Dyslipidemia
Conditions
Interventions
None listed
Sponsors
Koga Jun-ichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Outpatient patients or patients hospitalized at the Second Department of Internal Medicine, University of Occupational and Environmental Health, Japan, where the extended-release pemafibrate for dyslipidemia is prescribed (including switching from other medications). Patients without a prescription of pemafibrate are enrolled as controls.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study: - Patients who have not consented to participate in the study - Patients with a history of hypersensitivity to any component of the study drug - Patients with severe liver dysfunction, Child-Pugh class B or C liver cirrhosis, or biliary obstruction - Patients with cholecystolithiasis - Pregnant women or women who may be pregnant - Patients currently receiving cyclosporine or rifampicin - Other patients deemed inappropriate for participation by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in inflammatory markers from baseline at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in leukocyte count and differential count of leukocytes from baseline at 12 and 24 weeks Change in liver and kidney function from baseline at 12 and 24 weeks Change in serum lipids from baseline at 12 and 24 weeks Change in other blood test parameters from baseline at 12 and 24 weeks Change in oxidative stress markers from baseline at 24 weeks Occurrence of cardiovascular events through the study period | — |
Contacts
Public ContactJun-ichiro Koga
University of Occupational and Environmental Health, Japan
Outcome results
None listed