Japanese Database Research Articles

Evaluating the timing of triple therapy initiation for the treatment of asthma in Japan: prompt versus delayed

Objective In Japan, the optimal initiation timing and efficacy of single-inhaler triple therapy (SITT) in asthma management remain unexplored. This study investigated SITT initiation timing following an asthma exacerbation, and examined patient demographics and clinical characteristics. Methods Observational, retrospective cohort study in patients with asthma aged ≥15 years who initiated SITT following their earliest observed asthma exacerbation (February–November 2021), using data from Japanese health insurance claims databases (JMDC and Medical Data Vision [MDV]). The study period ended May 2022 for JMDC and September 2022 for MDV. Descriptive analyses were performed independently by database. Variables evaluated included timing of SITT initiation post exacerbation (prompt, delayed and late, ≤30, 31–180 and >180 days post index, respectively), patient demographics, clinical characteristics, and pre-index treatment. Results Of patients in the JMDC and MDV databases, most initiated SITT promptly after an asthma exacerbation, 60.8% (n = 951/1565) and 44.4% (n = 241/543), respectively. Delayed initiation occurred in 22.6% (n = 354/1565) and 26.3% (n = 143/543) of patients, and late initiation occurred in 16.6% (n = 260/1565) and 29.3% (n = 159/543), respectively. Most patients were indexed on a moderate asthma-related exacerbation, 97.1% (n = 1519/1565) and 68.7% (n = 373/543), respectively. Conclusion Most patients with asthma initiated SITT promptly following a moderate exacerbation, with delayed and late initiation more common among patients with complex clinical profiles. The findings underscore the necessity for future research to examine the interaction between patient characteristics, clinical outcomes, and the timing of SITT initiation to optimize treatment strategies, as clinical practice may vary by exacerbation severity.

Assessment of Cardiovascular Events Caused by New-Generation Androgen Receptor Pathway Inhibitors Used for Prostate Cancer: A Real-World Study in Japan.

Androgen receptor pathway inhibitors (ARPIs) that significantly improve the prognosis of patients with prostate cancer include abiraterone acetate (androgen synthesis inhibitor) and enzalutamide (androgen receptor inhibitor). A recent analysis of ARPI and cardiovascular events using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) has been reported; however, the evidence on cardiovascular events for abiraterone acetate and enzalutamide in real-world clinical practice is insufficient. Using a large Japanese database of medical institutions, the Japanese Medical Data Center (JMDC) medical institution database (JMDC Inc., Tokyo, Japan), this study tested the hypothesis that the risk of cardiovascular events with enzalutamide is lower than that with abiraterone acetate. Using the JMDC medical institution database, patients with new use of abiraterone acetate or enzalutamide who had not experienced a major cardiovascular event between October 2014 and February 2022 were included. After adjusting for age, comorbidities, and concomitant medications using propensity score matching, cumulative incidence rates were compared for cardiovascular death and all cardiovascular events as the primary endpoints, and major cardiovascular events, myocardial infarction, heart failure, and stroke as secondary endpoints. A total of 3,033 patients in the enzalutamide group and 2,021 in the abiraterone group met the eligibility criteria. After propensity score matching, the cohort included 1,940 patients in the enzalutamide group and 1,940 patients in the abiraterone group. Enzalutamide was associated with significantly lower cumulative rates of cardiovascular death (hazard ratio [HR]: 0.30, 95% confidence interval [CI]: 0.10-0.93), all cardiovascular events (HR: 0.79, 95% CI: 0.64-0.98), major cardiovascular events (HR: 0.79, 95% CI: 0.64-0.97), and myocardial infarction (HR: 0.62, 95% CI: 0.46-0.84) compared to abiraterone. In a national sample of males with prostate cancer, those newly treated with enzalutamide had a lower risk of adverse cardiovascular events than those treated with abiraterone acetate.

Genetic Analysis of Melanoma Types Using Japanese Genomic Database.

