Adverse Events In Elderly Patients Research Articles

Hidradenitis Suppurativa in Elderly Patients: Clinical and Therapeutical Outcomes-A Review of the Literature.

The management of hidradenitis suppurativa (HS) in elderly patients presents unique challenges due to its chronic inflammatory nature, heterogeneous clinical presentation and comorbidities. While HS typically affects the anogenital and intertriginous regions, elderly patients may exhibit atypical features such as the involvement of the neck, mammary area and gluteal region. The prevalence of HS in the elderly population is lower and the average age of disease onset is higher than in patients under 65. In contrast, it is unclear whether HS in the elderly has different clinical features. The elderly frequently present multiple comorbidities, including obesity, diabetes, and heart disease, which further complicate management decisions. Therapeutic interventions must consider the frailty and increased risk of multimorbidity and adverse events in elderly patients. While systemic antibiotics remain a mainstay of HS treatment, biologic agents such as TNFα inhibitors and secukinumab offer promising options for refractory cases. However, their safety and efficacy in elderly patients, particularly those with multiple comorbidities, require careful consideration. A comprehensive approach to managing HS in elderly patients involves not only pharmacological interventions but also lifestyle modifications and surgical options where appropriate. Multidisciplinary collaboration between dermatologists, geriatricians and other specialists is essential for tailoring treatment strategies and optimizing long-term outcomes and quality of life in special population.

Disproportionality Analysis of Osimertinib-related Adverse Events in Elderly Patients Using the Japanese Pharmacovigilance Database.

Osimertinib is a well-tolerated first- or second-line treatment option for elderly patients with epidermal growth factor receptor mutation-positive advanced non-small cell lung cancer. However, the safety of osimertinib in elderly patients requires further investigation. Herein, we identified safety signals for various osimertinib-related adverse events (AEs) in elderly patients by disproportionality analysis using the Japanese Adverse Drug Event Report (JADER) database. Data from the JADER database from April 2004 to March 2023 were obtained from the Pharmaceuticals and Medical Devices Agency website. Safety signal detection for osimertinib-related AEs in elderly patients (≥70 years old) was determined using the relative elderly reporting odds ratio (ROR). For osimertinib-related AEs, we extracted 92 preferred terms (PTs) and nine standardized MedDRA queries (SMQs). Safety signals in elderly patients were detected for "Cardiomyopathy (PT)" and "Cardiomyopathy (SMQ)". The symptoms most frequently associated with "Cardiomyopathy (SMQ)" included "Ejection fraction decreased (PT)", "Cardiomyopathy (PT)", and "Stress cardiomyopathy (PT)". Notably, 53.7% of these outcomes were "Recovery" or "Remission". The median time to the onset of "Cardiomyopathy (SMQ)" in elderly patients was 85 days (range=2-537 days). We demonstrated that patients ≥70 years potentially have increased osimertinib-related cardiomyopathy compared with patients <70 years. In the future, it is necessary to conduct research focusing on cardiomyopathy in elderly patients.

Effects of buccal acupuncture on postoperative analgesia in elderly patients undergoing laparoscopic radical gastrectomy: a randomized controlled trial.

This study aimed to evaluate the efficacy and safety of buccal acupuncture on postoperative analgesia, perioperative stress response and adverse events in elderly patients undergoing laparoscopic radical gastrectomy. It was a prospective, outcome assessor-blinded, randomized controlled trial, involving 90 patients aged 65-80 years who were treated with an elective laparoscopic radical gastrectomy. They were randomly assigned to buccal acupuncture group (Group B) and control group (Group C). Buccal acupuncture was applied to patients of Group B before the induction of general anesthesia, while no additional application was given to those in Group C. Patient-controlled intravenous analgesia (PCIA) with sufentanil was postoperatively performed in both groups. Sufentanil consumption and the Visual Analog Scale (VAS) score within 48 h postoperatively were assessed as primary outcomes. Secondary outcomes included peripheral levels of stress markers, intraoperative consumptions of anesthetic drugs and postoperative recovery. Patients in Group B presented significantly lower VAS scores within 24 h and less consumption of sufentanil within 48 h postoperatively (both p < 0.01). The awaking time, time to extubation and length of stay were significantly shorter in Group B than in Group C (p = 0.005, 0.001 and 0.028, respectively). Compared with Group C, stress response and inflammatory response within 24 h postoperatively were also significantly milder in Group B. The use of buccal acupuncture before general anesthesia induction favors the postoperative analgesic effect and recovery in elderly patients undergoing laparoscopic radical gastrectomy, the mechanism of which involves relieving postoperative stress response and inflammatory response. This study was registered in the Chinese Clinical Trial Registry (www.chictr.org.cn) on 15/06/2023 (ChiCTR2300072500).

