Higher Responsiveness for Women, High Transaminase Levels, and Fat Percentage to Pemafibrate Treatment for NAFLD

Iwadare, Takanobu; Kimura, Takefumi; Kunimoto, Hideo; Tanaka, Naoki; Wakabayashi, Shun‐ichi; Yamazaki, Tomoo; Okumura, Taiki; Kobayashi, Hiroyuki; Yamashita, Yūki; Sugiura, Ayumi; Joshita, Satoru; Umemura, Takeji

doi:10.3390/biomedicines10112806

Cited by 3 publications

(6 citation statements)

References 32 publications

(33 reference statements)

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“…Regarding the effects of PEM treatment, the intended metabolic shifts were achieved in terms of reductions in AST, ALT, GGTP, ALP, TG, and TC levels along with an increase in Alb levels. Furthermore, this investigation identified that 72-week PEM treatment responders with a > 30% decrease in ALT were predominantly women with higher AST, ALT, and fat mass (%) along with lower soft lean mass (%), SKM mass (%), and SMI, which corroborated previous findings of shortterm PEM treatment (10).…”

Section: Discussionsupporting

confidence: 89%

“…This prospectively registered, retrospectively observed cohort assessed the impact of an extended 72-week PEM regimen on body composition in patients with HTG-NAFLD. Similarly to short-term PEM administration (10), no notable alterations in body composition were observed, and consistent outcomes emerged across treatment-responsive subgroups. Regarding the effects of PEM treatment, the intended metabolic shifts were achieved in terms of reductions in AST, ALT, GGTP, ALP, TG, and TC levels along with an increase in Alb levels.…”

Section: Discussionmentioning

confidence: 72%

“…These incongruent results raised clinical questions about the potential of PEM to reduce body fat mass. Although short-term PEM treatment of HTG-NAFLD patients did not impact body fat mass or other related body composition parameters in our earlier study (10), longterm observations were considered necessary to confirm the body compositional changes from PEM.…”

Section: Introductionmentioning

confidence: 63%

“…Notably, those studies indicated that PEM did not lead to a reduction in BMI and that the therapeutic benefits of PEM were independent of weight loss. Our previous data from a 24-week PEM treatment study revealed that the treatment response to PEM was more favorable in patients with higher body fat (10). We therefore hypothesized that longer term PEM administration would alter body composition by stimulating PPARa and its target genes in adipose and muscle tissue in this 72-week PEM study.…”

Section: Discussionmentioning

confidence: 85%

“…Body composition and blood test data before, 24 weeks, and 72 weeks after PEM administration were used to retrospectively examine the therapeutic effect of long-term PEM administration in the HTG-NAFLD patients. Additionally, we defined responders as those showing an improvement of ALT >30% at 72 weeks according to previous studies (10)(11)(12), and conducted an analysis to identify predictive factors for responders using blood test and body composition data obtained before PEM administration.…”

Section: Patients and Clinical Examinationsmentioning

confidence: 99%

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Long-Term pemafibrate treatment exhibits limited impact on body fat mass in patients with hypertriglyceridemia accompanying NAFLD

Iwadare,

Kimura,

Kunimoto

et al. 2024

Front. Endocrinol.

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AimShort-term use of pemafibrate (PEM), a selective modulator of peroxisome proliferator-activated receptor alpha, has been reported to improve abnormal liver function in patients with nonalcoholic fatty liver disease with hypertriglyceridemia (HTG-NAFLD). This study aimed to clarify the effects and predictive factors of long-term 72-week PEM administration on body composition, and laboratory tests in HTG-NAFLD patients.MethodsFifty-three HTG-NAFLD patients receiving a 72-week PEM regimen were retrospectively enrolled. Routine blood and body composition results were analyzed immediately before and at the end of the study period.ResultsPEM treatment significantly improved liver enzyme levels such as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, and gamma-glutamyl transferase, along with lipid profiles including triglyceride, total cholesterol, and low-density lipoprotein cholesterol. PEM did not have any detectable impact on body composition parameters. The factors of female, higher AST (≥ 46 U/L) and fat mass (≥ 31.9%), as well as lower soft lean mass (< 61.6%), skeletal muscle mass (< 36%), and skeletal muscle mass index (< 6.9 kg/m2) were significantly associated with the treatment response status of a > 30% decrease in ALT. All patients completed the treatment without any adverse effects.ConclusionsLong-term PEM treatment had a positive impact on liver enzymes and lipid profiles, but it did not result in significant changes in body composition among HTG-NAFLD patients. In predicting the response to PEM treatment, the evaluation of AST and body composition may be useful.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 72%

Section: Introductionmentioning

confidence: 63%

Section: Discussionmentioning

confidence: 85%

Section: Patients and Clinical Examinationsmentioning

confidence: 99%

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Long-Term pemafibrate treatment exhibits limited impact on body fat mass in patients with hypertriglyceridemia accompanying NAFLD

Iwadare,

Kimura,

Kunimoto

et al. 2024

Front. Endocrinol.

