PMID- 26894924
OWN - NLM
STAT- MEDLINE
DCOM- 20170310
LR  - 20210504
IS  - 1724-6059 (Electronic)
IS  - 1121-8428 (Linking)
VI  - 29
IP  - 3
DP  - 2016 Jun
TI  - The effect of dapagliflozin on renal function in patients with type 2 diabetes.
PG  - 391-400
LID - 10.1007/s40620-016-0261-1 [doi]
AB  - BACKGROUND: Dapagliflozin's antihyperglycemic effects are mediated by inhibition 
      of renal sodium-glucose cotransporter-2; therefore, renal safety of dapagliflozin 
      was assessed. METHODS: Twelve double-blind, placebo-controlled, randomized 
      clinical trials were analyzed up to 24 weeks (N = 4545). Six of the 12 studies 
      included long-term data for up to 102 weeks (N = 3036). Patients with type 2 
      diabetes with normal or mildly impaired renal function [estimated glomerular 
      filtration rate (eGFR) 60 to <90 mL/min/1.73 m(2)] were treated with 
      dapagliflozin (2.5, 5, or 10 mg/day) or placebo. Renal adverse events (AEs) were 
      assessed. RESULTS: Mean eGFR showed small transient reductions with dapagliflozin 
      at week 1, but returned to near baseline values by week 24 and remained stable to 
      week 102. Mean eGFR changes were not very different for dapagliflozin 2.5, 5 and 
      10 mg versus placebo at 102 weeks: -0.74, 2.52 and 1.38 versus 
      1.31 mL/min/1.73 m(2), respectively. Renal AEs were similar in frequency to 
      placebo through 24 weeks (1.4, 1.3, 0.9, and 0.9 %, respectively) and 102 weeks 
      (2.4, 1.8, 1.9 and 1.7 %, respectively). Few were serious (0.2, 0.1, 0 and 0.3 %, 
      respectively, over 102 weeks). The most common renal event was serum creatinine 
      increase. In sub-group analyses in patients >/=65 years of age or those with 
      moderate renal impairment (eGFR 30 to <60 mL/min/1.73 m(2)), renal AEs occurred 
      more frequently with dapagliflozin than placebo. No events of acute tubular 
      necrosis were reported. CONCLUSION: In patients with normal or mildly impaired 
      renal function, dapagliflozin is not associated with increased risk of acute 
      renal toxicity or deterioration of renal function. All trials included in this 
      analysis are registered at ClinicalTrials.gov: NCT00263276, NCT00972244, 
      NCT00528372, NCT00736879, NCT00528879, NCT00855166, NCT00357370, NCT00680745, 
      NCT00683878, NCT00673231, NCT00643851, NCT00859898.
FAU - Kohan, Donald Elliott
AU  - Kohan DE
AD  - Department of Internal Medicine, University of Utah Health Sciences Center, Salt 
      Lake City, UT, USA.
FAU - Fioretto, Paola
AU  - Fioretto P
AD  - Department of Medicine, University of Padua, Padua, Italy.
FAU - Johnsson, Kristina
AU  - Johnsson K
AD  - Global Medical Affairs, AstraZeneca, Molndal, Sweden.
FAU - Parikh, Shamik
AU  - Parikh S
AD  - Global Medical Affairs, AstraZeneca, Wilmington, DE, USA.
FAU - Ptaszynska, Agata
AU  - Ptaszynska A
AD  - Bristol-Myers Squibb, Research and Development, Route 206 and Provinceline Road, 
      Princeton, NJ, 08543, USA. agata.ptaszynska@bms.com.
FAU - Ying, Lisa
AU  - Ying L
AD  - Bristol-Myers Squibb, Research and Development, Route 206 and Provinceline Road, 
      Princeton, NJ, 08543, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00859898
SI  - ClinicalTrials.gov/NCT00528879
SI  - ClinicalTrials.gov/NCT00683878
SI  - ClinicalTrials.gov/NCT00357370
SI  - ClinicalTrials.gov/NCT00855166
SI  - ClinicalTrials.gov/NCT00736879
SI  - ClinicalTrials.gov/NCT00643851
SI  - ClinicalTrials.gov/NCT00528372
SI  - ClinicalTrials.gov/NCT00263276
SI  - ClinicalTrials.gov/NCT00673231
SI  - ClinicalTrials.gov/NCT00972244
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160219
PL  - Italy
TA  - J Nephrol
JT  - Journal of nephrology
JID - 9012268
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Glucosides)
RN  - 0 (Hypoglycemic Agents)
RN  - 1ULL0QJ8UC (dapagliflozin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Benzhydryl Compounds/*adverse effects
MH  - Blood Pressure/drug effects
MH  - Diabetes Mellitus, Type 2/*drug therapy/physiopathology
MH  - Double-Blind Method
MH  - Female
MH  - Glomerular Filtration Rate/drug effects
MH  - Glucosides/*adverse effects
MH  - Humans
MH  - Hypoglycemic Agents/*adverse effects
MH  - Kidney/*drug effects/physiopathology
MH  - Male
MH  - Middle Aged
OTO - NOTNLM
OT  - Dapagliflozin
OT  - Renal
OT  - SGLT2
OT  - Safety
EDAT- 2016/02/20 06:00
MHDA- 2017/03/11 06:00
CRDT- 2016/02/20 06:00
PHST- 2015/10/29 00:00 [received]
PHST- 2016/01/03 00:00 [accepted]
PHST- 2016/02/20 06:00 [entrez]
PHST- 2016/02/20 06:00 [pubmed]
PHST- 2017/03/11 06:00 [medline]
AID - 10.1007/s40620-016-0261-1 [pii]
AID - 10.1007/s40620-016-0261-1 [doi]
PST - ppublish
SO  - J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 
      19.