Evaluation of the Short-term Effect of Pemafibrate on Liver Fibrosis Biomarkers Stratified by FIB-4 Index in Patients with Type 2 Diabetes Mellitus and Hypertriglyceridemia
Aims This study aimed to investigate the short-term effects of pemafibrate (PEMA) on the Fibrosis-4 index (FIB-4) and Aspartate Aminotransferase to Platelet Ratio Index (APRI) across three subgroups stratified according to FIB-4 for assessing the risk of liver fibrosis in patients with type 2 diabet...
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| Published in | Internal Medicine p. 5611-25 |
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| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
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The Japanese Society of Internal Medicine
03.07.2025
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| Abstract | Aims This study aimed to investigate the short-term effects of pemafibrate (PEMA) on the Fibrosis-4 index (FIB-4) and Aspartate Aminotransferase to Platelet Ratio Index (APRI) across three subgroups stratified according to FIB-4 for assessing the risk of liver fibrosis in patients with type 2 diabetes (T2D) and hypertriglyceridemia. Methods A total of 114 patients were stratified into three subgroups based on their FIB-4 score at the initiation of PEMA, following the FIB-4 classification: Group 1 (G1) (FIB-4<1.30, n =46), Group 2 (G2) (FIB-4 1.30 to <2.67, n =56), and Group 3 (G3) (FIB-4 ≥2.67, n =12). We evaluated the changes in FIB-4 and APRI three months after the initiation of PEMA in each subgroup. Subsequently, we compared the changes (Δ) in FIB-4 and APRI scores across the three subgroups. Additionally, we investigated the baseline parameters and changes in these parameters correlated with ΔFIB-4. Results The FIB-4 index exhibited a significant increase in G1 (p =0.003) but decrease in G3 (p =0.041). The APRI showed a significant reduction in both G2 (p <0.001) and G3 (p =0.034). ΔFIB-4 in G3 was significantly greater than that observed in G1 (p <0.001) and G2 (p =0.026), whereas ΔAPRI in G3 was significantly higher than that in G1 (p =0.002). ΔFIB-4 was inversely correlated with baseline FIB-4 and positively correlated with Δγ-glutamyl transpeptidase. Conclusions The short-term effect of PEMA on liver fibrosis markers was more pronounced in patients with T2DM and hypertriglyceridemia who exhibited elevated baseline FIB-4 values. |
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| AbstractList | Aims This study aimed to investigate the short-term effects of pemafibrate (PEMA) on the Fibrosis-4 index (FIB-4) and Aspartate Aminotransferase to Platelet Ratio Index (APRI) across three subgroups stratified according to FIB-4 for assessing the risk of liver fibrosis in patients with type 2 diabetes (T2D) and hypertriglyceridemia. Methods A total of 114 patients were stratified into three subgroups based on their FIB-4 score at the initiation of PEMA, following the FIB-4 classification: Group 1 (G1) (FIB-4<1.30, n =46), Group 2 (G2) (FIB-4 1.30 to <2.67, n =56), and Group 3 (G3) (FIB-4 ≥2.67, n =12). We evaluated the changes in FIB-4 and APRI three months after the initiation of PEMA in each subgroup. Subsequently, we compared the changes (Δ) in FIB-4 and APRI scores across the three subgroups. Additionally, we investigated the baseline parameters and changes in these parameters correlated with ΔFIB-4. Results The FIB-4 index exhibited a significant increase in G1 (p =0.003) but decrease in G3 (p =0.041). The APRI showed a significant reduction in both G2 (p <0.001) and G3 (p =0.034). ΔFIB-4 in G3 was significantly greater than that observed in G1 (p <0.001) and G2 (p =0.026), whereas ΔAPRI in G3 was significantly higher than that in G1 (p =0.002). ΔFIB-4 was inversely correlated with baseline FIB-4 and positively correlated with Δγ-glutamyl transpeptidase. Conclusions The short-term effect of PEMA on liver fibrosis markers was more pronounced in patients with T2DM and hypertriglyceridemia who exhibited elevated baseline