Subeesh Viswam, Maheswari Eswaran, Singh Hemendra, Beulah Thomas Elsa, Swaroop Ann Mary
Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bengaluru, India.
Department of Psychiatry, Ramaiah Medical College, Bengaluru, India.
Curr Drug Saf. 2019;14(1):21-26. doi: 10.2174/1574886313666181026100000.
BACKGROUND: The signal is defined as "reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously". OBJECTIVE: To detect novel adverse events of iloperidone by disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS) using Data Mining Algorithms (DMAs). METHODOLOGY: The US FAERS database consists of 1028 iloperidone associated Drug Event Combinations (DECs) which were reported from 2010 Q1 to 2016 Q3. We consider DECs for disproportionality analysis only if a minimum of ten reports are present in database for the given adverse event and which were not detected earlier (in clinical trials). Two data mining algorithms, namely, Reporting Odds Ratio (ROR) and Information Component (IC) were applied retrospectively in the aforementioned time period. A value of ROR-1.96SE>1 and IC- 2SD>0 were considered as the threshold for positive signal. RESULTS: The mean age of the patients of iloperidone associated events was found to be 44years [95% CI: 36-51], nevertheless age was not mentioned in twenty-one reports. The data mining algorithms exhibited positive signal for akathisia (ROR-1.96SE=43.15, IC-2SD=2.99), dyskinesia (21.24, 3.06), peripheral oedema (6.67,1.08), priapism (425.7,9.09) and sexual dysfunction (26.6-1.5) upon analysis as those were well above the pre-set threshold. CONCLUSION: Iloperidone associated five potential signals were generated by data mining in the FDA AERS database. The result requires an integration of further clinical surveillance for the quantification and validation of possible risks for the adverse events reported of iloperidone.
背景:信号被定义为“关于不良事件与药物之间可能的因果关系的报告信息,该关系以前未知或记录不完整”。 目的:使用数据挖掘算法(DMA),通过对美国食品药品监督管理局不良事件报告系统(FAERS)数据库进行比例失衡分析,检测伊潘立酮的新不良事件。 方法:美国FAERS数据库包含2010年第一季度至2016年第三季度报告的1028个与伊潘立酮相关的药物事件组合(DEC)。对于给定的不良事件,只有在数据库中至少有十份报告且在早期(临床试验中)未被检测到的情况下,我们才考虑对DEC进行比例失衡分析。在上述时间段内,回顾性应用了两种数据挖掘算法,即报告比值比(ROR)和信息成分(IC)。ROR-1.96SE>1和IC-2SD>0的值被视为阳性信号的阈值。 结果:发现与伊潘立酮相关事件患者的平均年龄为44岁[95%置信区间:36-51],不过有21份报告未提及年龄。经分析,数据挖掘算法对静坐不能(ROR-1.96SE=43.15,IC-2SD=2.99)、运动障碍(21.24,3.06)、外周水肿(6.67,1.08)、阴茎异常勃起(425.7,9.09)和性功能障碍(26.6-1.5)显示出阳性信号,因为这些均远高于预设阈值。 结论:通过对FDA AERS数据库进行数据挖掘,生成了与伊潘立酮相关的五个潜在信号。该结果需要进一步进行临床监测,以对伊潘立酮报告的不良事件的可能风险进行量化和验证。
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