Amputation Risk in Type II Diabetes Mellitus Patients Treated with SGLT-2 Inhibitors: A Systematic Literature Review of Randomized Clinical Trials.

IF 1.7 Q3 PHARMACOLOGY & PHARMACY

Drug Research Pub Date : 2024-11-01 Epub Date: 2024-08-02 DOI:10.1055/a-2366-8999

Farazul Hoda, Mohammad Chand Jamali, Mawrah Arshad, Mohammad Anwar Habib, Mohd Akhtar, Abul Kalam Najmi

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引用次数: 0

Abstract

Background: SGLT-2 inhibitors, prescribed for type 2 diabetes, have a heightened risk of amputation. The FDA issued a warning in May 2017, leading to the inclusion of a cautionary label. Vigilance is essential for patients and healthcare providers to promptly identify and address potential limb complications associated with the use of SGLT-2 inhibitors.

Method: A comprehensive search of electronic databases was conducted, covering the period from inception to May 2024. This systematic literature review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The quality of the included studies was assessed using the Cochrane risk of bias (ROB) tool. Inclusion and exclusion criteria were predefined, and data extraction was performed to summarize the findings.

Result: A total of 12 randomized control trial (RCT) studies were included in the present systematic review. 37,657 (54.89%) participants were randomly assigned to receive the different interventions of SGLT-2 inhibitor, whereas 30,959 (45.11%) received a placebo. Overall, 618 events were reported in the treatment group, whereas 396 events were reported in the placebo group.

Conclusion: In conclusion, patients treated with SGLT-2 inhibitors did not have any significant difference in amputation occurrences compared to placebo across various studies. However, canagliflozin usage has led to higher amputation events in certain trials.

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接受 SGLT-2 抑制剂治疗的 II 型糖尿病患者的截肢风险：随机临床试验的系统文献综述。

背景：用于治疗 2 型糖尿病的 SGLT-2 抑制剂会增加截肢风险。美国食品和药物管理局于 2017 年 5 月发出警告，从而将警示标签纳入其中。患者和医疗服务提供者必须保持警惕，及时发现并解决与使用 SGLT-2 抑制剂相关的潜在肢体并发症：方法：对电子数据库进行了全面检索，检索期从开始至 2024 年 5 月。该系统性文献综述遵循了系统性综述和荟萃分析首选报告项目（PRISMA）指南。采用 Cochrane 偏倚风险 (ROB) 工具评估了纳入研究的质量。预先确定了纳入和排除标准，并进行了数据提取以总结研究结果：本系统综述共纳入了 12 项随机对照试验 (RCT) 研究。37657名参与者（54.89%）被随机分配接受不同的SGLT-2抑制剂干预，而30959名参与者（45.11%）接受安慰剂干预。总体而言，治疗组报告了 618 起事件，而安慰剂组报告了 396 起事件：总之，在各项研究中，接受 SGLT-2 抑制剂治疗的患者截肢发生率与安慰剂相比没有显著差异。然而，在某些试验中，使用卡格列净会导致更高的截肢事件。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Research PHARMACOLOGY & PHARMACY-

CiteScore

3.50

自引率

0.00%

发文量

期刊介绍： Drug Research (formerly Arzneimittelforschung) is an international peer-reviewed journal with expedited processing times presenting the very latest research results related to novel and established drug molecules and the evaluation of new drug development. A key focus of the publication is translational medicine and the application of biological discoveries in the development of drugs for use in the clinical environment. Articles and experimental data from across the field of drug research address not only the issue of drug discovery, but also the mathematical and statistical methods for evaluating results from industrial investigations and clinical trials. Publishing twelve times a year, Drug Research includes original research articles as well as reviews, commentaries and short communications in the following areas: analytics applied to clinical trials chemistry and biochemistry clinical and experimental pharmacology drug interactions efficacy testing pharmacodynamics pharmacokinetics teratology toxicology.