Dyslipidemias, Hypercholesterolemia
Conditions
Brief summary
The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.
Interventions
None listed
Sponsors
Ahn-Gook Pharmaceuticals Co.,Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 19 years or older * Patients diagnosed with hypercholesterolemia who have been stably treated with atorvastatin or rosuvastatin monotherapy for at least 3 months, and for whom switching to fixed-dose combination pitavastatin/ezetimibe has been clinically decided * Patients with available clinical laboratory test results related to efficacy and safety (TC, TG, HDL-C, LDL-C, AST, ALT, Cr/eGFR) within 12 months prior to switching to fixed-dose combination pitavastatin/ezetimibe (no changes in statin regimen or dosage during that period) * Individuals (or their legally authorized representatives) who voluntarily provide written informed consent to participate in the study
Exclusion criteria
* Known hypersensitivity or history of hypersensitivity to any component of the investigational product * Patients with active liver disease or persistent, unexplained elevations of aminotransferase levels * Patients with severe hepatic impairment, biliary obstruction, or cholestasis * Patients currently receiving cyclosporine treatment * Patients diagnosed with myopathy * Pregnant or breastfeeding women, or women who may be pregnant * Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption * Any patient who, in the opinion of the investigator, is deemed unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of reaching the target LDL-C level | 12 months after administration |
Countries
South Korea
Contacts
Primary ContactHyunji Kim
Outcome results
None listed