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Introduction: Studies have reported an association between attention deficit hyperactivity disorder (ADHD) and somatic diseases; however, the correlation of mental disorders with the association between ADHD and somatic diseases remains uninvestigated. This study investigated and compared the prevalence of somatic diseases among adults with/without ADHD, stratified by the presence or absence of mental disorders. Methods: This cross-sectional study (October 2020-September 2021), using data (June 2013-September 2021) from a Japanese health insurance claims database, included adult participants with a medical record of and receiving medication for ADHD (ADHD group); the control group (matched 1:5 by age/sex) comprised participants without ADHD. The prevalence and odds ratio (OR; ADHD versus control) of type 2 diabetes mellitus (T2DM), diabetes complications, hypertension, cardiovascular disease (CVD), dyslipidemia, gout and hyperuricemia, chronic obstructive pulmonary disease (COPD), non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH), and atopic dermatitis were investigated. Pooled ORs for stratified analysis were calculated using the Mantel-Haenszel method. Results: In the matched analysis sets, the ORs for all somatic diseases were significantly higher for the ADHD group (n=15,028) versus the control group (n=74,796). On stratified analysis, the Mantel-Haenszel ORs were significant for NAFLD/NASH (1.53; 95% confidence interval [CI]: 1.34, 1.73), diabetes complications (1.39; 95% CI: 1.09, 1.77), and gout and hyperuricemia (1.34; 95% CI: 1.19, 1.51). Furthermore, the stratum-specific ORs for T2DM, hypertension, and dyslipidemia were >1 and <1 in the presence and absence of mental disorders, respectively. The prevalence of all somatic diseases except atopic dermatitis increased with age. For participants aged ≥40 years, the Mantel-Haenszel ORs were significant for all somatic diseases except CVD, COPD, and atopic dermatitis. Conclusions: The prevalence of several somatic diseases, including chronic disorders, was high among adults with ADHD, particularly in those aged ≥40 years and those with mental disorders.

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PURPOSE: Fracture risk assessment is recommended at three months after glucocorticoid (GC) therapy initiation. This study aimed to assess whether GC exposure in the initial 90 days of GC therapy is associated with subsequent hip and clinical vertebral fracture risk using the nationwide health insurance claims database of Japan (NDBJ). METHODS: Patients aged ≥ 50 years who were prescribed GC (≥ 70 mg prednisolone or equivalent; PSL) in the initial 90 days of GC therapy and were followed for hip and clinical vertebral fracture incidences for the subsequent 1080 days were selected from NDBJ. Associations of GC exposure with hip or clinical vertebral fracture risk were evaluated by Cox regression analysis adjusted for potential confounders. RESULTS: We selected 316,396 women and 299,871 men for the GC-exposed group and 43,164 women and 33,702 men for the reference group. Higher GC doses and longer prescription days in the initial 90 days of GC therapy were significantly and dose-dependently associated with increased fracture risk relative to the reference group. Patients receiving GC ≥ 5 mg PSL/day had a significantly increased fracture risk in the stratum of 30-59 days of GC prescription. In addition, female patients who received GC (≥ 1 and < 2.5 mg PSL/day) for 90 days in the initial 90 days of GC therapy had a significantly increased fracture risk. CONCLUSIONS: GC exposure in the initial 90 days of GC therapy was dose-dependently associated with hip and clinical vertebral fracture risk. GC may increase fracture risk with lower doses for shorter durations than previously reported. Fracture risk assessment three months after glucocorticoid (GC) therapy initiation is recommended. We found that GC exposure in the initial 90 days of GC therapy at lower daily doses for shorter durations than previously reported were significantly and dose-dependently associated with fracture risk using a nationwide health insurance claims database.

