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.

Nationwide epidemiology and health resource use among children with COVID-19 in Japan.

BACKGROUND: The COVID-19 pandemic posed substantial challenges to healthcare systems. Understanding the responses of pediatric health services is crucial for future pandemic planning and preparedness, yet such data remains limited. METHODS: In this retrospective cohort study, we analyzed data from administrative databases developed by Japan Medical Data Center and DeSC Healthcare Inc. The dataset comprised records of 2,612,511 children, totaling 60,224,888 person-months, from January 2020 to May 2022. Multivariate generalized estimation equations were used to examine the incidence rates of COVID-19 and associated health resource use. RESULTS: Our analysis revealed that the incidence rates of COVID-19 gradually increased from Wave I (2.2 cases per 100,000 person-months) to Wave V (177.8cases per 100,000 person-months), with a notable elevation during Wave VI (2367.7 cases per 100,000 person-months). While nucleic acid amplification tests were primarily used during Waves I-V, the use of rapid antigen tests markedly increased in Wave VI. The hospitalization rates increased gradually from 0.2 in Wave I to 10.2 events per 100,000 person-months in Wave VI, and the case-hospitalization risk decreased from 14.9% in Wave II to 0.7% in Wave VI. Additionally, we observed decreasing trends in the use of antibiotics (Wave I, 31.8%; Wave VI, 9.0%), whereas antipyretic use rose from Wave I (56.1%) to Wave VI (86.6%). CONCLUSIONS: Our study highlighted essential changes in the nationwide pediatric healthcare system's response to the COVID-19 pandemic. These findings provide valuable insights into the future pandemic planning and preparedness.

Decline incidence in upper gastrointestinal bleeding in several recent years: data of the Japan claims database of 13 million accumulated patients.

This study was to examine the recent trends in upper gastrointestinal bleeding in Japan using a large-scale real-world database. The incidence of upper gastrointestinal bleeding was evaluated in the Japan Medical Data Center claims database of 13,019,713 patients aged 20 to 74 years with traceability for 3 months from 2009 to 2014. The incidence was compared with peptic ulcers and gastroesophageal reflux disease. The prescription of medications was also evaluated. The incidence of bleeding was 0.137%, 0.121%, 0.113%, 0.106%, 0.099%, and 0.105% during 2009 to 2014 with a time-dependent decline (p<0.001). Peptic ulcers (>10 times higher than the incidence of bleeding) decreased with time (p<0.001), whereas gastroesophageal reflux disease increased (p = 0.006). Upper gastrointestinal bleeding was higher in male patients and older patients (60-74 years old) (p<0.001 respectively). The prescription rate of antithrombotic medications and proton pump inhibitors increased from 2009 to 2014 (p<0.001 respectively). The incidence of upper gastrointestinal bleeding decreased from 2009 to 2014 in this relatively large-scale real-world database in Japan, concomitant with the decrease in peptic ulcers. The decreased incidence might have been due to changes in the disease structure and therapeutic strategies over time.

Structural and organizational determinants of the capacity for COVID-19 testing and diagnoses in children: Insights from the 2009 influenza and COVID-19 pandemics.

BACKGROUND: This study explored factors associated with testing and diagnoses for children with COVID-19 at the hospital level and investigated whether the capacity of testing and diagnoses during the 2009 influenza pandemic was associated with that during COVID-19 pandemic. METHODS: In this observational study, we analyzed data obtained from the Japan Medical Data Center database, comprising 4906 medical facilities and 1.7 million infectious disease-related visits among children aged <20 years in 2020-2021. Multivariable generalized linear models were used to explore determinants of testing and diagnoses capacity for COVID-19 and investigate the association between the capacity during the 2009 influenza and COVID-19 pandemics. RESULTS: Public hospitals (adjusted incidence rate ratio [aIRR], 1.52; 95%CI, 1.26-1.82) and university hospitals (aIRR, 1.44; 95%CI, 1.14-1.80) were more likely to perform testing for COVID-19 among children, compared to clinics. The highest testing rate was observed in the department of internal medicine (aIRR, 1.64; 95%CI, 1.32-2.04), followed by pediatrics (aIRR, 1.40; 95%CI, 1.10-1.78) and otolaryngology (aIRR, 1.21; 95%CI, 0.89-1.64). Cubic spline models demonstrated the dose-response relationships between testing rate for influenza in 2009 and testing rates for COVID-19. Compared to the medical facilities in the lowest quartile of testing rate for influenza in 2009, those in the highest quartile were more likely to perform testing for COVID-19 (aIRR, 1.62; 95%CI, 1.43-1.83). CONCLUSIONS: Our study provides insights into the capacity of testing and diagnoses for children, highlighting the dose-response relationship between the 2009 influenza and COVID-19 pandemics, which could be valuable in preparing healthcare systems for future pandemics.

A Review of Studies Using Japanese Nationwide Administrative Claims Databases.