The purpose of this study is to compare genetic mutations, tumor mutation burden (TMB), and the effects of molecular targeted drugs and immune checkpoint inhibitors (ICIs) in head and neck mucosal melanoma (HNMUM) with those in skin melanoma (SKM) and ocular melanoma (OM). Data were analyzed for 72 consecutive patients with HNMUM, including 366 with SKM and 31 with OM, registered at the Japan National Cancer Center, Center for Cancer Genomics and Advanced Therapeutics (C-CAT) between June 2019 and October 2023. Genetic alterations and TMB were determined by FoundationOne CDx next-generation sequencing. The top 10 mutations in HNMUM were RAD21 (47.2%), NBN (45.8%), MYC (40.3%), LYN (31.9%), NRAS (29.1%), IRF4 (23.6%), DAXX (22.2%), KIT (22.2%), NOTCH3 (20.8%), and DDR1 (19.4%), with 16.6 ± 0.8 (mean ± SEM) mutations/individual. In SKM, BRAF (p = 0.04) mutation was associated with a significantly better prognosis. The TMB values were 5.7 ± 2.1 (mean ± SEM) in HNMUM, 4.1 ± 0.2 in SKM, and 3.4 ± 0.9 in OM, with no significant differences among the three groups. The median survival time for patients with distant metastases was 803 (95% confidence interval: 539-NA) days for HNMUM, 1413 (831-2172) days for SKM, and 1138 (438-NA) days for OM. The top 10 mutations in HNMUM are closer to those in OM than those in SKM. There was no significant difference in TMB values or survival rates with regard to the therapeutic effect of ICIs among the diseases, which suggests that current treatment of HNMUM with ICIs is appropriate. 3 Laryngoscope, 2024.

Potential of ChatGPT to Pass the Japanese Medical and Healthcare Professional National Licenses: A Literature Review.

This systematic review aimed to assess the academic potential of ChatGPT (GPT-3.5, 4, and 4V) for Japanese national medical and healthcare licensing examinations, taking into account its strengths and limitations. Electronic databases such as PubMed/Medline, Google Scholar, and ICHUSHI (a Japanese medical article database) were systematically searched for relevant articles, particularly those published between January 1, 2022, and April 30, 2024. A formal narrative analysis was conducted by systematically arranging similarities and differences between individual research findings together. After rigorous screening, we reviewed 22 articles. Except for one article, all articles that evaluated GPT-4 showed that this tool could pass each exam containing text only. However, some studies also reported that, despite the possibility to pass, the results of GPT-4 were worse than those of the actual examinee. Moreover, the newest model GPT-4V insufficiently recognized images, thereby providing insufficient answers to questions that involved images and figures/tables. Therefore, their precision needs to be improved to obtain better results.

Unchanged incidence of major adverse events amidst rising surgical interventions for osteoporotic vertebral fractures, 2015-2021.

Osteoporotic vertebral fracture (OVF) is a common condition in the aging population, often leading to increased morbidity and mortality. Here, we analyzed treatment trends and incidence of major adverse events in patients hospitalized for OVF. We conducted a cross-sectional descriptive study, using a large Japanese hospital administrative database. The cohort included hospitalized patients aged 65years or older, admitted for OVF from January 2015 to December 2021. The primary outcomes were the trend in the proportion of the patients undergoing surgery for OVF and the incidence of major adverse events within 30days of admission. As a secondary outcome, we evaluated the trend in hospitalization costs. The study cohort consisted of 14,714 patients, with a mean age of 82.4years. There was a significant increase in surgical interventions for OVF, from 3.7% of patients in 2015 to 9.8% in 2021 (p < 0.001). The incidence of major adverse events remained unchanged, with a risk ratio of 1.09 (95% confidence interval, 0.88 to 1.35) in 2021 compared to 2015. Average hospitalization costs increased significantly, from $7,570.6 (SD 6,047.0) in 2015 to $9,502.9 (SD 7,231.5) in 2021 (p < 0.001). Despite a significant increase in the proportion of surgical intervention for OVF, no reduction in the risk of major adverse events was observed between 2015 and 2021. Surgeons and policy makers need to interpret these findings and work towards an optimized approach to the management of OVF in the aging population.