Risk Factors Associated with Adverse Events Leading to Methotrexate Withdrawal in Elderly Rheumatoid Arthritis Patients: A Retrospective Cohort Study.

Background: Rheumatoid arthritis (RA) in elderly population represents a challenge for physicians in terms of therapeutic management. Methotrexate (MTX) is the first-line treatment among conventional synthetic-disease-modifying anti-rheumatic drugs (cs-DMARDs); however, it is often associated with adverse events (AEs). Therefore, the objective of this study was to identify the incidence and risk factors of MTX discontinuation due to AEs in elderly patients with RA in a long-term retrospective cohort study. Methods: Clinical sheets from elderly RA patients taking MTX from an outpatient rheumatology consult in a university centre were reviewed. To assess MTX persistence, we used Kaplan-Meir curves and Cox regression models to identify the risk of withdrawing MTX due to adverse events. Results: In total, 198 elderly RA patients who reported using MTX were included. Of them, the rates of definitive suspension of MTX due to AEs were 23.0% at 5 years, 35.6% at 10 years and 51.7% at 15 years. The main organs and system involved were gastrointestinal (15.7%) and mucocutaneous (3.0%). Factors associated with withdrawing MTX due to AEs were MTX dose ≥ 15 mg/wk (adjusted HR: 2.46, 95% CI: 1.22-4.96, p = 0.012); instead, the folic acid supplementation was protective for withdrawal (adjusted HR: 0.28, 95% CI: 0.16-0.49, p < 0.001). Conclusions: Higher doses of MTX increase the risk of withdrawals in elderly RA, while folic acid supplementation reduces the risk. Therefore, physicians working in therapeutic management for elderly patients using MTX must focus on using lower MTX doses together with the concomitant prescription of folic acid.

Intravenous Cetirizine Premedication to Mitigate Infusion-Related Reactions.

Infusion-related reactions (IRRs) are a recognized concern for chemotherapy, biologic agents, and newer immunotherapies. Antihistamines are frequently recommended to prevent or manage these reactions. For over 60 years, diphenhydramine has been the only H1 antihistamine for intravenous (IV) administration. It has been considered the standard of care as part of premedication regimens to prevent IRRs associated with these therapies despite the lack of a US Food and Drug Administration (FDA)-approved indication and no evidence of efficacy data. Intravenous cetirizine was approved in 2019 for acute urticaria treatment, making it the only second-generation H1 antihistamine that can be administered intravenously. Compared with diphenhydramine, cetirizine has an improved safety profile with less sedation, fewer contraindications, lower incidence of anticholinergic side effects, and minimal risk of adverse events in elderly patients. A head-to-head study demonstrated that IV cetirizine is as effective as IV diphenhydramine in reducing IRRs and may decrease chair time, treatment center visits, and the need for rescue medication. Over the past 3 decades, the FDA has addressed the issue of IRRs by mandating language regarding the requirement or recommendation for premedication in the label of over 50 FDA-approved infusion products. As more therapeutics have premedication required or recommended, IV cetirizine should be considered an antihistamine for preventing and treating IRRs. In this article, we describe a patient whose IRR was successfully managed with IV cetirizine and discuss first- vs. second-generation H1 antihistamines and their use in treating and preventing IRRs.

