scholarly journals Kidney Injury Following Ibuprofen and Acetaminophen: A Real-World Analysis of Post-Marketing Surveillance Data

2021 ◽  
Vol 12 ◽  
Author(s):  
Qi-hui Shao ◽  
Xue-dong Yin ◽  
Hong-xia Liu ◽  
Bin Zhao ◽  
Jian-quan Huang ◽  
...  
Keyword(s):  
Real World ◽  
Empirical Bayes ◽  
Geometric Mean ◽  
Adverse Event Reporting System ◽  
Young Patients ◽  
Kidney Injury ◽  
Reporting Odds Ratio ◽  
Middle Aged ◽  
Aged Patients ◽  
Post Marketing Surveillance

Background: Although kidney injury has been reported as a serious adverse effect in patients treated with ibuprofen or acetaminophen (APAP), there are still few real-world studies to compare the specific differences in the adverse effects of nephrotoxicity.Methods: Disproportionality analysis and Bayesian analysis were devoted to data-mining of the suspected kidney injury after using ibuprofen and APAP based on the FDA’s Adverse Event Reporting System (FAERS) from January 2004 to March 2021. The times to onset, fatality, and hospitalization rates of ibuprofen-associated kidney injury and APAP-associated kidney injury were also investigated.Results: 2,453 reports of ibuprofen-associated kidney injury and 1,288 reports of APAP-associated kidney injury were identified. Ibuprofen appeared to affected more middle-aged patients than elderly ones (27.76 vs 16.53%) while APAP appeared to affected more young patients than middle-aged patients (45.24 vs 29.10%) and elderly patients were fewer (13.99%). Compared to ibuprofen, APAP had the higher association with renal injury based on the higher reporting odds ratio (ROR = 2.45, 95% two-sided CI = 2.36–2.56), proportional reporting ratio (PRR = 2.39, χ2 = 2002.94) and empirical Bayes geometric mean (EBGM = 2.38, 95% one-sided CI = 2.3). In addition, APAP-associated kidney injury had earlier onset (32.74 vs 115.82 days, p < 0.0001) and a higher fatality rate (44.43 vs 7.36%, p < 0.001) than those of ibuprofen-associated kidney injury.Conclusion: The analysis of FAERS data provides a more accurate profile on the incidence and prognosis of kidney injury after ibuprofen and acetaminophen treatment, enabling continued surveillance and timely intervention in patients at risk of kidney injury using these drugs.

Cerebral Leptomeningeal Angiomatosis CT and MRI evaluation

1998 ◽  
Vol 11 (4) ◽  
pp. 463-470
Author(s):  
J. Tsitouridis ◽  
S. Stamos ◽  
J. Demertzis ◽  
P. Nikolopoulos
Keyword(s):  
Cerebral Cortex ◽  
Young Patients ◽  
Middle Aged ◽  
Vascular Calcifications ◽  
Aged Patients ◽  
Weber Syndrome ◽  
Sturge Weber Syndrome ◽  
Mri Evaluation ◽  
Ct And Mri

Leptomeningeal angiomatosis is an uncommon benign hamartomatous lesion usually involving the leptomeninges with or without cerebral cortex involvement. Three middle-aged patients with seizures from adulthood had undergone CT and MRI examinations and craniotomies which revealed leptomeningeal angiomatosis. Another two young patients with Sturge-Weber syndrome and leptomeningeal angiomatosis were also evaluated. MRI is clearly helpful in establishing the topography and vascular malformative nature of the lesion, while CT is more accurate in detecting vascular calcifications.

scholarly journals Focal choroidal excavation complicated with choroidal neovascularization in young and middle aged patients

2018 ◽  
Author(s):  
Wenyi Tang ◽  
Ting Zhang ◽  
Qinmeng Shu ◽  
Chunhui Jiang ◽  
Qing Chang ◽  
...  
Keyword(s):  
Choroidal Neovascularization ◽  
Retinal Thickness ◽  
Young Patients ◽  
Central Retinal Thickness ◽  
Middle Aged ◽  
Aged Patients ◽  
Focal Choroidal Excavation ◽  
Anti Vegf ◽  
Mean Width ◽  
The Mean

