Association between sodium-glucose cotransporter-2 inhibitor and adverse events in patients with moderate to severe chronic kidney disease: a systematic review and meta-analysis of randomized controlled trials.

IF 2.4 3区医学 Q3 PHARMACOLOGY & PHARMACY

European Journal of Clinical Pharmacology Pub Date : 2025-02-01 Epub Date: 2024-11-23 DOI:10.1007/s00228-024-03779-2

Satoru Mitsuboshi, Kotaro Hitoshi, Ai Ominato, Teruhisa Kinoshita, Yuka Sugimoto, Ayami Kajiwara-Morita, Motoki Urata, Koji Sato, Toshiyuki Sakamaki

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引用次数: 0

Abstract

Purpose: Although there is concern about the association of sodium-glucose cotransporter-2 inhibitor (SGLT2i) use with musculoskeletal pain, hypovolemia, and urinary tract infection in patients with severe chronic kidney disease (CKD), information on these adverse events is insufficient. The aim of this systematic review and meta-analysis was to assess whether SGLT2i increases the risk of urinary tract infection, hypovolemia, and musculoskeletal pain in these patients.

Methods: MEDLINE via PubMed, the Cochrane Central Register of Controlled Trials, and the ClinicalTrials.gov website were comprehensively searched to extract all relevant studies. Randomized controlled trials (RCTs) were selected that compared SGLT2i versus placebo, and the study populations consisted of patients with CKD stage 3 or higher.

Results: Eleven studies were eligible for inclusion. SGLT2i tended to increase the risk of hypovolemia [risk ratio (RR) 1.15, 95% confidence interval (CI) 0.98-1.35, P = 0.08, high certainty] but did not increase the risk of urinary tract infection (RR 1.03, 95% CI 0.94-1.12, P = 0.56, high certainty) or musculoskeletal pain (RR 0.69, 95% CI 0.41-1.17, P = 0.17, high certainty). Subgroup analysis of patients with heart disease was performed for the outcome of hypovolemia, and the results showed a significant difference in hypovolemia (RR 1.21, 95% CI 1.06-1.39, P < 0.01, moderate certainty) between SGLT2i and placebo.

Conclusion: This meta-analysis suggests that SGLT2i may increase the risk of hypovolemia in patients with moderate to severe CKD and heart disease but is not associated with urinary tract infection or musculoskeletal pain.

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钠-葡萄糖共转运体-2 抑制剂与中重度慢性肾病患者不良事件的关系：随机对照试验的系统回顾和荟萃分析。

目的：虽然钠-葡萄糖共转运体-2抑制剂（SGLT2i）的使用与重症慢性肾病（CKD）患者的肌肉骨骼疼痛、血容量不足和尿路感染有关，但有关这些不良事件的信息尚不充分。本系统综述和荟萃分析旨在评估 SGLT2i 是否会增加这些患者发生尿路感染、血容量不足和肌肉骨骼疼痛的风险：通过 PubMed 的 MEDLINE、Cochrane Central Register of Controlled Trials 和 ClinicalTrials.gov 网站进行了全面检索，以提取所有相关研究。选择了比较 SGLT2i 与安慰剂的随机对照试验（RCT），研究人群包括 CKD 3 期或以上的患者：有 11 项研究符合纳入条件。SGLT2i 有增加低血容量风险的趋势[风险比 (RR) 1.15，95% 置信区间 (CI)0.98-1.35，P = 0.08，高度确定性]，但不会增加尿路感染风险（RR 1.03，95% CI 0.94-1.12，P = 0.56，高度确定性）或肌肉骨骼疼痛风险（RR 0.69，95% CI 0.41-1.17，P = 0.17，高度确定性）。针对血容量不足的结果，对心脏病患者进行了亚组分析，结果显示血容量不足的结果存在显著差异（RR 1.21，95% CI 1.06-1.39，P 结论）：这项荟萃分析表明，SGLT2i 可能会增加中重度慢性肾脏病和心脏病患者发生低血容量的风险，但与尿路感染或肌肉骨骼疼痛无关。

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

European Journal of Clinical Pharmacology 医学-药学

CiteScore

5.40

自引率

3.40%

发文量

170

审稿时长

3-8 weeks

期刊介绍： The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed. Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor. Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves -a compound that is interesting and new in some basic or fundamental way, or -methods that are original in some basic sense, or -a highly unexpected outcome, or -conclusions that are scientifically novel in some basic or fundamental sense.