Abstract：
UNASSIGNED: Sodium glucose cotransporter-2 inhibitors (SGLT2is) have gained immense attention for a variety of indications. Limb amputations (LA) and fractures were reported in clinical trials. This network meta-analysis and meta-regression were carried out to quantify the risks of these events.
UNASSIGNED: Randomized clinical trials evaluating SGLT2is and reporting patients developing LA/fracture were included. Odds ratios (OR) with 95% confidence intervals (95% CI) were the effect estimates. Sub-group analyses and meta-regression analysis were carried out.
UNASSIGNED: Ninety articles were included (LA: 36 studies; 96522 participants and fracture: 66 studies; 102,862 participants). An increased risk of LA (OR: 1.2; 95% CI: 1.1, 1.3) was observed. Amongst SGLT2is, canagliflozin was associated with increased risk of LA (OR: 1.6, 95% CI: 1.1, 2.4) while dapagliflozin with fracture (OR: 1.1, 95% CI: 1, 1.2). Sub-group analysis revealed increased risk of LA with an OR of 1.3 among those in the age group of > 40 to < 65, body-mass index of > 30 kg/m2, HbA1c category of > 7%, duration of diabetes of > 10 years, type 2 diabetes, and an OR of 1.2 for SGLT2is administration of > 6 months.
UNASSIGNED: SGLT2is were observed with an increased risk of LA. High- risk categories were identified for which precautions should be recommended in the standard treatment guidelines.
UNASSIGNED: Open Science Framework (https://osf.io/5fwyk).
UNASSIGNED: Randomized clinical trials evaluating SGLT2is and reporting patients developing LA/fracture were included. Odds ratios (OR) with 95% confidence intervals (95% CI) were the effect estimates. Sub-group analyses and meta-regression analysis were carried out.
UNASSIGNED: Ninety articles were included (LA: 36 studies; 96522 participants and fracture: 66 studies; 102,862 participants). An increased risk of LA (OR: 1.2; 95% CI: 1.1, 1.3) was observed. Amongst SGLT2is, canagliflozin was associated with increased risk of LA (OR: 1.6, 95% CI: 1.1, 2.4) while dapagliflozin with fracture (OR: 1.1, 95% CI: 1, 1.2). Sub-group analysis revealed increased risk of LA with an OR of 1.3 among those in the age group of > 40 to < 65, body-mass index of > 30 kg/m2, HbA1c category of > 7%, duration of diabetes of > 10 years, type 2 diabetes, and an OR of 1.2 for SGLT2is administration of > 6 months.
UNASSIGNED: SGLT2is were observed with an increased risk of LA. High- risk categories were identified for which precautions should be recommended in the standard treatment guidelines.
UNASSIGNED: Open Science Framework (https://osf.io/5fwyk).
摘要：
■钠葡萄糖协同转运蛋白-2抑制剂(SGLT2is)因多种适应症而受到极大关注。在临床试验中报道了肢体截肢（LA）和骨折。进行网络荟萃分析和荟萃回归以量化这些事件的风险。
■纳入评估SGLT2is和报告发生LA/骨折患者的随机临床试验。具有95%置信区间(95%CI)的赔率比(OR)是效果估计。进行亚组分析和meta回归分析。
■纳入90篇文章（LA：36项研究；96522名参与者和骨折：66项研究；102,862名参与者）。观察到LA的风险增加（OR：1.2；95％CI：1.1，1.3）。在SGLT2is中，canagliflozin与LA风险增加相关(OR:1.6,95%CI:1.1,2.4),而dapagliflozin与骨折风险增加相关(OR:1.1,95%CI:1,1.2).亚组分析显示，在年龄>40至<65岁，体重指数>30kg/m2，HbA1c类别>7％的人群中，LA的风险增加，OR为1.3。糖尿病病程>10年，2型糖尿病,SGLT2给药>6个月的OR为1.2。
■观察到SGLT2is的LA风险增加。确定了高风险类别，应在标准治疗指南中建议采取预防措施。
■开放科学框架（https://osf.io/5fwyk）。
■纳入评估SGLT2is和报告发生LA/骨折患者的随机临床试验。具有95%置信区间(95%CI)的赔率比(OR)是效果估计。进行亚组分析和meta回归分析。
■纳入90篇文章（LA：36项研究；96522名参与者和骨折：66项研究；102,862名参与者）。观察到LA的风险增加（OR：1.2；95％CI：1.1，1.3）。在SGLT2is中，canagliflozin与LA风险增加相关(OR:1.6,95%CI:1.1,2.4),而dapagliflozin与骨折风险增加相关(OR:1.1,95%CI:1,1.2).亚组分析显示，在年龄>40至<65岁，体重指数>30kg/m2，HbA1c类别>7％的人群中，LA的风险增加，OR为1.3。糖尿病病程>10年，2型糖尿病,SGLT2给药>6个月的OR为1.2。
■观察到SGLT2is的LA风险增加。确定了高风险类别，应在标准治疗指南中建议采取预防措施。
■开放科学框架（https://osf.io/5fwyk）。