Epidemiological Analysis of Legionella Pneumonia in Japan: A National Inpatient Database Study.

Legionella pneumonia, a severe form of pneumonia, is caused by Legionella bacteria. The epidemiology of Legionnaires' disease in Japan, including seasonal trends, risk factors for severe disease, and fatality rates, is unclear. This study examined the epidemiology of Legionella pneumonia in Japan. This retrospective cohort study included data of adult patients hospitalized for Legionella pneumonia (identified using the International Classification of Diseases, 10th revision code, A481) in the Japanese Diagnosis Procedure Combination inpatient database, from April 2011 to March 2021. We performed multivariable logistic regression analysis to explore the prognostic factors of in-hospital mortality. Of 7,370 enrolled hospitalized patients from 1,140 hospitals (male, 84.4%; aged >50 years, 87.9%), 469 (6.4%) died during hospitalization. The number of hospitalized patients increased yearly, from 658 in 2016 to 975 in 2020. Multivariable logistic regression analysis revealed that higher in-hospital mortality was associated with older age, male sex, lower body mass index, worsened level of consciousness, comorbidities (congestive heart failure, chronic renal diseases, and metastasis), hospitalization from November to May, and ambulance use. However, lower in-hospital mortality was associated with comorbidity (liver diseases), hospitalization after 2013, and hospitalization in hospitals with higher case volume. The characterized epidemiology of Legionella pneumonia in Japan revealed a high mortality rate of 6.4%. To the best of our knowledge, this is the first study to demonstrate a higher mortality rate in winter and in patients with congestive heart failure and metastasis. Further research is needed to understand the complex interplay between the prognostic factors of Legionella pneumonia.

Validity of the Intake of Sugars, Amino Acids, and Fatty Acids Estimated Using a Self-administered Food Frequency Questionnaire in Middle-aged and Elderly Japanese: The Japan Public Health Center-based Prospective Study for the Next Generation (JPHC-NEXT) Protocol Area.

The Japanese database of food composition was revised in 2020, during which both the number of food items and the number of food items measured for sugars, amino acids, and fatty acids were increased. We evaluated the validity of estimated intakes of sugars, amino acids and fatty acids using a long food frequency questionnaire (long-FFQ) among middle-aged and elderly Japanese. From 2012 to 2013, 240 men and women aged 40-74 years from five areas in the JPHC-NEXT protocol were asked to respond to the long-FFQ and provide a 12-day weighed food record (WFR) as reference. The long-FFQ, which included 172 food and beverage items and 11 seasonings, was compared with a 3-day WFR, completed during each distinct season, and validity was assessed using Spearman's correlation coefficients. Percentage differences based on the long-FFQ with the 12-day WFR in men and women varied from -84.4% to 419.6%, and from -75.8% to 623.1% for sugars, -17.5% to 3.8% and -5.8% to 19.6% for amino acids, and -58.5% to 78.8% and -43.4% to 129.3% for fatty acids, respectively. Median values of correlation coefficients for the long-FFQ in men and women were 0.52 and 0.42 for sugars, 0.38 and 0.37 for amino acids, and 0.42 and 0.42 for fatty acids, respectively. The long-FFQ provided reasonable validity in estimating the intakes of sugars, amino acids, and fatty acids in middle-aged and elderly Japanese. Although caution is warranted for some nutrients, these results may be used in future epidemiological studies.

Occurrence of somnolence and respiratory depression induced by pregabalin and mirogabalin use and the influence of opioid treatment using the Japanese adverse drug event report database.

