Disproportionality analysis from World Health Organization data on migraine-specific medications and cerebrovascular diseases.

IF 2.4 3区医学 Q3 PHARMACOLOGY & PHARMACY

European Journal of Clinical Pharmacology Pub Date : 2025-04-01 Epub Date: 2025-02-24 DOI:10.1007/s00228-025-03812-y

Jaehyeong Cho, Hyesu Jo, Jaeyu Park, Kyeongmin Lee, Hayeon Lee, Soeun Kim, Yejun Son, Jeongseon Oh, Jinyoung Jeong, Sooji Lee, Jiyeon Oh, Hanseul Cho, Jee Myung Yang, Ho Geol Woo, Dong Keon Yon, Lee Smith

{"title":"Disproportionality analysis from World Health Organization data on migraine-specific medications and cerebrovascular diseases.","authors":"Jaehyeong Cho, Hyesu Jo, Jaeyu Park, Kyeongmin Lee, Hayeon Lee, Soeun Kim, Yejun Son, Jeongseon Oh, Jinyoung Jeong, Sooji Lee, Jiyeon Oh, Hanseul Cho, Jee Myung Yang, Ho Geol Woo, Dong Keon Yon, Lee Smith","doi":"10.1007/s00228-025-03812-y","DOIUrl":null,"url":null,"abstract":"Background: Migraine is a major cause of population ill health, with an estimated global prevalence of approximately 14-15%. However, given the limited research on the associations between specific migraine medications and adverse cerebrovascular events, this study aimed to investigate these relationships and their impact on cerebrovascular risk.Methods: This study utilized data from the global pharmacovigilance database, which covers 170 countries from 1968 to 2024. We examined the reporting frequency of adverse cerebrovascular events with 10 migraine medications, with analysis stratified by sex and age. The information component (IC) was calculated using a Bayesian method, while the reporting odds ratio (ROR) was calculated using a frequentist approach to compare reported versus non-reported outcomes.Results: Among the more than 140 million adverse drug events, 6,080 cases were identified as adverse cerebrovascular events associated with migraine-specific medications. Significant associations with cerebrovascular diseases were observed in both males (ROR, 1.24 [95% CI, 1.19-1.30]; IC 0.31 [IC0.25, 0.24]) and females (1.73 [1.67-1.79]; 0.78 [0.72]), with most age groups showing significance, except for those 75 years and older. Among the 10 medication categories, 6 categories were associated with adverse cerebrovascular diseases: CGRP antagonists (ROR, 1.22 [95% CI, 1.12-1.33]; IC, 0.28 [IC0.25,0.14]), ergot alkaloids (3.66 [2.97-4.51]; 1.84 [1.49]), 5-HT₁ receptor agonists (3.33 [2.97-4.51]; 1.72 [1.59]), beta-blockers (2.03 [1.94-2.13]; 1.02 [0.94]), calcium channel blockers (1.46 [1.30-1.64]; 0.54 [0.34]), and clonidine (2.18 [2.04-2.33]; 1.11 [1.00]).Conclusion: This study found that commonly used migraine medications are significantly associated with an increased risk of cerebrovascular diseases, highlighting the need for careful patient evaluation and selection.","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"571-581"},"PeriodicalIF":2.4000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Clinical Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00228-025-03812-y","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/24 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Migraine is a major cause of population ill health, with an estimated global prevalence of approximately 14-15%. However, given the limited research on the associations between specific migraine medications and adverse cerebrovascular events, this study aimed to investigate these relationships and their impact on cerebrovascular risk.

Methods: This study utilized data from the global pharmacovigilance database, which covers 170 countries from 1968 to 2024. We examined the reporting frequency of adverse cerebrovascular events with 10 migraine medications, with analysis stratified by sex and age. The information component (IC) was calculated using a Bayesian method, while the reporting odds ratio (ROR) was calculated using a frequentist approach to compare reported versus non-reported outcomes.

Results: Among the more than 140 million adverse drug events, 6,080 cases were identified as adverse cerebrovascular events associated with migraine-specific medications. Significant associations with cerebrovascular diseases were observed in both males (ROR, 1.24 [95% CI, 1.19-1.30]; IC 0.31 [IC_0.25, 0.24]) and females (1.73 [1.67-1.79]; 0.78 [0.72]), with most age groups showing significance, except for those 75 years and older. Among the 10 medication categories, 6 categories were associated with adverse cerebrovascular diseases: CGRP antagonists (ROR, 1.22 [95% CI, 1.12-1.33]; IC, 0.28 [IC_0.25,0.14]), ergot alkaloids (3.66 [2.97-4.51]; 1.84 [1.49]), 5-HT₁ receptor agonists (3.33 [2.97-4.51]; 1.72 [1.59]), beta-blockers (2.03 [1.94-2.13]; 1.02 [0.94]), calcium channel blockers (1.46 [1.30-1.64]; 0.54 [0.34]), and clonidine (2.18 [2.04-2.33]; 1.11 [1.00]).

Conclusion: This study found that commonly used migraine medications are significantly associated with an increased risk of cerebrovascular diseases, highlighting the need for careful patient evaluation and selection.

查看原文本刊更多论文

来自世界卫生组织关于偏头痛特异性药物和脑血管疾病数据的不相称性分析。

背景：偏头痛是人群健康不良的主要原因，估计全球患病率约为14-15%。然而，鉴于特定偏头痛药物与脑血管不良事件之间的关联研究有限，本研究旨在调查这些关系及其对脑血管风险的影响。方法：本研究利用全球药物警戒数据库的数据，涵盖170个国家，从1968年到2024年。我们检查了10种偏头痛药物的脑血管不良事件报告频率，并按性别和年龄进行了分层分析。使用贝叶斯方法计算信息分量（IC），而使用频率方法计算报告的优势比（ROR），以比较报告和未报告的结果。结果：在1.4亿多例药物不良事件中，6080例被确定为与偏头痛特异性药物相关的脑血管不良事件。两名男性患者均与脑血管疾病有显著相关性(ROR, 1.24 [95% CI, 1.19-1.30]；ic0.31 [IC0.25, 0.24])和雌性（1.73 [1.67-1.79]）；0.78[0.72])，除75岁及以上外，其余年龄组均有统计学意义。在10个用药类别中，6个类别与不良脑血管疾病相关：CGRP拮抗剂(ROR, 1.22 [95% CI, 1.12-1.33]；集成电路,0.28 [IC0.25, 0.14]),麦角生物碱(3.66[2.97—-4.51];1.84 [1.49])， 5-HT 1受体激动剂(3.33 [2.97-4.51]；1.72 [1.59])， β受体阻滞剂(2.03 [1.94-2.13]；1.02[0.94])，钙通道阻滞剂(1.46 [1.30-1.64]；0.54[0.34])，可乐定(2.18 [2.04-2.33]；1.11[1.00])。结论：本研究发现，常用的偏头痛药物与脑血管疾病风险增加显著相关，强调了对患者进行仔细评估和选择的必要性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

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.