Department of Clinical Medicine, The First Clinical Medical College, Nanchang University, Nanchang, China.
Department of Thoracic Surgery, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
Endokrynol Pol. 2020;71(4):325-333. doi: 10.5603/EP.a2020.0034.
Sodium glucose cotransporter 2 (SGLT2) inhibitors are insulin-independent and glucose-dependent anti-hyperglycaemic drugs that have shown potential as an adjuvant therapy to insulin for the treatment of type 1 diabetes mellitus (T1DM). The purpose of this meta-analysis is to systematically collect available data from randomised trials to determine SGLT-2 inhibitor efficacy in terms of glycaemic control, body mass index, and renal protection when compared with placebo.
Cochrane Library, MEDLINE, and EMBASE databases were searched for randomised controlled trials and metaanalyses (without language restrictions) conducted from January 2010 to September 2019.
Seventeen randomised controlled trials with 7325 participants were included. Sodium glucose cotransporter 2 therapy significantly reduced the level of glycated haemoglobin (HbA1c) (by 0.37%), body weight (by 2.88 kg), and estimated glomerular filtration (eGFR) (by 0.67 mL/min/1.73 m²) when compared with placebo (all outcomes, p < 0.00001). Subgroup analysis by HbA1c levels showed significant differences between six and 12 months of treatment (p < 0.1). The magnitude of the HbA1c lowering effect waned with longer duration of treatment after six months (up to 12 months). Subgroup analysis by body weight showed significant differences between 1 and 3-4 months of treatment (p < 0.1). Weight loss plateaued after 3-4 months of treatment; subsequently, the weight remained relatively stable until 12 months. Subgroup analysis by eGFR showed significant differences between six and 12 months of treatment (p < 0.1). The magnitude of the eGFR lowering effect increased with longer duration of treatment after six months (up to 12 months).
Sodium glucose cotransporter 2 inhibitors show significant therapeutic effects when compared with placebo. Although changes in HbA1c, body weight, and eGFR vary during treatment, the therapeutic effects of SGLT-2 inhibitors measured by these three outcomes can last up to 12 months. More long-term, randomised trials and extended studies are needed to determine the long-term effects of SGLT2 inhibitors as adjuvant therapy for T1DM patients.
钠-葡萄糖共转运蛋白 2（SGLT2）抑制剂是一种不依赖胰岛素、血糖依赖的降血糖药物，它在治疗 1 型糖尿病（T1DM）方面已显示出作为胰岛素辅助治疗的潜力。本荟萃分析的目的是系统地从随机试验中收集现有数据，以确定 SGLT-2 抑制剂在血糖控制、体重指数和肾脏保护方面的疗效，与安慰剂相比。
对 Cochrane 图书馆、MEDLINE 和 EMBASE 数据库进行了检索，以查找 2010 年 1 月至 2019 年 9 月期间进行的随机对照试验和荟萃分析（无语言限制）。
纳入了 17 项随机对照试验，共有 7325 名参与者。与安慰剂相比，SGLT2 治疗可显著降低糖化血红蛋白（HbA1c）（降低 0.37%）、体重（降低 2.88kg）和估计肾小球滤过率（eGFR）（降低 0.67ml/min/1.73m²）（所有结果，p<0.00001）。按 HbA1c 水平进行的亚组分析显示，治疗 6 个月和 12 个月之间有显著差异（p<0.1）。治疗 6 个月后，HbA1c 降低作用的幅度随治疗时间的延长而减弱（长达 12 个月）。按体重进行的亚组分析显示，治疗 1 个月和 3-4 个月之间有显著差异（p<0.1）。治疗 3-4 个月后体重减轻达到平台期，此后体重相对稳定，直至 12 个月。按 eGFR 进行的亚组分析显示，治疗 6 个月和 12 个月之间有显著差异（p<0.1）。治疗 6 个月后，随着治疗时间的延长，eGFR 降低作用的幅度增加（长达 12 个月）。
与安慰剂相比，SGLT2 抑制剂具有显著的治疗效果。尽管在治疗过程中 HbA1c、体重和 eGFR 发生变化，但通过这三个指标测量的 SGLT-2 抑制剂的治疗效果可持续长达 12 个月。需要更多的长期、随机试验和扩展研究来确定 SGLT2 抑制剂作为 T1DM 患者辅助治疗的长期效果。
