July 27, 2015
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Rates of diabetic ketoacidosis low with Invokana therapy

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Diabetic ketoacidosis occurred with low frequency in patients treated with Invokana, according to recent study findings published in Diabetes Care.

“On May 15, the FDA issued a Drug Safety Communication based upon a search of the FDA Adverse Event Reporting System database that indicated that medicines for type 2 diabetes in the sodium glucose cotransporter-2 inhibitor class … may lead to ketoacidosis,” the researchers wrote. “The FDA also noted that patients may present atypically, with only slightly increased levels of blood glucose.”

Gary Meininger, MD, and colleagues from Janssen, analyzed data from 17,596 patients from randomized studies of Invokana (canagliflozin, Janssen) to determine the rate of serious adverse events among them.

Gary Meininger

Gary Meininger

Overall, 0.07% of participants were diagnosed with diabetic ketoacidosis and related events; 0.07% who received 100 mg canagliflozin, 0.11% who received 300 mg canagliflozin and 0.03% of those on a comparator.

Blood glucose levels were greater than 300 mg/dL at the presentation of diabetic ketoacidosis in most participants with diabetic ketoacidosis and related events. The participants also were likely on insulin and had diabetic ketoacidosis-precipitating factors.

“In summary, [diabetic ketoacidosis] and related events occurred at a low frequency in patients participating in the randomized controlled canagliflozin type 2 diabetes clinical trial program,” the researchers wrote. “Although there are limited epidemiological data on the incidence of [diabetic ketoacidosis] in patients with type 2 diabetes, the overall incidence rates of these events in the current analysis are consistent with the broad range reported in existing observational data.” – by Amber Cox

Disclosure: All researchers report being full-time employees of Janssen Research & Development LLC.