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A Comparison of Alanine Aminotransferase Normalization between Pemafibrate and Bezafibrate in Patients with Nonalcoholic Fatty Liver Disease

Yamada-Shimizu,

Tamaki,

Kurosaki

et al. 2024

Intern. Med.

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Objective Pemafibrate is a recently developed selective peroxisome proliferator-activated receptor alpha modulator that can improve alanine aminotransferase (ALT) levels in patients with nonalcoholic fatty liver disease (NAFLD). However, the effectiveness of ALT normalization with pemafibrate and bezafibrate, a traditional fibrate, has not been compared. Methods In this retrospective study, we compared the effects of pemafibrate and bezafibrate on ALT normalization in patients with NAFLD. The primary endpoint was the ALT normalization rate at 12 months after administration. Patients Twenty and 14 patients with NAFLD receiving pemafibrate and bezafibrate, respectively, were included in this retrospective analysis. All patients had elevated ALT levels and dyslipidemia at entry. Results The ALT normalization rates at 3, 6, and 12 months were 40%, 55%, and 60% for pemafibrate and 14.3%, 28.6%, and 14.3% for bezafibrate, respectively. The ALT normalization rate at 12 months was significantly higher in patients treated with pemafibrate than in those treated with bezafibrate (p=0.01). Pemafibrate, when compared with bezafibrate, was shown to be a significant factor for ALT normalization in a multivariable analysis with an adjusted odds ratio (95% confidence interval) of 13.8 (1.6-115, p=0.01). Conclusion Pemafibrate is effective in ALT normalization in patients with NAFLD and may be used as a treatment for NAFLD.

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Effects of body composition and liver function after long-term pemafibrate treatment on dyslipidemia-associated non-alcoholic fatty liver disease

Ishikawa¹,

Terai²,

Igarashi³

et al. 2023

ceh

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Aim of the study Owing to the association between non-alcoholic fatty liver disease (NAFLD) and dyslipidemia, there is a need for new treatment strategies to manage both conditions concomitantly. Our aim in this study was to evaluate the effectiveness of pemafibrate in alleviating dyslipidemia-associated NAFLD, including the evaluation of its effects on liver function and body composition. Material and methods The study sample included 67 patients with dyslipidemia-associated NAFLD (29 males, mean age 65.7 years [range, 58.4-73.7]) who were administered pemafibrate continuously for a period of at least 12 months, between June 2019 and January 2022. Outcomes were the change in body composition indices (visceral adipose tissue index – VATI, subcutaneous adipose tissue index – SATI, and skeletal muscle index – SMI), lipid biochemistry, and liver function, reserve, and fibrosis score, from baseline to the 12-month time point of pemafibrate treatment. Results Pemafibrate treatment improved liver function (alanine aminotransferase, aspartate aminotransferase, g-glutamyl transpeptidase, and alkaline phosphatase), and lipid biochemistry (triglycerides and total cholesterol). Improvements in ferritin and hepatic reserve (Mac-2 binding protein, albumin-to-bilirubin score, and NAFLD fibrosis score) were also observed, as well as a decrease in SATI. Conclusions Pemafibrate improved dyslipidemia, liver function, and hepatic reserve. The positive effects of pemafibrate on body composition likely contributed to the improvements in liver function. Longer-term treatment may be necessary to influence VATI and thus to further evaluate the relationship between improved body composition and NAFLD with pemafibrate treatment.

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Higher Responsiveness for Women, High Transaminase Levels, and Fat Percentage to Pemafibrate Treatment for NAFLD

Cited by 3 publications

References 32 publications

Long-Term pemafibrate treatment exhibits limited impact on body fat mass in patients with hypertriglyceridemia accompanying NAFLD

Long-Term pemafibrate treatment exhibits limited impact on body fat mass in patients with hypertriglyceridemia accompanying NAFLD

A Comparison of Alanine Aminotransferase Normalization between Pemafibrate and Bezafibrate in Patients with Nonalcoholic Fatty Liver Disease

Effects of body composition and liver function after long-term pemafibrate treatment on dyslipidemia-associated non-alcoholic fatty liver disease

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