PMID- 27625142
OWN - NLM
STAT- MEDLINE
DCOM- 20180402
LR  - 20210504
IS  - 1753-0407 (Electronic)
IS  - 1753-0407 (Linking)
VI  - 9
IP  - 8
DP  - 2017 Aug
TI  - Efficacy and safety of dapagliflozin in Asian patients: A pooled analysis.
PG  - 787-799
LID - 10.1111/1753-0407.12484 [doi]
AB  - BACKGROUND: The efficacy and safety of dapagliflozin, a sodium-glucose 
      cotransporter 2 inhibitor, has been demonstrated predominantly in Western 
      populations. This study examined the efficacy and safety of dapagliflozin in 
      Asian patients with type 2 diabetes mellitus (T2DM) from eight Phase IIb/III 
      double-blind trials of up to 24 weeks, treated with placebo (n = 497) or 
      dapagliflozin 5 mg (n = 491) or 10 mg (n = 465). METHODS: Efficacy was assessed 
      in the pooled population receiving dapagliflozin 5, 10 mg or placebo over 24 
      weeks. Safety and tolerability were assessed by collating data for overall 
      adverse events (AEs) and AEs of special interest over the 24-week period. 
      RESULTS: Demographic and baseline characteristics were comparable across 
      treatment groups. Placebo-corrected adjusted mean changes from baseline at 24 
      weeks in the dapagliflozin 5 and 10 mg groups, respectively, were -0.52% and 
      -0.58% for HbA1c and -1.34 and -1.80 kg for body weight. Modest reductions in 
      blood pressure were also noted with dapagliflozin. Overall, 56.5%, 53.6%, and 
      58.7% of patients in the placebo and dapagliflozin 5 and 10 mg groups, 
      respectively, experienced AEs, compared with 2.8%, 4.1%, and 2.4% experiencing 
      serious AEs. Genital infections were more frequent with dapagliflozin 10 mg than 
      placebo, whereas the pattern for urinary tract infections was less clear. A 
      transient reduction in mean estimated glomerular filtration rate was noted with 
      dapagliflozin, but was not associated with an increased frequency of serious 
      renal AEs. In contrast, placebo-corrected reductions in urinary albumin : 
      creatinine ratio in patients with albuminuria at baseline suggest a potential 
      renoprotective effect of dapagliflozin. CONCLUSION: Dapagliflozin was efficacious 
      and well tolerated in Asian patients with T2DM.
CI  - (c) 2016 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John 
      Wiley & Sons Australia, Ltd.
FAU - Yang, Wenying
AU  - Yang W
AD  - China-Japan Friendship Hospital, Beijing, China.
FAU - Ji, Linong
AU  - Ji L
AD  - Peking University People's Hospital, Beijing, China.
FAU - Zhou, Zhiguang
AU  - Zhou Z
AD  - The Second Xiangya Hospital of Central South University, Changsha, China.
FAU - Cain, Valerie A
AU  - Cain VA
AD  - AstraZeneca, Wilmington, Delaware, USA.
FAU - Johnsson, Kristina M
AU  - Johnsson KM
AD  - AstraZeneca-Gothenburg, Molndal, Sweden.
FAU - Sjostrom, C David
AU  - Sjostrom CD
AD  - AstraZeneca-Gothenburg, Molndal, Sweden.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20161114
PL  - Australia
TA  - J Diabetes
JT  - Journal of diabetes
JID - 101504326
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Glucosides)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Placebos)
RN  - 1ULL0QJ8UC (dapagliflozin)
SB  - IM
MH  - Aged
MH  - Asia
MH  - Benzhydryl Compounds/adverse effects/*therapeutic use
MH  - Diabetes Mellitus, Type 2/*drug therapy/ethnology
MH  - Female
MH  - Glucosides/adverse effects/*therapeutic use
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Placebos
OTO - NOTNLM
OT  - Asian
OT  - dapagliflozin
OT  - efficacy
OT  - safety
OT  - sodium-glucose cotransporter 2 (SGLT2) inhibitors
OT  - 亚洲
OT  - 安全性
OT  - 有效性
OT  - 达格列净
OT  - 钠-葡萄糖共转运体-2抑制剂
EDAT- 2016/09/15 06:00
MHDA- 2018/04/03 06:00
CRDT- 2016/09/15 06:00
PHST- 2016/03/14 00:00 [received]
PHST- 2016/08/02 00:00 [revised]
PHST- 2016/09/08 00:00 [accepted]
PHST- 2016/09/15 06:00 [pubmed]
PHST- 2018/04/03 06:00 [medline]
PHST- 2016/09/15 06:00 [entrez]
AID - 10.1111/1753-0407.12484 [doi]
PST - ppublish
SO  - J Diabetes. 2017 Aug;9(8):787-799. doi: 10.1111/1753-0407.12484. Epub 2016 Nov 
      14.