Retrospective observational study evaluating the efficacy and safety of pemafibrate extended-release formulation in patients with dyslipidemia

Retrospective observational study evaluating the efficacy and safety of pemafibrate extended-release formulation in patients with dyslipidemia - PEMA-XR Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061542

Enrollment

100

Registered

2026-06-01

Start date

2025-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Outpatients with dyslipidemia treated at our institution Patients who initiated or switched to pemafibrate extended-release formulation Patients with available follow-up data for at least 12 months

Exclusion criteria

Exclusion criteria: Patients referred to another hospital during the follow-up period Patients who discontinued or self-discontinued pemafibrate extended-release formulation Patients who underwent surgery, chemotherapy, radiotherapy, or immunotherapy for malignancy during the study period Patients with primary lipid disorders Patients with insufficient data required for analysis

Design outcomes

Primary

Measure	Time frame
Changes in serum triglyceride levels at 6 and 12 months after initiation of pemafibrate extended-release formulation	—

Secondary

Measure	Time frame
Changes in HDL-C, LDL-C, AST, ALT, GGT, ALP, HbA1c, eGFR, uric acid, FIB-4 index, BMI, body composition parameters, attenuation imaging (ATI), shear wave elastography (SWE), and incidence of adverse events	—

Countries

Japan

Contacts

Public ContactSaori Inoue

Meitetsu Hospital Department of Endocrinology and Metabolism

saori7174914@gmail.com0570023100

Outcome results