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BACKGROUND CONTEXT: Morbid obesity (MO) has been associated with increased risk of adverse events following procedures such as posterior lumbar fusion (PLF). While preemptive bariatric surgery (BS) has been considered for those with MO (body mass index [BMI] ≥35 kg/m2), not all undergoing such intervention have significant weight loss, and the impact of BS has been shown to correlate with weight loss after different related procedures. PURPOSE: To examine outcomes following isolated single level PLF among patients with history of BS who subsequently did and did not transition out of the morbidly obese category. STUDY DESIGN/SETTING: Retrospective case-control study. PATIENT SAMPLE: The PearlDiver 2010-Q1 2020 MSpine database was used to identify adult patients undergoing elective isolated PLF. Patients were excluded if they had a history of infection, neoplasm, or trauma in the 90-days prior to their PLF and if they were not active in the database for at least 90 days following their surgery. Three sub-cohorts were defined: 1) MO controls without a history of BS (-BS+MO), 2) patients with prior BS procedure who remained MO (+BS+MO), and 3) patients with prior BS who were no longer MO at the time of PLF (+BS-MO). Matched 1:1:1 populations were created for these three sub-cohorts based on age, sex and Elixhauser Comorbidity Index (ECI). OUTCOME MEASURES: Ninety-day adverse events and readmission rates were assessed and compared between the three sub-cohorts (-BS+MO, +BS+MO, +BS-MO). METHODS: Univariable analyses and multivariable logistic regression were performed on the matched population to compare 90-day adverse events and readmission rates controlling for age, sex, and ECI. RESULTS: The current study identified PLF patients who were MO at the time of surgery but did not have a history of BS (-BS+MO, n=34,236), those who had BS and remained MO (+BS+MO, n=564), and those who had MS and were no longer MO (+BS-MO, n=209 which was only 27% of those who had BS). On multivariable analysis of the matched populations, those that had BS but remained MO (+BS+MO) were not at reduced odds of 90-day adverse events. However, those that had BS and were no longer MO (+BS-MO) were at reduced odds of 90-day any, severe, and minor adverse events (OR 0.41, 0.51, and 0.37, respectively with p<0.05 for all). CONCLUSIONS: Only 27% of those with a history of BS prior to PLF transitioned out of the MO category. Compared to those who were morbidly obese without BS, those who had BS were only at reduced risk of 90-day adverse events if they actually lost weight sufficient to drop out of morbidly obesity. These findings should be taken into account when counseling patients and interpreting prior studies.

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BACKGROUND: Pneumonia is the most serious form of acute respiratory infection and Streptococcus pneumoniae is a leading cause of pediatric bacterial pneumonia. Pneumococcal conjugate vaccines were introduced in the United States (US) in 2000 (7-valent [PCV7]) and 2010 (13-valent [PCV13]). This study estimated annual incidence rates (IRs) of all-cause pneumonia (ACP) among US children aged < 18 years before and after the introduction of PCV7 and PCV13. METHODS: ACP episodes were identified in the IBM MarketScan Commercial and Medicaid Databases using diagnosis codes. Annual IRs were calculated overall and by inpatient and outpatient settings as the number of episodes per 100,000 person-years (PY) for all children aged < 18 years and by age group (< 2, 2-4, and 5-17 years). National estimates of annual pneumonia IRs were extrapolated using Census Bureau data. Interrupted time series (ITS) analyses were used to assess immediate and gradual changes in monthly pneumonia IRs, adjusting for seasonality. RESULTS: In the commercially-insured population, ACP IRs declined between the pre-PCV7 period (1998-1999) and late PCV13 period (2014-2018) from 5,322 to 3,471 episodes per 100,000 PY for children aged < 2 years, from 4,012 to 3,794 episodes per 100,000 PY in children aged 2-4 years but increased slightly from 1,383 to 1,475 episodes per 100,000 PY in children aged 5-17 years. The ITS analyses indicated significant decreases in monthly ACP IRs in the early PCV7 period (2001-2005) among younger children and in the early PCV13 period (2011-2013) among all children. Increases were observed in the late PCV7 period (2006-2009) among all age groups, but were only significant among older children. IRs of inpatient ACP decreased across all age groups, but outpatient pneumonia IRs remained stable during the study timeframe, even increasing slightly in children aged 5-17 years. More prominent declines were observed for Medicaid-insured children across all age groups; however, Medicaid IRs were higher than IRs of commercially-insured children during the entire study timeframe. CONCLUSIONS: ACP disease burden remains high in US children of all ages despite overall reductions in incidence rates during 1998-2018 following the introduction of PCV7 and PCV13.

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PURPOSE: Early initiation of anti-osteoporosis medications (AOMs) is recommended for patients on long-term glucocorticoid (GC) therapy. This study aimed to clarify the real-world effectiveness of AOMs against incident hip and vertebral fractures in patients undergoing GC therapy using the nationwide health insurance claims database of Japan (NDBJ). METHODS: Patients aged ≥50 years who were prescribed GC (≥5 mg/day prednisolone or equivalent) for ≥90 days and who were followed up regarding AOM prescription and hip and clinical vertebral fracture incidences for the subsequent 1080 days between 2012 and 2018 were selected from NDBJ. Associations of AOMs prescribed within 90 days since GC therapy initiation with hip or vertebral fracture risk were evaluated by Cox proportional hazards regression using propensity score inverse probability weighting (IPW) for receiving any AOM or individual AOMs. RESULTS: In total, 96,475 women and 98,385 men were included in the analysis; 38.0 % of women and 27.6 % of men received AOMs. Patients who received any AOM and those who received bisphosphonates or denosumab had a significantly lower risk of hip and clinical vertebral fractures than those who received no AOM in both sexes after propensity score IPW. Teriparatide was associated with an increased risk of both fractures in women and an increased risk of clinical vertebral fractures in men. Selection biases such as confounding by indication might have caused an underestimation of AOMs' protective effects. CONCLUSIONS: Bisphosphonates and denosumab were associated with a lower fracture incidence in patients on long-term GC therapy in real-world settings.

