Journal of Pain Research (Aug 2024)
Gabapentinoids-Related Delirium Adverse Events: A Real-World Study from 2004 to 2022 Based on FAERS
Abstract
Zhongbiao Nie,1 Cuilv Liang,2 Zhihong Li,1 Xinqiang Han,3 Ran Zhang4 1Department of Pharmacy, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, 030032, People’s Republic of China; 2Department of Pharmacy, Second Affiliated Hospital, Fujian Medical University, Quanzhou, 362000, People’s Republic of China; 3Department of General, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, 030032, People’s Republic of China; 4Department of Nephrology, Affiliated Hospital of Shanxi University of Chinese Medicine, Taiyuan, 030024, People’s Republic of ChinaCorrespondence: Ran Zhang, Department of Nephrology, Affiliated Hospital of Shanxi University of Traditional Chinese Medicine, Taiyuan, 030024, People’s Republic of China, Tel +86-13633516515, Email [email protected]: This study comprehensively describes and evaluates the correlation between gabapentinoids and all types of delirium.Methods: We used AERSMine to select all adverse reaction data from 2004 Q1 to the 2022 Q4 in the FDA Adverse Event Reporting System (FAERS) database, and delirium events reported by gabapentinoids drugs were included in this study. Collected and analyzed the clinical details of these reports. We have developed four models. Among the four models, reporting odds ratio (ROR) and proportional reporting ratio (PRR) were used to evaluate the potential association between and delirium. We undertook a subgroup analysis for the age and sex cohorts.Results: A total of 2950 reports of gabapentinoids-related delirium was collected. Excluding cases with a history of delirium (Model 2), opioid drugs (Model 3), and other adverse events related to gabapentinoids drugs (Model 4), pain cases with gabapentin drugs as the main suspected drug were selected. In model 1, the reporting rates of delirium at the delirium and delirium tremens levels were higher in the gabapentinoids group than in the non-gabapentinoids group (ROR 1.09(1.05,1.13); ROR 1.54(1.16,2.04)). In model 2.3 the delira and the delirium level were higher in the gabapentinoids group (ROR 1.42(1.29,1.56), ROR 1.44(1.31,1.59); ROR 1.43(1.30,1.58), ROR 1.46(1.33,1.61)). There is no difference in delirium levels in Model 4. Delirium levels were higher in the gabapentinoids group than in the non-gabapentinoids group in ≥ 65 years old. The delirium and deliria levels were higher in the male group than in the female group.Conclusion: The delirium adverse reactions of the gabapentinoids group were significantly higher than those of non-gabapentinoids group in the first three models. However, with the removal of confounding factors, there was no significant difference in this type of adverse reaction in Model 4. In elderly and male patients, the incidence of delirium with gabapentinoids was significantly increased.Keywords: gabapentinoids, delirium, adverse reactions, FAERS, pharmacovigilance
