Incidence of adverse events prompting switching between biologics among adults with asthma: A retrospective cohort study.
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ABSTRACT:
SUBMITTER: Akenroye A
PROVIDER: S-EPMC10066822 | biostudies-literature | 2023 Apr
REPOSITORIES: biostudies-literature
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Incidence of adverse events prompting switching between biologics among adults with asthma: A retrospective cohort study.
Akenroye Ayobami A Zhou Guohai G Jackson John W JW Segal Jodi J Alexander G Caleb GC Singh Sonal S
Allergy 20221105 4
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Project description:BackgroundRecent systematic reviews support that non-operative management should be the standard treatment for all stable isolated lateral malleolar fractures (ILMFs), regardless of fibular fracture displacement. Surgical fixation of ILMFs carries a risk of adverse events (AEs), and many patients will later require implant removal. We wanted to estimate the incidence of AEs requiring revision after surgical fixation of "potentially stable" displaced ILMFs before non-operative treatment became standard care in our department.Materials and methodsTo identify patients with "potentially stable" ILMFs who had been treated surgically in a historical cohort, we retrospectively applied the stability-based classification system, introduced by Michelson et al., to a cohort of 1006 patients with ankle fractures treated surgically from 2011 to 2016. The primary outcome of this retrospective cohort study was the incidence of AEs that had functionally significant adverse effects on outcome and required revision in the first 12 months after surgery. AEs were graded and categorized using the Orthopedic Surgical Adverse Events Severity (OrthoSAVES) System.ResultsThe study population comprised 108 patients with "potentially stable" displaced ILMFs; 4 patients (3.7% [95% CI (0.1-7.3%]) experienced AEs requiring revision in the first twelve months after surgery. There were 5 additional patients (4.6%) with functionally significant AEs where revision surgery was not indicated within the first twelve months after surgical fixation. A further 5 patients (4.6%) had AEs managed in the outpatient clinic (grade II); 36 patients (33.3%) required secondary implant removal due to implant-related discomfort.ConclusionsSurgical fixation of ILMFs carries a risk of severe AEs, and many patients will subsequently need implant-removal procedures. Further prospective studies are required to ascertain whether non-operative treatment can lower the risk of AEs and the need for additional surgical procedures.
| S-EPMC9066775 | biostudies-literature
Project description:AbstractAdverse events (AEs) are unfortunate consequences of platelet donation. This study reports the incidence and severity of AEs and the associated risk factors in platelet donation at a major blood donation center in Riyadh, Saudi Arabia.A review of donation records was conducted between 2014 and 2017. Eligible study participants were 5007 platelet donors who had donated 7969 times. Each donation was accounted for as a single study subject. Participants' characteristics were described and analyzed as potential contributing factors to adverse events.The average age of platelet donors was 30.0±7.3 years. First-time donors comprised (n = 3,100, 61.9%) of the sample, and 1907 (38.1%) were multiple donors (periodic/routine). Their average BMI was 28.6 ± 4.9 kg/m2. Most donors have blood type "O" and Rheo "positive". The range of blood volume processed was 0 to 5273 ml, while the procedure duration ranged from 0 to 90 minutes. The average platelet yield was 3.8 ± 3.5 ∗1011 platelets per unit, and the average collected volume was 257.6 ± 86.1 ml. Incidence of AEs was 4.2%, of which 91.3% were mild and 8.7% were severe. AEs were vascular injuries (65.3%), vasovagal reactions (11.6%), and citrate toxicity (5.3%). AEs were associated with first-time donation, adj.OR (95%CI) = 1.5 (1.1-1.8) and lower BMI, adj. OR (95% CI) = 1.4 (1.1-1.8). Citrate toxicity was present in severe forms, unlike vascular injuries and vasovagal reactions that tended to be milder. Donors with hemoglobin levels above 16 g/dl, adj. OR (95% CI) = 1.3 (1.1-1.7) and platelet levels below 250,000, adj. OR (95% CI) = 1.3 (1.1-1.6) were more likely to contract AEs than others.Reporting adverse events is essential to establish a benchmark for the annual incidence rates to be compared against local and international figures. Blood donor centers should also take notice of blood donors characteristics that are associated with higher incidence and more severe forms of AEs during or after platelet donation.