Background: Gabapentinoid anticonvulsants are standard treatment for neuropathic pain and are often combined with opioids for treating cancer. It is assumed that this combination may heighten somnolence and respiratory depression due to the inhibitory effects of opioids on the central nervous system. Although pregabalin, a gabapentinoid, is known to increase somnolence frequency during opioid therapy, whether mirogabalin exerts similar effects on somnolence frequency under opioid therapy remains unknown. This study examined the signals of somnolence and respiratory depression in response to pregabalin and mirogabalin use by utilizing data from the Japanese Adverse Drug Event Report database and assessed their interaction with strong opioid analgesics. Methods: Information was obtained from the JADER database from April 2004 to August 2023 via the Pharmaceuticals and Medical Devices Agency website. The study focused on neuropathic pain medications, specifically "pregabalin" and "mirogabalin besilate." Adverse events were defined using preferred terms (PTs) from the Medical Dictionary for Regulatory Activities version 26.1. The PTs considered were "Somnolence (10041349)" and "Respiratory depression (10038678)." To investigate the effect of the combination of strong opioid analgesics with pregabalin and mirogabalin on the occurrence of somnolence, a multivariable logistic regression analysis was conducted. Results: Signals for somnolence were detected with the use of both drugs (pregabalin: information component (IC) [95% confidence intervals (CIs)]: 2.89 [2.70 to 3.08]; mirogabalin: IC [95% CIs] 2.50 [1.85 to 3.16]). When evaluating respiratory depression, a typical and serious adverse event of opioid analgesic use, a signal was detected with pregabalin use but not with mirogabalin use (pregabalin: (IC [95% CIs] 1.28 [0.83 to 1.73]; mirogabalin: IC [95% CIs] -0.15 [-2.20 to 1.89]). Multivariable analysis indicated that the use of strong opioid analgesics increased the occurrence of somnolence when combined with pregabalin but not when combined with mirogabalin (p = 0.004). Conclusion: While the safety of concomitant administation of mirogabalin with opioids remains controversial, caution should be exercised when using pregabalin, especially in combination with opioids for neuropathic pain, compared to that for mirogabalin.

SARS-CoV-2 mRNA vaccine-related myocarditis and pericarditis: An analysis of the Japanese Adverse Drug Event Report database

BackgroundThe association between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccines and myocarditis/pericarditis in the Japanese population has not been systematically investigated. This study was aimed at clarifying the association between SARS-CoV-2 mRNA vaccines (BNT162b2 and mRNA-1273) and myocarditis/pericarditis as well as influencing factors by using the Japanese Adverse Drug Event Report database. MethodsReporting odds ratios (RORs) and 95% confidence intervals (95% CIs) for the association between the vaccines and myocarditis/pericarditis were calculated using data from the database (April 2004-December 2023). Age, sex, onset time, and outcomes in symptomatic patients were evaluated. ResultsThe total number of reports was 880,999 (myocarditis: 1,846; pericarditis: 761). The adverse events associated with the vaccines included myocarditis (919 cases) and pericarditis (321 cases), with the ROR [95% CIs] being significant for both (myocarditis: 30.51 [27.82-33.45], pericarditis: 21.99 [19.03-25.40]). Furthermore, the ROR [95% CIs] of BNT162b2 and mRNA-1273 were 15.64 [14.15-17.28] and 54.23 [48.13-61.10], respectively, for myocarditis, and 15.78 [13.52-18.42] and 27.03 [21.58-33.87], respectively, for pericarditis. Furthermore, most cases were ≤30 years or male. The period from vaccination to onset was ≤8 days, corresponding to early failure type based on analysis using the Weibull distribution. Outcomes were recovery or remission for most cases; however, they were severe or caused death in some cases. ConclusionIn the Japanese population, SARS-CoV-2 mRNA vaccination was significantly associated with the onset of myocarditis/pericarditis. The influencing factors included age of ≤30 years and male. Furthermore, although most adverse events occurred early after vaccination, overall outcomes were good.

Characteristics of the studies using realist evaluation to assess interventions that address psychosocial healthcare issues in older adults: a scoping review

ObjectivesInterventions to address psychosocial healthcare issues in older adults are increasing. Realist evaluation (RE) helps us understand how these interventions work for their issues. It is significant to obtain implications...

