Real-world pharmacovigilance study of FDA adverse event reporting system events for finerenone.

OBJECTIVE: This study analyzed the signal mining of adverse events caused by finerenone based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) and evaluated the drug's safety to provide a reference for the safe administration of this medication in medical institutions. METHODS: FAERS data from the third quarter of 2021 to the fourth quarter of 2023 were used, and the adverse event codes of the Medical Dictionary for Regulatory Activities were compared. After the data were processed, adverse event reports that featured finerenone as the most suspected drug were extracted. RESULTS: A total of 905 reported cases of adverse events including finerenone as the first suspected drug were extracted. The ratio of male to female patients was 1.25, and most were aged 65-85 years (30.1%). The adverse events that were reported more frequently with positive signals were decreased glomerular filtration rate, hyperkalemia, increased blood creatinine, and dizziness. The adverse events that were concentrated on in investigations were metabolism and nutrition disorders and diseases of the renal and urinary system. CONCLUSIONS: Our study identified significant novel adverse events (AEs) signals for finerenone that could provide support for clinical monitoring of and risk identification for finerenone.

Efficacy and safety of antithrombotic therapy for preventing and treating pediatric thromboembolic disease: a systematic review.

This review used traditional and network meta-analyses (NMA) to conduct a comprehensive study of antithrombotic therapies in children with thromboembolic disease. We searched the PubMed, Embase, Cochrane Library, Web of Science and ClinicalTrials.gov databases from their inception to 26 February, 2023. And we finally included 16 randomized controlled trials. In the prevention of thromboembolic events (TEs), the use of anticoagulants had a low risk of TEs (relative risk (RR) 0.73, 95% CI 0.56 to 0.94) and a high risk of minor bleeding (RR 1.43, 95% CI 1.09 to 1.86) compared with no anticoagulants. In the treatment of TEs, direct oral anticoagulants (DOACs) were not inferior to standard anticoagulation in terms of efficacy and safety outcomes. In NMA, rivaroxaban and apixaban showed the lowest risk for TEs and major or clinically relevant nonmajor bleeding. According to the overall assessment of efficacy and safety, dabigatran may be the best choice for children with thromboembolic disease. The results of our study will provide references and suggestions for clinical drug selection.

Parents' perception and their decision on their children's vaccination against seasonal influenza in Guangzhou.

BACKGROUND: Seasonal influenza epidemic occurs every year in Guangzhou, which can affect all age groups. Young children are the most susceptible targets. Parents can decide whether to vaccinate their children or not based on their own consideration in China. The aim of this study was to identify factors that are important for parental decisions on vaccinating their children against seasonal influenza based on a modified health belief model (HBM). METHODS: A cross-sectional study was conducted in Guangzhou, China. A total of 335 parents who had at least on child aged between 6 months and 3 years were recruited from women and children's hospital in Guangzhou, China. Each eligible subject was invited for a face-to-face interview based on a standardized questionnaire. RESULTS: Uptake of seasonal influenza within the preceding 12 months among the target children who aged between 6 months and 36 months was 47.7%. Around 62.4% parents indicated as being "likely/very likely" to take their children for seasonal influenza vaccination in the next 12 months. The hierarchical logistic regression model showed that children's age (odds ratio [OR] =2.59, 95% confidence interval [CI]: 1.44-4.68), social norm (OR = 2.08, 95% CI: 1.06-4.06) and perceived control (OR = 2.96, 95% CI: 1.60-5.50) were significantly and positively associated with children's vaccination uptake within the preceding 12 months; children with a history of taking seasonal influenza vaccine (OR = 2.50, 95% CI: 1.31-4.76), perceived children's health status (OR = 3.36, 95% CI: 1.68-6.74), worry/anxious about their children influenza infection (OR = 2.31, 95% CI: 1.19-4.48) and perceived control (OR = 3.21, 95% CI: 1.65-6.22) were positively association with parental intention to vaccinate their children in the future 12 months. However, anticipated more regret about taking children for the vaccination was associated with less likely to vaccinate children within the preceding 12 months (OR = 0.21, 95% CI: 0.08-0.52). CONCLUSIONS: The modified HBM provided a good theoretical basic for understanding factors associated with parents' decisions on their children's vaccination against seasonal influenza.