Serious adverse events of diabetic ketoacidosis (DKA) and related events occurred at low frequency among 17,596 patients from randomized studies treated with canagliflozin. Most patients with DKA and related events had blood glucose >300 mg/dL at presentation of DKA, were on insulin, and had DKA-precipitating factors, including some with type 1 diabetes.
• Serious adverse events were reported in 12 patients (0.07%), including 4 (0.07%), 6 (0.11%), and 2 (0.03%) treated with canagliflozin 100 and 300 mg and controls, respectively.
• Incidence rates were 0.522, 0.763, and 0.238 per 1,000 patient-years.
• Incidence was consistent with limited existing observational data in the general population with type 2 diabetes.
Citation: Erondu N, Desai M, Ways K, Meininger G. Diabetic ketoacidosis and related events in the canagliflozin type 2 diabetes clinical program. Diabetes Care. [Published online ahead of print July 22, 2015]. doi: 10.2337/dc15-1251.
1. FDA website. FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood. http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm Update May 15, 2015. Accessed August 7, 2015.
This Week's Must Reads
Must Reads in Endocrinology
Labeling of Selective Androgen Receptor Modulators, JAMA; 2017 Nov 28; Van Wagoner, Eichner, et al