Abstract Background To investigate the clinical and optical coherence tomography (OCT) features of focal choroidal excavation (FCE) complicated with choroidal neovascularization (CNV) in young and middle aged patients. Methods We performed a retrospective review of 26 patients with FCE accompanied by CNV. All patients underwent a complete ophthalmic examination. We analyzed the clinical characteristics of patients, focusing on the spectral-domain OCT features. All patients received intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents. And we assessed the changes of central retinal thickness and best-corrected visual acuity (BCVA) after anti-VEGF therapy. Results The mean age of 26 patients was 35.5 ± 7.3 years (range, 21 - 48 years). Of the 26 FCE lesions, 11 were located subfoveally, 6 were parafoveal, and 9 were extrafoveal. The mean FCE depth was 129.8 ± 50.3 μm, and the mean width was 901.3 ± 306.0 μm. The FCE depth was correlated positively with the width, but not correlated with age or refractive error. CNV was located within the excavation (19 eyes) or adjacent to the excavation (7 eyes). After anti-VEGF therapy, the central retinal thickness was significantly reduced and the BCVA was significantly improved. In the absorption process of subretinal fluid, we found that the fluid in the excavations needed to be absorbed at the last. A small amount of residual fluid could still be seen in a few deep excavations even after a long-term follow-up. Conclusions FCE may be an important reason to cause CNV. Especially in young patients with idiopathic CNV, we should pay attention to the use of OCT to check the presence of FCE. Anti-VEGF therapy is generally effective for CNV associated with FCE.

scholarly journals Attentional bias scores in patients with depression and effects of age: a controlled, eye-tracking study

2017 ◽  
Vol 45 (5) ◽  
pp. 1518-1527 ◽  
Author(s):  
Shengfu Lu ◽  
Jiying Xu ◽  
Mi Li ◽  
Jia Xue ◽  
Xiaofeng Lu ◽  
...  
Keyword(s):  
Eye Tracking ◽  
Attentional Bias ◽  
Age Groups ◽  
Young Patients ◽  
Attentional Biases ◽  
Middle Aged ◽  
Aged Patients ◽  
Cross Sectional ◽  
Control Subjects ◽  
Two Age Groups

Objective To compare the attentional bias of depressed patients and non-depressed control subjects and examine the effects of age using eye-tracking technology in a free-viewing set of tasks. Methods Patients with major depressive disorder (MDD) and non-depressed control subjects completed an eye-tracking task to assess attention of processing negative, positive and neutral facial expressions. In this cross-sectional study, the tasks were separated in two types (neutral versus happy faces and neutral versus sad faces) and assessed in two age groups (‘young’ [18–30 years] and ‘middle-aged’ [31–55 years]). Results Compared with non-depressed control subjects ( n = 75), patients with MDD ( n = 90) had a significant reduced positive attentional bias and enhanced negative attentional bias irrespective of age. The positive attentional bias in ‘middle-aged’ patients with MDD was significantly lower than in ‘young’ patients, although there was no difference between the two age groups in negative attentional bias. Conclusions These results confirm that there are emotional attentional biases in patients with MDD and that positive attentional biases are influenced by age.

scholarly journals Clinical-hemodynamic features of ischemic stroke in patients of young age

2020 ◽  
pp. 26-29
Author(s):  
Olena Mialovytska ◽  
Yaroslav Nebor
Keyword(s):  
Ischemic Stroke ◽  
Young People ◽  
Young Patients ◽  
Linear Velocity ◽  
Young Age ◽  
Left Vertebral Artery ◽  
Control Group ◽  
Middle Aged ◽  
Aged Patients ◽  
Aged People

58 patients with ischemic stroke were examined (29 young people — the main group and 29 middle-aged people — control group). Among the examined young patients, cardio embolic subtype of stroke prevailed (66 %), and among middle-aged patients was observed in 10 %. The athe rothrombotic subtype of stroke prevailed in middle-aged people (69 %), and among young people — 24 %. The lacunar subtype of stroke in young people was 3 %, and in middle-aged people — 21 %. Patients of young had such subtypes of strokes as hemodyna mic and hemorheological, which respectively equaled 3 %. In middle age these subtypes of strokes were not observed among the examined patients. In young people the proportion of vascular pools with ische mic stroke was: vertebrobasilar — 41 %, carotid prevailed to some extend — 59 %. In middle-aged people the proportion of strokes prevailed in the carotid pool — 64 %, in the vertebrobasilar it was 29 %. Middle-aged people also had a “combined stroke” (stroke that occurred in several pools at once), it amounted to 7 %. As a result, Doppler study of cerebral vessels proved that in young people linear velocity in the right middle cerebral artery was authentically higher compared with middle-aged patients. At the same time, the linear velocity in middle-aged patients was statistically greater in the left vertebral artery. Keywords: ischemic stroke subtypes, young age, hemodynamic parameters

