| アブストラクト | Cannabidiol is the first cannabis-derived drug approved for the treatment of Lennox-Gastaut syndrome, Dravet syndrome, and Tuberous Sclerosis Complex. In the current study, we performed a descriptive analysis followed by a disproportionality analysis of potential adverse events caused by CBD extracted from the VigiBase((R)) database. Furthermore, the biological plausibility of the association between CBD and the serotonin 5-HT(1A) receptor as a possible cause of adverse events was analyzed and discussed. Data were extracted from the VigiBase((R)) database using the VigiLyze((R)) signal detection and signal management tool. Adverse events in VigiBase((R)) reports were coded using MedDRA, version 19 of Preferred Terms (PTs). Data were uploaded into SPSS software and analyzed via a disproportionality analysis. Statistically significant disproportionality signals for CBD were found for "weight decreased" (5.19 (95% CI: 4.54-5.70)), "hypophagia" (3.68 (95% CI: 3.22-5.27)), and "insomnia" (1.6 (95% CI: 1.40-1.83)). Positive IC025 values were found for "weight decreased" (2.2), "hypophagia" (1.3), and "insomnia" (0.5), indicating a surplus of reported cases. CBD's interactions with 5-HT(1A) serotonin receptors may offer a potential biological explanation for the occurrence of insomnia in patients. It is noteworthy that the risk profiles mentioned in the information for prescribing CBD as an antiepileptic agent by regulatory agencies showed disparities specifically related to the adverse event "insomnia". |
|---|
| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
|---|
| Pubmed追加日 | 2023/10/28 |
|---|
| 投稿者 | Calapai, Fabrizio; Mannucci, Carmen; McQuain, Liana; Salvo, Francesco |
|---|
| 組織名 | Department of Chemical, Biological, Pharmaceutical and Environmental Sciences,;University of Messina, 98125 Messina, Italy.;Department of Biomedical and Dental Sciences and Morphological and Functional;Imaging, University of Messina, 98125 Messina, Italy.;Universite de Bordeaux, European Training Programme in Pharmacovigilance and;Pharmacoepidemiology (Eu2P), F-33000 Bordeaux, France.;CHU de Bordeaux, Service de Pharmacologie Medicale, Centre Regional de;Pharmacovigilance de Bordeaux, F-33000 Bordeaux, France.;Universite de Bordeaux, INSERM, Bordeaux Population Health, U1219, AHeaD Team,;F-33000 Bordeaux, France. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37895891/ |
|---|
