NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Metabolic Diseases Hospital & Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China.
Diabetes Metab Res Rev. 2019 Oct;35(7):e3170. doi: 10.1002/dmrr.3170. Epub 2019 May 15.
The aim of the study is to update and determine the effects of sodium glucose cotransporter 2 (SGLT2) inhibitor therapy on fracture and bone mineral density (BMD) in patients with type 2 diabetes mellitus (T2DM).
We identified 27 eligible randomized controlled trials (RCTs) that compared the efficacy and safety of SGLT2 inhibitors to a placebo in 20 895 T2DM participants, with an average duration of 64.22 weeks. The relative risk (RR) of bone fracture and weighted mean difference (WMD) of changes in the BMD from baseline were determined to evaluate the risk of fracture. The degree of heterogeneity was evaluated by the I statistic, and publication bias was estimated using a funnel plot and Egger test.
The pooled RR was 1.02 (95% CI [0.81, 1.28]) with low heterogeneity, indicating that SGLT2 inhibitor treatment was not correlated with a higher risk of fracture. Additionally, no increased risk was found for patients with different ages, sexes, and levels of HbA1c and some biochemical indicators. Three trials with 1303 patients reported a change in the BMD from baseline. SGLT2 inhibitor treatment did not decrease the BMD at four skeletal sites (lumbar spine, femoral neck, total hip, and distal forearm), and the overall WMD was 0.08 (95% CI [-0.09, 0.26]). No significant publication bias was detected.
No increased risk for bone fracture was detected in patients with T2DM treated with SGLT2 inhibitors in this meta-analysis. SGLT2 inhibitor therapy did not appear to affect bone health, but more long-term detailed data are needed to validate this conclusion.
本研究旨在更新和确定钠-葡萄糖共转运蛋白 2（SGLT2）抑制剂治疗对 2 型糖尿病（T2DM）患者骨折和骨密度（BMD）的影响。
我们确定了 27 项符合条件的随机对照试验（RCT），这些试验比较了 SGLT2 抑制剂与安慰剂在 20895 例 T2DM 参与者中的疗效和安全性，平均持续时间为 64.22 周。通过相对风险（RR）评估骨折风险，确定骨骨折的相对风险（RR）和从基线变化的加权均数差异（WMD）。通过 I 统计量评估异质性程度，并使用漏斗图和 Egger 检验估计发表偏倚。
汇总 RR 为 1.02（95%CI[0.81, 1.28]），异质性较低，表明 SGLT2 抑制剂治疗与骨折风险增加无关。此外，对于不同年龄、性别以及 HbA1c 和一些生化指标水平的患者，均未发现更高的风险。有 3 项包含 1303 例患者的试验报告了从基线开始的 BMD 变化。SGLT2 抑制剂治疗并未降低 4 个骨骼部位（腰椎、股骨颈、全髋和远端前臂）的 BMD，总体 WMD 为 0.08（95%CI[-0.09, 0.26]）。未发现显著的发表偏倚。
本荟萃分析未发现 T2DM 患者接受 SGLT2 抑制剂治疗后骨折风险增加。SGLT2 抑制剂治疗似乎不会影响骨骼健康，但需要更多长期详细数据来验证这一结论。
