Evaluation of pregabalin-induced adverse events related to falls using the FDA adverse event reporting system and Japanese Adverse Drug Event Report databases
Evaluation of pregabalin-induced adverse events related to falls using the FDA adverse event reporting system and Japanese Adverse Drug Event Report databases
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使用 FDA 不良事件报告系统和日本不良药物事件报告数据库评估普瑞巴林引起的跌倒相关不良事件
DOI：
10.1111/jcpt.12790
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发表时间：
2018
影响因子：
2
通讯作者：
Nakamura Mitsuhiro
中科院分区：
文献类型：
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作者：
Mukai Ririka;Hasegawa Shiori;Umetsu Ryogo;Nakao Satoshi;Shimada Kazuyo;Uranishi Hiroaki;Masuta Mayuko;Suzuki Honami;Nishibata Yuri;Nakamura Mitsuhiro
已知和客观普瑞巴林用于治疗神经性和带状疱疹后疼痛以及广泛性焦虑。本研究的目的是利用美国食品和药物管理局不良事件报告系统（FAERS）数据库和日本不良药物事件等自发报告系统（SRS）分析，获得与跌倒（AEF）相关的不良事件（AE）的发病概况，例如“嗜睡”、“头晕”、“意识丧失”和“跌倒”发作以及年龄和给药剂量等多种临床因素组合。 报告（JADER）数据库。方法我们使用报告比值比（ROR）来分析普瑞巴林和 AEF 之间的关联。此外，我们还使用了发病时间分析。 结果和讨论 嗜睡和头晕等 AEF 的粗 ROR 均高于两个数据库的 ROR。 FAERS 和 JADER 数据库中，≥60 岁年龄组与 <60 岁年龄组 AEF 的调整 ROR 分别为 1.46 (95% CI = 1.39‐1.53；P< 0.0001) 和 2.58 (95% CI = 2.06‐3.27；P< 0.0001)。在 JADER 数据库中，普瑞巴林≤75 毫克/天和≥100 毫克/天的 AEF 中位范围和四分位数范围分别为 2.0 (0.0‐5.0) 和 2.0 (1.0‐4.3) 天。此外，57.2% 的 AEF（四个首选术语）在给药后 2 天内观察到。新内容和结论本研究首次使用 SRS 分析策略评估普瑞巴林和 AEF 之间的关系。与 <60 岁年龄组相比，≥60 岁年龄组发生 AEF 的风险可能会增加。 AEF 几乎发生在普瑞巴林给药后 1 周内，AEF 发作的中位时间为 2 天。我们的结果表明，应在开始服用普瑞巴林后 1 周内密切监测患者的 AEF。
What is known and objectivePregabalin is used for neuropathic and postherpetic pain and generalized anxiety. The aim of this study was to obtain the onset profiles of adverse events (AE) related to falls (AEFs) such as “somnolence,” “dizziness,” “loss of consciousness” and “fall” onset and several clinical factor combinations such as age and administered dose, using spontaneous reporting system (SRS) analysis such as the US Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database.MethodsWe used the reporting odds ratio (ROR) to analyse the association between pregabalin and AEFs. Additionally, we used the time‐to‐onset analysis.Results and discussionThe crude RORs of AEFs such as somnolence and dizziness were higher than one for both the databases. The adjusted RORs for AEFs in the ≥60 years age group compared to those in the <60 years age group for the FAERS and JADER databases were 1.46 (95% CI = 1.39‐1.53;P< 0.0001) and 2.58 (95% CI = 2.06‐3.27;P< 0.0001), respectively. In the JADER database, the median and quartile range for AEFs with pregabalin, at ≤75 and ≥100 mg/d, were 2.0 (0.0‐5.0) and 2.0 (1.0‐4.3) days, respectively. Additionally, 57.2% of AEFs (four preferred terms) were observed within 2 days after administration.What is new and conclusionsThis study is the first to evaluate the relationship between pregabalin and AEFs using the SRS analysis strategy. The risk of AEFs in the ≥60 years age group might increase compared to that in the <60 years age group. AEFs occurred almost within 1 week after pregabalin administration, and the median for AEF onset was 2 days. Our results show that patients should be closely monitored for AEFs for 1 week from the start of pregabalin administration.