Age and sex differences in sarcopenic dysphagia: A secondary data analysis

AbstractBackgroundAge and sex differences in sarcopenic dysphagia are unknown. The purpose is to characterize age and sex differences in sarcopenic dysphagia.MethodsA cross‐sectional and retrospective cohort study using information from the Japanese database on sarcopenic dysphagia was performed. We investigated age and sex differences between sarcopenic dysphagia and other forms of dysphagia. We investigated whether differences in prognosis for swallowing function, as assessed by the Food Intake Level Scale, and activities of daily living (ADL), as assessed by the Barthel Index were influenced by age and sex in patients with sarcopenic dysphagia.ResultsThe study included 460 patients, including 229 men and 231 women, with a mean age of 81 ± 10 years. Fifty‐eight percent of the patients had sarcopenic dysphagia. Age was independently associated with sarcopenic dysphagia (odds ratio (OR): 1.056, 95% confidence interval (CI): 1.035, 1.078), although sarcopenic dysphagia could also be seen in those younger than 65 years. Sex was not independently associated with sarcopenic dysphagia. The age cut‐off for the diagnosis of sarcopenic dysphagia was 82 years in all patients (sensitivity, 0.660; specificity, 0.644), 80 years in men (sensitivity, 0.619; specificity, 0.631), and 83 years in women (sensitivity, 0.723; specificity, 0.577). Sarcopenic dysphagia showed no significant differences in the improvement of swallowing function and ADL based on age and sex.ConclusionsSarcopenic dysphagia was most common in older adults in their 80s or older. The possibility of sarcopenic dysphagia should be considered when dysphagia is present in people 80 years of age or older.

Relationship between adherence to bictegravir/emtricitabine/tenofovir alafenamide fumarate and clinical outcomes in people with HIV in Japan: a claims database analysis

A lack of adherence to long-term antiretroviral therapy may impact viral suppression. The current study examined the relationship between medication adherence and clinical outcomes in people with human immunodeficiency virus infection (PWH) receiving bictegravir, emtricitabine, and tenofovir alafenamide fumarate (B/F/TAF). A retrospective cohort study using two Japanese claims databases was conducted. Adherence was measured by the proportion of days covered (PDC). Patients were grouped into 3 PDC category and persistence was estimated by Kaplan-Meier method. Cox regression analysis was performed to investigate whether the PDC was associated with treatment discontinuation. Among 952 patients, 820 (86.1%), 95 (10.0%), and 37 (3.9%) patients were grouped into the PDC ≥ 90%, 80– < 90%, and < 80% groups, respectively. Across all PDC groups, more than 90% of patients who received B/F/TAF were receiving treatment at 1 year. There was no significant difference in the risk of discontinuation between the lower PDC groups (80– < 90% and < 80%) and the PDC ≥ 90% group (0.400 [0.096, 1.661]; 2.244 [0.663, 7.594], hazard ratio [95% confidence interval], respectively). A drug resistance test was implemented for 15 patients, none of whom discontinued B/F/TAF after the test. The results suggest that events that could cause discontinuation, such as virologic failure, were not associated with PDC.

Wnt/β-catenin pathway as a potential target for Parkinson's disease: a cohort study of romosozumab using routinely collected health data in Japan.

Romosozumab is a monoclonal antibody approved for osteoporosis which targets sclerostin, an endogenous inhibitor of Wnt/β-catenin pathway. Given the essential roles of the Wnt/β-catenin pathway in various tissues, we hypothesized romosozumab treatment may influence other conditions. This cohort study included patients prescribed romosozumab or parathyroid receptor (PTHR) agonists after 1 January 2019, using a Japanese electronic medical record database. The outcomes of interest included autoimmune disease, interstitial pneumonia, cardiovascular outcome, Alzheimer's disease, Parkinson's disease (PD), serious infections, and malignancies. A stabilized inverse probability-weighted Cox proportional hazard model was used to estimate the hazard ratios. Age- and gender-based subgroup analyses were conducted. Exploratory outcomes based on three-digit International Classification of Diseases 10th Revision-based were also examined. In total, 2,673 patients treated with romosozumab and 5,980 treated with PTHR agonists were identified, respectively. While most outcomes of interest showed no association with romosozumab, the risk of PD decreased with romosozumab (hazard ratio [95% confidence interval], 0.37 [0.14-0.94]) compared with PTHR agonist. Regarding the cardiovascular outcome, no notable association was identified overall; however, gender-based subgroup analysis suggested that male sex may be a potential risk factor with romosozumab treatment. Only 16 of 903 exploratory outcomes were potentially influenced by romosozumab. Romosozumab lowered the risk of PD development compared with PTHR agonist. The study also highlights the utility of routinely collected health data for drug repositioning. While further validation is warranted, the findings suggest that the Wnt-β-catenin pathway holds promise as a therapeutic target for PD.

