Comparing the use of individual and composite terms to evaluate adverse drug event disproportionality: a focus on glucagon-like peptide-1 receptor agonists and diabetic retinopathy
Comparing the use of individual and composite terms to evaluate adverse drug event disproportionality: a focus on glucagon-like peptide-1 receptor agonists and diabetic retinopathy
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DOI：
10.1080/14740338.2021.1887136
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发表时间：
2021-03-28
影响因子：
3.1
通讯作者：
Farley, Joel F.
中科院分区：
文献类型：
--
作者：
Dauner, Daniel G.;Farley, Joel F.
背景：Support-6试验显示，与安慰剂组相比，赛马路德组的视网膜病变并发症发生率明显更高。观察性研究并没有始终如一地证实这一发现，这引发了人们对复合变量的适当性以及这种关系是否存在于整个药物类别或仅限于个别胰高血糖素样肽1激动剂(GLP-1RAs)的疑问。该研究的目的是评估使用单独术语和复合术语来评估GLP-1RAs和糖尿病视网膜病变事件之间的关联的差异。研究设计和方法：利用美国食品和药物管理局不良事件报告系统的报告来检查GLP-1RAs和糖尿病视网膜病变事件之间的关系。结果：4个GLP-1RA显示了糖尿病视网膜病变事件的信号。GLP-1RA药物类别有四个糖尿病视网膜病变信号。只有赛马路德对复合型糖尿病视网膜病变的预后有影响。GLP-1RA药物类别和综合糖尿病视网膜病变结果不符合PRR信号阈值。结论：与单独药物评估相比，使用药物类别水平和复合结果变量可能会掩盖糖尿病视网膜病变信号。我们的结果支持了持续-6试验的结果，并提示四种GLP-1RA与糖尿病视网膜病变事件之间存在关联。
Background: The SUSTAIN-6 trial showed significantly higher rates of retinopathy complications in the semaglutide group compared to placebo. Observational studies have not consistently corroborated this finding, raising questions about the appropriateness of composite variables and whether the relationship exists across the entire drug class or is limited to individual glucagon-like peptide 1 agonists (GLP-1RAs). The study objective was to evaluate the difference between using individual and composite terms to assess associations between GLP-1RAs and diabetic retinopathy events.Research Design and Methods: Reports from the US Food and Drug Administration Adverse Event Reporting System were utilized to examine relationships between GLP-1RAs and diabetic retinopathy events. A disproportionality analysis was conducted using the proportional reporting ratio.Results: Four GLP-1RAs demonstrated signals for diabetic retinopathy events. The GLP-1RA drug class had four diabetic retinopathy signals. Only semaglutide had a signal for the composite diabetic retinopathy outcome. The GLP-1RA drug class and the composite diabetic retinopathy outcome did not meet the PRR signal thresholds.Conclusions: The use of drug class level and composite outcome variables may mask diabetic retinopathy signals in comparison to individual drug assessments. Our results support the SUSTAIN-6 trial findings and suggest an association between four GLP-1RAs and diabetic retinopathy events.