FIB-4 values. Aims This study aimed to investigate the short-term effects of pemafibrate (PEMA) on the Fibrosis-4 index (FIB-4) and Aspartate Aminotransferase to Platelet Ratio Index (APRI) across three subgroups stratified according to FIB-4 for assessing the risk of liver fibrosis in patients with type 2 diabetes (T2D) and hypertriglyceridemia. Methods A total of 114 patients were stratified into three subgroups based on their FIB-4 score at the initiation of PEMA, following the FIB-4 classification: Group 1 (G1) (FIB-4<1.30, n =46), Group 2 (G2) (FIB-4 1.30 to <2.67, n =56), and Group 3 (G3) (FIB-4 ≥2.67, n =12). We evaluated the changes in FIB-4 and APRI three months after the initiation of PEMA in each subgroup. Subsequently, we compared the changes (Δ) in FIB-4 and APRI scores across the three subgroups. Additionally, we investigated the baseline parameters and changes in these parameters correlated with ΔFIB-4. Results The FIB-4 index exhibited a significant increase in G1 (p =0.003) but decrease in G3 (p =0.041). The APRI showed a significant reduction in both G2 (p <0.001) and G3 (p =0.034). ΔFIB-4 in G3 was significantly greater than that observed in G1 (p <0.001) and G2 (p =0.026), whereas ΔAPRI in G3 was significantly higher than that in G1 (p =0.002). ΔFIB-4 was inversely correlated with baseline FIB-4 and positively correlated with Δγ-glutamyl transpeptidase. Conclusions The short-term effect of PEMA on liver fibrosis markers was more pronounced in patients with T2DM and hypertriglyceridemia who exhibited elevated baseline FIB-4 values.Aims This study aimed to investigate the short-term effects of pemafibrate (PEMA) on the Fibrosis-4 index (FIB-4) and Aspartate Aminotransferase to Platelet Ratio Index (APRI) across three subgroups stratified according to FIB-4 for assessing the risk of liver fibrosis in patients with type 2 diabetes (T2D) and hypertriglyceridemia. Methods A total of 114 patients were stratified into three subgroups based on their FIB-4 score at the initiation of PEMA, following the FIB-4 classification: Group 1 (G1) (FIB-4<1.30, n =46), Group 2 (G2) (FIB-4 1.30 to <2.67, n =56), and Group 3 (G3) (FIB-4 ≥2.67, n =12). We evaluated the changes in FIB-4 and APRI three months after the initiation of PEMA in each subgroup. Subsequently, we compared the changes (Δ) in FIB-4 and APRI scores across the three subgroups. Additionally, we investigated the baseline parameters and changes in these parameters correlated with ΔFIB-4. Results The FIB-4 index exhibited a significant increase in G1 (p =0.003) but decrease in G3 (p =0.041). The APRI showed a significant reduction in both G2 (p <0.001) and G3 (p =0.034). ΔFIB-4 in G3 was significantly greater than that observed in G1 (p <0.001) and G2 (p =0.026), whereas ΔAPRI in G3 was significantly higher than that in G1 (p =0.002). ΔFIB-4 was inversely correlated with baseline FIB-4 and positively correlated with Δγ-glutamyl transpeptidase. Conclusions The short-term effect of PEMA on liver fibrosis markers was more pronounced in patients with T2DM and hypertriglyceridemia who exhibited elevated baseline FIB-4 values. |
| ArticleNumber | 5611-25 |
| Author | Mori, Yukiko Tanaka, Takumi Komoda, Yoshio Kubori, Motohiro Kitao, Takashi Ibata, Takeshi |
| Author_xml | – sequence: 1 fullname: Kitao, Takashi organization: Department of Cardiology, Minoh City Hospital, Japan – sequence: 2 fullname: Tanaka, Takumi organization: Department of Diabetes/Endocrinology and Metabolism, Minoh City Hospital, Japan – sequence: 3 fullname: Kubori, Motohiro organization: Department of Diabetes/Endocrinology and Metabolism, Minoh City Hospital, Japan – sequence: 4 fullname: Komoda, Yoshio organization: Department of Diabetes/Endocrinology and Metabolism, Minoh City Hospital, Japan – sequence: 5 fullname: Mori, Yukiko organization: Department of Diabetes/Endocrinology and Metabolism, Minoh City Hospital, Japan – sequence: 6 fullname: Ibata, Takeshi organization: Department of Diabetes/Endocrinology and Metabolism, Minoh City Hospital, Japan |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/40603095$$D View this record in MEDLINE/PubMed |
