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Empagliflozin/metformin was approved for use in the European Union in May 2015. [5] Empagliflozin/metformin was approved for use in the United States in August 2015. [6] [11] The extended release version was approved for use in the United States in December 2016. [12] [13] Empagliflozin/metformin was approved for use in Australia in May 2020. [2]
65% (300 mg dose) 99%: 1–2: 10.6 (100 mg dose); 13.1 (300 mg dose) 1096 ng/mL (100 mg dose); 3480 ng/mL (300 mg dose) 250 fold Dapagliflozin: 78%: 91%: 1–1.5: 12.9: 79.6 ng/mL (5 mg dose); 165.0 ng/mL (10 mg dose) 1200 fold Empagliflozin: 90–97% (mice); 89% (dogs); 31% (rats) 86.20%: 1.5: 13.2 (10 mg dose); 13.3h (25 mg dose)
Empagliflozin is an inhibitor of the sodium glucose co-transporter-2 (SGLT-2), and works by increasing sugar loss in urine. [2] Empagliflozin was approved for medical use in the United States and in the European Union in 2014. [13] [23] [24] It is on the World Health Organization's List of Essential Medicines. [25]
An analysis by KFF, a private nonprofit health policy organization, found that of the 167 million people with employer health insurance, 3.4 million took one of 10 drugs negotiated by Medicare.
To reduce the risk of developing ketoacidosis (a serious condition where the body produces high levels of blood acids called ketones) after surgery, the FDA has approved changes to the prescribing information for SGLT2 inhibitor diabetes medications, recommending they be temporarily stopped before scheduled surgery.
The most common side effects include urinary infections, nasopharyngitis, and upper respiratory tract infections . [5] [6] The most serious side effects include ketoacidosis (high blood levels of acids called ‘ketoacids’), pancreatitis (inflammation of the pancreas), hypersensitivity (allergic reactions) and hypoglycaemia (low blood sugar levels).
Dapagliflozin is used along with diet, exercise, and usually with other glucose-lowering medications, to improve glycaemic control in adults with type 2 diabetes. . Dapagliflozin, in addition to other SGLT2-inhibitors, was shown to reduce the rate of decline in kidney function and kidney failure in non-diabetic and type 2 diabetic adults when added to the existing treatment
The results from meta-analysis when canagliflozin was examined, showed that compared to a placebo, canagliflozin affects HbA1c. Meta-analysis studies also showed that 10 mg and 25 mg of empagliflozin, improved HbA1c compared with a placebo. [4]