title: Renal safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus.
abstract: 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.
authors.affiliation: Janssen Research & Development, LLC, Raritan, New Jersey.
authors.forename: Mehul
authors.identifier: 0000-0003-3489-1967
authors.initials: M
authors.lastname: Desai
authors.affiliation: Janssen Research & Development, LLC, Raritan, New Jersey.
authors.forename: Yshai
authors.initials: Y
authors.lastname: Yavin
authors.affiliation: Janssen Research & Development, LLC, Raritan, New Jersey.
authors.forename: Dainius
authors.initials: D
authors.lastname: Balis
authors.affiliation: Janssen Research & Development, LLC, Raritan, New Jersey.
authors.forename: Don
authors.initials: D
authors.lastname: Sun
authors.affiliation: Janssen Research & Development, LLC, Raritan, New Jersey.
authors.forename: John
authors.initials: J
authors.lastname: Xie
authors.affiliation: Janssen Research & Development, LLC, Raritan, New Jersey.
authors.forename: William
authors.initials: W
authors.lastname: Canovatchel
authors.affiliation: Janssen Research & Development, LLC, Raritan, New Jersey.
authors.forename: Norm
authors.initials: N
authors.lastname: Rosenthal
mesh_terms: D000328:Adult; D001559:Benzhydryl Compounds / Q000009:adverse effects; D000068896:Canagliflozin / Q000009:adverse effects*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D005960:Glucosides / Q000009:adverse effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects*; D015994:Incidence; D007668:Kidney / Q000187:drug effects; D007674:Kidney Diseases / Q000139:chemically induced* / Q000453:epidemiology; D008297:Male; D011358:Product Surveillance, Postmarketing; D016032:Randomized Controlled Trials as Topic; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D013453:Sulfonylurea Compounds / Q000009:adverse effects; D013997:Time Factors
chemical_list: D001559:Benzhydryl Compounds; D005960:Glucosides; D007004:Hypoglycemic Agents; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D013453:Sulfonylurea Compounds; D000068896:Canagliflozin; C529054:dapagliflozin; C057619:glimepiride; C570240:empagliflozin
keywords: 
  SGLT2 inhibitor; type 2 diabetes