers across Korea in a real-world setting. Treatment decisions, including initiation and continuation of Baroezet Tablet, will be made according to routine clinical practice. Patients with contraindications to the study drug, including hypersensitivity to its components, active liver disease, or pregnancy, will be excluded.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun Jeong Kong | Contact | 82-10-3206-5162 | yjkong246@daewoong.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple centers in Republic of Korea | Seoul | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Percent change in total cholesterol (TC) from baseline to approximately 12 weeks after treatment initiation.
| Baseline to Week 12 |
| Percent Change in Triglycerides (TG) | Percent change in triglyceride (TG) levels from baseline to approximately 12 weeks. | Baseline to Week 12 |
| Percent Change in Total Cholesterol (TC) | Percent change in total cholesterol (TC) from baseline to approximately 24 weeks after treatment initiation. | Baseline to Week 24 |
| Percent Change in Triglycerides (TG) | Percent change in triglyceride (TG) levels from baseline to approximately 24 weeks. | Baseline to Week 24 |