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FDA OKs Liraglutide for use in Adolescents with Type 2 Diabetes



The US Food and Drug Administration (FDA) has expanded the indication for the glucose-lowering drug liraglutide ( Victoza Novo Nordisk) to include patients as young as 10 years, making it the first noninsulin drug approved for treatment for pediatric type 2 diabetes for almost 20 years.

Liraglutide, a subcutaneous injectable glucagon-like peptide-1 receptor agonist, has been available for treatment of adults with type 2 diabetes since 2010. It is the first drug except insulin to be specifically approved for the treatment of type 2 diabetic adolescents. since metformin was approved for pediatric use in 2000. Although type 2 diabetes was previously considered a condition primarily for older adults, its incidence has increased in young adults and children. More than 5,000 new cases are diagnosed in the United States each year among the younger than 20 years, according to data from the Centers for Disease Control and Prevention, as reported in an FDA new indication message.

The new authorization was based on data on the efficacy and safety of liraglutide in combination with metformin compared to metformin alone in children and adolescents with type 2 diabetes (ELLIPSE) trials. This trial was presented in April 201

9 at the Pediatric Academic Societies 2019 Meeting and was simultaneously published online in the New England Journal of Medicine . [1356500] Among 135 obese patients aged 10 to 17 years who had type 2 diabetes inadequately controlled with diet and exercise, metformin and / or insulin experienced those treated with liraglutuid, a drop of 0.64 percentage points in HbA1c compared to patients receiving placebo, with which the HbA1c levels increased 0.42 percentage points ( P <.001). Several patients in the liraglutide group achieved an HbA1c level <7% (64% versus 38%; P <.001), and the differences remained significant for 52 weeks.

At that time, ELLIPSE lead researcher William V. Tamborlane, MD, from Yale University, New Haven, Connecticut, told Medscape Medical News that the study was "practice change" because "metformin fails quickly as type 2 diabetic and insulin monotherapy is the only second-line drug approved for children with type 2 diabetes. "

Authorization comes at a time when doctors express alarm over the effect of pediatric type 2 diabetes. At the latest US Diabetes Association (ADA) 2019 Scientific Sessions, the results were presented from two major trials, Restoring Insulin Secretion (RISE) and Type 2 Diabetes Treatment Options in adolescents and adolescents (TODAY-2), which highlighted the problem. 19659002] In RISE, adults with prediabetes or onset diabetes who received treatment grew in beta cell function in the study year compared to those receiving placebo. These results were in contrast to the data presented at the ADA meeting in 2018 on youth. In these patients, early treatment of one year with metformin or insulin was unable to prevent deterioration of the beta cell function.

Today 2, involving more than 500 patients diagnosed with type 2 diabetes during their early teens, was an alarmingly high number of diabetes-related complications occurred at the time patients were in the middle of 20 & 39; s. These complications included cardiovascular events and pregnancy complications.

In August 2017, the FDA gave liraglutide a labeling indication to reduce the risk of myocardial infarction, stroke and cardiovascular death in adults with type 2 diabetes who have established cardiovascular disease. If the drug can prevent cardiovascular events in adolescents with type 2 diabetes, it is not known.

Liraglutide's label also contains a box warning of the increased risk of thyroid loss cells, as well as warnings of pancreatitis, pendulum, hypoglycaemia when used with insulin or sulfonylureas, renal impairment or renal failure, hypersensitivity and acute gall bladder disease. The most common side effects are nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation.

"The FDA calls for drugs to be made available to the widest number of patients when there is evidence of safety and efficacy," said Lisa Yanoff, MD, acting director of the Division of Metabolism and Endocrinology Products at the FDA Center for Drug Evaluation. and Research.

"Victoza has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes. The extended indication provides an additional treatment option at a time when an increasing number of children are diagnosed with this disease," she said.

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