2023年6月21日

米裏亞姆·e·塔克2023年6月21日,美國食品和藥物管理局(FDA)批準了empagliflozin (Jardiance,勃林格殷格翰集團)和empagliflozin結合二甲雙胍(Synjardy, BI)治療2型糖尿病在孩子10歲以上。這隻代表批準第二口服治療選擇兒童和青少年2型糖尿病患者在二甲雙胍;後者似乎不如成人對兒科患者有效。注射glucagonlike peptide-1 (GLP-1)受體激動劑也可用於青少年2型糖尿病患者。這些包括日常liraglutide (Victoza)和每周延長釋放exenatide (Bydureon / Bydureon BCise)。Jardiance成人2型糖尿病患者已獲批準自2014年以來,和Synjardy自2015年以來已經被批準。“與成人相比,兒童2型糖尿病患者治療方法有限,即使出現症狀疾病和一般兒童進步更快,”米歇爾·凱裏說,醫學博士,英裏。“今天的審批提供急需的額外治療兒童2型糖尿病患者的選擇,”凱裏,副主任治療審查部門的糖尿病、脂質紊亂,和肥胖在FDA藥物評價和研究中心。2型糖尿病呈指數增長,孩子,主要是2型糖尿病非白種人是呈指數增長,兒童和青少年在美國。青年尋找糖尿病的研究數據顯示,青少年2型糖尿病的發病率增長了大約5%每年在2002年至2015年之間,它繼續上升。 A more recent study found that a doubling of cases occurred during the pandemic, with youth often presenting with more severe disease. The majority of cases are among non-White racial groups. Safety and efficacy data for empagliflozin for children came from the Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO) trial . That trial included 157 patients aged 10 to 17 years with A1c of 7% or above. Patients were randomly assigned to receive empagliflozin 10 mg or 25 mg daily, linagliptin (a DPP-4 inhibitor) 5 mg, or placebo for 26 weeks. Over 90% were also taking metformin, 40% in combination with insulin. All patients were also given diet and exercise advice. At week 26, the children treated with empagliflozin showed an average 0.2 percentage point decrease in A1c, compared with a 0.7-point increase among those taking placebo. Use of empagliflozin was also associated with lower fasting plasma glucose levels compared to placebo. Side effects were similar to those seen in adults except for a higher risk of hypoglycemia, regardless of other glucose-lowering therapies that were being taken. Reduction in A1c for participants treated with linagliptin was not statistically significant in comparison with placebo. There was a numerical reduction of 0.34% (P = .2935). "Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it's important to recognize and treat diabetes early in its course," said Lori Laffel, MD, lead investigator of the DINAMO study, in a press release from BI. "These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin [has been] the only globally available oral treatment for youth," added Laffel, chief of the Pediatric, Adolescent, and Young Adult Section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, Boston, Massachusetts. Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR's Shots blog, and Diabetes Forecast magazine. She is on Twitter @MiriamETucker. For more diabetes and endocrinology news, follow us on Twitter and Facebook . Credits: