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IntroductionThe antipsychotic dosage of Chinese schizophrenia patients has rarely been studied, although nonstandard dosage has impact on prognosis.ObjectivesTo describe the dosage of antipsychotics in China routine practice.MethodsThis was a retrospective cohort study using de-identified data from a Chinese mental health hospital. The included patients were adults (≥18 years) with at least one diagnosis of schizophrenia (ICD-10: F20) and one prescription of any antipsychotic between 2014 and 2019. Date of first identified antipsychotic prescription was defined as index date, patients were followed up until last prescription of antipsychotics, end of 2019, or discontinuation (>60 days without antipsychotic prescription), whichever was earliest. Dosage was summarized using defined daily dose (DDD), calculated by cumulative average daily dose (CAD) with a unit of DDDs/day, i.e., total DDDs of all antipsychotics in follow-up period divided by total days of follow-up. CAD was categorized into low (<0.5 DDDs/day), moderate (0.5-1.5 DDDs/day), and high (>1.5 DDDs/day) groups.Results13554 patients were included with an average follow-up of 269.9 days. Median CAD was 0.8 DDDs/day (IQR=0.5-1.3), patients with hospitalization during follow-up and used multiple antipsychotics at the same time had larger median CAD, 1.0 DDDs/day and 1.2 DDDs/days, respectively. There were 3245 (23.9%), 7627 (56.3%), and 2682 (19.8%) patients in low, moderate, and high groups, respectively. The median CAD of high dosage group was 2.5 DDDs/day (IQR=1.9-10.5).ConclusionsCAD of most Chinese schizophrenia patients was low or moderate. Association between CAD and hospitalization and multiple concurrent antipsychotics merit further research.

Hospital-based registry data, including patients’ information collected by academic societies or government based research groups, were previously used for clinical research in Japan. Now, real-world data routinely obtained in healthcare settings are being used in clinical epidemiology and pharmacoepidemiology. Real-world data include a database of claims originating from health insurance associations for reimbursement of medical fees, diagnosis procedure combinations databases for acute inpatient care in hospitals, a drug prescription database, and electronic medical records, including patients’ medical information obtained by doctors, derived from electronic records of hospitals. In the past ten years, much evidence of clinical epidemiology and pharmacoepidemiology studies using real-world data has been accumulated. The purpose of this review was to introduce clinical epidemiology and pharmacoepidemiology approaches and studies using real-world data in Japan.

Background Postoperative sepsis is a severe complication associated with increased mortality and potential long-term cognitive decline, including dementia. However, the relationship between postoperative sepsis and dementia remains poorly understood. Methods This retrospective cohort study used data from the National Database in Taiwan, covering the period from January 1, 2005, to December 31, 2022. The index period for surgeries was set between January 1, 2008, and December 31, 2013, allowing the identification of patients without prior dementia. A landmark period of 12 months following surgery was defined to capture the number of postoperative sepsis events, which were then analyzed for their impact on dementia risk. After 1:4 propensity score matching (PSM), dementia and mortality were evaluated using Cox proportional hazards and Fine-Gray competing risk models. Results Following PSM, 778 patients were in the postoperative sepsis group and 3,112 in the non-postoperative sepsis group. Dementia incidence was higher in the postoperative sepsis group (26%) compared to the non- postoperative sepsis group (13.6%), with a hazard ratio (HR) of 1.25 (95% CI, 1.03–1.52). A dose–response relationship was observed, with dementia rates of 24.5% for one postoperative sepsis event and 34.9% for two or more events, the latter showing an HR of 1.77 (95% CI, 1.17–2.66). Mortality was also elevated in the postoperative sepsis group (40.5% vs. 31.6%; HR 1.45, 95% CI, 1.28–1.65). Conclusions Postoperative sepsis is significantly associated with increased dementia risk in a dose-dependent manner. These findings highlight the importance of enhancing perioperative infection control to reduce both immediate and long-term cognitive complications.

Hip fractures are a major public health concern, especially among older adults. Chronic obstructive pulmonary disease (COPD) is a famous comorbidity that can increase post-fracture outcomes. This retrospective population-based cohort study evaluated the impact of COPD on mortality and contralateral hip fracture risk following pertrochanteric fracture. We included patients diagnosed with pertrochanteric fracture (ICD-10-CM S72.1) between January 1, 2016, and December 31, 2022, from Taiwan's National Health Insurance Research Database. Mortality risk was assessed using Cox proportional hazards models, adjusted for sex, age, and Charlson Comorbidity Index (CCI) score. Contralateral hip fracture risk was estimated using competing risk analysis with death as a competing event. Subgroup analyses were stratified by sex, age, and CCI group. After adjustment, COPD was significantly associated with higher 1-year mortality (AHR: 1.12, 95% CI: 1.06-1.19, p<0.0001). Conversely, COPD patients had a lower 1-year incidence of contralateral hip fracture compared with non-COPD patients (3.12% vs 4.40%; adjusted subdistribution HR: 0.70, 95% CI: 0.61-0.81, p<0.0001). Similar patterns were observed across all subgroups. COPD is an independent predictor of increased 1-year mortality after pertrochanteric fracture. The observed reduction in contralateral fracture risk likely reflects the competing risk of early mortality. These findings suggest that elderly patients with COPD should pay more attention in post-hip fracture management with personalized rehabilitation strategies.