BACKGROUND: Administrative claims databases are increasingly being used worldwide for research purposes. We reviewed original published articles that used one of the four nationwide administrative claims databases in Japan: the National Database of Health Insurance Claims and Specific Health Checkups (NDB), NDB Open Data, the JMDC Claims Database, and the Diagnosis Procedure Combination (DPC) database. METHODS: Studies published from January 2010 to July 2022 using the JMDC and DPC databases, and from January 2013 to July 2022 using the NDB and NDB Open Data were identified using PubMed. The number of original articles was divided into 19 fields. The annual growth rate of the number of studies was calculated using the four databases. RESULTS: Overall, 1047 studies were included (95 for the NDB, 31 for the NDB Open Data, 222 for the JMDC database, and 699 for the DPC databases). Studies using one of these four databases increased from around 2010, and the average annual growth rate was approximately 41% from 2010 to 2021. DPC database studies had a higher proportion of articles on surgery (19.2%), urology (3.0%), neurosurgery (6.2%), anesthesiology (1.9%), and emergency medicine (14.0%), whereas the NDB and JMDC data had higher proportions of those regarding internal medicine. CONCLUSIONS: Since 2010, these four databases have increasingly attracted attention, and the number of studies using them has grown rapidly. Our review suggests that each has unique features, and researchers should understand the database characteristics to operate their studies.

Impacts of routine varicella vaccination program and COVID-19 pandemic on varicella and herpes zoster incidence and health resource use among children in Japan.

PURPOSE: To determine the epidemiological trends in pediatric varicella and herpes zoster incidence and changes in healthcare resource use from 2005 to 2022 using a nationally representative database in Japan. MATERIALS AND METHODS: We conducted a retrospective observational study consisting of 3.5 million children with 177 million person-months during 2005-2022 using Japan Medical Data Center (JMDC) claims database in Japan. We investigated trends in incidence rates of varicella and herpes zoster and changes in healthcare resource use (e.g., antiviral use, office visits, and healthcare costs) over 18 years. Interrupted time-series analyses were used to investigate the impact of the routine varicella vaccination program in 2014 and infection prevention measures against COVID-19 on incidence rates of varicella and herpes zoster and related healthcare utilization. RESULTS: After the introduction of the routine immunization program in 2014, we observed level changes in incidence rates (45.6 % reduction [95 %CI, 32.9-56.0] of varicella cases, antiviral use (40.9 % reduction [95 %CI, 25.1-53.3]), and relevant healthcare costs (48.7 % reduction [95 %CI, 38.2-57.3]). Furthermore, infection prevention measures against COVID-19 were associated with additional level changes in varicella rates (57.2 % reduction [95 %CI, 44.5-67.1]), antiviral use (65.7 % reduction [59.7-70.8]), and healthcare costs (49.1 % [95 %CI, 32.7-61.6]). In contrast, the changes in incidence and healthcare costs for herpes zoster were relatively small, which showed 9.4 % elevated level change with a decreasing trend and 8.7 % reduced level change with a decreasing trend after the vaccine program and the COVID-19 pandemic. The cumulative incidence of herpes zoster in children born after 2014 was lower than that before 2014. CONCLUSIONS: Varicella incidence and healthcare resource use were largely affected by the routine immunization program and infection prevention measures against COVID-19, while these impacts on herpes zoster were relatively small. Our study indicates that immunization and infection prevention measures largely changed pediatric infectious disease practices.

Prescription of Choreito, a Japanese Kampo Medicine, with Antimicrobials for Treatment of Acute Cystitis: A Retrospective Cohort Study.

Choreito, a Japanese Kampo medicine, is used to treat Japanese female patients for the quick relief of inflammatory symptoms associated with acute cystitis. We evaluated whether Choreito is effective in reducing antibiotic use and the number of clinic visits for these patients. Females aged 18-49 years who had acute cystitis for the first time, with no history of medical insurance use within 90 days prior to their visit, and no hospitalizations within the 30 days after their first visit were identified from the JMDC Claims Database between April 2018 and March 2021. For the 30 days after their first visit, patients who were given their first antimicrobial prescriptions with or without Choreito were compared regarding (i) the number of clinic visits, (ii) total antimicrobial prescription days, and (iii) the number of antimicrobial prescriptions adjusted for their age, Charlson comorbidity index, and the COVID-19 pandemic period (after April 2020). For the 319 and 8515 patients with or without a Choreito prescription, respectively, multivariable Poisson regression analyses showed that Choreito was significantly associated with a 5% shortening of a patient's total antimicrobial prescription days (Beta, 0.950; p = 0.038), whereas no significant difference was observed in the number of clinic visits and antimicrobial prescriptions (p = 0.624 and p = 0.732, respectively). The prescription of Choreito in combination with antimicrobials was associated with a slight reduction in total antimicrobial use for acute cystitis among females.

Impact of Depression Onset and Treatment on the Trend of Annual Medical Costs in Japan: An Exploratory, Descriptive Analysis of Employer-Based Health Insurance Claims Data.