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Leite NC, Salles GF, Araujo AL, Villela-Nogueira CA, Cardoso CR. Prevalence and associated factors of non-alcoholic fatty liver disease in patients with type-2 diabetes mellitus. Liver Int 29: 113-119, 2009. 30. Georgescu EF, Ionescu R, Niculescu M, et al. Angiotensin-receptor blockers as therapy for mild-to-moderate hypertension-associated non-alcoholic steatohepatitis. World J Gastroenterol 15: 942-954, 2009. 3. Nakahara T, Hyogo H, Yoneda M, et al. Type 2 diabetes mellitus is associated with the fibrosis severity in patients with nonalcoholic fatty liver disease in a large retrospective cohort of Japanese patients. J Gastroenterol 49: 1477-1484, 2014. 35. Anstee QM, Berentzen TL, Nitze LM, et al. Prognostic utility of Fibrosis-4 Index for risk of subsequent liver and cardiovascular events, and all-cause mortality in individuals with obesity and/or type 2 diabetes: a longitudinal cohort study. Lancet Reg Health Eur 36: 100780, 2023. 12. Angulo P, Hui JM, Marchesini G, et al. The NAFLD fibrosis score: a noninvasive system that identifies liver fibrosis in patients with NAFLD. Hepatology 45: 846-854, 2007. 16. Higashiura Y, Tanaka M, Mori K, et al. High fibrosis-4 index predicts the new onset of ischaemic heart disease during a 10-year period in a general population. Eur Heart J Open 16: 2022. 2. Mantovani A, Byrne CD, Bonora E, Targher G. Nonalcoholic Fatty Liver Disease and Risk of Incident Type 2 Diabetes: A Meta-analysis. Diabetes Care 41: 372-382, 2018. 13. Sterling RK, Lissen E, Clumeck N, et al. Development of a simple noninvasive index to predict significant fibrosis in patients with HIV/HCV coinfection. Hepatology 43: 1317-1325, 2006. 22. Morishita A, Oura K, Takuma K, et al. Pemafibrate improves liver dysfunction and non-invasive surrogates for liver fibrosis in patients with non-alcoholic fatty liver disease with hypertriglyceridemia: a multicenter study. Hepatol Int 17: 606-614, 2023. 36. Belfort R, Harrison SA, Brown K, et al. A placebo-controlled trial of pioglitazone in subjects with nonalcoholic steatohepatitis. N Engl J Med 355: 2297-2307, 2006. 33. Hagström H, Talbäck M, Andreasson A, et al. Repeated FIB-4 measurements can help identify individuals at risk of severe liver disease. J Hepatol 73: 1023-1029, 2020. 23. Ichikawa T, Oba H, Owada M, et al. Evaluation of the effects of pemafibrate on metabolic dysfunction-associated steatotic liver disease with hypertriglyceridemia using magnetic resonance elastography combined with fibrosis-4 index and the magnetic resonance imaging-aspartate aminotransferase score. JGH Open 7: 959-965, 2023. 20. Ikeda S, Sugihara T, Kihara T, et al. Pemafibrate Ameliorates Liver Dysfunction and Fatty Liver in Patients with Non-Alcoholic Fatty Liver Disease with Hypertriglyceridemia: A Retrospective Study with the Outcome after a Mid-Term Follow-Up. Diagnostics (Basel) 11: 2316, 2021. 8. Eslam M, Newsome PN, Sarin SK, et al. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol 73: 202-209, 2020. 27. Hatanaka T, Kakizaki S, Saito N, et al. 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. Intern Med 60: 2167-2174, 2021. 4. Seko Y, Yano K, Takahashi A, et al. FIB-4 Index and Diabetes Mellitus Are Associated with Chronic Kidney Disease in Japanese Patients with Non-Alcoholic Fatty Liver Disease. Int J Mol Sci 25: 171, 2019. 29. Ichikawa T, Yamashima M, Yamamichi S, et al. Pemafibrate Reduced Liver Stiffness in Patients with Metabolic Dysfunction-associated Steatotic Liver Disease Complicated with Hyperlipidemia and Liver Fibrosis with a Fibrosis-4 Index Above 1.3. 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| References_xml | – reference: 8. Eslam M, Newsome PN, Sarin SK, et al. