Dataset Information

Real-world safety evaluation of musculoskeletal adverse events associated with Korean pediatric fluoroquinolone use: a nationwide longitudinal retrospective cohort study.

ABSTRACT: Though the pediatric use of fluoroquinolones (FQs) is limited for musculoskeletal safety concerns, the clinical usefulness still exists. This study examined the association between FQs and musculoskeletal adverse events (AEs) as well as the possible risk factors associated with the pediatric FQs uses. This population-based, longitudinal, retrospective study was conducted using Korean National Sample Cohort database originating between 2002 and 2015. An FQ-treated pediatric cohort (<18 years old) was compared to a control treated with amoxicillin. Propensity score matching (PSM) and a Cox proportional hazard model was used to estimate the hazard ratio (HR) for a diagnosis of musculoskeletal AEs within 60 days of the first prescription. Among one million participants, total of 15,706 and 147,840 children were eligible for the FQ and amoxicillin cohorts, respectively. The PSM cohorts showed a slightly increased risk of musculoskeletal AEs after FQ treatment (HR, 1.19; 95% confidence interval, 1.01-1.40; p?=?0.042). This association was stronger in males, older patients, and some FQs users. This study indicates that pediatric FQ use is associated with a risk of musculoskeletal AEs and that FQ use should be carefully monitored in groups with certain risk factors. Well-designed pragmatic trials could be expected to clarify these issues.

SUBMITTER: Kim Y

PROVIDER: S-EPMC6934562 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Real-world safety evaluation of musculoskeletal adverse events associated with Korean pediatric fluoroquinolone use: a nationwide longitudinal retrospective cohort study.

Kim Yoonhye Y Paik Minwoo M Khan Chanjoo C Kim Yae-Jean YJ Kim EunYoung E

Scientific reports 20191227 1

Though the pediatric use of fluoroquinolones (FQs) is limited for musculoskeletal safety concerns, the clinical usefulness still exists. This study examined the association between FQs and musculoskeletal adverse events (AEs) as well as the possible risk factors associated with the pediatric FQs uses. This population-based, longitudinal, retrospective study was conducted using Korean National Sample Cohort database originating between 2002 and 2015. An FQ-treated pediatric cohort (<18 years old) ...[more]

PMID: 31882917

Similar Datasets

Project description:Background & Aims: Immune checkpoint inhibitors (ICIs) have transformed the landscape of cancer treatment, and ICI-related toxicities (i.e., immune-related adverse events (irAEs) have been reported in many clinical studies. However, the toxicity data of real-world have not been fully assessed. Methods: Patients with histologically confirmed solid tumors who had been treated with PD-1 inhibitors were included in the study. Patient data were collected from electronic medical records, including basic characteristics, data of irAEs, management and outcome. Incidences of irAEs were pooled and compared, and the risk of irAEs was also analyzed. Results: A total of 362 solid tumor patients treated with sintilimab (n = 171), camrelizumab (n = 60), toripalimab (n = 72), and pembrolizumab (n = 59) were included. In total, any grade irAEs, grade 1–2 irAEs, and grade ≥3 irAEs accounted for 47.24%, 38.67% and 8.56% of cases, reapectively. Further, 29.24% of patients discontinued immunotherapy due to irAEs, with pneumonitis being the main reason for discontinuation. By comparing the toxicity profiles between different ICIs, we found that reactive capillary haemangiomas were camrelizumab-specific. Additionally, the frequency of irAEs was association with ICIs type, the pooled incidence (standardized rate) of irAEs related to sintilimab, camrelizumab, toripalimab and pembrolizumab were 55.56% (52.81%), 48.33% (55.55%), 33.33% (29.23%) and 38.98% (38.29%), respectively. Sintilimab and camrelizumab had higher incidences of any grade and grade 1–2 than toripalimab (55.56% vs. 33.33%, p = 0.002; 48.54% vs. 25.00%, p = 0.0001) and pembrolizumab (55.56% vs. 38.98%, p = 0.0028; 48.54% vs. 25.42%, p = 0.002), while the grade ≥3 irAEs of pembrolizumab (13.56%) were approximately 1.63- to 1.93-fold higher than other ICIs, and the standardized grade ≥3 of pembrolizumab was significantly higher than that of sintilimab (13.21% vs. 7.12%, p = 0.026), especially for grade ≥3 pneumonitis. Multivariate analysis found that cumulative cycles of ICI (OR = 1.081; 95% CI: 1.023–1.142; p = 0.006), and lung cancer (OR = 1.765; 95% CI: 1.105–2.820; p = 0.017) were independent risk factors for irAEs. Conclusion: The frequency of irAEs is associated with ICI type. The pooled incidence of irAEs related to sintilimab and pneumonitis caused by pembrolizumab were higher. These data indicate the importance of having different monitoring priorities for different PD-1 inhibitors.

Project description:BackgroundRisankizumab, a humanized IgG1 monoclonal antibody that selectively inhibits IL-23, is currently approved for the treatment of moderate-to-severe plaque psoriasis and Crohn's disease. The real-world safety study of risankizumab in a large- sample population is currently lacking. The aim of this study was to evaluate risankizumab-associated adverse events (AEs) and characterize the clinical priority through the data mining of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).MethodsDisproportionality analyses were performed by calculating the reporting odds ratios (RORs), deemed significant when the lower limit of the 95% confidence interval was greater than 1, to quantify the signals of risankizumab-related AEs from the second quarter (Q2) of 2019 to 2022 Q3. Serious and non-serious cases were compared, and signals were prioritized using a rating scale.ResultsRisankizumab was recorded in 10,235 reports, with 161 AEs associated with significant disproportionality. Of note, 37 PTs in at least 30 cases were classified as unexpected AEs, which were uncovered in the drug label, such as myocardial infarction, cataract, pancreatitis, diabetes mellitus, stress, and nephrolithiasis. 74.68%, 25.32%, and 0% PTs were graded as weak, moderate, and strong clinical priorities, respectively. A total of 48 risankizumab-related AEs such as pneumonia, cerebrovascular accident, cataract, loss of consciousness, cardiac disorder, hepatic cirrhosis, and thrombosis, were more likely to be reported as serious AEs. The median TTO of moderate and weak signals related to risankizumab was 115 (IQR 16.75-305) and 124 (IQR 29-301) days, respectively. All of the disproportionality signals had early failure type features, indicating that risankizumab-associated AEs gradually decreased over time.ConclusionOur study found potential new AE signals and provided valuable evidence for clinicians to mitigate the risk of risankizumab-associated AEs based on an extensive analysis of a large-scale postmarketing international safety database.

Dataset Information

Real-world safety evaluation of musculoskeletal adverse events associated with Korean pediatric fluoroquinolone use: a nationwide longitudinal retrospective cohort study.

Publications

Real-world safety evaluation of musculoskeletal adverse events associated with Korean pediatric fluoroquinolone use: a nationwide longitudinal retrospective cohort study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets