PMID- 29848902 OWN - NLM STAT- MEDLINE DCOM- 20181114 LR - 20221207 IS - 1348-4540 (Electronic) IS - 0918-8959 (Linking) VI - 65 IP - 7 DP - 2018 Jul 28 TI - Improved cardiometabolic risk factors in Japanese patients with type 2 diabetes treated with ipragliflozin: a pooled analysis of six randomized, placebo-controlled trials. PG - 693-705 LID - 10.1507/endocrj.EJ17-0491 [doi] AB - To examine differential improvements among cardiovascular risk factors in response to treatment with ipragliflozin in Japanese type 2 diabetes mellitus (T2DM) patients, we conducted a pooled analysis of six randomized, double-blind trials of Japanese T2DM patients who received ipragliflozin 50 mg/day or placebo and had patient-level data for cardiometabolic risk parameters. Risk factors included glycated hemoglobin (HbA1c), body weight, homeostatic model assessment for insulin resistance and beta-cell function (HOMA-R and HOMA-beta, respectively), systolic blood pressure, fasting serum insulin concentrations, and the concentration of uric acid, lipids, and liver enzymes from baseline to end of treatment (EOT; 12-24 weeks). The primary endpoint of each trial was the change in HbA1c from baseline to EOT. Changes in risk factors from baseline to EOT were compared between ipragliflozin-treated and placebo groups, and between two subgroups (high- and low-risk groups for each parameter). All parameters, except low-density lipoprotein cholesterol (LDL-C) and non high-density lipoprotein cholesterol (non HDL-C), improved significantly in the ipragliflozin group. Subgroup analysis revealed a significantly greater improvement in the high-risk group versus low-risk group in HbA1c, HOMA-R, HOMA-beta, aspartate transaminase, alanine transaminase, and gamma-glutamyltransferase, but not in any of the lipid parameters or blood pressure. Liver function improvement in the ipragliflozin group was significantly correlated with changes in body weight, HbA1c, HOMA-beta, and HOMA-R. This analysis demonstrated that, in Japanese T2DM patients, ipragliflozin 50 mg/day was associated with improvements in cardiometabolic risk factors, except for LDL-C and non HDL-C. FAU - Kashiwagi, Atsunori AU - Kashiwagi A AD - Kusatsu General Hospital, Kusatsu, Shiga 525-8585, Japan. FAU - Sakatani, Taishi AU - Sakatani T AD - Astellas Pharma Inc., Chuo-ku, Tokyo 103-8411, Japan. FAU - Nakamura, Ichiro AU - Nakamura I AD - Astellas Pharma Inc., Chuo-ku, Tokyo 103-8411, Japan. FAU - Akiyama, Noriko AU - Akiyama N AD - Astellas Pharma Inc., Chuo-ku, Tokyo 103-8411, Japan. FAU - Kazuta, Kenichi AU - Kazuta K AD - Astellas Pharma Inc., Chuo-ku, Tokyo 103-8411, Japan. FAU - Ueyama, Eiji AU - Ueyama E AD - Astellas Pharma Inc., Chuo-ku, Tokyo 103-8411, Japan. FAU - Takahashi, Hideyuki AU - Takahashi H AD - Astellas Pharma Inc., Chuo-ku, Tokyo 103-8411, Japan. FAU - Kosakai, Yoshinori AU - Kosakai Y AD - Astellas Pharma Inc., Chuo-ku, Tokyo 103-8411, Japan. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20180529 PL - Japan TA - Endocr J JT - Endocrine journal JID - 9313485 RN - 0 (Blood Glucose) RN - 0 (Glucosides) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Thiophenes) RN - 3N2N8OOR7X (ipragliflozin) SB - IM MH - Aged MH - Blood Glucose/analysis MH - Body Mass Index MH - Cardiovascular Diseases/*etiology MH - Diabetes Mellitus, Type 2/complications/*drug therapy MH - Double-Blind Method MH - Female MH - Glucosides/*therapeutic use MH - Glycated Hemoglobin/analysis MH - Humans MH - Hypoglycemic Agents/*therapeutic use MH - Insulin Resistance MH - Japan MH - Male MH - Middle Aged MH - Risk Factors MH - Thiophenes/*therapeutic use MH - Treatment Outcome OTO - NOTNLM OT - Cardiometabolic risk factors OT - Ipragliflozin OT - Liver function OT - Pooled analysis OT - Type 2 diabetes mellitus EDAT- 2018/06/01 06:00 MHDA- 2018/11/15 06:00 CRDT- 2018/06/01 06:00 PHST- 2018/06/01 06:00 [pubmed] PHST- 2018/11/15 06:00 [medline] PHST- 2018/06/01 06:00 [entrez] AID - 10.1507/endocrj.EJ17-0491 [doi] PST - ppublish SO - Endocr J. 2018 Jul 28;65(7):693-705. doi: 10.1507/endocrj.EJ17-0491. Epub 2018 May 29.