PMID- 30393249 OWN - NLM STAT- MEDLINE DCOM- 20190514 LR - 20221207 IS - 1348-4540 (Electronic) IS - 0918-8959 (Linking) VI - 66 IP - 1 DP - 2019 Jan 28 TI - Effect of ipragliflozin on liver function in Japanese type 2 diabetes mellitus patients: a subgroup analysis of the STELLA-LONG TERM study (3-month interim results). PG - 31-41 LID - 10.1507/endocrj.EJ18-0217 [doi] AB - This subgroup analysis of STELLA-LONG TERM, an ongoing 3-year post-marketing surveillance study on the long-term efficacy and safety of ipragliflozin, assessed the effect of ipragliflozin on liver function in type 2 diabetes mellitus (T2DM) patients. Patients were divided according to baseline liver function (normal [male: ALT /=31, female: ALT >/=21]). We evaluated changes in aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (gamma-GTP), alkaline phosphatase (ALP), and fatty liver index (FLI) at 3 months of treatment; the proportion of patients with abnormal liver function whose liver function normalized after 3 months of treatment; and correlations between changes in ALT levels and efficacy variables/laboratory values. Liver function was normal in 2,570 and abnormal in 3,239 patients. Only patients with abnormal liver function showed a statistically/clinically significant decrease in AST, ALT, gamma-GTP, and ALP levels at 3 months (all p < 0.05 vs. baseline). The FLI significantly decreased from 63.2677 +/- 26.4363 (baseline) to 56.7137 +/- 27.6484 (3 months) (p < 0.05) in the overall patient population. Liver function normalized in 20.5% (543/2,648) of patients with abnormal liver function. There was no obvious correlation between changes in ALT and changes in efficacy/laboratory parameters. Liver function improved after 3-month treatment with ipragliflozin in T2DM patients with abnormal liver function. FAU - Tabuchi, Hiromi AU - Tabuchi H AD - Astellas Pharma Inc., Chuo-ku, Tokyo 103-8411, Japan. FAU - Maegawa, Hiroshi AU - Maegawa H AD - Department of Medicine, Shiga University of Medical Science, Otsu, Shiga 520-2192, Japan. FAU - Tobe, Kazuyuki AU - Tobe K AD - First Department of Internal Medicine, University of Toyama, Sugitani, Toyama 930-0194, Japan. FAU - Nakamura, Ichiro AU - Nakamura I AD - Astellas Pharma Inc., Chuo-ku, Tokyo 103-8411, Japan. FAU - Uno, Satoshi AU - Uno S AD - Astellas Pharma Inc., Chuo-ku, Tokyo 103-8411, Japan. LA - eng PT - Journal Article DEP - 20181103 PL - Japan TA - Endocr J JT - Endocrine journal JID - 9313485 RN - 0 (Glucosides) RN - 0 (Sodium-Glucose Transporter 2 Inhibitors) RN - 0 (Thiophenes) RN - 3N2N8OOR7X (ipragliflozin) RN - EC 2.3.2.2 (gamma-Glutamyltransferase) RN - EC 2.6.1.1 (Aspartate Aminotransferases) RN - EC 2.6.1.2 (Alanine Transaminase) RN - EC 3.1.3.1 (Alkaline Phosphatase) SB - IM MH - Aged MH - Alanine Transaminase/*metabolism MH - Alkaline Phosphatase/*metabolism MH - Asian People MH - Aspartate Aminotransferases/*metabolism MH - Diabetes Mellitus, Type 2/*drug therapy/metabolism MH - Female MH - Glucosides/*therapeutic use MH - Humans MH - Japan MH - Liver/metabolism MH - Liver Function Tests MH - Male MH - Middle Aged MH - Non-alcoholic Fatty Liver Disease/*metabolism MH - Product Surveillance, Postmarketing MH - Sodium-Glucose Transporter 2 Inhibitors/*therapeutic use MH - Thiophenes/*therapeutic use MH - gamma-Glutamyltransferase/*metabolism OTO - NOTNLM OT - Ipragliflozin OT - Japan OT - Liver function OT - Post-marketing surveillance OT - Type 2 diabetes mellitus EDAT- 2018/11/06 06:00 MHDA- 2019/05/15 06:00 CRDT- 2018/11/06 06:00 PHST- 2018/11/06 06:00 [pubmed] PHST- 2019/05/15 06:00 [medline] PHST- 2018/11/06 06:00 [entrez] AID - 10.1507/endocrj.EJ18-0217 [doi] PST - ppublish SO - Endocr J. 2019 Jan 28;66(1):31-41. doi: 10.1507/endocrj.EJ18-0217. Epub 2018 Nov 3.