PMID- 28083972 OWN - NLM STAT- MEDLINE DCOM- 20180403 LR - 20210504 IS - 1463-1326 (Electronic) IS - 1462-8902 (Print) IS - 1462-8902 (Linking) VI - 19 IP - 6 DP - 2017 Jun TI - Renal safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus. PG - 897-900 LID - 10.1111/dom.12876 [doi] AB - The incidence of renal-related adverse events (AEs) with canagliflozin in patients with type 2 diabetes mellitus from a pooled population of patients in 7 active- and placebo-controlled trials (N = 5598) and in a 104-week study vs glimepiride (N = 1450) was low and similar in canagliflozin and non-canagliflozin groups. In the study vs glimepiride, canagliflozin was associated with an initial acute decrease in estimated glomerular filtration rate (eGFR) that attenuated over time, while eGFR declined progressively over 104 weeks with glimepiride. The incidence of renal-related AEs with canagliflozin was generally stable over time, while the incidence with glimepiride increased over 104 weeks. In the present analysis, based on postmarketing reports from the US Food and Drug Administration Adverse Event Reporting System, a potential signal was identified for acute kidney injury with all approved sodium glucose co-transporter 2 (SGLT2) inhibitors (ie, canagliflozin, dapagliflozin and empagliflozin). The early onset of acute kidney injury events with SGLT2 inhibitors in postmarketing reports probably reflects the acute changes in eGFR attibutable to the known renal haemodynamic effects of SGLT2 inhibition. CI - (c) 2017 Janssen Research & Development. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. FAU - Desai, Mehul AU - Desai M AUID- ORCID: 0000-0003-3489-1967 AD - Janssen Research & Development, LLC, Raritan, New Jersey. FAU - Yavin, Yshai AU - Yavin Y AD - Janssen Research & Development, LLC, Raritan, New Jersey. FAU - Balis, Dainius AU - Balis D AD - Janssen Research & Development, LLC, Raritan, New Jersey. FAU - Sun, Don AU - Sun D AD - Janssen Research & Development, LLC, Raritan, New Jersey. FAU - Xie, John AU - Xie J AD - Janssen Research & Development, LLC, Raritan, New Jersey. FAU - Canovatchel, William AU - Canovatchel W AD - Janssen Research & Development, LLC, Raritan, New Jersey. FAU - Rosenthal, Norm AU - Rosenthal N AD - Janssen Research & Development, LLC, Raritan, New Jersey. LA - eng PT - Evaluation Study PT - Journal Article DEP - 20170316 PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Benzhydryl Compounds) RN - 0 (Glucosides) RN - 0 (Hypoglycemic Agents) RN - 0 (Sodium-Glucose Transporter 2 Inhibitors) RN - 0 (Sulfonylurea Compounds) RN - 0SAC974Z85 (Canagliflozin) RN - 1ULL0QJ8UC (dapagliflozin) RN - 6KY687524K (glimepiride) RN - HDC1R2M35U (empagliflozin) SB - IM MH - Adult MH - Benzhydryl Compounds/adverse effects MH - Canagliflozin/*adverse effects MH - Diabetes Mellitus, Type 2/*drug therapy MH - Female MH - Glomerular Filtration Rate/drug effects MH - Glucosides/adverse effects MH - Humans MH - Hypoglycemic Agents/*adverse effects MH - Incidence MH - Kidney/drug effects MH - Kidney Diseases/*chemically induced/epidemiology MH - Male MH - Product Surveillance, Postmarketing MH - Randomized Controlled Trials as Topic MH - Sodium-Glucose Transporter 2 Inhibitors MH - Sulfonylurea Compounds/adverse effects MH - Time Factors PMC - PMC5485046 OTO - NOTNLM OT - SGLT2 inhibitor OT - type 2 diabetes EDAT- 2017/01/14 06:00 MHDA- 2018/04/04 06:00 PMCR- 2017/06/27 CRDT- 2017/01/14 06:00 PHST- 2016/11/16 00:00 [received] PHST- 2017/01/06 00:00 [revised] PHST- 2017/01/09 00:00 [accepted] PHST- 2017/01/14 06:00 [pubmed] PHST- 2018/04/04 06:00 [medline] PHST- 2017/01/14 06:00 [entrez] PHST- 2017/06/27 00:00 [pmc-release] AID - DOM12876 [pii] AID - 10.1111/dom.12876 [doi] PST - ppublish SO - Diabetes Obes Metab. 2017 Jun;19(6):897-900. doi: 10.1111/dom.12876. Epub 2017 Mar 16.