Effect of pemafibrate on fatty acid levels and liver enzymes in non‐alcoholic fatty liver disease patients with dyslipidemia: A single‐arm, pilot study

Seko, Yuya; Yamaguchi, Kanji; Umemura, Atsushi; Yano, Kota; Takahashi, Aya; Okishio, Shinya; Kataoka, Seita; Okuda, Keiichiroh; Moriguchi, Michihisa; Okanoue, Takeshi; Itoh, Yoshito

doi:10.1111/hepr.13571

Cited by 29 publications

(49 citation statements)

References 41 publications

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“…Another important finding was the significant reduction in ALT and -GTP levels, which is consistent with the findings of previous studies 16,32,33) . NAFLD, a hepatic manifestation of metabolic aminotransferase (ALT) and gamma-glutamyl transpeptidase ( -GTP) levels were found (p 0.001 and p 0.002, respectively).…”

Section: Laboratory Outcomessupporting

confidence: 91%

Effects of Pemafibrate in Patients with Stroke and Hypertriglyceridemia: Baseline Cerebral Artery Diseases and 3-Month Laboratory Outcomes

Hoshino

Ishizuka

Toi

et al. 2022

JAT

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The role of hypertriglyceridemia in stroke is poorly understood. The Pemafibrate for Prevention of Atherosclerotic Diseases in Stroke (PPAR Stroke) study was designed to assess the effects of a novel selective peroxisome proliferator-activated receptor alpha modulator, pemafibrate, on vascular outcomes in stroke patients with hypertriglyceridemia.Methods: This was a prospective single-arm study including 74 patients (mean age, 64.1 years; male 75.7%) with stroke and hypertriglyceridemia (defined as fasting serum triglycerides levels of ≥ 150 mg/dL) who were treated with pemafibrate at 0.2 mg or 0.1 mg/day. The present report assessed the association of hypertriglyceridemia with cerebral large and small vessel diseases at baseline and changes in laboratory parameters after a three-month pemafibrate therapy.Results: Patients with triglycerides levels of ≥ 227 mg/dL (higher than the median) more often presented with intracranial artery atherosclerotic stenosis than those with triglycerides levels of 150-227 mg/dL (44.4% vs. 21.6%, p 0.037). On the other hand, no differences were found in the prevalence of extracranial artery atherosclerosis and cerebral small vessel diseases. Mean triglycerides levels were significantly reduced from 285 mg/dL at baseline to 175 mg/dL at 3 months (p 0.001). High-density lipoprotein cholesterol levels increased from 48 mg/dL to 53 mg/dL (p 0.001). In addition, significant reductions in alanine aminotransferase, -glutamyl transpeptidase, and interleukin-6 levels were observed (p 0.001, p 0.002, and p 0.044, respectively). Conclusions:Higher triglycerides levels are associated with intracranial artery atherosclerosis. Pemafibrate showed pleiotropic effects not only in ameliorating atherogenic dyslipidemia but also in the reduction of the levels of inflammatory markers and hepatobiliary enzymes.stroke and other vascular events 2) . Moreover, atherogenic dyslipidemia, which designates high TG with low HDL-C levels, is predictive of recurrent vascular events in patients with stroke or transient ischemic attack (TIA) 3,4) . However, there are not sufficient evidences that support cardiovascular benefits from treating atherogenic dyslipidemia thus far. Fibrates, peroxisome proliferator-activated receptor alpha (PPAR ) agonists, have been the most effective agents for lowering TG and modestly increasing Copyright©2021 Japan Atherosclerosis Society This article is distributed under the terms of the latest version of CC BY-NC-SA defined by the Creative Commons Attribution License.

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Section: Laboratory Outcomessupporting

confidence: 91%

Effects of Pemafibrate in Patients with Stroke and Hypertriglyceridemia: Baseline Cerebral Artery Diseases and 3-Month Laboratory Outcomes

Hoshino

Ishizuka

Toi

et al. 2022

JAT

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“…There are some advantages to this study. First, the treatment period with pemafibrate on NAFLD in this study is longer than in past studies, which had 12-24 weeks of follow-up [ 6 , 7 ]. Second, no patients with diabetes were included.…”

