Jardiance aprobado por la FDA para el tratamiento de tipo 2 Diabetes

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Los Estados Unidos. Food and Drug Administration approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in type 2 diabéticos adultos.

"Jardiance provides an additional treatment option for the care of patients with type 2 diabetes," said Curtis J. Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research. “It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”

Jardiance is a sodium glucose co-transporter 2 (SGLT2) inhibidor de la. It works by blocking the reabsorption of glucose (azúcar en la sangre) by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels. The drug's safety and effectiveness were evaluated in seven clinical trials with 4,480 pacientes con el tipo 2 diabetes receiving Jardiance. The pivotal trials showed that Jardiance improved hemoglobin A1c levels (a measure of blood sugar control) en comparación con placebo.

Jardiance has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, sulfonilureas, pioglitazona, y la insulina. Jardiance should not be used: to treat people with type 1 diabetes; in those who have increased ketones in their blood or urine (cetoacidosis diabética); and in those with severe renal impairment, end stage renal disease, or in patients on dialysis.

The FDA is requiring four post-marketing studies for Jardiance:

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  • Completion of an ongoing cardiovascular outcomes trial.
  • A pediatric pharmacokinetic/pharmacodynamic study.
  • A pediatric safety and efficacy study. As part of the safety and efficacy study, the effect on bone health and development will be evaluated.
  • A nonclinical (animal) juvenile toxicity study with a particular focus on renal development, bone development, and growth.

Side Effects of Jardiance

Jardiance can cause dehydration, leading to a drop in blood pressure (hipotensión) that can result in dizziness and/or fainting and a decline in renal function. Las personas mayores, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to this risk. The most common side effects of Jardiance are urinary tract infections and female genital infections.

Jardiance is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.

Fuente: POR LA FDA

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