ABSTRACT
BACKGROUND: Atogepant, an orally administered, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist, is being investigated for the treatment of migraine. METHODS: We collected data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Four algorithms (ROR, PRR, BCPNN, and EBGM) were used as measures to detect signals of atogepant-associated adverse events (AEs) in real-world data. RESULT: Of the 3,552,072 reports, 2876 expressly stated the use of atogepant. Women accounted for the majority of adverse events (AEs), with a notable age concentration of 45-65 years. The percentage of reported adverse events was the highest in the United States. Significant system organ categories (SOC) included nervous system disorders, gastrointestinal disorders, nervous system disorders, surgical and medical procedures, ear and labyrinth disorders. Notably, preferred terms (PTs) related to atogepant include migraine, constipation, nausea, vertigo, somnolence, decreased appetite, dizziness and fatigue. Unexpected adverse events such as abnormal dreams, self-injurious ideation, brain fog, tension headache, nightmare, brain neoplasm, feeling abnormal, euphoric mood, hyperacusis and post concussion syndrome were also identified. CONCLUSIONS: The present investigation has detected new and unexpected signals of atogepant-related adverse drug reactions (ADRs). In order to confirm these solve safety issues that were previously overlooked, more research is necessary.
ABSTRACT
BACKGROUND AND AIM: Gastritis and duodenitis, prevalent diseases of the digestive system, impose a significant global burden. This study aimed to examine their incidence and prevalence patterns worldwide, including changes over the past 30 years. METHODS: The age-standardized incidence rate (ASIR) and age-standardized prevalence rate (ASPR) of gastritis and duodenitis, stratified by age, sex, geographical region, and sociodemographic index (SDI), were obtained from the Global Burden of Disease 2019. The dynamic trends were captured by calculating the average annual percentage changes (AAPC). RESULTS: In 2019, the global ASIR and ASPR of gastritis and duodenitis were 379.88/100 000 (95% uncertainty interval [UI]: 312.42/100 000-448.12/100 000) and 518.11/100 000 (95% UI: 420.62/100 000-631.66/100 000), respectively. The highest rates were observed among the 50-69 age group (ASIR: 856.48/100 000; ASPR: 1158.04/100 000) and in low SDI regions (ASIR: 443.33/100 000; ASPR: 631.22/100 000). From 1990 to 2019, there was a significant decrease in global ASIR (AAPC = -0.34%, 95% confidence interval [CI]: -0.36% to -0.31%) and ASPR (AAPC = -0.34%, 95% CI: -0.37% to -0.31%) of gastritis and duodenitis. However, ASIR (AAPC = 0.47%, 95% CI: 0.42%-0.52%) and ASPR (AAPC = 0.51%, 95% CI: 0.47%-0.52%) of gastritis and duodenitis experienced a significant increase in low SDI regions. CONCLUSIONS: Despite a significant decrease in the global incidence and prevalence of gastritis and duodenitis, these conditions continue to impose a burden on individuals aged 50-69 years and low SDI regions. Targeted interventions for those specific populations and regions are necessary.