Analyzing actual crime victimizations of people with dementia in criminal court judgment databases in Japan

ABSTRACT People with dementia suffer not only from symptoms but also from social vulnerability including an increased risk of abuse and criminal victimization. In existing quantitative studies, the data are based on reports by people with dementia themselves, their family members, or concerned persons, which may be insufficient to accurately identify the actual mechanisms and circumstances of abuse or victimization. To speculate on the exact realities of people with dementia victimization, we extracted criminal sentences of perpetrators collected from the Japanese judgment database. A total of 152 cases in approximately 23 years included various victimization situations; these cases were classified into six categories of harm (physical, psychological, neglect, sexual, financial, and miscellaneous) and five categories of perpetrator (spouse, child, other family, supporter, and stranger or other). There were 93 cases of physical victimization by the spouse or child, which were statistically analyzed. Through case inspections, we provide an accurate victimization process of people with dementia and propose a four-class typology of physical victimization by the family: care exhaustion, antipathy to people with dementia, self-righteous or self-contained family, and continuous abuse type. These case scrutinies and their classifications may contribute to interventions regarding the support of people with dementia and their families.

The Association Between Deep Vein Thrombosis, Pulmonary Embolism, and Janus Kinase Inhibitors: Reporting Status and Signal Detection in the Japanese Adverse Drug Event Report Database.

Although Janus kinase (JAK) inhibitors have expanding indications, deep vein thrombosis (DVT) and pulmonary embolism (PE) are serious adverse events associated with their use. Moreover, their analysis using the Japanese database of spontaneous adverse drug reaction reports has not yet been conducted. The objective of this study was to analyze the Japanese Adverse Drug Event Report database (JADER) to evaluate the association between JAK inhibitors and DVT and PE. JADER reports from April 2004 to October 2023 were analyzed. A classification of reports for the period covered was performed by drug, and an imbalance analysis was performed with oral JAK inhibitors as the target drug and DVT, PE, and "embolic and thrombotic events, venous" (Standardised MedDRA Query; SMQ) as the target adverse events. Reported odds ratios (ROR) and information components (IC) were calculated for signal detection. Overall, 6631 JAK inhibitor-related adverse events were reported, including 60 and 41 cases of DVT and PE, respectively. The ROR and IC of the JAK inhibitors for DVT were 2.52 (1.95-3.25) and 1.27 (0.41-2.13), while those of baricitinib for DVT were 4.37 (2.83-6.73) and 1.90 (0.47-3.33), respectively. ROR signals were detected for JAK inhibitors for PE and "embolic and thrombotic events, venous (SMQ)," overall and for several JAK inhibitors but none for IC. Several JAK inhibitors are under postmarketing phase vigilance, and the number of reported adverse events is low. However, when administering these drugs, care should be taken to avoid the development of thromboembolism, considering the patient's background.

Short-term Functional Outcomes and Treatment Trends between Branch Atheromatous Disease and Lacunar Infarction: Retrospective Cohort Study of the Nationwide Multicenter Registry.