Iron deficiency anemia is one of the most common types of anemia, but real-world clinical management practices in Japan are unclear. This study retrospectively explored iron prescription patterns, treatment effectiveness, and assessments. Patients with at least one treatment period between September 2020 and September 2022 were included and classified into three groups (ferric carboxymaltose [FCM]: 7437 patients, saccharated ferric oxide [SFO]: 98,648 patients, and oral iron: 359,547 patients). Iron-related laboratory values over time and testing proportions were evaluated. Median baseline hemoglobin levels were lowest with FCM (FCM: 8.10 g/dL, SFO: 8.70 g/dL, oral iron: 9.70 g/dL), but changes in hemoglobin levels by 12 weeks were greatest with FCM (FCM: 3.20 g/dL, SFO: 2.60 g/dL, oral iron: 1.70 g/dL). The median serum ferritin level at 8 weeks after FCM treatment was 43.70 ng/mL for ≤500 mg, versus 123.30 ng/mL for >500 to ≤1500 mg. All groups had a low proportion of serum ferritin and transferrin saturation (TSAT) testing at diagnosis (<38%), which decreased further for post-treatment assessment (<24%). This study suggests the importance of prescribing an appropriate total iron cumulative dose per the package insert, along with diagnosis and assessments based on serum ferritin/TSAT.

IntroductionThis real-world study evaluated whether long-term use of eldecalcitol (ELD) increases the risk of adverse events (AEs), namely, hypercalcemia, acute kidney injury (AKI), and urolithiasis, and analyzed the ELD-induced risk of rare AEs such as osteonecrosis of the jaw (ONJ) and atypical femoral fracture (AFF).Materials and methodsPatient records were retrieved from Medical Data Vision (MDV) and Japan Medical Data Center (JMDC) databases. The ELD-treated osteoporosis patient cohort (ELD cohort) was analyzed to determine the incidence rate of the aforementioned AEs. The patient cohort that was prescribed active vitamin D3 other than ELD (AVD cohort) was analyzed as the reference.ResultsIncidence rates of hypercalcemia, AKI, and urolithiasis in the ELD cohort were 0.942, 0.517, 2.465 events per 100 person-years, respectively, in the MDV dataset, and 0.687, 0.155, 3.785, respectively, in the JMDC dataset. The incidence rates of these AEs in the ELD cohort remained relatively constant throughout ELD treatment. A small number of patients experienced ONJ or AFF during ELD or AVD treatment. The number of ONJ and AFF cases in the both cohorts decreased over time. The two cohorts showed no difference in the concomitant use of anti-bone resorptive agents such as bisphosphonates and denosumab.ConclusionThe risk of hypercalcemia and AKI associated with ELD use observed in this retrospective analysis is similar to that reported previously in the Japanese post-marketing surveillance of ELD. Furthermore, ELD, similar to AVD, may not increase the risk of ONJ and AFF.

Background Anxiety and depression are prevalent psychological consequences following patients with traumatic spinal cord injury (tSCI). This study aims to estimate within-cohort temporal changes to compare the incidence of anxiety or depression among tSCI patients between two decades (2000–2009 and 2010–2019). Methods A retrospective cohort study of hospitalized tSCI patients ( n  = 4,960) used to compare the incidence of anxiety or depression within three years post-tSCI between the two decades. Incidence rate ratios (IRR) was estimated using Poisson regression, and Cox regression was assessed the relative risk with adjustment of age, sex, comorbidities, Charlson Comorbidity Index (CCI), and Catastrophic Illness Card status. Results The incidence rate of anxiety or depression significantly increased from 208.46 to 350.44 per 10,000 person-years (IRR = 1.68, 95% CI: 1.35–2.08, p  < 0.0001). The highest increase was among patients aged 20–34 years (IRR = 1.90, 95% CI: 1.12–3.22, p  = 0.0176). Adjusted Cox regression showed that tSCI patients from 2010 to 2019 had a higher risk of anxiety or depression (AHR = 1.67, 95% CI: 1.33–2.08, p  < 0.0001) than those from 2000 to 2009. The risk was particularly elevated among younger patients, those without a catastrophic illness card (AHR = 1.71, p  < 0.0001), and those with lower CCI scores (CCI = 0, AHR = 1.77, p  = 0.0003; CCI = 1–2, AHR = 1.79, p  = 0.0026). Conclusions This study indicated an increasing anxiety or depression in tSCI patients, especially among younger adults and those without catastrophic illness status. Early psychiatric screening, multidisciplinary care, and psychosocial support are critical to improving long-term outcomes.

