SGLT2 Inhibitor–Associated Euglycemic Diabetic Ketoacidosis: A South Australian Clinical Case Series and Australian Spontaneous Adverse Event Notifications

Meyer, Emily J.; Gabb, Genevieve; Jesudason, David

doi:10.2337/dc17-1721

Cited by 95 publications

(87 citation statements)

References 5 publications

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“…39 It was recently reported that euglycaemic diabetic ketoacidosis occurs in both patients with T1DM and patients with T2DM being treated with SGLT2 inhibitors. 40 group, which is similar to the 52-week data in DEPICT-1 (40.2% and 42.1%, respectively). There were also clinically meaningful reductions from baseline in both total daily insulin dosage and body weight, and these effects were maintained over 52 weeks.…”

Section: Discussionsupporting

confidence: 83%

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Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT‐5): 52‐week results from a randomized, open‐label, phase III clinical trial

Araki

Watada

Uchigata

et al. 2019

Diabetes Obesity Metabolism

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Aims To investigate the safety and tolerability of 5 and 10 mg dapagliflozin added to insulin therapy over 52 weeks in Japanese patients with inadequately controlled type 1 diabetes mellitus (T1DM). Materials and methods This randomized, open‐label, parallel‐group, multicentre phase III clinical trial was conducted from October 26, 2015 to June 15, 2017. The primary endpoint was the occurrence of adverse events such as hypoglycaemia and diabetic ketoacidosis. Secondary endpoints included changes in glycaemic parameters, total daily insulin dosage and body weight over time. The efficacy of dapagliflozin in patients stratified by body mass index (BMI) <25.0 and ≥25.0 kg/m2 was evaluated in a subgroup analysis. Results In total, 151 patients received 5 mg (n = 76) or 10 mg (n = 75) dapagliflozin once daily for 52 weeks. Adverse events were observed in 88.2% and 73.3% of patients in the 5 and 10 mg dapagliflozin groups, respectively. Severe hypoglycaemia was reported in 2.6% (n = 2) and 6.7% (n = 5) of patients, and diabetic ketoacidosis in 2.6% (n = 2) and 1.3% (n = 1) of patients in the 5 and 10 mg dapagliflozin groups, respectively. The adjusted mean (95% confidence interval) changes in glycated haemoglobin at week 52 were −0.33% (−0.50, −0.15) and −0.36% (−0.53, −0.18) in the 5 and 10 mg dapagliflozin groups, respectively. There were no differences in efficacy parameters when stratified by BMI. Conclusions This study demonstrated the long‐term safety and tolerability of dapagliflozin added to insulin therapy in Japanese patients with inadequately controlled T1DM.

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Section: Discussionsupporting

confidence: 83%

“…It was recently reported that euglycaemic diabetic ketoacidosis occurs in both patients with T1DM and patients with T2DM being treated with SGLT2 inhibitors . In this study, the three patients who developed diabetic ketoacidosis experienced euglycaemic diabetic ketoacidosis.…”

Section: Discussionmentioning

confidence: 72%

Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT‐5): 52‐week results from a randomized, open‐label, phase III clinical trial

Araki

Watada

Uchigata

et al. 2019

Diabetes Obesity Metabolism

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“…In severe COVID 19 infection, the hypoxic state may further increase the risk of lactic acidosis. Although there are no specific data on sodium-glucose cotransporter 2 (SGLT2) inhibitor use during COVID-19 infection, it is advisable to withhold these during acute illness because of the increased risk of dehydration and euglycaemic ketoacidosis [52,53], as well as difficulties in maintaining usual perineal hygiene. Glucagon-like peptide-1 receptor agonist (GLP-1RA) therapy should probably be temporarily discontinued in patients with haemodynamic instability (which compromises absorption from subcutaneous sites), renal dysfunction, and gastrointestinal dysfunction (which prevents adequate oral intake).…”

Section: Management Of Patients With Diabetes and Covid-19mentioning

confidence: 99%

Prevention and management of COVID-19 among patients with diabetes: an appraisal of the literature

et al. 2020

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The coronavirus disease 2019 (COVID-19) pandemic has emerged as one of the greatest challenges faced by humankind in the recent past. People with diabetes and related comorbidities are at increased risk of its complications and of COVID-19-related death. Older age, multi-morbidity, hyperglycaemia, cardiac injury and severe inflammatory response are predictors of poor outcome. The complex interplay between COVID-19, diabetes and the effects of related therapies is being explored. Most patients experience a mild illness with COVID-19, while people with diabetes are at increased risk of severe disease. Optimising glycaemic control and adopting measures to prevent disease spread are critical aspects. The management of mild disease is supportive, while very many immunomodulatory and antiviral therapies are being investigated for the treatment of severe disease. Several of these agents have specific considerations for use in people with diabetes. Since mass population lockdowns are considered a key step in controlling disease spread, it follows that, in addition to the direct vulnerability to severe COVID-19, people with diabetes can be affected by limited access to healthcare, insulin, other medications and blood glucose monitoring equipment. Measures to prevent disease spread at the individual and community level are the key to mitigating the rapidly escalating pandemic, while agents for chemoprophylaxis and vaccines are being explored. People with diabetes should be recognised as a vulnerable group for complicated disease and are at risk during times of disturbed social systems. Strategies are needed to safeguard the health of patients with diabetes during the pandemic. This review summarises the current knowledge and perceived challenges for prevention and management of COVID-19 in people with diabetes.

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“…Euglycemic diabetic ketoacidosis can result in delayed diagnosis and treatment, as well as potential for adverse metabolic consequences 17. Since the recent introduction of the SGLT2 inhibitors, several case reports and series describing euglycemic diabetic ketoacidosis in patients treated with these agents have been published 212223. The entity of euglycemic diabetic ketoacidosis is not limited to patients using SGLT2 inhibitors, however, as it has also been described in the setting of alcohol use disorders, pregnancy, and chronic liver disease 924…”

Section: Epidemiologymentioning

confidence: 99%

Diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome: review of acute decompensated diabetes in adult patients

French

Donihi

Korytkowski

2019

BMJ

136

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Diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome (HHS) are life threatening complications that occur in patients with diabetes. In addition to timely identification of the precipitating cause, the first step in acute management of these disorders includes aggressive administration of intravenous fluids with appropriate replacement of electrolytes (primarily potassium). In patients with diabetic ketoacidosis, this is always followed by administration of insulin, usually via an intravenous insulin infusion that is continued until resolution of ketonemia, but potentially via the subcutaneous route in mild cases. Careful monitoring by experienced physicians is needed during treatment for diabetic ketoacidosis and HHS. Common pitfalls in management include premature termination of intravenous insulin therapy and insufficient timing or dosing of subcutaneous insulin before discontinuation of intravenous insulin. This review covers recommendations for acute management of diabetic ketoacidosis and HHS, the complications associated with these disorders, and methods for preventing recurrence. It also discusses why many patients who present with these disorders are at high risk for hospital readmissions, early morbidity, and mortality well beyond the acute presentation.

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SGLT2 Inhibitor–Associated Euglycemic Diabetic Ketoacidosis: A South Australian Clinical Case Series and Australian Spontaneous Adverse Event Notifications

Cited by 95 publications

References 5 publications

Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT‐5): 52‐week results from a randomized, open‐label, phase III clinical trial

Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT‐5): 52‐week results from a randomized, open‐label, phase III clinical trial

Prevention and management of COVID-19 among patients with diabetes: an appraisal of the literature

Diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome: review of acute decompensated diabetes in adult patients

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