The association between serum uric acid / serum creatinine ratio and in-hospital outcomes in elderly patients with acute myocardial infarction

BackgroundThe role of Serum uric acid (SUA) in acute myocardial infarction (AMI) was controversial, which might be influenced by the renal clearance function of the patients. The present study aimed to explore the association between serum uric acid to serum creatinine ratio (SUA/Scr), reflecting a net production of SUA, and the in-hospital outcomes of elderly patients with AMI.MethodsIn this retrospective study, a total of 330 elderly AMI patients (≥ 75 years) were enrolled. Data of SUA and Scr on admission were collected to calculate SUA/Scr ratio. Logistic regression analysis and receiver-operating curves were performed to assess the association between SUA/Scr ratio and in-hospital major adverse cardiovascular events (MACEs) and all-cause death.ResultsAmong the 330 patients, 68 patients had MACEs and 44 patients died. Patients with MACEs or died had lower SUA/Scr values compared with those without MACEs or survival (P < 0.05). Univariate logistic analysis showed that a lower value of SUA/Scr (< 3.45) was significantly associated with in-hospital MACEs (odd ratios (OR): 2.359, 95% confidential interval (CI): 1.369–4.065, P = 0.002) and death (OR: 2.424, 95% CI: 1.275–4.608, P = 0.007). After correcting for confounding factors, a lower SUA/Scr value was still independently associated with in-hospital MACEs (OR: 2.144, 95% CI: 1.169–3.934, P = 0.014) and death (OR: 2.125, 95% CI: 1.050–4.302, P = 0.036). Subgroup analysis showed that the association between a lower SUA/Scr ratio and increased risk of in-hospital outcomes could observed only in males (OR: 2.511, 95%CI: 1.211–5.207, P = 0.013 for MACEs; OR: 2.730, 95% CI: 1.146–6.502, P = 0.023 for death).ConclusionsA lower SUA/Scr ratio was associated with an increased risk of in-hospital adverse events in elderly patients with AMI, especially in males, which maybe a marker of poor outcomes for elderly AMI patients.

Development and external validation of a nomogram for predicting postoperative adverse events in elderly patients undergoing lumbar fusion surgery: comparison of three predictive models

BackgroundThe burden of lumbar degenerative diseases (LDD) has increased substantially with the unprecedented aging population. Identifying elderly patients with high risk of postoperative adverse events (AEs) and establishing individualized perioperative management is critical to mitigate added costs and optimize cost-effectiveness to the healthcare system. We aimed to develop a predictive tool for AEs in elderly patients with transforaminal lumbar interbody fusion (TLIF), utilizing multivariate logistic regression, single classification and regression tree (hereafter, “classification tree”), and random forest machine learning algorithms.MethodsThis study was a retrospective review of a prospective Geriatric Lumbar Disease Database (age ≥ 65). Our outcome measure was postoperative AEs, including prolonged hospital stays, postoperative complications, readmission, and reoperation within 90 days. Patients were grouped as either having at least one adverse event (AEs group) or not (No-AEs group). Three models for predicting postoperative AEs were developed using training dataset and internal validation using testing dataset. Finally, online tool was developed to assess its validity in the clinical setting (external validation).ResultsThe development set included 1025 patients (mean [SD] age, 72.8 [5.6] years; 632 [61.7%] female), and the external validation set included 175 patients (73.2 [5.9] years; 97 [55.4%] female). The predictive ability of our three models was comparable, with no significant differences in AUC (0.73 vs. 0.72 vs. 0.70, respectively). The logistic regression model had a higher net benefit for clinical intervention than the other models. A nomogram based on logistic regression was developed, and the C-index of external validation for AEs was 0.69 (95% CI 0.65–0.76).ConclusionThe predictive ability of our three models was comparable. Logistic regression model had a higher net benefit for clinical intervention than the other models. Our nomogram and online tool (https://xuanwumodel.shinyapps.io/Model_for_AEs/) could inform physicians about elderly patients with a high risk of AEs within the 90 days after TLIF surgery.

Increasing serum miR-409-3p predicts the major adverse cardiac adverse events in elderly patients after hip fracture surgery

BackgroundMajor adverse cardiovascular events (MACE) are critical complications responsible for the morbidity and mortality of elderly hip fracture patients. There was an urgent need to explore an effect biomarker for predicting MACE in elderly patients receiving hip fracture surgery.ObjectiveThis study focused on an age-related miRNA, miR-409-3p, and assessed its significance in elderly hip fracture patients.MethodsA total of 267 hip fracture patients were enrolled in this study including 104 elderly patients (age ≥ 60 years). All patients were followed up for 1 year to monitor the occurrence of MACE. The risk factors for the occurrence of MACE were evaluated by the logistic regression analysis.ResultsElderly age and reduced cardiac and renal function were identified as risk factors for MACE in hip fracture patients. Elderly patients also showed a high incidence of MACE. In elderly hip fracture patients, significant upregulation of miR-409-3p was observed, which was associated with patients’ elderly age, higher level of revised cardiac risk index (RCRI), lower left ventricular ejection fraction (LVEF), and higher levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), creatine kinase-MB (CK-MB), and high sensitivity troponin I (hsTnI). Additionally, miR-409-3p was identified as an independent factor for the MACE in elderly patients received hip fracture surgery.ConclusionUpregulated miR-409-3p was an age-related miRNA and could predict the occurrence of MACE in elderly hip fracture patients.

Comprehensive geriatric assessment to predict adverse events in elderly patients undergoing posterior lumbar fusion surgery.

Although comprehensive geriatric assessment (CGA) has been used widely, its impact on adverse events in elderly patients has not been fully examined. The present study aimed to investigate the relationships between subcomponents of CGA and adverse events (AEs) in elderly patients undergoing posterior lumbar fusion surgery. A total of 242 eligible elderly patients enrolled. Our CGA included activities of daily living, instrumental activities of daily living, nutritional status, cardiac function, pulmonary function, renal function, frailty, cognition, anxiety, depression, delirium, chronic pain score, comorbidity and polypharmacy. Comprehensive complication index was used to summarize postoperative complications and its severity. Logistic regression was performed to determine the relationships between subcomponents of a CGA and postoperative AEs. Present study found that female were more vulnerable to have AEs. Postoperative major AEs were associated with delirium (odds ratio (OR): 4.302, 95% confidence interval (CI) 1.720-10.761, p = 0.002), nutritional status (OR: 3.030, 95%CI 1.218-7.541, p = 0.017), cognitive impairment (OR: 4.122, 95%CI 1.179-14.407, p = 0.027), Charlson comorbidity index (CCI) (OR: 4.800, 95%CI 1.852-12.440, p = 0.001) and severe dependent (OR: 3.772, 95%CI 1.116-9.841, p = 0.007). Further analysis showed that delirium (OR: 2.824, 95%CI 1.068-7.467, p = 0.036) and CCI (OR: 3.221, 95%CI 1.184-8.766, p = 0.022) were independently related to major AEs. These results indicate that preoperative screening preoperative delirium, cognitive, nutrition and CCI are essential to prevent postoperative major AEs of the surgical elderly.

LONG-TERM POST-MARKETING SURVEILLANCE DATA FROM ELDERLY PATIENTS WITH CENTRAL NERVOUS SYSTEM MALIGNANCIES TREATED WITH TUMOR TREATING FIELDS (TTFIELDS) THERAPY

Abstract AIMS Glioblastoma (GBM) has a poor prognosis, which is compounded by an increase in treatment-related toxicity with age. TTFields are electric fields that exert physical forces to disrupt cellular processes critical for cancer cell viability. Subgroup analysis of the phase 3 EF-14 study demonstrated TTFields therapy to be well-tolerated in patients ≥65 years with newly diagnosed (nd) GBM. We report safety data in elderly patients from a global post- marketing surveillance (PMS) analysis of patients with central nervous system (CNS) malignancies receiving TTFields. METHOD PMS data was collected from patients receiving TTFields (October 2011–March 2022) in North America, Europe, Middle East, Africa, and Japan. Adverse events (AEs) were categorized using MedDRA version 25.1. RESULTS Overall, 25,898 patients were included (diagnoses: ndGBM [68%], recurrent GBM [26%], anaplastic astrocytoma/oligodendroglioma [4%], other [2%]). Of these, 7808 patients (30%) were elderly (&amp;gt;65 years). 75% of elderly patients experienced ≥1 AE, with 57% related to TTFields; comparable frequencies to the overall population (73% and 56%, respectively). The most common treatment-related AE in elderly patients was skin reaction (45%; overall population: 43%). Incidence of treatment-related fall and fracture in elderly patients was 1% and &amp;lt;1%, respectively. Incidence of treatment-related ‘quality-of-life decreased’ was 2% (elderly and overall). No systemic toxicities were reported, regardless of age group. CONCLUSIONS These real-world data demonstrate TTFields has a tolerable safety profile in elderly patients with CNS malignancies, consistent with elderly subgroup data from EF-14, and with no new safety signals. Most AEs were localised, manageable, mild–moderate skin reactions.

