Thanks for posting that warning. I had read an article recently on this topic of increased risk of peri-operative DKA with SGLT2 Inhibitors.
The scary thing with this is:
a. That the patient’s blood sugar does not even need to be high for this to occur, and
b. There may not be the presence of ketones in the urine, as these drugs can inhibit excretion.
There are 2 simple bedside tests that you would normally do to monitor diabetic patients, regular finger prick blood glucose levels (BGL or BSL) and dipstick test for urine for ketones in the urine.
So that means that this class of drugs can basically mask DKA, as BGLs may be in the normal target range, or only slightly higher, and there may not be ketonuria present, 2 things you would normally expect to see with DKA & will only can be identified with a blood test.
So a very important warning, not only for peri-operative patients, but also when patients are on this class of drugs & are unwell also (see TGA/Govt link below), because it appears that traditional simple tests in the suspicion of DKA are not helpful for patients on SGLT2 inhibitors.
For people who want to know, below is a link to explain DKA, it’s life threatening & requires ICU/HDU admission.
SGLT2 inhibitors are not approved for use in Type 1 diabetes, not here in Australia or by the FDA for the USA, as these patients are more at risk of DKA.
AstraZenica’s drug Forxiga is approved for use as an adjunct in the EU & Japan for Type 1 DM with BGL not controlled well with insulin, so it’s restricted:
In type 1 diabetes, it appears that the risks outweigh the benefits of improvement in A1C, however it seems that there has been some off label use of SGLT2 Inhibitors for Type 1 DM & some countries have approved use in Type 1 DM.
Risks also are there for Type 2 DM patients on SGLT2 drugs for DKA, as noted in TGA & Diabetes Australia warning above, in part.
I think that people need to look at clinical trials, how they were designed & conducted, because results can look great depending on inclusion in statistical data (the foot ulcer thing was an eye opener with Invokana). Large open label trials for extra indications post market approval may identify safety and treatment concerns that previously were not identified and also on reports from Drs and Pharmacists of SAEs (serious adverse events) and AEs (Adverse Events).
I think it was @ArchibaldSheeran that mentioned the Big Pharma $$$ push behind SGLT2 drugs & that is exactly right, as it’s a multi-billion dollar market, especially now with CKD & CVD indications coming on board.
You also need to think about real life treatment situations where patients are not being monitored under clinical trial conditions; which @Prestonian has identified. Diabetes is a chronic and complex disease, so safety is extremely important. Patients on DMX-200 from past clinical trials have been on the drug for ~ 3 years. It’s also probably something to consider in the big scheme of things, because they wouldn’t be, without benefit & no longer under trial conditions.
GLTAH
DXB Price at posting:
26.5¢ Sentiment: Buy Disclosure: Held
(20min delay)