在儿童2型糖尿病中使用达帕格利弗洛辛或萨克萨格利普丁
Naim Shehadeh1,2, Timothy Barrett3, Pietro Galassetti4
1Rambam Health Care Campus, Haifa, Israel.
NEJM evidence
|February 6, 2024
概括
与安慰剂相比,达帕格利弗洛辛在患有2型糖尿病的儿童和青少年中显著改善了A1C. 虽然萨克萨格利普丁没有显著的差异,但这两种药物在一般情况下都能耐受,而头痛在达帕格利弗洛辛中更为常见.
科学领域:
- 儿科内分泌学 儿科内分泌学
- 代谢障碍 代谢障碍 代谢障碍
- 临床试验 临床试验
背景情况:
- 在儿童群体中,2型糖尿病 (T2D) 发病率的增加需要扩大治疗选择.
- 目前对儿童和青少年T2D的治疗策略有限.
- 这项研究解决了在这个年龄组有效的T2D管理的需要.
研究的目的:
- 评估达帕格利弗洛辛和萨克萨格利普丁在未经控制的T2D的儿科患者的疗效和安全性.
- 为了比较达帕格利弗洛辛和萨克萨格利普丁与安慰剂实现的A1C降低.
- 在52周的时间内评估长期安全性.
主要方法:
- 一项为期26周的3期随机试验,延长26周,涉及10至17岁未经控制的T2D患者.
- 参与者接受了甲福尔,胰岛素或两者,并随机分配给达帕格利弗洛辛,萨克萨格利普丁或安慰剂.
- 允许根据第12周的A1C水平进行剂量调整.
主要成果:
- 达帕格利弗洛辛在26周显示A1C的统计显著降低,比安慰剂降低了-1.03个百分点 (P<0.001).
- 萨克萨利普丁显示,与安慰剂相比,A1C降低 -0.44个百分点 (P=0.078) 是无意义的 (P=0.078).
- 各组的不良事件相似;头痛是达帕格利弗洛辛治疗中最常见的非严重事件.
结论:
- 达帕格利弗洛辛是一种有效的治疗方法,可以改善T2D的儿科患者的血糖控制.
- 萨克萨格利普丁在这个人群中没有达到有效性的主要终点.
- 这两种药物总体上都是安全的,耐受性很好,在常见的不良事件方面具有不同的安全性.
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