Section: Discussionmentioning

confidence: 94%

“…also reported that 17 patients with NAFLD treated with pemafibrate for six months showed decreases in ALT and γ-GTP levels. A recent Japanese single-arm prospective study for 12 weeks of pemafibrate therapy reported on 20 pa- tients with NAFLD and showed significant reductions of AST, ALT and γ-GTP and an elevation of platelet count [ 6 ]. These three short-term studies did not demonstrate significant improvement in markers of hepatic fibrosis.…”

Section: Discussionmentioning

confidence: 99%

“…We previously reported the short-term outcomes of patients with NAFLD treated with pemafibrate that showed significant improvement in markers of hepatic inflammation and function at three months [ 5 ]. Existing studies reporting the effects of pemafibrate in patients with NAFLD are limited to short-term outcomes [ 6 , 7 ]. There are no reports of long-term outcomes in the literature at this time.…”

Section: Introductionmentioning

confidence: 99%

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Pemafibrate improves hepatic inflammation, function and fibrosis in patients with non-alcoholic fatty liver disease: a one-year observational study

Shinozaki¹,

Tahara²,

Lefor³

et al. 2021

ceh

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“…A single-arm prospective study reported by Seko et al ( 22 ) showed that the levels of transaminase, γ-GTP and fasting TG at baseline were significantly reduced and that HDL cholesterol and the platelet count were significantly elevated in comparison to the values at 12 weeks in 20 patients with NAFLD. Another retrospective study ( 23 ) showed that the transaminase and γ-GTP levels were decreased in patients with fatty liver disease who were treated with pemafibrate.…”

Section: Discussionmentioning

confidence: 97%

Impact of Pemafibrate in Patients with Hypertriglyceridemia and Metabolic Dysfunction-associated Fatty Liver Disease Pathologically Diagnosed with Non-alcoholic Steatohepatitis: A Retrospective, Single-arm Study

et al. 2021

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Objective The therapeutic effect of pemafibrate on metabolic dysfunction-associated fatty liver disease (MAFLD) remains unknown. This retrospective, single-arm study investigated the efficacy and safety of pemafibrate in MAFLD patients with hypertriglyceridemia. Methods A total of 10 patients who received pemafibrate (oral, 0.1 mg, twice a day) at Gunma Saiseikai Maebashi Hospital between September 2018 and September 2019 were included. All patients underwent a liver biopsy, and the disease grade and stage were pathologically assessed based on the FLIP algorithm. Results The median age was 66.0 (53.8-74.8) years old, and 5 patients (50.0%) were men. All patients were diagnosed with non-alcoholic steatohepatitis (NASH). The fasting and non-fasting triglyceride (TG) levels were 175 (149-247) mg/dL and 228 (169-335) mg/dL, respectively. The AST and ALT values at 6 months were significantly lower than at baseline [AST: 28.0 (22.0-33.8) U/L vs. 43.5 (24.0-55.0) U/L, p=0.008, ALT: 23.0 (14.8-26.5) U/L vs. 51.5 (23.0-65.3) U/L, p=0.005, respectively], especially in NASH patients with significant activity and advanced fibrosis (p=0.040 and 0.014, respectively). Fasting TG levels were significantly lower and HDL-C levels significantly higher at 6 months than at baseline (p=0.005 and 0.032, respectively). At six months, FIB-4, the aspartate aminotransferase-to-platelet ratio index, and the macrophage galactose-specific lectin-2 binding protein glycosylation isomer level were significantly improved compared with baseline (p=0.041, 0.005 and 0.005, respectively). Treatment-related adverse events were not observed. Conclusion Pemafibrate treatment may be safe and effective for MAFLD patients with hypertriglyceridemia.

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Effect of pemafibrate on fatty acid levels and liver enzymes in non‐alcoholic fatty liver disease patients with dyslipidemia: A single‐arm, pilot study

Cited by 29 publications

References 41 publications

Effects of Pemafibrate in Patients with Stroke and Hypertriglyceridemia: Baseline Cerebral Artery Diseases and 3-Month Laboratory Outcomes

Effects of Pemafibrate in Patients with Stroke and Hypertriglyceridemia: Baseline Cerebral Artery Diseases and 3-Month Laboratory Outcomes

Pemafibrate improves hepatic inflammation, function and fibrosis in patients with non-alcoholic fatty liver disease: a one-year observational study

Impact of Pemafibrate in Patients with Hypertriglyceridemia and Metabolic Dysfunction-associated Fatty Liver Disease Pathologically Diagnosed with Non-alcoholic Steatohepatitis: A Retrospective, Single-arm Study

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