PMID- 26948203
OWN - NLM
STAT- MEDLINE
DCOM- 20170306
LR  - 20170306
IS  - 1878-0334 (Electronic)
IS  - 1871-4021 (Linking)
VI  - 10
IP  - 3
DP  - 2016 Jul-Sep
TI  - Effects of body mass index or dosage on gastrointestinal disorders associated 
      with extended-release metformin in type 2 diabetes: Sub-analysis of a Phase IV 
      open-label trial in Chinese patients.
PG  - 137-42
LID - S1871-4021(16)30001-7 [pii]
LID - 10.1016/j.dsx.2016.01.004 [doi]
AB  - AIM: To determine whether gastrointestinal (GI) tolerability of metformin 
      monotherapy varies according to baseline BMI or at doses >1500mg/day in patients 
      newly diagnosed with type 2 diabetes. METHODS: We performed a sub-analysis of the 
      safety population from a prospective, multicenter, Phase IV open-label study in 
      which 371 Chinese patients with type 2 diabetes received extended-release 
      metformin monotherapy for 16 weeks. The incidence, severity and duration of GI 
      adverse events (AEs) were compared between normal-weight (BMI<25kg/m(2), n=155) 
      and overweight/obese (BMI>/=25kg/m(2), n=216) patients. The primary objective was 
      to determine whether baseline BMI affect the incidence, severity and duration of 
      GI AEs, using Fisher's exact test and Student's t-test. Secondary objectives were 
      to compare these factors according to final metformin dose (</=1500mg/day versus 
      2000mg/day). RESULTS: The proportion of patients who reported >/=1 GI AE did not 
      differ significantly between BMI groups (25.2% of the normal-weight group versus 
      21.3% of the overweight/obese group; p=0.3840). Patients who reported GI AEs in 
      the two BMI groups experienced similar GI AE severity (p=0.5410), mean duration 
      (p=0.3572) and duration distribution (p=0.1347). There was no significant 
      difference in GI AE severity and duration between metformin dosage groups 
      (</=1500mg/day versus 2000mg/day). CONCLUSIONS: Newly-diagnosed Chinese type 2 
      diabetes patients of normal weight are no more likely than overweight/obese 
      patients to suffer from increased incidence rates, severity or duration of GI AEs 
      when treated with first-line extended-release metformin monotherapy. Doses of 
      2000mg/day did not increase the severity or duration of GI AEs.
CI  - Copyright (c) 2016 Diabetes India. Published by Elsevier Ltd. All rights reserved.
FAU - Guo, Lixin
AU  - Guo L
AD  - Department of Endocrinology, Beijing Hospital of the Ministry of Health, Beijing, 
      China.
FAU - Guo, Xiaohui
AU  - Guo X
AD  - Department of Endocrinology, Peking University First Hospital, Beijing, China.
FAU - Li, Yan
AU  - Li Y
AD  - Department of Endocrinology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen 
      University, Guangzhou, China.
FAU - Hong, Xu
AU  - Hong X
AD  - Department of Endocrinology, Beijing Friendship Hospital, Capital Medical 
      University, Beijing, China.
FAU - Jiang, Xiaozhen
AU  - Jiang X
AD  - Department of Endocrinology, Shanghai Pudong New Area People's Hospital, 
      Shanghai, China.
FAU - Su, Qing
AU  - Su Q
AD  - Department of Endocrinology, Xin Hua Hospital Affiliate to Shanghai Jiao Tong 
      University School of Medicine, Shanghai, China.
FAU - Zhao, Dong
AU  - Zhao D
AD  - Department of Endocrinology, The Luhe Teaching Hospital of the Capital Medical 
      University, Beijing, China.
FAU - Wu, Xiaojing
AU  - Wu X
AD  - Department of Biostatistics, PPD Pharmaceutical Development (Beijing) Co, Ltd, 
      Beijing, China.
FAU - Ji, Linong
AU  - Ji L
AD  - Department of Endocrinology and Metabolism, Peking University People's Hospital, 
      No 11, Xizhimen South Street, Beijing, 100044, China. Electronic address: 
      jilinong@gmail.com.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
DEP - 20160114
PL  - Netherlands
TA  - Diabetes Metab Syndr
JT  - Diabetes & metabolic syndrome
JID - 101462250
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Body Mass Index
MH  - Diabetes Mellitus, Type 2/complications/*drug therapy
MH  - Female
MH  - Gastrointestinal Diseases/*chemically induced/epidemiology
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Metformin/administration & dosage/*adverse effects/toxicity
MH  - Middle Aged
MH  - No-Observed-Adverse-Effect Level
MH  - Obesity/complications
MH  - Overweight/complications
OTO - NOTNLM
OT  - Adverse drug event
OT  - Chinese
OT  - Diabetes mellitus
OT  - Gastrointestinal
OT  - Glucophage
OT  - type 2
EDAT- 2016/03/08 06:00
MHDA- 2017/03/07 06:00
CRDT- 2016/03/08 06:00
PHST- 2016/01/08 00:00 [received]
PHST- 2016/01/09 00:00 [accepted]
PHST- 2016/03/08 06:00 [entrez]
PHST- 2016/03/08 06:00 [pubmed]
PHST- 2017/03/07 06:00 [medline]
AID - S1871-4021(16)30001-7 [pii]
AID - 10.1016/j.dsx.2016.01.004 [doi]
PST - ppublish
SO  - Diabetes Metab Syndr. 2016 Jul-Sep;10(3):137-42. doi: 10.1016/j.dsx.2016.01.004. 
      Epub 2016 Jan 14.