研究钠-葡萄糖共转运蛋白2抑制剂的癌症风险：世卫组织全球药物警戒数据库Vigibase®的歧化分析

IF 4 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Safety Pub Date : 2025-04-15 DOI:10.1007/s40264-025-01546-5

Paul Gautier, Meyer Elbaz, Frédéric Bouisset, Fabien Despas, François Montastruc

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引用次数: 0

摘要

钠-葡萄糖共转运蛋白2抑制剂（SGLT-2is）的使用因其心血管益处而显著增加。自首次临床试验以来，sglt -2是否会增加癌症风险一直受到关注，但由于先前研究方法的局限性，这个问题仍不清楚。方法：与胰高血糖素样肽-1 （GLP-1）类似物和二肽基肽酶-4 （DPP-4）抑制剂相比，我们在2014年至2023年期间使用Vigibase®进行了歧化分析，以评估SGLT-2i的使用与不同亚型癌症报告风险之间的关系。结果：644例与SGLT-2i使用相关的癌症报告中，427例（66.3%）为男性，平均年龄66.5±9.7岁。钠-葡萄糖共转运蛋白2抑制剂显示膀胱癌（ROR 4.46, 95% CI 3.23-6.17）和肾癌（ROR 1.84, 95% CI 1.25-2.69）的报告优势比增加，但对所有其他癌症亚型没有影响。结论：在这个使用假设生成方法的歧化分析中，sglt -2与报告膀胱癌和肾癌的风险增加有关。迫切需要通过进一步的长期观察研究来澄清这一信号。

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Investigating Risk of Cancer with Sodium-Glucose Cotransporter 2 Inhibitors: A Disproportionality Analysis in the WHO Global Pharmacovigilance Database Vigibase^®.

Introduction: Use of sodium-glucose cotransporter 2 inhibitors (SGLT-2is) has significantly increased due to their cardiovascular benefits. Whether SGLT-2is increase risk of cancer has been of concern since first clinical trials, but this question remains unclear because of methodological limitations in previous studies.

Methods: We conducted a disproportionality analysis using Vigibase^® between 2014 and 2023 to estimate the association between SGLT-2i use and the risk of reporting of different subtypes of cancers, compared with glucagon like peptide-1 (GLP-1) analogues and dipeptidyl peptidase-4 (DPP-4) inhibitors.

Results: Among 644 reported cases of cancer associated with SGLT-2i use, 427 (66.3%) were male, with a mean age of 66.5 ± 9.7 years. Sodium-glucose cotransporter 2 inhibitors showed increased reporting odds ratio for bladder cancer (ROR 4.46, 95% CI 3.23-6.17) and kidney cancer (ROR 1.84, 95% CI 1.25-2.69), but not for all other cancer subtypes.

Conclusion: In this disproportionality analysis with a hypothesis-generating approach, SGLT-2is are associated with an increased risk of reporting bladder and kidney cancer. There is a need of an urgent clarification of this signal with further long-term observational studies.

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来源期刊

Drug Safety 医学-毒理学

CiteScore

7.60

自引率

7.10%

发文量

112

审稿时长

6-12 weeks

期刊介绍： Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.