Efficacy and safety of new systemic therapies in moderate-to-severe atopic dermatitis in the elderly: meta-analysis

Objective: To systematically evaluate the efficacy and safety of new systemic therapies (biological agents and JAK inhibitors) in moderate-to-severe elderly atopic dermatitis. Methods: The database of Embase, PubMed, Web of Science,Cochrane, the Global Resource of Eczema Trials database, ClinicalTrials. Gov, CNKI, Wanfang, VIP were used to search for literatures of randomized controlled trials (RCTs) and real-world studies of the treatment of moderate-to-severe AD with the new systemic therapies from January 2014 to February 2023. Two reviewers independently screened the literature, extracted the data and evaluated the risk of bias included in the study. Data were analyzed by Review Manager 5.3 software for meta-analysis and odds ratio (OR) and 95% confidence interval were used as the effect statistics. The heterogeneity and publication bias were assessed. Results: A total of five studies (523 elderly patients and 802 young patients) using dupilumab were included for meta-analysis. Dupilumab showed good efficacy in elderly AD, with 74.6%(390/523) of patients whose EASI reached 75, which there was no significant difference with young patients (OR=0.79, 95%CI:0.58-1.07, P=0.122); the proportion of elderly patients with NRS improvement≥4 was 68.7%(244/355), and there was no significant difference with young patients (OR=0.79, 95%CI:0.55-1.14, P=0.213). The most common adverse reactions were conjunctivitis, facial and neck erythema and injection site reactions, and there are no serious adverse events in both groups. The incidence of adverse events in elderly patients was 24.3%(65/267), which was not significantly different from that in young patients (OR=1.07, 95%CI:0.65-1.77, P=0.789). There are few studies on other biological agents and JAK inhibitors in elderly AD patients. We only found 4 studies of elderly AD patients using JAK inhibitors (2 studies on abrocitinib and 2 studies on upadacitinib). The clinical efficacy of abrocitinib in the elderly was not significantly different from that in the young. The incidence of serious adverse events of abrocitinib and upadacitinib increased in the elderly and was dose-related. Conclusion: The efficacy and safety of dupilumab in elderly AD patients were similar to those in the young patients, and the JAK inhibitor needs to be further studied and verified.

Elevated High Sensitivity Cardiac Troponin T is Nonlinearly Associated with Poor Prognosis in Aging COVID-19 Patients: A Retrospective Study.

To evaluate the relationship between high-sensitivity cardiac troponin T (hs-cTnT) and prognosis in elderly patients with coronavirus disease 2019 (COVID-19). This study recruited 1399 COVID-19 patients aged 65 years or older admitted to Taizhou Hospital or Enze Hospital in Zhejiang Province from December 15, 2022, to January 4, 2023. The Cox regression model was used to evaluate the relationship between hs-cTnT level and in-hospital death. The logistic regression model was used to evaluate the relationship between hs-cTnT level and major adverse events. The restricted cubic spline (RCS) model is used for nonlinear analysis. The increase of peak hs-cTnT was associated with the increased risk of death (HR 9.49; 95% CI 1.19-75.48; trend p = 0.012) and major adverse events (OR 20.59; 95% CI 10.41-40.71; trend p < 0.001). RCS model showed the association between peak hs-cTnT and death and major adverse events were nonlinear (P for non-line < 0.001). Starting from the limit of quantification of hs-cTnT (3ng/L), the risk of death and major adverse events had a steep S-shaped increase until hs-cTnT reached the 90th percentile point (hs-cTnT = 131 ng/L), followed by a plateau period. Peak hs-cTnT has good predictive value for death and major adverse events, with AUC of 0.834 and 0.804, respectively. Peak hs-cTnT has high predictive value for the risk of in-hospital death and major adverse events in elderly patients with COVID-19. The association between peak hs-cTnT and death and major adverse events were nonlinear.

