PMID- 30095664
OWN - NLM
STAT- MEDLINE
DCOM- 20180905
LR  - 20221207
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 97
IP  - 32
DP  - 2018 Aug
TI  - Clinical adverse effects of sodium-glucose cotransporter 2 inhibitors: Protocol 
      for a systematic review and meta-analysis.
PG  - e11853
LID - 10.1097/MD.0000000000011853 [doi]
LID - e11853
AB  - BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a novel class 
      of oral antidiabetic drugs, which mainly increase urinary glucose excretion 
      through reducing renal glucose reabsorption. There is still a concern about the 
      overall safety profile of SGLT2 inhibitors. In this systematic review and 
      meta-analysis, we will assess the clinical adverse effects of SGLT2 inhibitors in 
      type 2 diabetes mellitus. METHODS: This systemic review and meta-analysis 
      described in this protocol will be conducted to follow the Preferred Reporting 
      Items for Systematic Reviews and Meta-Analyses guideline. We will search Medline, 
      EMbase, the Cochrane library and the ClinicalTrials.gov Website from 1946 to June 
      2018. Studies will be screened by title, abstract, and full text independently in 
      duplicate. Double-blinded, placebo-controlled, and randomized controlled trials 
      reporting safety data of SGLT2 inhibitors will be eligible for inclusion. 
      Outcomes will include adverse events (AEs) varying degrees and AEs occurring in 
      >/=3% patients or AEs aroused concerns by the Food and Drug Administration (FDA). 
      The assessment of risk bias and data synthesis will be performed using STATA 
      software (version12, Statacorp, College Station, TX). Outcomes will be reported 
      by risk ratios for dichotomous outcomes and weighted mean difference (WMD) for 
      continuous outcomes and their 95% confidence intervals. Subgroup, sensitivity, 
      regression analyses will be performed to evaluate intertrial heterogeneity and 
      bias of the results. I statistic will be used to evaluate heterogeneity among 
      studies. RESULTS: This systemic review and meta-analysis will evaluate AEs 
      occurring in >/=3% patients or AEs aroused concerns by the FDA of SGLT2i as 
      compared to placebo. CONCLUSION: Our study will provide a comprehensive picture 
      of AEs of SGLT2 inhibitors.
FAU - Li, Hao
AU  - Li H
AD  - Department of Pharmacy, Shanghai Children's Medical Center, Shanghai Jiao Tong 
      University School of Medicine Department of Pharmacy, Renji Hospital, School of 
      Medicine, Shanghai Jiaotong University, Shanghai, P.R. China.
FAU - Shi, Fang-Hong
AU  - Shi FH
FAU - Huang, Shi-Ying
AU  - Huang SY
FAU - Zhang, Shun-Guo
AU  - Zhang SG
FAU - Gu, Zhi-Chun
AU  - Gu ZC
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
SB  - IM
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Glycated Hemoglobin
MH  - Humans
MH  - Hypoglycemic Agents/*adverse effects/therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Research Design
MH  - *Sodium-Glucose Transporter 2 Inhibitors
MH  - Systematic Reviews as Topic
PMC - PMC6133482
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2018/08/11 06:00
MHDA- 2018/09/06 06:00
PMCR- 2018/08/10
CRDT- 2018/08/11 06:00
PHST- 2018/08/11 06:00 [entrez]
PHST- 2018/08/11 06:00 [pubmed]
PHST- 2018/09/06 06:00 [medline]
PHST- 2018/08/10 00:00 [pmc-release]
AID - 00005792-201808100-00055 [pii]
AID - MD-D-18-04920 [pii]
AID - 10.1097/MD.0000000000011853 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2018 Aug;97(32):e11853. doi: 10.1097/MD.0000000000011853.