Effect and safety of pemafibrate for patients with type 2 diabetes mellitus and hypertriglyceridemia: a retrospective analysis of clinical data

Q: What are the key findings of this study?

Pemafibrate significantly decreased triglyceride levels from 278.9 mg/dL to 125.0 mg/dL and increased HDL-C levels after 3 months in patients with type 2 diabetes and hypertriglyceridemia.

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Type 2 diabetes mellitus and hypertriglyceridemia (n=100). Intervention: Pemafibrate vs. Baseline. Primary outcome: Triglyceride levels at 3 months (p=<0.001).

Q: What does this research mean for the field?

Pemafibrate significantly decreases triglyceride levels and increases HDL-C levels after 3 months of treatment in patients with type 2 diabetes and hypertriglyceridemia. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To evaluate the real-world clinical efficacy and safety of pemafibrate on lipid profiles, liver markers, and renal parameters in diabetic patients with elevated triglycerides.

Aki Okamoto; Hirohide Yokokawa; Tomoko Nagamine; Kento Goto; Hiroshi Fukuda; Teruhiko Hisaoka; Toshio Naito

doi:10.1186/s12902-025-01872-w

February 11, 2025BMC Endocrine DisordersOpen Access

Effect and safety of pemafibrate for patients with type 2 diabetes mellitus and hypertriglyceridemia: a retrospective analysis of clinical data

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Key result

Pemafibrate is associated with a ~55% reduction in triglycerides and higher HDL-C in T2D.

P<0.001
n=100

Figures

Why the study?

Clinical examinations of the efficacy of pemafibrate for Japanese patients with hypertriglyceridemia in actual clinical settings remain limited.

Does pemafibrate improve lipid metabolism and liver function in patients with type 2 diabetes mellitus and hypertriglyceridemia?

Key Points

To evaluate the real-world clinical efficacy and safety of pemafibrate on lipid profiles, liver markers, and renal parameters in diabetic patients with elevated triglycerides.
Retrospective clinical analysis of N=100 patients (72 males, mean age 52.9 years) with type 2 diabetes mellitus and hypertriglyceridemia.
Evaluated changes in lipid metabolism, liver function tests, and renal function over at least 3 months of pemafibrate treatment.
Triglyceride levels decreased significantly and high-density lipoprotein cholesterol levels increased significantly after 3 months, while low-density lipoprotein cholesterol showed no significant change.
Liver-related markers significantly decreased, serum creatinine levels significantly dropped in patients switching from other fibrates, and no severe adverse events occurred.

Study Design

Type

Observational (n=100)

Multicenter

No

Structured PICO

Does pemafibrate improve lipid metabolism and liver function in patients with type 2 diabetes mellitus and hypertriglyceridemia?

P

Population

n=100 adults (age ≥20 years) with type 2 diabetes mellitus and hypertriglyceridemia (TG ≥150 mg/dL) with stable HbA1c and BMI, mean age 59.2, 72% male, from a single clinic in Japan. Excluded: serious liver injury, gallstones, pregnant women, cyclosporine or rifampicin treatment.

I

Intervention

Pemafibrate 0.1 mg or 0.2 mg orally twice daily for 3 months

O

Outcome

Changes in TG and HDL-C levels from baseline to 3 monthssurrogate

Main Result

Absolute Event Rate: 125% vs 278.9%

p-value: p=<0.001

In a real-world Japanese cohort, pemafibrate significantly reduced triglycerides and improved liver function parameters without deteriorating renal function in patients with type 2 diabetes and hypertriglyceridemia.

Limitations

Selection bias due to small sample size and single medical institution
Lack of a control group
Heterogeneous concomitant glucose-lowering drugs
Health behavior factors were not evaluated
Relatively short follow-up period
Small sample size and selection bias from a single medical institution specializing in diabetes
Participants were receiving a heterogeneous group of concomitant glucose-lowering drugs
Health behavior was not evaluated
Follow-up period was relatively short

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Implication

May support pemafibrate for lipid improvement in T2DM with hypertriglyceridemia; leaves open need for outcome trials.

Abstract

OBJECTIVES: Fibrates are suitable for the treatment of patients with high triglyceride (TG) levels. Although pemafibrate (PEMA) has been reported to have beneficial and pleiotropic actions, clinical examinations of the efficacy of PEMA for Japanese patients with hypertriglyceridemia are still limited in actual clinical settings. The aim was to evaluate the efficacy of PEMA by analyzing data from diabetic patients treated with PEMA in clinical practice. METHODS: Patients with type 2 diabetes mellitus and hypertriglyceridemia who were started on PEMA for at least 3 months were included in the analysis. Changes in lipid metabolism, liver function, renal function, and blood tests from before to after 3 months of PEMA treatment were evaluated. RESULTS: A total of 100 eligible patients were included in the analysis (72 males, mean age 52.9 years). TG levels decreased significantly, and high-density lipoprotein cholesterol levels increased significantly after 3 months of therapy. Low-density lipoprotein cholesterol levels were not significantly changed. Liver-related parameters showed a significant decrease. In addition, a significant decrease in creatinine levels was found in patients switching from other fibrates. There were no severe adverse events. CONCLUSION: PEMA showed beneficial effects on lipid metabolism and liver function. The improvement of lipid metabolism was found in patients switching from other fibrates. It is possible that PEMA may improve lipid metabolism in patients with hypertriglyceridemia. CLINICAL TRIAL NUMBER: Not applicable.

Discussion

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Cite This Study

Okamoto et al. (2025) conducted an observational in Type 2 diabetes mellitus and hypertriglyceridemia (n=100). Pemafibrate vs. Baseline was evaluated on Triglyceride levels at 3 months (p=<0.001). Pemafibrate significantly decreased triglyceride levels from 278.9 mg/dL to 125.0 mg/dL and increased HDL-C levels after 3 months in patients with type 2 diabetes and hypertriglyceridemia.

synapsesocial.com/papers/6a1258d1e407b2669634ad4d https://doi.org/10.1186/s12902-025-01872-w

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Effect and safety of pemafibrate for patients with type 2 diabetes mellitus and hypertriglyceridemia: a retrospective analysis of clinical data

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Effect and safety of pemafibrate for patients with type 2 diabetes mellitus and hypertriglyceridemia: a retrospective analysis of clinical data

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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