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索格列净:用于 1 型糖尿病的药物评价。

Sotagliflozin: A Review in Type 1 Diabetes.

机构信息

Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.

出版信息

Drugs. 2019 Dec;79(18):1977-1987. doi: 10.1007/s40265-019-01230-w.

Abstract

Sotagliflozin (Zynquista™) is the first dual inhibitor of sodium-glucose co-transporter-1 and -2 (SGLT1 and 2). In the phase 3, inTANDEM 1-3 trials, adjunctive use of oral sotagliflozin (200 mg or 400 mg once daily) improved glycaemic control and reduced bodyweight and insulin requirements relative to placebo over 24 weeks of treatment in adults whose type 1 diabetes (T1D) was inadequately controlled by insulin therapy. Similar benefits were seen with the drug in patients who were overweight/obese [i.e. body mass index (BMI) ≥ 27 kg/m] in inTANDEM 1 and 2 (pooled). The benefits of sotagliflozin were largely maintained over 52 weeks of treatment. Overall, use of sotagliflozin in this setting is generally well tolerated and reduces, or at least does not increase, the likelihood of hypoglycaemia; however, as with other SGLT inhibitors, sotagliflozin carries a risk of diabetic ketoacidosis (DKA). On the basis of its risk/benefit profile, sotagliflozin is indicated in the EU as an adjunct to insulin in adults with T1D with a BMI ≥ 27 kg/m who have failed to achieve adequate glycaemic control despite optimal insulin therapy, thus expanding the currently limited adjunctive oral treatment options available for use in this population.

摘要

索格列净(Zynquista™)是首个钠-葡萄糖共转运蛋白 1 和 2(SGLT1 和 2)双重抑制剂。在 3 期 inTANDEM 1-3 临床试验中,与安慰剂相比,在接受胰岛素治疗血糖控制仍不理想的 1 型糖尿病(T1D)成人患者中,每日口服索格列净(200 mg 或 400 mg)辅助治疗 24 周可改善血糖控制,降低体重和胰岛素需求。在 inTANDEM 1 和 2 (汇总)中,超重/肥胖(BMI≥27 kg/m)的患者中也观察到了该药物的类似获益。索格列净的获益在 52 周的治疗中基本保持。总体而言,在这种情况下使用索格列净通常具有良好的耐受性,并降低(或至少不增加)低血糖的发生风险;然而,与其他 SGLT 抑制剂一样,索格列净存在发生糖尿病酮症酸中毒(DKA)的风险。基于其风险/获益特征,在欧盟,索格列净被批准与胰岛素联合用于 BMI≥27 kg/m 的血糖控制不佳的 T1D 成人患者,这些患者尽管接受了最佳胰岛素治疗,但仍未达到足够的血糖控制,从而扩大了目前在该人群中可用的有限的辅助口服治疗选择。

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