Compared with TZD, GLP-1RA had better effects on liver fat content, body mass index, and waist circumference in overweight or obese patients with NAFLD or NASH.

Compared with TZD, GLP-1RA had better effects on liver fat content, body mass index, and waist circumference in overweight or obese patients with NAFLD or NASH.

Currently, sixty-five original sprinkle drug products are available in various dosage forms including tablets, powders, granules, immediate-release capsules, extended-release capsules, delayed-release capsules, and multiparticulate drug delivery systems. By sprinkling on soft food vehicles, these products provide dosing flexibility and convenience of administration, which potentially improve the compliance of patients with dysphagia. Due to these advantages, the growth of sprinkle products picked up since the 1990s, and several regulatory issues regarding this dosage form have been raised and documented. In this article, the types of sprinkle formulations were discussed by dividing them into seven categories, and the commercial products were summarized in terms of the drug substance, pharmaceutical excipients, storage conditions and administration methods. In addition, several US Food and Drug Administration guidelines related to the regulatory issues of sprinkle formulations were reviewed, which led to the conclusion that the future development of this promising dosage form demands integrated guidance for industry rather than scattered information in various documents.

Fine-tuned transformer-based models demonstrated reasonable performance in ADR detection from GLP-1 receptor agonist tweets, with BERTweet-base performing best. However, state-of-the-art LLMs, particularly ChatGPT 4o-mini, substantially outperformed these models, highlighting their potential for pharmacovigilance tasks.

Isatuximab, a cluster of differentiation 38 (CD38)-targeting monoclonal antibody, is used to treat relapsed or refractory multiple myeloma.This study aimed to detect the safety signal of isatuximab and to compare the reporting ratio with daratumumab, another CD38-targeting monoclonal antibody.Food and Drug Administration Adverse Event Reporting System (FAERS) data from Q1 2020 to Q1 2022 were analyzed.A disproportionality analysis was performed, and adverse events (AEs) that satisfied the criteria for a safety signal were identified.The reporting odds ratio (ROR) of the safety signal was calculated for both isatuximab and daratumumab.The relative index (ROR ratio for fatigue) was compared between isatuximab and daratumumab.From 347 isatuximab-AE pairs, 14 were identified as safety signals.Three AEs (pulmonary embolism, atrial fibrillation, and tumor lysis syndrome) were not included on the drug label, although pulmonary embolism might be a complication of multiple myeloma or an AE of coadministered immunomodulatory agents instead.Squamous cell skin cancer (ROR, 84.25 vs. 6.12),pneumocystis jirovecii pneumonia (ROR, 67.78 vs. 2.94), lymphopenia (ROR, 26.66 vs. 1.96), bronchitis (ROR, 23.31 vs. 2.55), pneumonia (ROR, 19.52 vs. 3.39), pulmonary embolism (ROR, 18.22 vs. 3.97), atrial fibrillation (ROR, 12.51 vs. 3.93), and neutropenia (ROR, 4.48 vs. 1.47) were frequently reported with isatuximab.These AEs need to be considered when using isatuximab.