药物警戒中的参照物:准量化偏差分析》。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-08-01 Epub Date: 2024-05-04 DOI:10.1007/s40264-024-01433-5
Christopher A Gravel, William Bai, Antonios Douros
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引用次数: 0

摘要

背景和目的:目前尚不清楚在基于自发报告的比例失调分析中,哪种参照物最适合减少偏倚。我们使用两种经过充分研究的药物-事件组合进行了准定量偏倚分析,以评估不同的参照物如何影响药物警戒中偏倚的方向性:我们使用美国食品和药物管理局不良事件报告系统,重点研究了两种具有刺激性报告倾向的药物-事件组合:利伐沙班和肝毒性,以及卡格列净和急性肾损伤。我们使用一个非限制性参照物(完整数据)和两个限制性参照物(活性参照物、活性参照物与类别排除)评估了三个比例失调分析估计值(报告几率比、比例报告比、信息成分)的方向性。分析在两个日历时间段内进行,根据外部事件(直接口服抗凝剂的批准、美国食品药品管理局关于钠-葡萄糖共转运体 2 抑制剂急性肾损伤的安全警告)进行定义,假设外部事件会改变报告率:无论采用哪种比较药,利伐沙班和肝毒性都没有出现假阳性信号。如果仅限于批准后的初始阶段,则会出现假阳性信号,受限的比较药物表现更差。在卡格列洛嗪和急性肾损伤方面出现了假阳性信号,而受限比较药的表现较好。限制在食品与药物管理局发出警告之前的时间段削弱了所有比较者在卡格列净和急性肾损伤方面的假阳性信号:我们无法确定特定参照物的比例失调分析估计值的方向性是否存在一致且可预测的模式。基于相关外部事件的日历时间限制具有相当大的影响。
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Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis.

Background and objective: It is unclear which comparator is the most appropriate for bias reduction in disproportionality analyses based on spontaneous reports. We conducted a quasi-quantitative bias analysis using two well-studied drug-event combinations to assess how different comparators influence the directionality of bias in pharmacovigilance.

Methods: We used the US Food and Drug Administration Adverse Event Reporting System focusing on two drug-event combinations with a propensity for stimulated reporting: rivaroxaban and hepatotoxicity, and canagliflozin and acute kidney injury. We assessed the directionality of three disproportionality analysis estimates (reporting odds ratio, proportional reporting ratio, information component) using one unrestricted comparator (full data) and two restricted comparators (active comparator, active comparator with class exclusion). Analyses were conducted within two calendar time periods, defined based on external events (approval of direct oral anticoagulants, Food and Drug Administration safety warning on acute kidney injury with sodium-glucose cotransporter 2 inhibitors) hypothesized to alter reporting rates.

Results: There were no false-positive signals for rivaroxaban and hepatotoxicity irrespective of the comparator. Restricting to the initial post-approval period led to false-positive signals, with restricted comparators performing worse. There were false-positive signals for canagliflozin and acute kidney injury, with restricted comparators performing better. Restricting to the period before the Food and Drug Administration warning weakened the false-positive signal for canagliflozin and acute kidney injury across comparators.

Conclusions: We could not identify a consistent and predictable pattern to the directionality of disproportionality analysis estimates with specific comparators. Calendar time-based restrictions anchored on relevant external events had a considerable impact.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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