| S-EPMC7769365 | biostudies-literature
Project description:ObjectiveSeveral biological DMARDs (bDMARDs) have demonstrated anti-inflammatory effects in PsA. However, their comparative cardiovascular safety profiles remain unknown. We evaluated the risk of major adverse cardiovascular events (MACEs) in PsA patients on therapy with different classes of bDMARDs and apremilast.MethodsThis nationwide cohort study involved the administrative healthcare database of the French health insurance scheme linked to the hospital discharge database. All adults with PsA who were new users of bDMARDs/apremilast (neither in the year before the index date) during 2015-19 were included. Patients with previous cardiovascular diseases were excluded. End of follow-up was 31 December 2019. The primary endpoint was an occurrence of MACEs in a time-to-event analysis with propensity score-weighted Cox and Fine-Gray models.ResultsBetween 2015 and 2019, we included 9510 bDMARD new users [mean age 48.5 (s.d. 12.7) years; 42% men], including 7289 starting a TNF inhibitor, 1058 an IL-12/23 inhibitor and 1163 an IL-17 inhibitor, with 1885 apremilast new users [mean age 54.0 (s.d. 12.5) years; 44% men]. MACEs occurred in 51 (0.4%) patients. After propensity score weighting, the risk of MACEs was significantly greater with IL-12/23 (weighted hazard ratio 2.0, 95% CI 1.3, 3.0) and IL-17 (weighted hazard ratio 1.9, 95% CI 1.2, 3.0) inhibitors than TNF inhibitors, with no significant increased risk with apremilast (weighted hazard ratio 1.3, 95% CI 0.8, 2.2). Similar results were observed with the Fine-Gray competing risks survival model.ConclusionAnalysis of a large database revealed a small overall number of MACEs, and the risk of MACEs was greater for PsA new users of IL-12/23 and IL-17 vs TNF inhibitors.
| S-EPMC8996783 | biostudies-literature
Project description:BackgroundImmune checkpoint inhibitors (ICIs) have become common lines of therapy for genitourinary cancers (GUcs). Given their widespread use, understanding the risk factors, comparative profiles, and timing of immune-related adverse events (irAEs) is essential.MethodsWe created an IRB-approved retrospective registry of all patients who received at least one dose of an ICI for any indication between 1 February 2011 and 7 April 2022 at a comprehensive cancer center and its outreach clinics. Dichotomous outcomes were modeled using multivariable logistic regression. Survival outcomes were compared using multivariable Cox regression.ResultsAmong 3101 patients, 196 had renal cell carcinoma (RCC) and 170 had urothelial tumors. RCC patients were more likely to experience irAEs (OR 1.78; 95% CI 1.32-2.39), whereas urothelial carcinoma patients were not (OR 1.22; 95% CI 0.88-1.67). RCC patients were more prone to dermatitis, thyroiditis, acute kidney injury, and myocarditis, compared to other tumors, while urothelial carcinoma patients were not. The impact of irAEs on survival was not significantly different for GUcs compared to other tumors.ConclusionsRCC primaries have a significantly different irAE profile than most tumors, as opposed to urothelial primaries. Further, RCC was more likely to experience any irAEs. Heterogeneity of survival benefits by irAEs was not seen.
| S-EPMC11394475 | biostudies-literature
Project description:BackgroundThe promotion of safer healthcare interventions in hospitals is a relevant public health topic. This study is aimed to investigate predictors of Adverse Events (AEs) taking into consideration the Charlson Index in order to control for confounding biases related to comorbidity.MethodsThe study was a retrospective cohort study based on a two-stage assessment tool which was used to identify AEs. In stage 1, two physicians reviewed a random sample of patient records from 2008 discharges. In stage 2, reviewers independently assessed each screened record to confirm the presence of AEs. A univariable and multivariable analysis was conducted to identify prognostic factors of AEs; socio-demographic and some main organizational variables were taken into consideration. Charlson comorbidity Index was calculated using the algorithm developed by Quan et al.ResultsA total of 1501 records were reviewed; mean patients age was 60 (SD: 19) and 1415 (94.3%) patients were Italian. Forty-six (3.3%) AEs were registered; they most took place in medical wards (33, 71.7%), followed by surgical ones (9, 19.6%) and intensive care unit (ICU) (4, 8.7%). According to the logistic regression model and controlling for Charlson Index, the following variables were associated to AEs: type of admission (emergency vs elective: OR 3.47, 95% CI: 1.60-7.53), discharge ward (surgical and ICU vs medical wards: OR 2.29, 95% CI: 1.00-5.21 and OR 4.80, 95% CI: 1.47-15.66 respectively) and length of stay (OR 1.03, 95% CI 1.01-1.04). Among patients experiencing AEs a higher frequency of elderly (≥65 years) was shown (58.7% vs 49.3% among patients without AEs) but this difference was not statistically significant. Interestingly, a higher percentage of patients admitted through emergency department was found among patients experiencing AEs (69.7% vs 55.1% among patients without AEs).ConclusionsThe incidence of AEs was associated with length of stay, type of admission and unit of discharge, independently by comorbidity. On the basis of our results, it appears that organizational characteristics, taking into account the adjustment for comorbidity, are the main factors responsible for AEs while patient vulnerability played a minor role.