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol 73: 202-209, 2020. – reference: 7. Eslam M, Sanyal AJ, George J; International Consensus Panel. MAFLD: A Consensus-Driven Proposed Nomenclature for Metabolic Associated Fatty Liver Disease. Gastroenterology 158: 1999-2014, 2020. – reference: 4. Seko Y, Yano K, Takahashi A, et al. FIB-4 Index and Diabetes Mellitus Are Associated with Chronic Kidney Disease in Japanese Patients with Non-Alcoholic Fatty Liver Disease. Int J Mol Sci 25: 171, 2019. – reference: 30. Georgescu EF, Ionescu R, Niculescu M, et al. Angiotensin-receptor blockers as therapy for mild-to-moderate hypertension-associated non-alcoholic steatohepatitis. World J Gastroenterol 15: 942-954, 2009. – reference: 32. Newsome PN, Buchholtz K, Cusi K, et al. A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. N Engl J Med 384: 1113-1124, 2021. – reference: 25. Nomoto H, Kito K, Iesaka H, et al. Preferable effects of pemafibrate on liver function and fibrosis in subjects with type 2 diabetes complicated with liver damage. Diabetol Metab Syndr 15: 214, 2023. – reference: 3. Nakahara T, Hyogo H, Yoneda M, et al. Type 2 diabetes mellitus is associated with the fibrosis severity in patients with nonalcoholic fatty liver disease in a large retrospective cohort of Japanese patients. J Gastroenterol 49: 1477-1484, 2014. – reference: 17. Saito Y, Okumura Y, Nagashima K, et al. Impact of the Fibrosis-4 Index on Risk Stratification of Cardiovascular Events and Mortality in Patients with Atrial Fibrillation: Findings from a Japanese Multicenter Registry. J Clin Med 21: 584, 2020. – reference: 20. Ikeda S, Sugihara T, Kihara T, et al. Pemafibrate Ameliorates Liver Dysfunction and Fatty Liver in Patients with Non-Alcoholic Fatty Liver Disease with Hypertriglyceridemia: A Retrospective Study with the Outcome after a Mid-Term Follow-Up. Diagnostics (Basel) 11: 2316, 2021. – reference: 23. Ichikawa T, Oba H, Owada M, et al. Evaluation of the effects of pemafibrate on metabolic dysfunction-associated steatotic liver disease with hypertriglyceridemia using magnetic resonance elastography combined with fibrosis-4 index and the magnetic resonance imaging-aspartate aminotransferase score. JGH Open 7: 959-965, 2023. – reference: 9. Rinella ME, Lazarus JV, Ratziu V, et al. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. J Hepatol 79: 1542-1556, 2023. – reference: 1. Leite NC, Salles GF, Araujo AL, Villela-Nogueira CA, Cardoso CR. Prevalence and associated factors of non-alcoholic fatty liver disease in patients with type-2 diabetes mellitus. Liver Int 29: 113-119, 2009. – reference: 33. Hagström H, Talbäck M, Andreasson A, et al. Repeated FIB-4 measurements can help identify individuals at risk of severe liver disease. J Hepatol 73: 1023-1029, 2020. – reference: 14. Shah AG, Lydecker A, Murray K, et al. Comparison of noninvasive markers of fibrosis in patients with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol 7: 1104-1112, 2009. – reference: 15. Wai CT, Greenson JK, Fontana RJ, et al. A simple noninvasive index can predict both significant fibrosis and cirrhosis in patients with chronic hepatitis C. Hepatology 38: 518-526, 2003. – reference: 6. Zhou YY, Zhou XD, Wu SJ, et al. Synergistic increase in cardiovascular risk in diabetes mellitus with nonalcoholic fatty liver disease: a meta-analysis. Eur J Gastroenterol Hepatol 30: 631-636, 2018. – reference: 16. Higashiura Y, Tanaka M, Mori K, et al. High fibrosis-4 index predicts the new onset of ischaemic heart disease during a 10-year period in a general population. 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| Snippet | Aims This study aimed to investigate the short-term effects of pemafibrate (PEMA) on the Fibrosis-4 index (FIB-4) and Aspartate Aminotransferase to Platelet... |
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| SubjectTerms | hypertriglyceridemia liver fibrosis marker pemafibrate Type 2 Diabetes |
| Title | Evaluation of the Short-term Effect of Pemafibrate on Liver Fibrosis Biomarkers Stratified by FIB-4 Index in Patients with Type 2 Diabetes Mellitus and Hypertriglyceridemia |
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