Aim The objective of this study was to evaluate the reported associations between the syndrome of inappropriate antidiuretic hormone secretion (SIADH) and a variety of proton pump inhibitors (PPI) through analysis of the reports extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods FAERS reports from January 2004 to March 2020 were used to conduct disproportionality and Bayesian analyses. The definition of SIADH relied on the preferred terms provided by the Medical Dictionary for Regulatory Activities. The time to onset, mortality, and hospitalization rates of PPI-related SIADH were also investigated. Results The study identified a total of 273 reports of PPI-associated SIADH, which appeared to influence more elderly than middle-aged patients (71.1% vs. 12.5%). Women were more affected than men (48.7% vs. 41.8%). Rabeprazole had a stronger SIADH association than other PPIs based on the highest reporting odds ratio (reporting odds ratio = 13.3, 95% confidence interval (CI) = 7.2, 24.9), proportional reporting ratio (proportional reporting ratio = 13.3, χ2 = 113.7), and empirical Bayes geometric mean (empirical Bayes geometric mean = 13.3, 95% CI = 7.9). The median time to SIADH onset was 22 (interquartile range 6–692) days after PPI administration. PPI-associated SIADH generally led to a 2.95% fatality rate and a 79.7% hospitalization rate. The highest hospitalization death rate occurred in esomeprazole (91.2%). Conclusion According to our findings, more attention should be paid to SIADH within the first several months after the administration of PPIs. For women older than 65 years, dexlansoprazole may reduce the incidence of PPI-associated SIADH. Nonetheless, larger epidemiological studies are suggested to verify this conclusion.
The objective of this study was to systematically evaluate the clinical efficacy of the complementary use of corticosteroids in the treatment of community-acquired pneumonia (CAP). We searched all relevant documents in five scientific databases from inception to June 2022 to collect clinical trials (randomized controlled trials and controlled trials) reporting on the adjunctive use of corticosteroids in CAP treatment. The primary outcome was mortality, and secondary outcomes included the time to clinical stability, therapeutic efficacy, duration of antibiotic treatment and length of hospital/ICU stay. Therapeutic efficacy was defined as the rate of achieving clinical recovery with no fever, improvement or disappearance of cough. Clinical stability was defined by improvements in laboratory values. Two researchers independently screened the literature according to the inclusion and exclusion criteria, extracted data and evaluated the quality of literature. Statistical analysis and meta-analysis of intervention measures and indicators were performed with IBM SPSS and RevMan 5.4 software. Nine randomized controlled trials comprising 2673 participants with CAP (1335 in the corticosteroid group and 1338 in the control group) were identified and included in this study. The mean cumulative corticosteroid dose and treatment duration were 298.00±287.140 mg and 5.22±1.787 days, respectively. Corticosteroid treatment was not associated with a significant decrease in mortality (RR; 95% CI, 0.96 [0.67–1.38], P=0.83). Because of the low number of included patients in our study, more studies with larger sample sizes and high-quality randomized, double-blind controlled trials are needed to confirm the results.
It has been recently shown that the adjunct use of corticosteroids in the treatment of community-acquired pneumonia shorten the time taken to reach clinical stability (time to clinical stability) in patients with community-acquired pneumonia (CAP). Considering the hyperglycemic effects of corticosteroids, there are concerns about the efficacy and safety of this therapy for children with CAP. Our objective is to evaluate the influence of recent advances in adjunct corticosteroid use and/or aerosolized antibiotic administration on admission to hospital with our main outcome being duration of fever and hospital stay, and additional outcomes as the time to clinical stability therapeutic efficacy, C-reactive protein and defervescence at 24, 48, and 72 hours after starting treatment in a well-defined cohort of children with community-acquired pneumonia. Therapeutic efficacy is defined as the rate of achieving clinical recovery with no fever, improvement or disappearance of cough, and improved or normal laboratory values. Five academic literature databases will be searched using Boolean keyword searches. Articles eligible for inclusion are those that present original research with the study topic as CAP, the study was designed as a randomized controlled trial (RCT) or clinical trial (CT) or an observational study with controls. The review will result in a narrative synthesis that summarizes the effectiveness of corticosteroid use in children.
Background: There are few real-world studies comparing the incidence, clinical features, and prognosis of aneurysm and artery dissection related to various vascular endothelial growth factor inhibitor (VPI) regimens. This study evaluated the recent evidence of aneurysm and artery dissection after VPI therapy. The purpose was to evaluate and compare the links between different VPIs and aneurysm and artery dissection by investigating the Food and Drug Administration Adverse Event Reporting System (FAERS).Methods: Using FAERS data from January 2004 to March 2020, disproportionality analysis was used for data mining to screen suspected aneurysm and artery dissection cases after different VPI treatments. The times to onset and fatality rates of suspected drugs were also investigated to assess prognoses.Results: In total, there were 634 reports of aneurysm and artery dissection events after VPI. Ramucirumab appeared to have a stronger association than other VPIs, based on the reporting odds ratio (ROR = 3.68, 95% [2.18, 6.23]). The results showed a significant difference in onset time (P < 0.001), and a quick onset occurred in 60.13% of cases. The median time to aneurysm and artery dissection was 79.5 (IQR: 19–273.5) days after VPI administration. The results also showed that men were more affected than women (59.68% vs. 40.32%), and patients older than 45 years were more affected than younger patients (68.12% vs. 3.93%). Finally, the suspected drugs generally led to a 19.98% fatality rate and a 29.81% hospitalization rate. The highest death rate was associated with Aflibercept (25.49%).Conclusions: We identified signals for aneurysm and artery dissection following various VPIs in real-world practice using the FAERS, which represents the first step for continued pharmacovigilance investigation.
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