PMID- 34567926
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220427
IS  - 2190-1678 (Print)
IS  - 2190-1686 (Electronic)
IS  - 2190-1678 (Linking)
VI  - 12
IP  - 4
DP  - 2021 Oct
TI  - Real-world evidence for long-term safety and effectiveness of ipragliflozin in 
      treatment-naive versus non-naive Japanese patients with type 2 diabetes mellitus: 
      subgroup analysis of a 3-year post-marketing surveillance study (STELLA-LONG 
      TERM).
PG  - 430-444
LID - 10.1007/s13340-021-00501-w [doi]
AB  - BACKGROUND: STELLA-LONG TERM was a 3-year post-marketing surveillance study that 
      evaluated the long-term safety and effectiveness of ipragliflozin in Japanese 
      patients with type 2 diabetes mellitus (T2DM). This subgroup analysis examined 
      the safety and effectiveness of ipragliflozin in treatment-naive and non-naive 
      patients. MATERIALS AND METHODS: Patients were stratified into two subgroups: 
      treatment-naive (patients who had not received any antidiabetic drugs before 
      starting ipragliflozin monotherapy) and non-naive (all other patients). Patients 
      who had added or switched antidiabetic drugs during follow-up were excluded from 
      the analysis from that point. The incidence of adverse drug reactions (ADRs) and 
      changes from baseline in glycosylated hemoglobin (HbA1c), body weight, fasting 
      plasma glucose (FPG) and laboratory parameters were assessed. RESULTS: Of the 
      11,051 patients in the safety analysis set, 1980 patients (17.92%) were 
      treatment-naive and 9071 (82.08%) were non-naive. In the safety analysis set, 
      treatment-naive patients reported significantly lower incidences of ADRs (10.81% 
      vs 20.87%; p < 0.001) and serious ADRs (0.86% vs 2.09%; p < 0.001) compared with 
      non-naive patients, as well as significantly lower incidences of 
      polyuria/pollakiuria, volume depletion-related events, skin complications and 
      renal disorders. In the effectiveness analysis, sustained and significant 
      reductions from baseline to 36 months were observed in HbA1c, FPG and body weight 
      in both treatment-naive and non-naive patients (all p < 0.001 vs baseline). 
      CONCLUSIONS: Over 3 years, ipragliflozin was better tolerated in treatment-naive 
      than in non-naive Japanese patients with T2DM and had similar efficacy in these 
      populations. Therefore, ipragliflozin is a useful first-line treatment option for 
      patients with T2DM. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02479399. 
      SUPPLEMENTARY INFORMATION: The online version contains supplementary material 
      available at 10.1007/s13340-021-00501-w.
CI  - (c) The Japan Diabetes Society 2021.
FAU - Maegawa, Hiroshi
AU  - Maegawa H
AUID- ORCID: 0000-0002-4611-8149
AD  - Department of Medicine, Shiga University of Medical Science, Seta-tsukinowa-cho, 
      Otsu, Shiga 520-2192 Japan. GRID: grid.410827.8. ISNI: 0000 0000 9747 6806
FAU - Tobe, Kazuyuki
AU  - Tobe K
AD  - First Department of Internal Medicine, Graduate School of Medicine and 
      Pharmaceutical Sciences for Research, University of Toyama, Toyama, Japan. GRID: 
      grid.267346.2. ISNI: 0000 0001 2171 836X
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
SI  - ClinicalTrials.gov/NCT02479399
PT  - Journal Article
DEP - 20210324
PL  - Japan
TA  - Diabetol Int
JT  - Diabetology international
JID - 101553224
PMC - PMC8413411
OTO - NOTNLM
OT  - Ipragliflozin
OT  - Japan
OT  - Post-marketing surveillance study
OT  - Sodium-glucose transporter 2 inhibitors
OT  - Type 2 diabetes mellitus
COIS- Conflict of interestHM received lecture fees from MSD K.K., Nippon Boehringer 
      Ingelheim Co. Ltd., Mitsubishi Tanabe Pharma Corporation, Sanofi K.K., Astellas 
      Pharma Inc., Takeda Pharmaceutical Co. Ltd., Kowa Pharmaceutical Co. Ltd., 
      Daiichi Sankyo Co. Ltd., Novo Nordisk Pharma Ltd., Eli Lilly Japan K.K. and 
      Kissei Pharmaceutical Co. Ltd.; research support from Astellas Pharma Inc., Astra 
      Zeneca K.K., Nippon Boehringer Ingelheim Co. Ltd., Sunstar Inc., Mitsubishi 
      Tanabe Pharma Corporation, Kyowa Hakko 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., Kyowa Hakko 
      Kirin Co. Ltd., Taisho Pharma Co. Ltd., Kowa Pharmaceutical Co. Ltd., Ono 
      Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Sanofi K.K., Mitsubishi Tanabe 
      Pharma Corporation, Sanwa Kagaku Kenkyusho Co. Ltd., Eli Lilly Japan K.K., 
      Sumitomo Dainippon Pharma Co. Ltd., Novo Nordisk Pharma Ltd., Bayer Yakuhin Ltd., 
      Teijin Pharma Limited, Shionogi & Co. Ltd., Fuji Yakuhin Co. Ltd., Pfizer Inc., 
      MIKI Corporation, Mochida Pharmaceutical Co. Ltd., Novartis Pharma K.K. and Nipro 
      Corporation. KT 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. IN and SU are employees of 
      Astellas Pharma Inc.
EDAT- 2021/09/28 06:00
MHDA- 2021/09/28 06:01
PMCR- 2022/03/24
CRDT- 2021/09/27 06:13
PHST- 2020/12/07 00:00 [received]
PHST- 2021/02/25 00:00 [accepted]
PHST- 2021/09/27 06:13 [entrez]
PHST- 2021/09/28 06:00 [pubmed]
PHST- 2021/09/28 06:01 [medline]
PHST- 2022/03/24 00:00 [pmc-release]
AID - 501 [pii]
AID - 10.1007/s13340-021-00501-w [doi]
PST - epublish
SO  - Diabetol Int. 2021 Mar 24;12(4):430-444. doi: 10.1007/s13340-021-00501-w. 
      eCollection 2021 Oct.