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PURPOSE: To investigate the real-world dose of systemic corticosteroids in the treatment of non-infectious uveitis (NIU) in Japan. STUDY DESIGN: A retrospective, observational study. METHODS: Patients newly registered at the Japan Medical Data Center health insurance claims database with a diagnosis of NIU who received systemic corticosteroids were identified, and their systemic corticosteroid dose (prednisolone equivalent) was assessed over 12 months of treatment (data extraction period: January 2008 to May 2017). RESULTS: The mean cumulative systemic corticosteroid dose in 12 months in 1641 new patients with NIU who received systemic corticosteroids was 593.7 mg. The mean systemic corticosteroid dose was highest at month 1 (10.7, 218.1, 16.7, and 23.0 mg/day in Behçet's disease [BD]-associated NIU [n = 19], Vogt-Koyanagi-Harada [VKH] disease-associated NIU [n = 49], sarcoidosis-associated NIU [n = 27], and "undifferentiated NIU" [NIU without specific primary disease information, n = 1545], respectively) and decreased over time. Systemic corticosteroids were prescribed at month 12 to 68.4%, 22.4%, 44.4%, and 5.6% of patients with BD-associated NIU, VKH disease-associated NIU, sarcoidosis-associated NIU, and undifferentiated NIU, respectively (mean dose, 6.0-14.3 mg/day). Multivariate regression analysis identified female sex, middle age (30 to < 40 years), VKH disease, and immunosuppressive agent use as background factors associated with higher systemic corticosteroid dose. CONCLUSIONS: The systemic corticosteroid dose was highest at month 1 and decreased over time in all disease categories. This database research revealed that some patients with NIU continued being prescribed systemic corticosteroids for at least 1 year.

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PURPOSE: Early initiation of anti-osteoporosis medications (AOMs) is recommended for patients on long-term glucocorticoid (GC) therapy. This study aimed to examine whether physicians prescribe AOMs as soon as GC therapy is initiated, and whether a delay in AOM initiation affects hip and vertebral fracture incidence, using the nationwide health insurance claims database of Japan (NDBJ). METHODS: Patients aged ≥50 years who were prescribed GC (≥5 mg/day prednisolone or equivalent) for ≥90 days and who were followed for AOM use and hip and vertebral fracture events for the subsequent 1080 days in 2012-2018 were selected from NDBJ. Delay in AOM initiation was defined as the number of days without AOMs following GC therapy initiation. Associations between delay in AOM initiation and hip and vertebral fracture risk were evaluated by Cox proportional hazards regression. RESULTS: In total, 92,143 women and 94,772 men were included in the analysis, of which only 39.3% of women and 28.5% of men received AOMs within 90 days from GC therapy initiation. Approximately, 15% of hip fractures and 30% of vertebral fractures occurred before AOM initiation in patients with delayed AOM initiation. HRs of both fractures were significantly greater in patients with a longer delay in AOM initiation (p value for trend<0.001). After excluding patients who had fractures before AOM initiation, the magnitude of HRs significantly decreased, and HR trends for hip fracture became insignificant. CONCLUSIONS: Delayed initiation of AOMs may result in increased fracture events, which may be reduced by early initiation of AOMs.

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BACKGROUND: Generalized pustular psoriasis (GPP) is a rare and severe phenotype of psoriasis characterized by sudden outbreak of widespread coalescent sterile pustules associated with a spectrum of systemic symptoms. OBJECTIVE: We aimed to describe the epidemiology and treatment of GPP in Brazil from the public health care system perspective. METHODS: This was a retrospective public claims database study, using outpatient and inpatient databases, with information from January 2018 to August 2020, based on records of health resource utilization by patients with GPP. Outpatient treatment regimens and fatal inpatient outcomes were described. RESULTS: In total, 1458 outpatients of all ages were identified, of whom 53% were women. We estimated the GPP prevalence in Brazil to be between 0.7 and 0.9 per 100,000. Acitretin was the most commonly dispensed drug. Of all the outpatients, 769 outpatients could be tracked in the inpatient database, and 151 had hospital admissions during the study period. Of them, 5.3% had a fatal outcome during hospitalization. A primary skin condition or an infection was the most frequent hospitalization cause. LIMITATION: The International Classification of Diseases codes for GPP and psoriasis have not been previously validated in this context. CONCLUSION: GPP is a rare disease in Brazil and affects individuals of all ages and both sexes. Hospitalizations and disease-related deaths highlight the need for its prompt diagnosis, close medical follow-up, and effective treatment.

