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达格列净作为辅助治疗在血糖控制不佳的 1 型糖尿病患者中的疗效。

Efficacy of dapagliflozin as an adjunct therapy in patients with inadequately controlled type 1 diabetes mellitus.

机构信息

a University Hospitals , Leuven , Belgium.

出版信息

Expert Opin Pharmacother. 2018 Apr;19(6):617-622. doi: 10.1080/14656566.2018.1450387. Epub 2018 Mar 14.

Abstract

There is a clear unmet clinical need in people with Type 1 diabetes (T1DM) considering present day insulin therapy. New insulin analogues and novel technologies allowing more tailored insulin administration have improved the quality of life of people with T1DM, but issues like hypoglycemia, weight gain and variability in glucose profiles remain problematic. Areas covered: In this review, the clinical efficacy, safety and tolerability of dapagliflozin, a sodium-glucose cotransporter type 2 inhibitor, in type 1 diabetes (T1DM) is described based on a review of phase 2 and 3 studies to date. Expert opinion: Dapagliflozin has shown promising results as an adjunct therapy in T1DM, resulting in better glucose control, weight loss and lower blood pressure. No increase in hypoglycemia risk, in particular severe hypoglycemia, was observed, but, in comparison with reports in Type 2 diabetes (T2DM), genital infections were more prevalent. Dapagliflozin use was accompanied with decreases in insulin doses, but, to date, only a low risk of diabetic ketoacidosis (DKA) was reported. However, caution is needed when interpreting this data, arising from well controlled clinical trials, with intensive education programs around ketone measurements and DKA prevention. Further studies will need to establish how high the DKA risk is and how to mitigate this in a real-world setting.

摘要

在考虑当今胰岛素治疗的 1 型糖尿病 (T1DM) 患者中,存在明显的临床未满足需求。新型胰岛素类似物和新的技术允许更定制化的胰岛素给药,提高了 T1DM 患者的生活质量,但低血糖、体重增加和血糖谱变异性等问题仍然存在。

涵盖领域

在这篇综述中,根据迄今为止的 2 期和 3 期研究,描述了钠-葡萄糖共转运蛋白 2 抑制剂达格列净在 1 型糖尿病 (T1DM) 中的临床疗效、安全性和耐受性。

专家意见

达格列净作为 T1DM 的辅助治疗显示出有前景的结果,可改善血糖控制、减轻体重和降低血压。未观察到低血糖风险增加,特别是严重低血糖,但与 2 型糖尿病 (T2DM) 的报告相比,生殖器感染更为常见。达格列净的使用伴随着胰岛素剂量的减少,但迄今为止,仅报告了低风险的糖尿病酮症酸中毒 (DKA)。然而,需要谨慎解释这些数据,这些数据来自精心控制的临床试验,并围绕酮体测量和 DKA 预防进行了强化教育计划。需要进一步的研究来确定 DKA 的风险有多高,以及如何在现实环境中减轻这种风险。

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