Study Compared Newly Initiated Use Of SGLT2 Inhibitor To New Initiation Of Another Class Of Diabetes Drugs To Assess The DKA Side Effect
All of these newer diabetes medicines are part of the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors class of drugs:
Invokamet (canagliflozin and metformin)
Invokamet XR (canagliflozin and metformin extended-release)
Xigduo XR (dapagliflozin and metformin extended-release)
Qtern (dapagliflozin and saxagliptin)
Glyxambi (empagliflozin and linagliptin)
Synjardy (empagliflozin and metformin hydrochloride)
Synjardy XR (empagliflozin and metformin hydrochloride)
The SGLT2 inhibitor class of diabetes drugs is approved by the FDA for treatment of type 2 diabetes (T2D).
A "To the Editor" letter in the June 8, 2017 edition of The New England Journal of Medicine (NEJM), titled "Risk of Diabetic Ketoacidosis after Initiation of an SGLT2 Inhibitor", is likely causing some concerns among doctors and patients about the safety of Jardiance, Invokana, Farxiga, and the other SGLT2 inhibitors.
From the start of that letter we get some introductory information about this drug-safety concern raised for these newer diabetes drugs:
Inhibitors of sodium–glucose cotransporter 2 (SGLT2) decrease plasma glucose by blocking the reabsorption of glucose at the proximal tubule. Case reports have suggested that SGLT2 inhibitors may be associated with an increased risk of diabetic ketoacidosis, which led to a warning from the Food and Drug Administration (FDA) in May 2015. The objective of our study was to assess the risk of diabetic ketoacidosis after the initiation of an SGLT2 inhibitor. [footnotes omitted]
A June 7, 2017 MedPage Today article, "Study Warns of Diabetic Ketoacidosis With SGLT2 Inhibitors in T2D", provides a summary and some commentary about the recent medical study which is described in this June 2017 NEJM letter to the editor:
The newest class of drugs for treating type 2 diabetes carries a greater risk for diabetic ketoacidosis compared to other classes of drugs, a new study suggests.
Newly initiated use of an SGLT2 inhibitor was associated with a roughly twofold greater risk of diabetic ketoacidosis versus new initiation of a DPP4 inhibitor (HR 2.2, 95% CI 1.4 to 3.6), according to Michael Fralick, MD, of Brigham and Women's Hospital, and colleagues....
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As background, these are the dipeptidyl peptidase IV (DPP-4) inhibitor drugs currently approved by the FDA:
Kombiglyze XR (saxagliptin and metformin HCl)
Kazano (alogliptin and metformin HCl)
Oseni (alogliptin and pioglitazone)
Glyxambi (empagliflozin and linagliptin)
Janumet XR (sitagliptin and metformin HCl)
Janumet (sitagliptin/ and metformin HCl)
Jentadueto (linagliptin and metformin HCl)
Returning to the MedPage Today article:
The research group also noted that patients who were prescribed SGLT2 inhibitors tended to be younger with fewer coexisting illnesses, although were more likely to be placed on insulin compared to patients on DPP4 inhibitors.
"The authors correctly remarked on the higher proportion of patients on insulin therapy in the SGLT2 group, since they may have been misclassified and may have been patients with type 1 diabetes or type 2 diabetes with insulin deficiency," Ronald Tamler, MD, medical director of the Clinical Diabetes Institute at Mount Sinai Health System, told MedPage Today, who was not involved with the study.
It is important to know that if diabetic ketoacidosis (DKA) is not treated, it can lead to severe illness or death. In more detail, possible complications of DKA include these medical conditions:
- Cerebral Edema (fluid buildup in the brain)
- Bowel Necrosis (death of bowel tissue due to low blood pressure)
We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for diabetes patients who have developed diabetic ketoacidosis (DKA), with or without cerebral edema and bowel necrosis.
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