INTRODUCTION: We aimed to clarify medical expenses in Japanese individuals before and after major depressive disorder (MDD) diagnosis, and to determine whether MDD treatment also reduces medical costs for comorbid physical conditions. METHODS: This was an exploratory, descriptive, retrospective analysis of insurance claims data from JMDC Inc. Cohort A included individuals aged 18-64 years between January 2015 and December 2019. Cohorts B and C included Cohort A individuals with diabetes/hypertension ('chronic disease'), and sleep/anxiety disorders ('high depression risk'), respectively. Individuals in Cohorts A-C with an MDD diagnosis were analyzed by year of MDD onset (Cohorts A-CMDD2015-2019). Diagnoses and median medical costs were derived from International Classification of Diseases 10 codes. RESULTS: Total medical and non-neuropsychiatric drug costs in MDD onset years were 170,390-182,120 and 8480-9586 yen higher, respectively, for Cohorts AMDD2015-2019 than for Cohort A. In Cohort AMDD2019, total medical and non-neuropsychiatric drug costs increased incrementally from 2015 to 2019 (total changes: + 165,130 and + 7365 yen, respectively), to a greater degree than in Cohort A (+ 10,510 and + 1246 yen, respectively). Neuropsychiatric drug costs increased in the year of MDD onset only and decreased thereafter. After MDD onset, decreases in total medical and non-neuropsychiatric drug costs were observed (Cohorts AMDD2015-2019). Non-neuropsychiatric drug costs also decreased after MDD onset in the chronic disease groups (Cohorts CMDD2015-2019), but not in patients with MDD recurrence. CONCLUSION: Treating MDD reduces medical costs for comorbid physical conditions and may be a useful strategy for improving healthcare efficiency in Japan.

Medications for attention-deficit/hyperactivity disorder in Japan: A retrospective cohort study of label compliance.

AIM: To assess label compliance in prescription of medications approved for treatment of attention-deficit/hyperactivity disorder (ADHD) in Japan at the time of this study: methylphenidate (MPH), atomoxetine, and guanfacine. METHODS: Retrospective descriptive study was conducted in prevalent-user cohorts from the Japan Medical Data Center database. Patients who were prescribed a study drug between January 1, 2013 and September 30, 2018 and were in the database for ≥30 days were included. A prescription was considered compliant if all 4 criteria were satisfied: appropriate age, daily dose not exceeding the approved maximum, no contraindicated concurrent medications, and no contraindicated conditions. RESULTS: Among 17 418 patients who were prescribed a study drug during 2013-2018, 73% were male and 53% were children (aged <18 years). Fewer than 2% of prescriptions were for patients outside the approved age, 10%-13% of patients in the atomoxetine and MPH cohorts received ≥1 prescription exceeding maximum approved dose, no patients were co-prescribed a contraindicated medication, and 16%-18% of patients in the MPH cohorts had ≥1 contraindicated condition. During their first 500 days of use, for approximately 73%-86% of patients, all prescriptions were compliant with all label requirements. CONCLUSIONS: Among patients exposed to ADHD medications in Japan during 2013-2018, nearly all prescriptions for these medications were label-compliant for age. For >85% of patients, all prescriptions were label-compliant for dose, and for approximately 80%, all prescriptions were label-compliant for contraindicated conditions. We did not find evidence of widespread abuse or noncompliant use of prescribed ADHD medications.

Dose Adjustment of Methotrexate Administered Concomitantly with Golimumab for Rheumatoid Arthritis in Japanese Real-World Clinical Settings.

INTRODUCTION: The combination of methotrexate (MTX) with biological disease-modifying antirheumatic drugs (bDMARDs) is a recommended treatment option for rheumatoid arthritis (RA) patients showing an inadequate response to MTX monotherapy. However, the adequate dose of MTX, especially in long-term treatment with bDMARDs/MTX combination therapy, remains under-addressed. Since RA patients require long-term treatment, we examined the effects of using golimumab (GLM) in the long run as well as its persistency and associated factors. METHODS: We used the Japan Medical Data Center Inc. (JMDC) administrative claims data of 489 patients receiving GLM therapy for calculating the persistency in patients with constant, reduced, or escalated MTX dosing. The factors associated with GLM persistency were assessed using Cox proportional hazard modeling, controlling for the dose adjustment of concomitant MTX, age, sex, RA disease period, and the initial dose of GLM or concomitant MTX during GLM/MTX combination therapy. RESULTS: During GLM/MTX combination therapy, up to 52% of patients were reported to experience dose adjustments of concomitant MTX treatment (i.e., dose reduction and escalation in 34% and 18% of patients, respectively). Persistency was similar in the MTX dose-reduction patients and the MTX dose-constant patients. In the Cox proportional hazard model, no significant differences were observed in association with GLM persistency, including with respect to MTX dose adjustment. CONCLUSIONS: GLM prescription was continued in 80% or more (1 year) and 50% or more (3 years) of RA patients receiving reduced concomitant MTX dosing, suggesting that MTX dose adjustment (including MTX reduction) could be considered in GLM/MTX combination therapy.