PMID- 33786273
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211124
IS  - 2190-1678 (Print)
IS  - 2190-1686 (Electronic)
IS  - 2190-1678 (Linking)
VI  - 12
IP  - 2
DP  - 2021 Apr
TI  - Safety and effectiveness of ipragliflozin in Japanese patients with type 2 
      diabetes mellitus and impaired renal function: subgroup analysis of a 3-year 
      post-marketing surveillance study (STELLA-LONG TERM).
PG  - 181-196
LID - 10.1007/s13340-020-00470-6 [doi]
AB  - STELLA-LONG TERM, a 3-year post-marketing surveillance study, evaluated the 
      safety and effectiveness of the sodium-glucose cotransporter 2 inhibitor 
      ipragliflozin in Japanese type 2 diabetes mellitus (T2DM) patients. Final results 
      in the safety (n = 6697) and effectiveness populations (n = 5625) were analyzed 
      by stratifying patients by baseline estimated glomerular filtration rate (eGFR, 
      mL/min/1.73 m(2)) into four subgroups (>/= 90, 60 to < 90, 45 to < 60, and < 45) 
      and two subgroups (>/= 60 and < 60). Adverse drug reaction (ADR) incidence, and 
      changes from baseline in glycosylated hemoglobin (HbA1c), bodyweight, and eGFR 
      were assessed. The percentage of patients experiencing ADRs and serious ADRs was 
      similar across most eGFR subgroups. Polyuria/pollakiuria was the most common ADR. 
      Renal disorders and volume depletion ADRs were more frequent in the subgroups 
      with more severe renal impairment at baseline than in those with an eGFR of 60 
      to < 90 or >/= 90 mL/min/1.73 m(2). Bodyweight and HbA1c decreased in all 
      subgroups, the latter by - 0.91% to - 0.40% (P < 0.05 vs. baseline). eGFR 
      increased in the 45 to < 60 mL/min/1.73 m(2) subgroup 
      (+ 1.42 +/- 8.77 mL/min/1.73 m(2); P = 0.006). It decreased in the >/= 90 and 60 
      to < 90 mL/min/1.73 m(2) subgroups (- 8.27 +/- 13.73 and 
      - 1.22 +/- 10.34 mL/min/1.73 m(2); P < 0.001), but not to < 60 mL/min/1.73 m(2). In 
      conclusion, there were no new or unexpected safety findings in Japanese patients 
      treated with ipragliflozin for T2DM, and long-term sustained improvements in 
      HbA1c and bodyweight were observed regardless of the presence of renal 
      impairment.
CI  - (c) The Japan Diabetes Society 2020.
FAU - Tobe, Kazuyuki
AU  - Tobe K
AD  - First Department of Internal Medicine, Graduate School of Medicine and 
      Pharmaceutical Sciences for Research, University of Toyama, 2630 Sugitani, 
      Toyama, 930-0194 Japan. GRID: grid.267346.2. ISNI: 0000 0001 2171 836X
FAU - Maegawa, Hiroshi
AU  - Maegawa H
AD  - Department of Medicine, Shiga University of Medical Science, Shiga, Japan. GRID: 
      grid.410827.8. ISNI: 0000 0000 9747 6806
FAU - Nakamura, Ichiro
AU  - Nakamura I
AD  - Operational Excellence, Medical Affairs Japan, Astellas Pharma Inc., Tokyo, 
      Japan. GRID: grid.418042.b
FAU - Uno, Satoshi
AU  - Uno S
AD  - Data Science, Development, Astellas Pharma Inc., Tokyo, Japan. GRID: 
      grid.418042.b
LA  - eng
PT  - Journal Article
DEP - 20201123
PL  - Japan
TA  - Diabetol Int
JT  - Diabetology international
JID - 101553224
PMC - PMC7943685
OTO - NOTNLM
OT  - Diabetes mellitus
OT  - Ipragliflozin
OT  - Post-marketing surveillance
OT  - Renal impairment
OT  - Sodium-glucose cotransporter 2 inhibitor
COIS- Conflict of interestTobe K received lecture fees from MSD K.K., Novo Nordisk 
      Pharma Ltd., Kowa Pharmaceutical Co. Ltd.; grants from Daiichi Sankyo Co. Ltd., 
      Ono Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., Nippon Boehringer 
      Ingelheim Co. Ltd., MSD K.K., Mitsubishi Tanabe Pharma Corporation, Teijin Pharma 
      Limited, Eli Lilly Japan K.K., Asahi Kasei Pharma Corporation, The Mitsubishi 
      Foundation, and Suntory Global Innovation Center Ltd. Maegawa H has received 
      lecture fees from MSD K.K., Sanofi K.K., Astellas Pharma Inc., Nippon Boehringer 
      Ingelheim Co. Ltd., Takeda Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma 
      Corporation, Daiichi Sankyo Co. Ltd., Astra Zeneca K.K., Eli Lilly Japan K.K., 
      Novo Nordisk Pharma Ltd. and Sumitomo Dainippon Pharma Co. Ltd.; research support 
      from Astellas Pharma Inc., Astra Zeneca K.K., Nippon Boehringer Ingelheim Co. 
      Ltd., Sunstar Inc., Mitsubishi Tanabe Pharma Corporation, Kyowa Kirin Co. Ltd., 
      Nissan Chemical Corporation and MIKI Corporation; grants from Takeda 
      Pharmaceutical Co. Ltd., Astellas Pharma Inc., MSD K.K., Nippon Boehringer 
      Ingelheim Co. Ltd., Mitsubishi Tanabe Pharma Corporation, Daiichi Sankyo Co. 
      Ltd., Sumitomo Dainippon Pharma Co. Ltd., Kowa Pharmaceutical Co. Ltd., Taisho 
      Pharma Co. Ltd., Ono Pharmaceutical Co. Ltd., Sanofi K.K., Sanwa Kagaku Kenkyusho 
      Co. Ltd., Eli Lilly Japan K.K., Novo Nordisk Pharma Ltd., Bayer Yakuhin Ltd., 
      Teijin Pharma Limited, Shionogi & Co. Ltd., Novartis Pharma K.K. and Nipro 
      Corporation. Nakamura I and Uno S are employees of Astellas Pharma Inc.
EDAT- 2021/04/01 06:00
MHDA- 2021/04/01 06:01
PMCR- 2021/11/23
CRDT- 2021/03/31 06:41
PHST- 2020/08/21 00:00 [received]
PHST- 2020/10/12 00:00 [accepted]
PHST- 2021/03/31 06:41 [entrez]
PHST- 2021/04/01 06:00 [pubmed]
PHST- 2021/04/01 06:01 [medline]
PHST- 2021/11/23 00:00 [pmc-release]
AID - 470 [pii]
AID - 10.1007/s13340-020-00470-6 [doi]
PST - epublish
SO  - Diabetol Int. 2020 Nov 23;12(2):181-196. doi: 10.1007/s13340-020-00470-6. 
      eCollection 2021 Apr.