| S-EPMC4155122 | biostudies-literature
Project description:Background and aimsQuetiapine is an atypical antipsychotic predominantly metabolized by the cytochrome P450 3A4 (CYP3A4) enzyme. We studied the risk of adverse events following coprescription of clarithromycin (a strong CYP3A4 inhibitor) versus azithromycin (not a CYP3A4 inhibitor) in quetiapine users.Materials and methodsThis was a population-based retrospective cohort study from 2004 to 2020 in Ontario, Canada in adult quetiapine users newly co-prescribed clarithromycin (n = 16,909) or azithromycin (n = 25,267). The primary outcome was the composite of hospital encounters with encephalopathy (defined as a diagnosis of delirium, disorientation, transient alteration of awareness, transient ischemic attack, or unspecified dementia), a fall, or a fracture within 30 days of new coprescription. Secondary outcomes were individual components of the composite outcome, hospital encounter with computed tomography (CT) head scan, and all-cause mortality.ResultsCoprescription of clarithromycin versus azithromycin with quetiapine was associated with a higher risk of the primary composite outcome (365 of 16,909 clarithromycin users [2.2%] vs. 309 of 16,929 azithromycin users [1.8%]; absolute risk increase, 0.34% [95% confidence interval, CI, 0.04-0.63]; relative risk [RR], 1.19 [95% CI, 1.02-1.38]). This was primarily driven by an increase in fragility fractures (78 of 16,909 clarithromycin users [0.5%] vs. 45 of 16,923 azithromycin users [0.3%]; absolute risk increase, 0.20% [95% CI, 0.07-0.32]; RR, 1.74 [95% CI, 1.21-2.52]). Hospital encounters with a CT head scan were higher in clarithromycin users (220 of 16,909 [1.3%] vs. 175 of 16,923 azithromycin users [1.0%]; absolute risk increase, 0.27% [95% CI, 0.04-0.50]; RR, 1.26 [95% CI, 1.04-1.54]), but there was no difference in hospital encounters with encephalopathy, falls, or all-cause mortality between macrolide groups.ConclusionAmong adults taking quetiapine, concurrent use of clarithromycin compared with azithromycin was associated with a small but statistically greater 30-day risk of a hospital encounter for encephalopathy, falls, or fracture, which was predominantly related to a higher rate of fragility fractures.
| S-EPMC10290079 | biostudies-literature
Project description:BackgroundStudies have shown the efficacy of asthma biologics in real-world settings, confirming the generalizability of randomized controlled trial (RCT) results, but studies on more than one biologic are scarce. Accordingly, little is known about the different background characteristics in users of asthma biologics. This study aimed to describe the backgrounds of asthma patients using biologics (omalizumab, mepolizumab, benralizumab, and dupilumab) and examine the effectiveness of these biologics for reducing asthma exacerbations and total systemic corticosteroid doses.MethodsWe conducted a retrospective cohort study using self-controlled methods to evaluate the association between the use of biologics and reduction in exacerbations and hospitalizations using a large-scale health insurance claims database in Japan.ResultsOf 355 continuously treated asthma patients using biologics, 119, 82, 69, and 85 patients were assigned to the omalizumab, mepolizumab, benralizumab, and dupilumab groups, respectively. The baseline characteristics differed among users of biologics. The incidence ratios of exacerbations and hospitalizations during biologics use were 0.68 (95% confidence interval, 0.62-0.74) and 0.65 (0.55-0.77) compared with the period before biologics use. The total systemic corticosteroid dose equivalent to prednisolone per person-year was reduced from a median of 600 [interquartile range, 90-1713] mg to 164 [0-1010] mg (P < .001). Similar results were obtained for individual biologics with a few exceptions.ConclusionsThe background characteristics of biologics users differed in a real-world setting. Our results confirmed findings from RCTs demonstrating that each biologic (omalizumab, mepolizumab, benralizumab, and dupilumab) is associated with decreased exacerbation numbers and corticosteroid-sparing effects, even outside of the controlled settings of RCTs.
