{"title":"使用钠葡萄糖共转运体-2 抑制剂导致截肢和骨折的风险：网络 Meta 分析和 Meta 回归。","authors":"Kannan Sridharan, Gowri Sivaramakrishnan","doi":"10.1080/14740338.2024.2377755","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Research design and methods: </strong>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.</p><p><strong>Results: </strong>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/m<sup>2</sup>, 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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Protocol registration: </strong>Open Science Framework (https://osf.io/5fwyk).</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"797-804"},"PeriodicalIF":3.1000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Risk of limb amputation and bone fractures with sodium glucose cotransporter-2 inhibitors: a network meta-analysis and meta-regression.\",\"authors\":\"Kannan Sridharan, Gowri Sivaramakrishnan\",\"doi\":\"10.1080/14740338.2024.2377755\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Research design and methods: </strong>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.</p><p><strong>Results: </strong>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/m<sup>2</sup>, 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.</p><p><strong>Conclusions: </strong>SGLT2is were observed with an increased risk of LA. 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引用次数: 0
摘要
背景：钠葡萄糖共转运体-2抑制剂（SGLT2is）因其多种适应症而备受关注。临床试验中报告了截肢（LA）和骨折。这项网络荟萃分析和荟萃回归旨在量化这些事件的风险：研究设计：纳入了评估 SGLT2is 并报告患者发生 LA/骨折的随机临床试验。效应估计值为具有 95% 置信区间 (95% CI) 的比值比 (OR)。进行了亚组分析和元回归分析：共纳入 90 篇文章（LA：36 项研究；96522 名参与者；骨折：66 项研究；102862 名参与者）。观察到 LA 风险增加（OR：1.2；95% CI：1.1，1.3）。在 SGLT2 类药物中，canagliflozin 与 LA 风险增加有关（OR：1.6，95% CI：1.1，2.4），而 dapagliflozin 与骨折有关（OR：1.1，95% CI：1，1.2）。亚组分析显示，年龄大于 40 至 30 kg/m2、HbA1c 值大于 7%、糖尿病病程大于 10 年的 2 型糖尿病患者发生 LA 的风险增加，OR 值为 1.3；服用 SGLT2is 超过 6 个月的患者发生 LA 的风险增加，OR 值为 1.2：结论：SGLT2is 会增加 LA 的风险。结论：观察到 SGLT2is 会增加 LA 的风险，并确定了高风险类别，应在标准治疗指南中建议采取预防措施：协议注册：开放科学框架 (https://osf.io/5fwyk)。
Risk of limb amputation and bone fractures with sodium glucose cotransporter-2 inhibitors: a network meta-analysis and meta-regression.
Background: 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.
Research design and methods: 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.
Results: 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.
Conclusions: 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.
Protocol registration: Open Science Framework (https://osf.io/5fwyk).
期刊介绍：
Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports.
Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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