Madrid, May 30 (EUROPA PRESS) –
The European Commission has granted marketing authorization «Zynquista» (sotagliflozina), developed by Sanofi and the Lexicon, at daily doses of 200 milligrams (mg) and 400 mg, as a supplement to insulin therapy to improve glycemic control in adults with type 1 diabetes (T1D) and with body mass index (BMI) of 27 kg per square are entirely achieved adequate glycemic control despite optimal therapy with insulin.
«Sotagliflozina, dual inhibitor of SGLT-1 / SGLT2, as add-on therapy to insulin demonstrated improved glycemic control with weight loss, lower glycemic variability and less risk of severe hypoglycemia. The potential risk of ketosis with & # 39 is controlled with the selection of appropriate patient education and improvement of diabetes, "said Dr. Javier Ampudia.
«Zynquista» with 39 & # is an oral dual inhibitor of both proteins responsible for the regulation of glucose, proteins known as sodium glucose cotransportadoras-type 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for the absorption of glucose in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption in the kidney.
"Dual mechanism of action" Zynquista "offers significant benefits of treatment for adults with type 1 diabetes, including reducing the reabsorption of blood sugar in the kidney by inhibiting SGLT2 and absorption delaying sugar diet by local inhibition of SGLT1 in the gastrointestinal tract," said Global Director research and development Sanofi, John Reid.
Permission marketing is based on the results of clinical trials program «Intandem», which included three Phase III Evaluation of efficacy and safety studies sotagliflozina approximately 3,000 adults with type 1 diabetes under control. "We are proud to have developed a" Zynquista "in combination with insulin through a wide range of clinical Phase 3 trials conducted to date in adults with type 1 diabetes, and has now been approved in the European Union. We understand that the European Commission recognizes the clinical benefits sotaglifozina for adults with type 1 diabetes and their seven & # 39; advertisements and physicians involved in clinical trials, "he added executive vice president and medical director of the Lexicon, Pablo Lapuerta.
These three tests have shown that, compared with only one insulin treatment with sotagliflozina administered in doses of 200 mg and 400 mg as an adjuvant oral administration of insulin produces a consistent and significant reduction in adults with DT1 entirely controlled by the base to the 24 th week, mean levels of glycosylated hemoglobin (HbA1c), body weight and systolic blood pressure and a significant improvement in time target blood glucose range. This was accomplished without the usual increase in severe hypoglycemia with insulin and enhanced reduction of severe hypoglycemia at a dose of 400 mg in 52 weeks.
In accordance with the selective inhibitors of SGLT2, clinical trials sotagliflozina they have shown an increased risk of genital fungal infections, diabetic ketoacidosis, recognizing that affects people with type 1 diabetes are more likely than people with type 2 diabetes.
In addition, some experts in the field of diabetes, to consider the risk of diabetic ketoacidosis associated with SGLT inhibitors with & # 39 is controlled by an appropriate choice of patient education and monitoring of ketones. The risk of diabetic ketoacidosis will be addressed by careful selection of patients for treatment sotagliflozina and through risk management plan and mitigation strategies, including health professionals and teachers of educational activities for patients, supporting its safe use.