DataSheet_1_Psychiatric adverse events associated with GLP-1 receptor agonists: a real-world pharmacovigilance study based on the FDA Adverse Event Reporting System database.docx

BackgroundGlucagon-like peptide-1 receptor agonists (GLP-1 RAs) are widely used due to their profound efficacy in glycemic control and weight management. Within real-world contexts, the manifestation of certain psychiatric adverse events (AEs) has been observed, which is potentially linked to the administration of GLP-1 RAs. The objective of this study was to undertake a comprehensive investigation and characterization of the psychiatric AEs associated with GLP-1 RAs.MethodsWe retrieved reports of AEs associated with treatment with GLP-1 RAs during the period from the first quarter (Q1) of 2004 to Q1 2023 from the FDA Adverse Event Reporting System (FAERS) database. Descriptive analysis was performed to examine the clinical characteristics and time to onset of the psychiatric AEs caused by GLP-1 RAs. Moreover, disproportionality analyses were performed using the reporting odds ratio (ROR) to identify GLP-1 RA-related psychiatric AEs.ResultsA total of 8,240 reports of psychiatric AEs were analyzed out of 181,238 AE reports with treatment with GLP-1 RAs. Among these cases, a higher percentage was represented by women compared to men (65.89% vs. 30.96%). The median age of these patients was 56 years, with an interquartile range (IQR) of 48–67 years, based on data available in 286 case reports. This study showed that the median time to onset of the overall GLP-1 RA-related AEs was 31 days (IQR = 7–145.4 days), which varied among GLP-1 RA regimens. Specifically, exenatide had a significantly longer onset time at 45 days (IQR = 11–213 days), with statistically significant differences from the onset times of the other five GLP-1 RAs (pConclusionOur findings demonstrate a significant association between GLP-1 RAs and the development of specific psychiatric AEs. Despite the observational nature of this pharmacovigilance study and the inherent limitations of the FAERS database, our preliminary findings in this work could provide a better basis for understanding the potential psychiatric AEs that may occur with GLP-1 RA treatment, assisting clinicians to focus on these AEs and provide early intervention for optimal risk management.</p

Identification and structural elucidation of steroidal saponins from the root of <i>Paris polyphylla</i> by HPLC-ESI-QTOF-MS/MS

<div><p>The root of <i>Paris polyphylla</i> (RPP) is widely used as a traditional Chinese medicine for a long time due to the good properties of heat-clearing and detoxicating, detumescence, sedation, acesodyne and haemostasis. To clarify on the bioactive substances and ensure the safety in clinical medication, a feasible and accurate strategy was developed by applying the high-performance liquid chromatography coupled to electrospray ionisation and quadrupole time-of-flight-mass spectrometry (HPLC-ESI-QTOF-MS/MS). Separation was performed an Agilent poroshell 120 EC-C18 column (2.7 × 100 mm, i.d., 2.7 μm) with 0.1% formic acid aqueous solution and acetonitrile as the mobile phase under gradient conditions. Based on the proposed strategy, 30 constituents, mainly including steroidal saponins, were characterised or tentatively identified, 2 of which were the first to be reported as the potential new steroidal saponins in RPP. In conclusion, the HPLC-ESI-QTOF-MS/MS is a feasible and credible technique to separate and identify steroidal saponins from botanical extracts.</p></div

Additional file 1 of Incidence and risk of fatal adverse events in cancer patients treated with HER2-targeted antibody-drug conjugates: a systematic review and meta-analysis of randomized controlled trials

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