The medicine that helps patients with diabetes better regulate their blood sugar has been given the green light by the Food and Drug Administration in the United States.
The Food and Drug Administration (FDA) made its judgement after reviewing the findings of 23 clinical studies that included over 5,000 patients, including over 300 individuals with stage 3 renal disease. In a phase 3 research, participants were given bexagliflozin either as a monotherapy for the whole 24 weeks or in conjunction with other medications that reduce A1c as well as fasting glucose and systolic blood pressure, which resulted in a moderate reduction in blood pressure.
In high-risk patients who were either paralysed or unstable due to their type 2 diabetes, the Bexagliflozin (BEST) effectiveness and safety study in phase 3 was successful in meeting its efficacy and safety goals.
Lower limb amputation, potassium deficiency, urosepsis, pyelonephritis, Fournier’s gangrene, and genital fungal infections, amongst other adverse events, are also warned of in the information that can be provided to patients regarding SGLT2 inhibitors, just like other adverse events that have been identified with SGLT2 inhibitors.
In the end, the FDA decides that type 2 diabetics may be included in the study as long as they have a glomerular filtration rate (GFR) that is lower than 30 mL/min/1.73 m2 in order to qualify.