Association Between Antipsychotics and Osteoporosis Based on Real-World Data

2020 ◽  
Vol 54 (10) ◽  
pp. 988-995 ◽  
Author(s):  
Satoshi Yokoyama ◽  
Shoki Wakamoto ◽  
Yuki Tanaka ◽  
Chihiro Nakagawa ◽  
Kouichi Hosomi ◽  
...  
Keyword(s):  
Real World ◽  
Adverse Event Reporting System ◽  
Health Concern ◽  
Serum Prolactin ◽  
Reporting Odds Ratio ◽  
Administrative Claims ◽  
Real World Data ◽  
Claims Database ◽  
World Data ◽  
Potential Association

Background: Osteoporosis, which is a major public health concern, has been known to reduce health-related quality of life. Some studies have suggested that antipsychotics could perhaps cause osteoporosis by increasing serum prolactin levels. However, the association between antipsychotics and the risk for developing osteoporosis has been controversial. Objective: The present study aimed to assess the association between antipsychotic use and onset of osteoporosis in real-world settings. Methods: A multimethod data-mining approach using different algorithms and databases was used. First, disproportionality analysis was conducted using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database (2004-2017) with reporting odds ratio (ROR) and information component (IC) being used to indicate a signal. Furthermore, a sequence symmetry analysis using data from a large Japanese administrative claims database (2005-2017; JMDC Inc, Japan) was conducted. Short-term intervals (ie, 12, 24, and 36 months) were set to investigate the association between antipsychotic use and onset of osteoporosis using the adjusted sequence ratio (SR) to indicate a signal. Results: No potential association between osteoporosis and all antipsychotics was observed in the FAERS database, except for perphenazine, which exhibited significant signals using both ROR and IC. Moreover, no potential association between osteoporosis and antipsychotics was observed in the JMDC claims database, except for sulpiride and aripiprazole. None of the antipsychotics indicated significant signals using all analyzed items (ROR, IC, and adjusted SR). Conclusion and Relevance: Real-world data show no association between antipsychotic use and the onset of osteoporosis. Further pharmacoepidemiological studies are needed for causality assessment.

scholarly journals Data-driven methodology for discovery and response to pulmonary symptomology in hypertension through statistical learning and data mining: Application to COVID-19 related pharmacovigilance

eLife ◽  
2021 ◽  
Vol 10 ◽  
Author(s):  
Xuan Xu ◽  
Jessica Kawakami ◽  
Nuwan Indika Millagaha Gedara ◽  
Jim Riviere ◽  
Emma Meyer ◽  
...  
Keyword(s):  
Empirical Bayes ◽  
Quantitative Methods ◽  
Randomized Clinical Trials ◽  
Geometric Mean ◽  
Single Agent ◽  
Adverse Event Reporting System ◽  
Antihypertensive Agents ◽  
Drug Event ◽  
Antithrombotic Agents ◽  
Drug Classes

Background: Potential therapy and confounding factors including typical co‐administered medications, patient's disease states, disease prevalence, patient demographics, medical histories, and reasons for prescribing a drug often are incomplete, conflicting, missing, or uncharacterized in spontaneous adverse drug event (ADE) reporting systems. These missing or incomplete features can affect and limit the application of quantitative methods in pharmacovigilance for meta-analyses of data during randomized clinical trials.Methods: Data from patients with hypertension were retrieved and integrated from the FDA Adverse Event Reporting System. 134 antihypertensive drugs out of 1151 drugs were filtered and then evaluated using the Empirical Bayes Geometric Mean (EBGM) of the posterior distribution to build ADE-drug profiles with an emphasis on the pulmonary ADEs (pADE). Afterward, the Graphical Least Absolute Shrinkage and Selection Operator (GLASSO) captured drug associations based on pADEs by correcting hidden factors and confounder misclassification. Selected drugs were then compared using the Friedman test in drug classes and clusters obtained from GLASSO.Results: Following multiple filtering stages to exclude insignificant and noise-driven reports, we found that drugs from antihypertensives agents, urologicals, and antithrombotic agents (macitentan, bosentan, epoprostenol, selexipag, sildenafil, tadalafil, and beraprost) form a similar class with a significantly higher incidence of pADEs. Macitentan and bosentan were associates with 64% and 56% of pADEs, respectively. Because these two medications are prescribed in diseases affecting pulmonary function and may be likely to emerge among the highest reported pADEs, in fact, they serve to validate the methods utilized here. Conversely, doxazosin and rilmenidine were found to have the least pADEs in selected drugs from hypertension patients. Nifedipine and candesartan were also found by signal detection methods to form a drug cluster, shown by several studies an effective combination of these drugs on lowering blood pressure and appeared an improved side effect profile in comparison with single-agent monotherapy.Conclusions: We consider pADE profiles in multiple long-standing groups of therapeutics including antihypertensive agents, antithrombotic agents, beta-blocking agents, calcium channel blockers, or agents acting on the renin-angiotensin system, in patients with hypertension associated with high-risk for COVID-19. We found that several individual drugs have significant differences between their drug classes and compared to other drug classes. For instance, macitentan and bosentan from endothelin receptor antagonists show major concern while doxazosin and rilmenidine exhibited the least pADEs compared to the outcomes of other drugs. Using techniques in this study, we assessed and confirmed the hypothesis that drugs from the same drug class could have very different pADE profiles affecting outcomes in acute respiratory illness.Funding: GJW and MJD accepted funding from BioNexus KC for funding on this project, but BioNexus KC had no direct role in this article.