Incidence of adverse events for procedural sedation and analgesia for cardioversion using thiopental in elderly patients: a multicenter prospective observational study.

The incidence and characteristics of thiopental-related adverse events (AEs) in elderly patients during procedural sedation and analgesia (PSA) have not been well studied. We aimed to characterize thiopental-related AE in elderly patients during PSA and compare the incidence of AE in elderly patients with non-elderly adults. This is a secondary analysis of the Japanese Procedural Sedation and Analgesia Registry (JPSTAR). We included all adult patients who received thiopental for PSA in the emergency departments and excluded patients who received concomitant sedative(s) in addition to thiopental or patients with missing body weight data. We compared the incidence of AE between the non-elderly (18-64 years) and elderly groups (≥65 years). The JPSTAR had data on 379 patients who received thiopental for PSA and included 311 patients for analysis. Most (222/311, 71.3%) were elderly. Cardioversion was the most common reason for PSA (96.1%). The AE incidence between groups overall was similar, however, hypoxia was significantly more frequent in the elderly compared with the non-elderly group (10.3% versus 2.2%; adjusted odds 5.63, 95% confidence interval 1.27-25.0). The initial and total doses of thiopental were significantly lower in the elderly group than in the non-elderly group (1.95 mg/kg versus 2.21 mg/kg and 2.33 mg/kg versus 2.93 mg/kg, respectively). Although elderly patients received lower doses of thiopental, hypoxic events were significantly more frequent in this group compared with the non-elderly patients. However, the AE incidence was similar.

Treating and Managing Laryngopharyngeal Reflux Disease in the Over 65s: Evidence to Date.

The clinical presentation and therapeutic outcomes of elderly patients may be different from those in younger populations, leading to additional diagnostic and therapeutic difficulties. The present study reviewed the findings on the epidemiology, and clinical, diagnostic, and therapeutic outcomes of elderly patients with laryngopharyngeal reflux (LPR). A PubMed, Cochrane Library, and Scopus literature search was conducted on the epidemiological, clinical, diagnostic, and therapeutic findings of elderly LPR patients. The prevalence of LPR in the elderly population remains unknown. From a clinical standpoint, older LPR patients report overall lower symptom scores and related quality-of-life outcomes at the time of the diagnosis. The required treatment time to obtain symptom relief appears to be longer in older compared with younger patients. Particular attention needs to be paid to prolonged medication use because the elderly population is characterized by polypharmacy and there is a higher risk of proton-pump inhibitor (PPI) interactions and adverse events. The plasma clearance of most PPIs is reduced with age, which must be considered by practitioners in the prescription of antireflux therapy. The clinical presentation and treatment efficacy of elderly LPR patients differ from those in younger patients. Practitioners need to carefully consider the risk of drug interactions and adverse events in elderly patients.

Adverse Hemodynamic Effects of Dexmedetomidine in Critically Ill Elderly Adults

Background: Dexmedetomidine is a currently recommended first-line sedative agent for critically ill patients requiring mechanical ventilation. Recent trials demonstrated no difference in clinical outcomes between patients treated with dexmedetomidine vs usual care, but significantly more hemodynamic adverse effects in the dexmedetomidine group. One subgroup analysis suggested a 90-day mortality benefit in elderly patients, but no distinction was made between groups regarding age when reporting adverse effects. Given potential decreased baroreceptor function in the elderly, adverse hemodynamic effects of dexmedetomidine may impact them more. Objective: To assess the incidence of adverse hemodynamic effects of dexmedetomidine in elderly ICU patients compared to other sedative agents to clarify the role of dexmedetomidine in this patient population. Methods: This was a single-center, retrospective study including mechanically ventilated elderly patients requiring sedative agents for ≥12 hours. The primary outcome evaluated was composite end point of incidence of bradycardia and hypotension. Secondary outcomes included incidence of each adverse event individually, hospital and ICU length of stay, and duration of mechanical ventilation. Results: There was no difference in adverse events between the two groups (58.7% vs 74.1% in the dexmedetomidine vs usual care groups, P =.074). There was no difference in hospital or ICU length of stay. Patients in the dexmedetomidine group were on the ventilator longer than patients in the usual care group with a median of 6 vs 3 days, respectively (P = 0.004). Conclusion: In this single-center, retrospective study dexmedetomidine had a similar incidence of adverse events in elderly patients compare to the usual care group.