Introduction Major depressive disorder (MDD) is one of the most common mental disorders worldwide, estimated to affect 10–15% of the population per year. Treatment resistant depression (TRD) is estimated to affect a third of these patients who show difficulties in social and occupational function, decline of physical health, suicidal thoughts and increased health care utilization. We describe the prevalence of MDD, TRD and associated healthcare resource utilization in Maccabi Healthcare Services (MHS), a 2.5 million-member state-mandated health service in Israel. Methods All MHS members with an MDD diagnosis were identified within the years 2017–2018 and prevalence assessed by age, sex and TRD. To assess the incidence of MDD, members aged 18–65 years at the start of any MDD episode were identified between 1 st January 2016 and 31 st May 2018 with at least one systemic first-line antidepressant treatment within three months before or after the initial episode. Treatment patterns, time on first-line treatment, and healthcare resource utilization were compared by TRD. Results A total of 4960 eligible MDD patients were identified (median age = 51 years, 65% female), representing a period prevalence of 0.218%, and of those, a high proportion of patients received drug treatment (92%). Among incident MDD cases ( n  = 2553), 24.4% had TRD. Factors associated with TRD included increasing age and personality disorder. Median time on treatment was 3.7 months (longer for those without TRD than those with) and 81.9% of patients purchased more than one month’s supply of therapy. In the year after index, patients with TRD had a significant increased number of visits to primary care physicians, psychiatrists, emergency room visits, general hospitalizations, and psychiatric hospitalizations. Conclusion Our study shows that prevalence of MDD in Israel is low compared to other countries, however once diagnosed, patients' are likely to receive drug treatment. Among patients diagnosed with MDD, the proportion of TRD is similar to other countries, increases with age and is associated with increased healthcare utilization, therefore should be a focus of continued research for finding effective long term treatment options.

Introduction The persistence of golimumab (GLM) treatment in Japanese patients with rheumatoid arthritis (RA) has been evaluated previously, but evidence of long-term real-world use is lacking. This study assessed the long-term persistence of GLM use, its influencing factors, and impact of prior medications in patients with RA in actual clinical practice in Japan. Methods This is a retrospective cohort study of patients with RA using data from a hospital insurance claims database in Japan. The identified patients were stratified as only GLM treatment (naïve), had one biological disease-modifying anti-rheumatic drug (bDMARD)/Janus kinase (JAK) inhibitor treatment prior to GLM [switch (1)] and had at least two bDMARDs/JAK prior to GLM treatment [switch (≥ 2)]. Patient characteristics were evaluated using descriptive statistics. Kaplan–Meier survival and Cox regression methods were used to analyze GLM persistence at 1, 3, 5, and 7 years and the associated factors. Treatment differences were compared using a log-rank test. Results GLM persistence rate in the naïve group was 58.8%, 32.1%, 21.4%, and 11.4% at 1, 3, 5, and 7 years, respectively. Overall persistence rates in the naïve group were higher than in switch groups. Higher GLM persistence was observed among patients aged 61–75 years and those concomitantly using methotrexate (MTX). Also, women were less likely to discontinue treatment compared to men. Higher Charlson Comorbidity Index score, initial GLM dose of 100 mg, and switch from bDMARDs/JAK inhibitor were related to a lower persistence rate. As a prior medication, infliximab showed the longest persistence for subsequent GLM, and using this as a reference, tocilizumab, sarilumab, and tofacitinib subgroups had significantly shorter persistence, respectively ( p  = 0.001, 0.025, 0.041). Conclusion This study presents the long-term real-world results for persistence of GLM and its potential determinants. These most recent and long-term observations demonstrated that GLM and other bDMARDs continue to benefit patients with RA in Japan.

Large population-based studies examining differences in ICI-associated cardiotoxicity across cancer types and agents are limited. Data of 5518 cancer patients who received at least one cycle of ICIs were extracted from a large network of health care organizations. ICI treatment groups were classified by the first ICI agent(s) (ipilimumab, nivolumab, pembrolizumab, cemiplimab, avelumab, atezolizumab, or durvalumab) or its class (PD-1 inhibitors, PD-L1 inhibitors, CTLA4-inhibitors, or their combination (ipilimumab + nivolumab)). Time to first cardiac adverse event (CAE) (arrhythmia, acute myocardial infarction, myocarditis, cardiomyopathy, or pericarditis) developed within one year after ICI initiation was analyzed using a competing-risks regression model adjusting for ICI treatment groups, patient demographic and clinical characteristics, and cancer sites. By month 12, 12.5% developed cardiotoxicity. The most common cardiotoxicity was arrhythmia (9.3%) and 2.1% developed myocarditis. After adjusting for patient characteristics and cancer sites, patients who initiated on monotherapy with ipilimumab (adjusted Hazard Ratio (aHR): 2.00; 95% CI: 1.49–2.70; p < 0.001) or pembrolizumab (aHR: 1.21; 95% CI: 1.01–1.46; p = 0.040) had a higher risk of developing CAEs within one year compared to nivolumab monotherapy. Ipilimumab and pembrolizumab use may increase the risk of cardiotoxicity compared to other agents. Avelumab also estimated a highly elevated risk (aHR: 1.92; 95% CI: 0.85–4.34; p = 0.117) compared to nivolumab and other PD-L1 agents, although the estimate did not reach statistical significance, warranting future studies.