Branch atheromatous disease (BAD) is a form of ischemic stroke that presents with imaging findings similar to those of lacunar infarction, but has a different pathogenesis and is known to cause progressive paralysis. Due to regional variations, the epidemiology of BAD is not wellunderstood, and its relationship with functional prognosis remains unclear. Using a comprehensive Japanese stroke database, we investigated its epidemiological characteristics and associations with functional outcomes. In this multicenter cohort study, we retrospectively analyzed data from the Saiseikai Stroke Database (2013-2021) including 27 hospitals. We used multivariable logistic regression to calculate adjusted odds ratios (ORs) with 95% confidence intervals (CIs) of BAD compared with LI for functional outcomes at discharge. Ischemic stroke caused by BAD or LI was included and demographic characteristics and clinical data were evaluated and contrasted between BAD and LI. Of the 5,966 analyzed patients, 1,549 (25.9%) had BAD and 4,434 (74.1%) had LI. BAD was associated with worse functional outcomes (adjusted OR of 2.77, 95%CI: 2.42-3.17, relative to LI) and extended hospital stays (median 19 days for BAD vs. 13 days for LI). Moreover, aggressive treatment strategies, including the use of argatroban and dual antiplatelet therapy, were more common in BAD patients. BAD presented worse functional outcomes and longer hospital stays than LI, necessitating treatment plans that take into account its progression and prognosis.

Enzalutamide Prolonged the Duration of Drug Use in Comparison to Abiraterone Acetate and Cabazitaxel after Upfront Docetaxel: A Large Japanese Database Study.

In the United States, a total of 268,490 men were found to have prostate cancer in 2022, thus making it the most common cancer in men, accounting for 27% of all cancers in the male population. Among all cancers in men, it was the fifth leading cause of death, with 34,500 deaths and a mortality rate of 11%. In 2019, the total number of cases was 94,748, making it the leading cancer in males, accounting for 11% of all male cancers. In terms of mortality, it ranked seventh, with 13,217 deaths and a mortality rate of 1.6%. However, new treatment options for metastatic castration-sensitive prostate cancer (mCSPC) have emerged. Docetaxel has been shown to be effective for both mCSPC and castration-resistant prostate cancer (CRPC). Upfront docetaxel has not been approved in Japan, nor has it been validated in large-scale studies. Furthermore, several agents can be used after docetaxel treatment, but it is unclear which is the most effective. We used a large Japanese health insurance database to determine which agent would be the most effective as a next-line therapy in patients who had received docetaxel. We used data from medical institutions using the Diagnosis Procedure Combination (DPC), which provides a comprehensive evaluation of medical classifications. The Medical Data Vision database covers approximately 23% of DPC hospitals in Japan. This study analyzed 2938 patients with mCSPC who received docetaxel, followed by CRPC, between April 2008 and December 2021. The study focused on three agents: enzalutamide, abiraterone acetate, and cabazitaxel. Other agents were excluded due to the small number of patients. The following data were analyzed: age, date of CRPC diagnosis, presence of bone metastasis, drug type, and prognosis. This study included 1997 patients with CRPC after upfront docetaxel therapy for mCSPC (enzalutamide [ENZ] group, n = 998; abiraterone acetate [ABI] group, n = 617; and cabazitaxel [CBZ] group, n = 382). The overall survival (OS) time from drug initiation was 456 days in the enzalutamide group, which was significantly longer than that in the cabazitaxel group (p = 0.017, HR 0.94) (ENZ: ABI p = 0.54, HR 0.94; ABI: CBZ p = 0.14, HR 0.75). OS was also compared for the third-line drug in the group that received enzalutamide as the second-line drug, the group that used abiraterone acetate as the third-line drug (ENZ-ABI group), and the group that used abiraterone acetate as the second-line drug. OS from the start of the third-line drug was compared between the ENZ-ABI group and the ABI-ENZ group, which received enzalutamide as the third-line drug, but showed no significant difference (269 vs. 281 days, p = 0.85; HR 1.03). ENZ was shown to prolong OS relative to cabazitaxel after the cessation of docetaxel. ENZ was associated with a longer duration of drug use than ABI and CBZ.