scholarly journals Aneurysm and Artery Dissection Following the Use of Vascular Endothelial Growth Factor Inhibitor: A Real‐World Analysis Using a Spontaneous Reporting System

2021 ◽  
Author(s):  
Shuyue Wang ◽  
Mingzhu Chen ◽  
Xinghui Zhang ◽  
Lingjian Zhang ◽  
Min Jia ◽  
...  
Keyword(s):  
Vascular Endothelial Growth Factor ◽  
Growth Factor ◽  
Real World ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Artery Dissection ◽  
Reporting Odds Ratio ◽  
Vascular Endothelial ◽  
Endothelial Growth Factor

Background Pharmacological inhibition of angiogenesis via the vascular endothelial growth factor pathway is an important therapeutic target that prevents tumor growth and the formation of metastases. Although vascular endothelial growth factor inhibitor (VPI) is well understood as a well‐defined safety profile, few real‐world studies are comparing the incidence, clinical features, and prognosis of the aneurysm and artery dissection. Methods and Results To evaluate and compare the links between different VPIs and aneurysm and artery dissection, we identified 634 reports with VPIs in the US Food and Drug Administration Adverse Event Reporting System database ranging between January 2004 to March 2020. We used the reporting odds ratio for the association between the use of VPIs and aneurysm and artery dissection. The reporting odds ratio (3.68, 95%, 2.18‒6.23) shows that ramucirumab has a stronger correlation than other VPIs. The results show a significant difference in onset time ( P <0.001). The median time to aneurysm and artery dissection was 79.5 (interquartile interval, 19.0–273.5) days after VPI administration. The results also show that VPI‐associated aneurysm and artery dissection was reported more often in men (n=336, 59.68% versus n=227, 40.32%), and there were more cases in patients aged between 45 to 74 years than those <45 years (n=312, 68.12% versus n=18, 3.93%); patients aged ≥75 years accounted for 27.95% (n=128). Finally, the suspected drugs generally led to 19.98% deaths and 29.81% hospitalizations. Conclusions We identified signals for aneurysm and artery dissection following various VPIs in real‐world practice via the Food and Drug Administration Adverse Event Reporting System, which represents the first step for continued pharmacovigilance investigation.

scholarly journals Adverse outcomes associated with the treatment of Toxoplasma infections

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ahmed M. Shammaa ◽  
Thomas G. Powell ◽  
Imaan Benmerzouga
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Real World ◽  
Odds Ratio ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Adverse Outcomes ◽  
Reporting Odds Ratio ◽  
Real World Data ◽  
Suspect Drug

AbstractAdverse outcomes associated with the treatment of Toxoplasma gondii infections in patients with various health backgrounds have not been characterized. The aim of this study was to identify the adverse outcomes and adverse events associated with the current clinical treatments of Toxoplama gondii infections using real world data reported to the FDA adverse event reporting system (FAERS). Data submitted to FAERS between 2013 and 2019 was retrieved and analyzed. Reporting odds ratio of death was calculated for the drugs having ≥ 25 reports of adverse outcomes. The adverse event profiles for the same drugs were analyzed and the reporting odds ratio was calculated relative to all other drugs used in the treatment of Toxoplasma infections. There were 503 cases reporting the treatment of Toxoplasma infections in the FAERS database. Death (DE) was the adverse outcome in 102 reports, of which 23 (22.5%) anti-Toxoplasma drugs were listed as the primary suspect drug (PS). Clindamycin (2.04; 1.07–3.90) followed by pyrimethamine (1.53; 0.99–2.36) were the most likely to be associated with death. Adverse events analysis suggest that sulfonamides formulations may have a less favorable safety profile. Our study represents the first real-world analysis of adverse outcomes and events associated with the treatment of Toxoplasma infections. Our findings support the need to better understand the current first-line agents for Toxoplasma infections, in addition to underscoring the need to identify safer regimens.

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