| S-EPMC8585664 | biostudies-literature
Project description:BackgroundResearch into adverse events (AEs) has highlighted the need to improve patient safety. AEs are unintended injuries or complications resulting in death, disability or prolonged hospital stay that arise from health care management. We estimated the incidence of AEs among patients in Canadian acute care hospitals.MethodsWe randomly selected 1 teaching, 1 large community and 2 small community hospitals in each of 5 provinces (British Columbia, Alberta, Ontario, Quebec and Nova Scotia) and reviewed a random sample of charts for nonpsychiatric, nonobstetric adult patients in each hospital for the fiscal year 2000. Trained reviewers screened all eligible charts, and physicians reviewed the positively screened charts to identify AEs and determine their preventability.ResultsAt least 1 screening criterion was identified in 1527 (40.8%) of 3745 charts. The physician reviewers identified AEs in 255 of the charts. After adjustment for the sampling strategy, the AE rate was 7.5 per 100 hospital admissions (95% confidence interval [CI] 5.7- 9.3). Among the patients with AEs, events judged to be preventable occurred in 36.9% (95% CI 32.0%-41.8%) and death in 20.8% (95% CI 7.8%-33.8%). Physician reviewers estimated that 1521 additional hospital days were associated with AEs. Although men and women experienced equal rates of AEs, patients who had AEs were significantly older than those who did not (mean age [and standard deviation] 64.9 [16.7] v. 62.0 [18.4] years; p = 0.016).InterpretationThe overall incidence rate of AEs of 7.5% in our study suggests that, of the almost 2.5 million annual hospital admissions in Canada similar to the type studied, about 185 000 are associated with an AE and close to 70 000 of these are potentially preventable.
| S-EPMC408508 | biostudies-literature
Project description:Physicians often consider various nonmedical factors in hospital admission decision-making and may admit socially tenuous patients despite low-acuity medical needs. Evidence showing whether these patients are subject to the same risks of hospitalization as those considered definitely medically appropriate is limited. Our study sought to inform this risk/benefit discussion by quantifying the number of adverse events (AEs) experienced by both patient populations by using the Institute for Healthcare Improvement Global Trigger Tool methodology. We found no difference in the percentage of admissions with AEs between the two groups (27.3% vs 29.3%; risk ratio 0.93, 95% CI 0.65-1.34, P = .70) nor in AEs per 1,000-patient days (76.8 vs 70.4; incidence rate ratio = 1.09, 95% CI 0.77-1.55, P = .61). Thus, the number of AEs experienced during hospitalization does not appear to be related to the appropriateness of admission based on the level of medical acuity.
| S-EPMC6932594 | biostudies-literature
Project description:ObjectiveThis study aimed to determine the incidence of postoperative major adverse cardiac events for patients undergoing carotid endarterectomy.MethodsThis single-center, retrospective study recruited 171 carotid endarterectomy patients between January 1999 and June 2018. Patients who received a carotid endarterectomy in conjunction with other surgery were excluded. The primary outcomes were the incidences of major adverse cardiac events (comprising myocardial infarction, significant arrhythmias, congestive heart failure, and cardiac death) within 7 days, 7-30 days, and > 30 days-1 year, postoperatively. The secondary outcomes were the factors related to major adverse cardiac events and the incidence of postoperative stroke. The patients' charts were reviewed, and direct contact was made with them to obtain information on their status post discharge.ResultsThe incidences of major adverse cardiac events within 7 days, 7-30 days, and >30 days-1 year of the carotid endarterectomy were 3.5% of patients (95% confidence interval: 0.008-0.063), 1.2% (95% confidence interval: 0.004-0.028), and 1.8% (95% confidence interval: 0.002-0.037), respectively. The major adverse cardiac events occurring within 7 days were arrhythmia (2.3% of patients), cardiac arrest (1.8%), myocardial infarction (1.2%), and congestive heart failure (1.2%), while the corresponding postoperative stroke rate was 4.7%.ConclusionThe 7-day incidence of major adverse cardiac events after the carotid endarterectomy was 3.5%. The most common major adverse cardiac event during that period was cardiac arrhythmia.
| S-EPMC8744171 | biostudies-literature