PMID- 28669071
OWN - NLM
STAT- MEDLINE
DCOM- 20190118
LR  - 20221207
IS  - 1435-5922 (Electronic)
IS  - 0944-1174 (Linking)
VI  - 53
IP  - 1
DP  - 2018 Jan
TI  - Effects of canagliflozin, an SGLT2 inhibitor, on hepatic function in Japanese 
      patients with type 2 diabetes mellitus: pooled and subgroup analyses of clinical 
      trials.
PG  - 140-151
LID - 10.1007/s00535-017-1364-8 [doi]
AB  - BACKGROUND: We aimed to investigate the efficacy of canagliflozin (based on its 
      effect on liver function and blood glucose levels) and its safety in high alanine 
      aminotransferase (ALT) patients (ALT >30 U/L). METHODS: This post hoc analysis of 
      canagliflozin in type 2 diabetes mellitus (T2DM) patients was divided into Study 
      1 (pooled analysis of 12- and 24-week placebo-controlled, monotherapy studies) 
      and Study 2 (52-week monotherapy/combination therapy study). The canagliflozin 
      100 mg group data were compared with placebo or baseline ALT subgroup (baseline 
      ALT >30 or </=30 U/L) data. The primary endpoint was change in ALT level from 
      baseline. Secondary endpoints were changes in efficacy-related parameters. 
      Adverse events (AEs) were evaluated. RESULTS: The mean ALT change at 12 weeks was 
      -10.3 +/- 11.7 and -3.2 +/- 17.6 U/L in the canagliflozin vs. placebo group in the 
      high ALT subgroup (P = 0.0206); no significant difference was shown in the low 
      ALT subgroup (Study 1). In both ALT subgroups, glycosylated hemoglobin (HbA1c) 
      and body weight were significantly reduced in the canagliflozin vs. placebo group 
      (all P < 0.0001). The mean change in ALT at 52 weeks was -16.0 +/- 18.8 U/L in the 
      high ALT subgroup (P < 0.0001, Study 2). The incidence of AEs or serious AEs in 
      the high ALT subgroup in the canagliflozin group was similar to that in the 
      placebo group (Study 1) or low ALT subgroup (Studies 1 and 2). CONCLUSIONS: In 
      T2DM patients with impaired liver function, canagliflozin may improve liver 
      function, reduce HbA1c and body weight, and be well tolerated.
FAU - Seko, Yuya
AU  - Seko Y
AD  - Department of Gastroenterology and Hepatology, Kyoto Prefectural University of 
      Medicine, Kyoto, Japan. yuyaseko@koto.kpu-m.ac.jp.
FAU - Sumida, Yoshio
AU  - Sumida Y
AD  - Department of Gastroenterology and Hepatology, Kyoto Prefectural University of 
      Medicine, Kyoto, Japan.
FAU - Sasaki, Kazuyo
AU  - Sasaki K
AD  - Mitsubishi Tanabe Pharma Corporation, Osaka, Japan.
FAU - Itoh, Yoshito
AU  - Itoh Y
AD  - Department of Gastroenterology and Hepatology, Kyoto Prefectural University of 
      Medicine, Kyoto, Japan.
FAU - Iijima, Hiroaki
AU  - Iijima H
AD  - Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
FAU - Hashimoto, Toshio
AU  - Hashimoto T
AD  - Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
FAU - Ishii, Shinichi
AU  - Ishii S
AD  - Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
FAU - Inagaki, Nobuya
AU  - Inagaki N
AD  - Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate 
      School of Medicine, Kyoto, Japan.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20170701
PL  - Japan
TA  - J Gastroenterol
JT  - Journal of gastroenterology
JID - 9430794
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 0SAC974Z85 (Canagliflozin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Blood Glucose/drug effects
MH  - Body Weight/drug effects
MH  - Canagliflozin/*administration & dosage/adverse effects/pharmacology
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects/pharmacology
MH  - Liver Diseases/drug therapy/physiopathology
MH  - Liver Function Tests
MH  - Male
MH  - Middle Aged
MH  - Randomized Controlled Trials as Topic
MH  - Sodium-Glucose Transporter 2 Inhibitors/*administration & dosage/adverse 
      effects/pharmacology
OTO - NOTNLM
OT  - Alanine aminotransferase
OT  - Canagliflozin
OT  - Hepatic function
OT  - Japan
OT  - Type 2 diabetes mellitus
EDAT- 2017/07/03 06:00
MHDA- 2019/01/19 06:00
CRDT- 2017/07/03 06:00
PHST- 2016/09/30 00:00 [received]
PHST- 2017/06/18 00:00 [accepted]
PHST- 2017/07/03 06:00 [pubmed]
PHST- 2019/01/19 06:00 [medline]
PHST- 2017/07/03 06:00 [entrez]
AID - 10.1007/s00535-017-1364-8 [pii]
AID - 10.1007/s00535-017-1364-8 [doi]
PST - ppublish
SO  - J Gastroenterol. 2018 Jan;53(1):140-151. doi: 10.1007/s00535-017-1364-8. Epub 
      2017 Jul 1.