Study on disproportionality in the detection of potential signals between quetiapine and diabetic ketoacidosis.

IF 2.7 3区医学 Q3 PHARMACOLOGY & PHARMACY

European Journal of Clinical Pharmacology Pub Date : 2025-07-28 DOI:10.1007/s00228-025-03895-7

Haiya Liang, Dandan Mao, Yan Zhao, Rongjing Zhou

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引用次数: 0

Abstract

Purpose: Quetiapine is an atypical second-generation antipsychotic. Diabetic ketoacidosis (DKA) is an acute metabolic complication, most commonly encountered in type 1 diabetes, and it can be life-threatening if not treated promptly. This study aimed to assess quetiapine-associated DKA using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods: We performed a retrospective investigation on the FAERS from the first quarter of 2004 to the second quarter of 2024 using the reporting odds ratio (ROR) and proportional reporting ratio (PRR) from the disproportionality analysis. According to the Medical Dictionary for Regulatory Activities (MedDRA) 26.1, preferred terms (PTs) of reports on adverse drug reactions (ADRs) were classified using System Organ Classification (SOC), and filtered based on hyperglycemia and new-onset diabetes mellitus in the Standardized MedDRA Query (SMQ).

Results: We collected 65,536 ADR reports with quetiapine as the primary suspected drug, including 27 system organ classifications. There were 3,046 cases related to DKA, predominantly from the United States, with a slightly higher proportion of females (51.31%) than males (45.63%). The most common severe ADR outcome (539 cases, 17.70%) was hospitalization-initial or prolonged, followed by death (333 cases, 10.93%). Additionally, compared to the other three second-generation antipsychotics (clozapine, olanzapine, and risperidone), quetiapine exhibited a stronger association with DKA (ROR = 31.05, ROR025 = 29.87).

Conclusion: Quetiapine could be associated with DKA; therefore, physicians should be aware of this potentially fatal adverse event. Studies are needed to investigate the matter further.

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喹硫平与糖尿病酮症酸中毒电位信号检测的歧化性研究。

目的：喹硫平是一种非典型的第二代抗精神病药。糖尿病酮症酸中毒（DKA）是一种急性代谢并发症，最常见于1型糖尿病，如果不及时治疗，可能危及生命。本研究旨在使用美国食品和药物管理局不良事件报告系统（FAERS）数据库评估喹硫平相关的DKA。方法：采用报告优势比（ROR）和比例报告比（PRR）对2004年第一季度至2024年第二季度的FAERS进行回顾性调查。根据MedDRA医学词典（Medical Dictionary for Regulatory Activities, MedDRA） 26.1，采用系统器官分类（System Organ Classification， SOC）对药物不良反应（adr）报告的首选词（preferred terms, PTs）进行分类，并在标准化MedDRA查询（SMQ）中根据高血糖和新发糖尿病进行筛选。结果：共收集到以喹硫平为主要可疑药物的不良反应报告65,536份，包括27个系统器官分类。DKA相关病例3046例，主要来自美国，女性（51.31%）略高于男性（45.63%）。最常见的严重不良反应结局是首次住院或延长住院（539例，17.70%），其次是死亡（333例，10.93%）。此外，与其他三种第二代抗精神病药物（氯氮平、奥氮平和利培酮）相比，喹硫平与DKA的相关性更强（ROR = 31.05, ROR025 = 29.87）。结论：喹硫平可能与DKA相关；因此，医生应该意识到这种潜在的致命不良事件。需要进行研究以进一步调查此事。

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.