Comparison of the prognostic value of frailty assessment tools in patients aged ≥ 65 years hospitalized in a cardiac care unit with acute coronary syndrome.

BACKGROUNDFrailty is associated with adverse events in elderly patients with acute coronary syndrome (ACS). Our aim was to compare the prognostic value of four frailty scales in patients aged ≥ 65 years hospitalized with ACS in a cardiac care unit (CCU).METHODSPatients aged ≥ 65 years with ACS were included. Frailty was assessed using the Fried frailty scale (reference standard), the Edmonton Frail Scale (EFS), the FRAIL scale, and the Clinical frailty scale (CFS). The primary end point was all-cause mortality and the secondary end point was unscheduled rehospitalization.RESULTSOne hundred and seventy four patients aged ≥ 65 years with ACS were recruited. The median follow-up was 637.5 days. Frailty was identified in 41.4%, 40.2%, 39.1% and 36.3% patients by the Fried frailty scale, EFS, FRAIL scale and CFS, respectively. The agreement coefficients were 0.88, 0.86, and 0.79 for the FRAIL scale, EFS and CFS, respectively. In the Cox regression model, frailty was associated with all-cause mortality regardless of the scale used (univariate: hazard ratio [HR] 95% CI = 10.5, 2.4–46.8 Fried frailty scale; 12.0, 2.7–53.4 FRAIL scale; 7.1, 2.0–25.2 EFS; 8.3, 2.4–29.6 CFS. Multivariate: HR = 5.1, 1.1–23.8 Fried frailty scale; 5.7, 1.2–26.8 FRAIL scale; 3.7, 1.0–14.0 EFS; 4.2, 1.1–15.9 CFS). The FRAIL scale had the highest HR. In the univariate analysis, frailty was associated with unscheduled rehospitalization (HR = 3.2, 1.7–6.0 Fried frailty scale; 3.4, 1.8–6.3 FRAIL scale; 3.5, 1.8–6.6 EFS; 3.1, 1.7–5.8 CFS). In the multivariate analysis, only the EFS independently predicted unscheduled rehospitalization (HR = 2.2, 1.1–4.63).CONCLUSIONSFrailty assessed by the Fried frailty scale, FRAIL scale, EFS and CFS is associated with all-cause mortality and unscheduled rehospitalization in elderly patients hospitalized in a CCU with ACS. The adjusted HR of the FRAIL scale for all-cause mortality was the highest among the scales compared, whereas the EFS was an independent predictor of unscheduled rehospitalization. These data should be taken into consideration when choosing a frailty assessment tool.

Analysis of drug adverse events in elderly patients based on the Japanese Adverse Drug Event Report Database.

Compared with the general adult population, pharmacokinetics and changes in drug responsiveness occur to a greater extent in the elderly. Interactions may occur between drugs used in combination to treat various diseases and may cause adverse events (AEs). We conducted a cross-sectional risk assessment of AEs in elderly patients based on information gathered from Japanese medical practices with the goal of obtaining information that will contribute to optimizing pharmacotherapy. The Japanese Adverse Drug Event Report database was used to determine the incidence of AEs in elderly patients (aged 80 years or older) compared with patients aged less than 80 years old by evaluating the reporting odds ratio using the data obtained from reports. Hypnotics and anxiolytics, as well as anticoagulants and theophylline, were identified as groups of drugs that warrant special attention in the elderly. Hypnotics and anxiolytics, especially those that are short-acting, tend to cause delirium and geriatric syndromes including falls and fractures. With respect to anticoagulants, no increase in the risk of bleeding was evident and the dose was believed to be properly adjusted; however, there was an increased risk of anemia. Theophylline toxicity tended to occur more frequently in the elderly, suggesting the need for drug monitoring. Based on these cross-sectional studies, the evaluation of the risk of AEs for drugs commonly used in the elderly based on near real-world information was achieved.

