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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients With Dyslipidemia | Patients With Dyslipidemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Litorvazet Tablet 10/10mg | Drug | Ezetimibe 10 mg + Atorvastatin 10 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL-C Levels Compared to Baseline | Change in LDL-C Levels at Week 24 Compared to Baseline | at Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in LDL-C levels compared to baseline [excluding primary endpoints]. | Changes in LDL-C levels at Week 12 compared to baseline [excluding primary endpoints]. | at Week 12 |
| Percentage changes (%) in LDL-C levels compared to baseline [excluding primary endpoints]. |
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Inclusion Criteria:
Exclusion Criteria:
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To estimate LDL-C changes at Week 24 in a dyslipidemia population on Ezetimibe/Atorvastatin, clinical trial data from participants with similar baseline conditions were used. The standard deviation (SD) of LDL-C changes ranged from 23.57 to 38.91 mg/dL in two studies, and a pooled SD was calculated.
With a 20% dropout rate, 3,000 participants (2,400 evaluable) were included. Assuming an SD of 33 mg/dL for LDL-C changes, a two-sided 95% confidence interval with a 1.32 mg/dL margin of error was generated. Including the dropout rate, a total of 3,000 participants were selected.
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| Name | Affiliation | Role |
|---|---|---|
| Sung-Mi Park, Dr. | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | 02841 | 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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| Litorvazet Tablet10/20mg |
| Drug |
Ezetimibe 10 mg + Atorvastatin 20 mg |
|
| Litorvazet Tablet 10/40mg | Drug | Ezetimibe 10 mg + Atorvastatin 40 mg |
|
Percentage changes (%) in LDL-C levels at Week 12 compared to baseline [excluding primary endpoints]. |
| at Week 12 |
| Changes in LDL-C levels compared to baseline [excluding primary endpoints]. | Changes in LDL-C levels at Week 24 compared to baseline [excluding primary endpoints]. | at Week 24 |
| Percentage changes (%) in LDL-C levels compared to baseline [excluding primary endpoints]. | Percentage changes (%) in LDL-C levels at Week 24 compared to baseline [excluding primary endpoints]. | at Week 24 |
| Changes in HDL-C levels compared to baseline | Changes in HDL-C levels at Week 12 compared to baseline. | at Week 12 |
| Percentage changes (%) in HDL-C levels compared to baseline | Percentage changes (%) in HDL-C levels at Week 12 compared to baseline. | at Week 12 |
| Changes in HDL-C levels compared to baseline | Changes in HDL-C levels at Week 24 compared to baseline. | at Week 24 |
| Percentage changes (%) in HDL-C levels compared to baseline | Percentage changes (%) in HDL-C levels at Week 24 compared to baseline. | at Week 24 |
| Changes in Non-HDL-C levels compared to baseline | Changes in Non-HDL-C levels at Week 12 compared to baseline | at Week 12 |
| Percentage changes (%) in Non-HDL-C levels compared to baseline | Percentage changes (%) in Non-HDL-C levels at Week 12 compared to baseline | at Week 12 |
| Changes in Non-HDL-C levels compared to baseline | Changes in Non-HDL-C levels at Week 24 compared to baseline | at Week 24 |
| Percentage changes (%) in Non-HDL-C levels compared to baseline | Percentage changes (%) in Non-HDL-C levels at Week 24 compared to baseline | at Week 24 |
| Changes in TG levels compared to baseline | Changes in TG levels at Week 12 compared to baseline. | at Week 12 |
| Percentage changes (%) in TG levels compared to baseline | Percentage changes (%) in TG levels at Week 12 compared to baseline. | at Week 12 |
| Changes in TG levels compared to baseline | Changes in TG levels at Week 24 compared to baseline | at Week 24 |
| Percentage changes (%) in TG levels compared to baseline | Percentage changes (%) in TG levels at Week 24 compared to baseline | at Week 24 |
| Changes in TC levels compared to baseline | Changes in TC levels at Week 12 compared to baseline | at Week 12 |
| Percentage changes (%) in TC levels compared to baseline | Percentage changes (%) in TC levels at Week 12 compared to baseline | at Week 12 |
| Changes in TC levels compared to baseline | Changes in TC levels at Week 24 compared to baseline | at Week 24 |
| Percentage changes (%) in TC levels compared to baseline | Percentage changes (%) in TC levels at Week 24 compared to baseline | at Week 24 |
| Changes in ALT levels compared to baseline | Changes in ALT levels at Week 12 compared to baseline | at Week 12 |
| Changes in AST levels compared to baseline | Changes in AST levels at Week 12 compared to baseline | at Week 12 |
| Percentage changes (%) in ALT levels compared to baseline | Percentage changes (%) in ALT levels at Week 12 compared to baseline | at Week 12 |
| Percentage changes (%) in AST levels compared to baseline | Percentage changes (%) in AST levels at Week 12 compared to baseline | at Week 12 |