Allelic frequency of pathogenic α1-antitrypsin variants in the Japanese population: Results from a survey of open Japanese genetic variation databases

α1-antitrypsin deficiency (AATD) is a hereditary disorder with a global prevalence that differs across regions. AATD is highly prevalent in Europe and North America but rarely found in Asian countries, including Japan, possibly because of the founder effect of the pathogenic SERPINA1 variants PI*Z and PI*S. However, AATD remains underdiagnosed even in high-prevalence and low-prevalence regions, possibly because of lack of awareness. In this study, we surveyed open Japanese genetic variation databases to estimate AATD prevalence in Japan. We identified allelic frequencies (AFs) of 5 among the 14 major pathogenic SERPINA1 variants from three datasets, collectively derived from 63,119 Japanese participants. The mean AF was determined to be 8.56 × 10−4 (95% confidence interval [CI]: 6.43 × 10−4 to 1.12 × 10−3). Given that this represents the entire Japanese population, one AATD patient was speculated to be born per 1.37 × 106 births (95% CI: 7.97 × 105 to 2.42 × 106) in Japan. Our results support the prevailing notion that AATD is extremely rare in Japan.

Surgery on admission and following day reduces hip fracture complications: a Japanese DPC study

IntroductionThe efficacy of early surgery in preventing complications among Japanese elderly patients with hip fractures requires further investigation. This study aims to use a comprehensive Japanese hip fracture case database to determine whether surgery within the day of admission and the following day reduces the incidence of complications and mortality during hospitalization in elderly hip fracture patients.Materials and methodsWe retrospectively analyzed the Japanese National Administrative DPC (Diagnosis Procedure Combination) database from April 2016 to March 2022. Approximately 1100 DPC-affiliated hospitals consistently provided medical records with consent for research. The study investigated the association between postoperative pneumonia, deep vein thrombosis, pulmonary embolism, and mortality during hospitalization after propensity score matching, focusing on surgeries conducted on the day of admission and the following day.ResultsAfter one-to-one propensity score matching for age, gender, and comorbidity, we identified 146,441 pairs of patients who underwent surgery either within the day of admission and the following day or after the third day of admission. Surgery on the third day or later was independently associated with increased risks of pneumonia, deep vein thrombosis, pulmonary embolism, and mortality during hospitalization with risk ratios of 1.367 (95% CI 1.307–1.426), 1.328 (95% CI 1.169–1.508), 1.338 (95% CI 1.289–1.388), and 1.167 (95% CI 1.103–1.234), respectively.ConclusionA comprehensive study of elderly Japanese patients with hip fractures in the DPC database showed that surgery on admission and the following day is crucial for preventing complications like pneumonia, deep vein thrombosis, pulmonary embolism, and mortality during hospitalization.

Improvement of medication adherence for desmopressin by adjusting the prescription dosage in male patients with overactive bladder: A claims database analysis.

Desmopressin is widely used for nocturia in patients with nocturnal polyuria. We investigated the continuation rate and adherence for desmopressin in patients with overactive bladder and nocturia using a claims database and evaluated factors that improved adherence. Patients with nocturia in a Japanese claims database who started desmopressin between September 2019 and July 2021 were evaluated. Drug persistence was assessed using the Kaplan-Meier method for initial prescription of desmopressin. The proportion of days covered (PDC) was also evaluated among patients with prescription persistence. Multivariate analysis was performed using logistic regression analysis to identify factors predicting adherence to desmopressin. The study included 72,888 patients entered into Japan Medical Data Center (JMDC) database between September 2019 and July 2021. For the 236 patients prescribed desmopressin formulations, mean prescription duration was 114 days. Among the total cases, 90 (38.1%) cases were prescribed only once, mean PDC was 0.60, and the number of high-adherence patients (PDC ≥ 0.80) was 108 (45.8%). Desmopressin prescription doses were fixed in 216 patients and adjusted in 20 patients. Multivariate analysis identified prescription dose adjustment for desmopressin as significantly associated with high PDC. Desmopressin showed a 38% dropout rate after the first dose. However, high medication continuation and high medication adherence rates (PDC) could be maintained with prescription adjustments. Careful patient monitoring and appropriate adjustment of the desmopressin dosage appear to be important factors in improving nocturia.