Optimal anticoagulation in elderly patients with atrial fibrillation: Which drug at which dose?

Aging is an important risk factor for adverse events in elderly patients with atrial fibrillation (AF) and complicates the management of anticoagulation. Underuse of oral anticoagulants (OACs) is common in elderly patients because of comorbidities, the altered physiological function of multiple organs, frailty, risk of falls, and the lack of randomized controlled trials (RCTs) specifically for elderly patients. Nevertheless, current data still support OACs use for reducing ischemic stroke with positive net clinical benefits. Sub-analyses of RCTs and real-world cohort studies showed that non-vitamin K antagonist OACs (NOACs) would be more favorable choices compared to warfarin for stroke prevention in the elderly. This review will discuss important data on stroke prevention and the use of NOACs in elderly AF patients.

Comprehensive geriatric assessment as a useful tool in predicting adverse events in elderly patients with diffuse large B-cell lymphoma

We conducted a multicenter prospective study on whether a comprehensive geriatric assessment (CGA) can predict the adverse events (AEs) of chemotherapy in elderly patients with diffuse large B-cell lymphoma (DLBCL). Patients aged ≥ 65 years with newly diagnosed DLBCL underwent a pretreatment baseline CGA consisting of six assessment tools: activities of daily living (ADL), instrumental ADL (IADL), mood, nutritional status, comorbidities, and cognitive function. An attending physician chose each patient’s treatment but was blind to CGA results. Patients were grouped as “dependent” or “independent” according to the CGA. The primary endpoint was to evaluate the association between chemotherapy-induced grade 3–4 toxicity and CGA. Of 86 patients, 78 completed the designated CGA. The median age was 79 years (65–89). Seventy-two patients were treated with a cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP-like) regimen, and six were treated with low-toxicity regimens. Forty-one patients were classified as dependent and 37 as independent. In multivariate analysis, an impairment of IADL was independently associated with grade 3–4 leukopenia (odds ratio [OR] 0.63; 95% confidence interval [CI] 0.43–0.92, p = 0.017) and anemia (OR 0.67; 95% CI 0.50–0.90, p = 0.008). The presence of a comorbidity was also associated with grade 3–4 non-hematological toxicity (OR 2.17; 95% CI 1.37–3.43, p = 0.001). The 4-year survival rate tended to be longer in the independent (72.7%) compared to dependent (56.9%) group. Overall, a CGA may be a useful tool for predicting serious AEs associated with chemotherapy in elderly patients with DLBCL.

The risk of pulmonary adverse drug reactions of rebamipide and other drugs for acid-related diseases: An analysis of the national pharmacovigilance database in South Korea.

ObjectiveThe objective of this case/non‐case study was to detect rebamipide‐related pulmonary adverse events (AE) compared with other drugs for acid‐related disorders based on population‐level data.MethodsFrom 2009 to 2018, AE reports on drugs for acid‐related disorders, which are anatomical therapeutic chemical code A02B drugs, in the Korea Adverse Events Reporting System (KAERS) database were examined. The reporting odds ratio (ROR) was calculated, and the odds of reporting pulmonary AE for rebamipide and all other A02B drugs were compared. Furthermore, a stratified analysis according to patients’ age and sex was conducted.ResultsAltogether 13 (0.05%) and 157 (0.11%) cases of pulmonary AE were reported for rebamipide and all other A02B drugs, respectively. The risk of reporting pulmonary AE was significantly lower for rebamipide than for all other A02B drugs (ROR 0.49, 95% confidence interval [CI] 0.28–0.87). The number of reports of pulmonary AE for rebamipide was significantly higher among patients aged ≥65 years than those aged <65 years (ROR 19.36, 95% CI 2.50–149.97).ConclusionsRebamipide was less often reported for pulmonary AE. However, healthcare professionals need to be aware of the risk of pulmonary AE in elderly patients.