AACE/ACE advise no change in recommendations for SGLT-2 inhibitors following meeting on DKA risk – October 27, 2015

AACE/ACE announced today that they do not advise any changes to current recommendations for SGLT-2 inhibitor use following last weekend’s meeting on the risk of diabetic ketoacidosis (DKA). The expert writing committee concluded that based on available evidence, the prevalence of DKA with SGLT-2 inhibitors is infrequent and the risk/benefit ratio “overwhelmingly favors” continued use of the class. The group called on pharmaceutical companies to continue investigating the mechanisms behind the risk and encouraged all stakeholders to continue educating providers about how to identify and treat DKA, especially DKA that occurs at lower-than-expected blood glucose levels. AACE/ACE also released a more extensive summary with specific information on likely precipitating factors (insulin deficiency, surgery, extensive exercise, stressful medical conditions), diagnostic methods (direct measurements of beta-hydroxybutyrate and arterial pH to confirm a diagnosis made by bicarbonate or urine ketone measurements), and recommendations to minimize the risk (stopping the drug before anticipated triggers, avoiding excess alcohol and ketogenic diets). The committee did not recommend routine ketone monitoring for patients with type 2 diabetes on SGLT-2 inhibitors.

We were very glad to see that the summary also addressed the use of SGLT-2 inhibitors in type 1 diabetes. While emphasizing that the class is not approved for this indication, the group encouraged the continuation of ongoing studies in type 1 diabetes, citing promising benefits from initial trials. They also outlined specific recommendations to minimize the risk of DKA in this population, including in the case of off-label use. These include use of lower SGLT-2 inhibitor doses, more conservative adjustment of insulin doses, and maintenance of carbohydrate intake. This impressively comprehensive and specific set of conclusions is exactly what we had hoped would come out of this meeting, and we too encourage everyone in the diabetes field to help transmit them as widely as possible. We also believe it’s very important to educate patients about DKA risk – many, many patients do not have the slightest idea what normal ketone levels are and wouldn’t know what a ketone meter looked like if it bit them (or for that matter a strip!). While active ketone monitoring may not be required in type 2 diabetes, it is more likely that it would be part of the equation in type 1. AACE/ACE plan to publish a complete white paper with clinical recommendations in a future issue of Endocrine Practice and we do hope that patient education becomes more of a priority to ensure optimal management.

-- by Emily Regier and Kelly Close