Papazisis Georgios, Spachos Dimitrios, Siafis Spyridon, Pandria Niki, Deligianni Eleni, Tsakiridis Ioannis, Goulas Antonios
Department of Clinical Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Laboratory of Medical Physics, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Front Psychiatry. 2021 May 20;12:640264. doi: 10.3389/fpsyt.2021.640264. eCollection 2021.
The latest decade, an emerging issue has been the abuse potential of the gabapentinoids pregabalin and gabapentin. The aim of our study was to assess this safety signal combining two different methods of surveillance: search analytics big data and the FDA spontaneous reporting system database. Analysis of big data and the FAERS was used to detect pregabalin's and gabapentin's abuse potential in comparison with two controls, clonazepam and levetiracetam, and further, the correlation between these domains was investigated. Data from the United States between 2007 and 2020Q2 were analyzed. The FAERS analysis revealed the following pattern of signals: clonazepam > pregabalin ≥ gabapentin > levetiracetam, for both the primary term "drug abuse and dependence" and the secondary terms (withdrawal, tolerance, overdose). The Google domain pattern was slightly different: clonazepam ≥ gabapentin ≥ pregabalin≥ levetiracetam. A monotonic correlation was found between FAERS and Google searches for gabapentin ( = 0.558; < 0.001), pregabalin ( = 0.587; < 0.001), and clonazepam ( = 0.295; = 0.030). Our results revealed that there is preliminary evidence of a safety signal for the abuse potential of pregabalin and gabapentin. Analysis of the FAERS database, supplemented by big data search analytics, suggests that there is potential of using these methods as a supplementary tool to detect drug abuse-related safety signals in pharmacovigilance.
最近十年，加巴喷丁类药物普瑞巴林和加巴喷丁的潜在滥用问题日益凸显。我们研究的目的是结合两种不同的监测方法来评估这一安全信号：搜索分析大数据和美国食品药品监督管理局（FDA）自发报告系统数据库。通过对大数据和FDA不良事件报告系统（FAERS）进行分析，将普瑞巴林和加巴喷丁的潜在滥用情况与两种对照药物氯硝西泮和左乙拉西坦进行比较，并进一步研究这些领域之间的相关性。分析了2007年至2020年第二季度来自美国的数据。FAERS分析揭示了以下信号模式：对于主要术语“药物滥用和依赖”以及次要术语（戒断、耐受性、过量），氯硝西泮>普瑞巴林≥加巴喷丁>左乙拉西坦。谷歌搜索领域的模式略有不同：氯硝西泮≥加巴喷丁≥普瑞巴林≥左乙拉西坦。在FAERS和谷歌搜索中发现加巴喷丁（r = 0.558；P < 0.001）、普瑞巴林（r = 0.587；P < 0.001）和氯硝西泮（r = 0.295；P = 0.030）之间存在单调相关性。我们的结果表明，有初步证据显示普瑞巴林和加巴喷丁存在潜在滥用的安全信号。由大数据搜索分析补充的FAERS数据库分析表明，有可能将这些方法用作药物警戒中检测药物滥用相关安全信号的辅助工具。
