Dyslipidemia
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGLitorvazet Tablet 10/10mg
Ezetimibe 10 mg + Atorvastatin 10 mg
DRUGLitorvazet Tablet10/20mg
Ezetimibe 10 mg + Atorvastatin 20 mg
DRUGLitorvazet Tablet 10/40mg
Ezetimibe 10 mg + Atorvastatin 40 mg
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in LDL-C Levels Compared to Baseline | at Week 24 | Change in LDL-C Levels at Week 24 Compared to Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage changes (%) in LDL-C levels compared to baseline [excluding primary endpoints]. | at Week 12 | Percentage changes (%) in LDL-C levels at Week 12 compared to baseline \[excluding primary endpoints\]. |
| Changes in HDL-C levels compared to baseline | at Week 12 | Changes in HDL-C levels at Week 12 compared to baseline. |
| Percentage changes (%) in HDL-C levels compared to baseline | at Week 12 | Percentage changes (%) in HDL-C levels at Week 12 compared to baseline. |
| Changes in Non-HDL-C levels compared to baseline | at Week 12 | Changes in Non-HDL-C levels at Week 12 compared to baseline |
| Percentage changes (%) in Non-HDL-C levels compared to baseline | at Week 12 | Percentage changes (%) in Non-HDL-C levels at Week 12 compared to baseline |
| Changes in TG levels compared to baseline | at Week 12 | Changes in TG levels at Week 12 compared to baseline. |
| Percentage changes (%) in TG levels compared to baseline | at Week 12 | Percentage changes (%) in TG levels at Week 12 compared to baseline. |
| Changes in TC levels compared to baseline | at Week 12 | Changes in TC levels at Week 12 compared to baseline |
| Percentage changes (%) in TC levels compared to baseline | at Week 12 | Percentage changes (%) in TC levels at Week 12 compared to baseline |
| Changes in ALT levels compared to baseline | at Week 12 | Changes in ALT levels at Week 12 compared to baseline |
| Changes in AST levels compared to baseline | at Week 12 | Changes in AST levels at Week 12 compared to baseline |
| Percentage changes (%) in ALT levels compared to baseline | at Week 12 | Percentage changes (%) in ALT levels at Week 12 compared to baseline |
| Percentage changes (%) in AST levels compared to baseline | at Week 12 | Percentage changes (%) in AST levels at Week 12 compared to baseline |
| Changes in LDL-C levels compared to baseline [excluding primary endpoints]. | at Week 12 | Changes in LDL-C levels at Week 12 compared to baseline \[excluding primary endpoints\]. |
| Changes in diastolic blood pressure compared to baseline | at Week 12 | Changes in diastolic blood pressure at Week 12 compared to baseline |
| Percentage changes (%) in systolic blood pressure compared to baseline | at Week 12 | Percentage changes (%) in systolic blood pressure at Week 12 compared to baseline |
| Percentage changes (%) in diastolic blood pressure compared to baseline | at Week 12 | Percentage changes (%) in diastolic blood pressure at Week 12 compared to baseline |
| Changes in HbA1c levels compared to baseline | at Week 12 | Changes in HbA1c levels at Week 12 compared to baseline |
| Percentage changes (%) in HbA1c levels compared to baseline | at Week 12 | Percentage changes (%) in HbA1c levels at Week 12 compared to baseline |
| Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels | at Week 12 | Changes in LDL-C levels at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels |
| Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels | at Week 12 | Goal attainment rates at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels |
| Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels | at Week 12 | Changes in LDL-C levels at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels |
| Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels | at Week 12 | Goal maintenance rates at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels |
| Changes in LDL-C levels 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 at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment |
| Goal maintenance rates 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 at Week 12 in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment |
| 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 | at Week 12 | 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 |
| Goal attainment rates 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 at Week 12 in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment |
| Changes in systolic blood pressure compared to baseline | at Week 12 | Changes in systolic blood pressure at Week 12 compared to baseline |
Countries
South Korea
Outcome results
None listed