| Changes in ALT levels compared to baseline | Changes in ALT levels at Week 24 compared to baseline | at Week 24 |
| Changes in AST levels compared to baseline | Changes in AST levels at Week 24 compared to baseline | at Week 24 |
| Percentage changes (%) in ALT levels compared to baseline | Percentage changes (%) in ALT levels at Week 24 compared to baseline | at Week 24 |
| Percentage changes (%) in AST levels compared to baseline | Percentage changes (%) in AST levels at Week 24 compared to baseline | at Week 24 |
| Changes in systolic blood pressure compared to baseline | Changes in systolic blood pressure at Week 12 compared to baseline | at Week 12 |
| Changes in diastolic blood pressure compared to baseline | Changes in diastolic blood pressure at Week 12 compared to baseline | at Week 12 |
| Percentage changes (%) in systolic blood pressure compared to baseline | Percentage changes (%) in systolic blood pressure at Week 12 compared to baseline | at Week 12 |
| Percentage changes (%) in diastolic blood pressure compared to baseline | Percentage changes (%) in diastolic blood pressure at Week 12 compared to baseline | at Week 12 |
| Changes in systolic blood pressure compared to baseline | Changes in systolic blood pressure at Week 24 compared to baseline | at Week 24 |
| Changes in diastolic blood pressure compared to baseline | Changes in diastolic blood pressure at Week 24 compared to baseline | at Week 24 |
| Percentage changes (%) in systolic blood pressure compared to baseline | Percentage changes (%) in systolic blood pressure at Week 24 compared to baseline | at Week 24 |
| Percentage changes (%) in diastolic blood pressure compared to baseline | Percentage changes (%) in diastolic blood pressure at Week 24 compared to baseline | at Week 24 |
| Changes in HbA1c levels compared to baseline | Changes in HbA1c levels at Week 12 compared to baseline | at Week 12 |
| Percentage changes (%) in HbA1c levels compared to baseline | Percentage changes (%) in HbA1c levels at Week 12 compared to baseline | at Week 12 |
| Changes in HbA1c levels compared to baseline | Changes in HbA1c levels at Week 24 compared to baseline | at Week 24 |
| Percentage changes (%) in HbA1c levels compared to baseline | Percentage changes (%) in HbA1c levels at Week 24 compared to baseline | at Week 24 |
| Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels | Changes in LDL-C levels at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels | at Week 12 |
| Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels | Goal attainment rates at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels | at Week 12 |
| Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels | Changes in LDL-C levels at Week 24 in patients who did not achieve their therapeutic targets based on baseline risk levels | at Week 24 |
| Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels | Goal attainment rates at Week 24 in patients who did not achieve their therapeutic targets based on baseline risk levels | at Week 24 |
| Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels | Changes in LDL-C levels at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels | at Week 12 |
| Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels | Goal maintenance rates at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels | at Week 12 |
| Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels | Changes in LDL-C levels at Week 24 in patients who achieved their therapeutic targets based on baseline risk levels | at Week 24 |
| Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels | Goal maintenance rates at Week 24 in patients who achieved their therapeutic targets based on baseline risk levels | at Week 24 |
| Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | Changes in LDL-C levels at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | at Week 12 |
| Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | Goal maintenance rates at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | at Week 12 |
| Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | Changes in LDL-C levels at Week 24 in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | at Week 24 |
| Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | Goal maintenance rates at Week 24 in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | at Week 24 |
| Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | Changes in LDL-C levels at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | at Week 12 |
| Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | Goal attainment rates at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | at Week 12 |
| Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | Changes in LDL-C levels at Week 24 in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | at Week 24 |
| Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | Goal attainment rates at Week 24 in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment | at Week 24 |