背景:药物警戒研究表明氯氮平病史以药物不良反应(ADR)为特征。
目标:在一篇2021年的文章中,英国(英国)在VigiBase中超过90%的欧洲氯氮平相关致命结局,世界卫生组织的药物警戒数据库。两个可能相反的假设可以解释这种差异:1)其他西欧国家报告的致命结果较少,主要反映了对VigiBase的报告不足,2)英国报告数量越多,反映出实际相对死亡率越高。
方法:对2022年12月31日氯氮平介绍的VigiBase报告进行了ADR和致命结局的十大原因研究。英国与其他11个报告最多的西方国家(德国,丹麦,法国,芬兰,爱尔兰,意大利,荷兰,挪威,西班牙,瑞典和瑞士)。在控制人口和氯氮平处方后,对9个国家(爱尔兰和瑞士除外)进行了比较。
结果:英国占全球氯氮平相关致死结局的29%,德国2%,其他国家都<1%。非特异性标签“死亡”是世界上最大的原因(46%)和英国(33%)。“肺炎”居世界第二(8%),英国(12%),爱尔兰(8%)和芬兰(14%)。假设我们对人口和氯氮平使用的修正是正确的,其他国家仅少报了英国氯氮平致死结局数的1-10%.
结论:与英国相比,不同的西欧国家始终向VigiBase报告不足,但对于氯氮平相关的ADR/致命性结局有不同的报告/发布方式。三个斯堪的纳维亚登记册表明,随着氯氮平使用量的增加,生命得以挽救,但这不能在药物警戒数据库中进行研究.
BACKGROUND: Pharmacovigilance studies indicate clozapine history is marked by adverse drug reactions (ADRs).
OBJECTIVE: In a 2021 article, the United Kingdom (UK) had >90 % of European clozapine-related fatal outcomes in VigiBase, the World Health Organization\'s pharmacovigilance database. Two possibly opposing hypotheses could explain this disparity: 1) fewer reported fatal outcomes in other Western European countries mainly reflect underreporting to VigiBase, and 2) the higher number of UK reports reflects higher real relative mortality.
METHODS: VigiBase reports from clozapine\'s introduction to December 31, 2022, were studied for ADRs and the top 10 causes of fatal outcomes. The UK was compared with 11 other top reporting Western countries (Germany, Denmark, France, Finland, Ireland, Italy, Netherlands, Norway, Spain, Sweden and Switzerland). Nine countries (except Ireland and Switzerland) were compared after controlling for population and clozapine prescriptions.
RESULTS: The UK accounted for 29 % of worldwide clozapine-related fatal outcomes, Germany 2 % and <1 % in each of the other countries. The nonspecific label \"death\" was the top cause in the world (46 %) and in the UK (33 %). \"Pneumonia\" was second in the world (8 %), the UK (12 %), Ireland (8 %) and Finland (14 %). Assuming that our corrections for population and clozapine use are correct, other countries underreported only 1-10 % of the UK clozapine fatal outcome number.
CONCLUSIONS: Different Western European countries consistently underreport to VigiBase compared to the UK, but have different reporting/publishing styles for clozapine-related ADRs/fatal outcomes. Three Scandinavian registries suggest lives are saved as clozapine use increases, but this cannot be studied in pharmacovigilance databases.