SGLT2i-associated DKA flagged up in study
SGLT2i-associated DKA may not be limited to any particular “demographic or comorbid subpopulation”, according to a study.
The research, published in Diabetologia, also suggested the serious complication could “occur at any duration” during use of the type 2 diabetes drug. The conclusions were made following a trawl of data in the US.
In May 2015, the US Food and Drug Administration (FDA) warned that sodium-glucose cotransporter-2 inhibitors may lead to ketoacidosis requiring hospitalisation.
The alert came on the back of 20 cases of DKA in people treated with SGLT2 inhibitors from March 2013 to June 6, 2014.
In this new study, SGLT2 inhibitors and diabetic ketoacidosis: data from the FDA Adverse Event Reporting System, a detailed analysis was carried out of DKA reports where an SGLT2i was listed among suspect or concomitant drugs in the US Food and Drug Administration’s Adverse Event Reporting System (FAERS).
Researchers analysed the entire public FAERS up to September (third quarter (Q3)) 2016 to extract the number of reports, background indications and concomitant medications, and to calculate proportional reporting ratios (PRRs) and safety signals.
They then mined single FAERS files from the first quarter (Q1) of 2014 to 2016 Q3 to obtain detailed information on DKA reports.
The database contained more than 2,500 DKA reports in which a SGLT2i was listed as suspect or concomitant drug.
The study team concluded: “The proportional reporting ratio of DKA in reports including vs those not including an SGLT2i and having a diabetes indication was 7.9 (95% CI 7.5, 8.4) and was higher for type 1 diabetes.
“Several concomitant conditions were less prevalent in DKA reports with SGLT2i vs DKA reports filed for other drugs. A detailed analysis of 2397 DKA reports for SGLT2i from 2014 Q1 to 2016 Q3 revealed a predominance of women, an extremely wide range of age and body weight, and a highly variable duration of SGLT2i treatment before onset of DKA. In 37 individuals (1.54%), DKA was fatal.
“Based on the profile of these reports, SGLT2i-associated DKA may not be limited to any particular demographic or comorbid subpopulation and can occur at any duration of SGLT2i use.”
In April 2016 the UK government updated its advice on the risk of diabetic ketoacidosis from SGLT2 inhibitors. To view it, click here.