Biases affecting the proportional reporting ratio (PRR) in spontaneous reports pharmacovigilance databases: the example of sertindole
Biases affecting the proportional reporting ratio (PRR) in spontaneous reports pharmacovigilance databases: the example of sertindole
复制标题
DOI：
10.1002/pds.848
复制
发表时间：
2003-06-01
影响因子：
2.6
通讯作者：
Begaud, B
中科院分区：
文献类型：
--
作者：
Moore, N;Hall, G;Begaud, B
背景药物不良反应自发报告数据库中报告不一致性的自动测量是识别药物相关警报的新兴工具。舍吲哚是一种新的非典型精神抑制剂，已知可延长QT间期，1998年11月被暂停使用，因为在英国，舍吲哚的所有报告中，提示心律失常的致命反应报告的比例几乎是其他非典型精神抑制剂的10倍。这种过度的风险没有预测在临床前数据，并没有发现在上市前试验。方法报告模式随时间进行了分析。处方事件监测（PEM）的研究和一个大的回顾性队列允许的实际死亡率与非典型精神抑制剂的比较，并评估发生的死亡的比例reported.Results有迹象表明，可能的报告相关的恶名，监督和市场规模的影响。在PEM研究中，舍吲哚和其他精神抑制剂的死亡率基本相似。心源性死亡已超过其他causesofdeath.Conclusion报告比例的两到三倍，表明可能的反应的差异报告，不一定是差异发生。在舍吲哚治疗期间，没有迹象表明所有原因或心脏死亡的风险实际增加，但只是报告的风险增加。专利药品委员会（CPMP）于2001年10月撤销了对舍吲哚的暂停。版权所有（C）2003约翰威利父子有限公司。
Background Automated measures of reporting disproportionality in databases of spontaneous reports of adverse drug reactions are an emerging tool to identify drug-related alerts. Sertindole, a new atypical neuroleptic known to prolong the QT interval, was suspended in November 1998 because the proportion of reports of fatal reactions suggesting arrhythmia among all reports with sertindole was almost ten times higher than that for other atypical neuroleptics in the UK. This excess risk was not predicted in preclinical data and had not been found in premarketing trials.Method Reporting patterns over time were analysed. Prescription Event Monitoring (PEM) studies and a large retrospective cohort allowed for the comparison of actual death rates with atypical neuroleptics, and to assess which proportion of the deaths that occurred were reported.Results There were indications of possible skewing of reporting related to notoriety, surveillance and market size effects. Death rates in PEM studies were essentially similar between sertindole and other neuroleptics. Cardiac deaths had been two to three times more often reported than other causes of death.Conclusion Proportional reporting ratios indicate differential reporting of possible reactions, not necessarily differential occurrence. There was no indication of an actual increase of risk of all causes or cardiac deaths during sertindole treatment, but only an increased risk of its being reported. The suspension of sertindole was rescinded by Committee on Proprietary Medicinal Products (CPMP) in October 2001. Copyright (C) 2003 John Wiley Sons, Ltd.