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Early treatment of HIV infection depends on timely diagnosis, but many persons living with HIV/AIDS (PLWHA) are unaware of their infection. Though many patients seeking medical attention for sexually transmitted diseases have HIV, many patients' HIV co-infection is undiagnosed in Japan. This is the first report to analyze the timing of syphilis infection in PLWHA of all ages through the use of the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), containing clinical data of the largest group of HIV-positive patients available in Japan. Overall, 1521 PLWHA (male 93.2%) newly diagnosed and started on antiretroviral therapy were identified in 2016, and 646 (42.5%) patients had a diagnosis of syphilis between 2011 and 2018. Although 100 patients were diagnosed with syphilis before their HIV diagnosis, only 17 (17.0%) had been tested for HIV. Over 50 patients per year became infected with syphilis even after their HIV diagnosis (2017, n = 65 (4.3%); 2018, n = 58 (3.8%)). Although early diagnosis of HIV infection is important, most syphilis patients in Japan had not been properly tested for HIV infection. Since a certain number of HIV patients developed syphilis after HIV diagnosis, education for newly diagnosed HIV patients is important.

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PURPOSE: To characterize newly diagnosed primary open-angle glaucoma (OAG) patients and to describe their treatment journey in United States clinical practice according to the use of topical therapy, laser trabeculoplasty, and surgical procedures. DESIGN: Retrospective claims database study. PARTICIPANTS: Patients with at least 2 diagnoses of OAG 7 days or more apart and within 1 year, with the first (index) diagnosis in 2010, at least 30 months of continuous enrollment before index diagnosis with no OAG diagnosis or medication (exception for ocular hypertension diagnosis), and 48 months of continuous enrollment. METHODS: Analysis of United States healthcare insurance claims database (July 2007-December 2014). MAIN OUTCOME MEASURES: Treatment patterns and ophthalmology visits were evaluated over 48 months in 4 cohorts based on initial therapy after the index diagnosis: (1) drug monotherapy, (2) combination drug therapy, (3) glaucoma procedure, or (4) no claims for treatment. Treatment modification was defined as an addition to or change in drug therapy or procedure. RESULTS: In total, 83.0% of patients (5120/6172) began a drug therapy (69.5%) or underwent a procedure initially (13.5%); topical prostaglandin analogs (n = 2887/5120 [56.4%]) and laser trabeculoplasty (n = 705/5120 [13.8%]) were the most common. During the 4-year follow-up, 58.3% of patients (2109/3620) who began drug monotherapy experienced no further treatment modification. Over this period, 43.8% of patients who began treatment (2242/5120) experienced a treatment modification to the first treatment. Two thirds (1505/2242 [67.1%]) of these patients subsequently underwent a third treatment modification. Ophthalmology visits declined over time regardless of initial therapy, with the greatest decrease among the untreated and first-treatment procedure cohorts. CONCLUSIONS: The high rates of 2 or 3 treatment modifications over the 4-year period suggest an unmet need for glaucoma therapies with durable and predictable actions.

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Aim: To explore fracture outcomes with tapentadol or oxycodone, two opioids with differing mechanisms of action. Materials & methods: Retrospective cohort pilot study, using MarketScan® Commercial and Medicare Supplemental claims databases, on patients with postoperative pain, back pain, or osteoarthritis and ≥1 claim for tapentadol (n = 16,457), oxycodone (n = 1,356,920), or both (n = 15,893) between June 2009 and December 2015. Results: During 266,826 and 9,007,889 days of tapentadol and oxycodone treatment, patients evidenced 1080 and 72,275 fractures, respectively. Fracture rates per treatment-year were 1.512 for tapentadol and 3.013 for oxycodone. Conclusion: Examination of administrative claims has inherent limitations, but this exploratory analysis indicates a lower fracture rate with tapentadol than oxycodone in the analyzed dataset, which needs confirmation by further clinical trials.

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Background and purpose: Several recent randomized controlled trials (RCTs) in non-metastatic castration resistant prostate cancer (nmCRPC) have demonstrated a significant improvement in metastasis-free survival (MFS); however, an improvement in overall survival (OS) is not reported yet. Since the surrogacy of MFS to OS has not been formally investigated in nmCRPC in Japan, this study evaluated the correlation between MFS and OS among a nmCRPC population in Japan. Methods: This is a retrospective longitudinal observational cohort study in patients with nmCRPC using the Japanese Medical Data Vision (MDV) database covering over 20 million patients. A total of 1236 patients with CRPC who had no prior medical history of cancer except prostate cancer and no distant metastasis, and who fulfilled PCWG2 criteria, were identified. Following the identification of nmCRPC, patients' medical records were investigated for subsequent events of metastasis and death. Results: The median follow-up time was 24 months. Median MFS was 28 months (95% CI: 24.0 to 33.0 months) and median OS could not be estimated (95% CI: not estimated). There was a statistically significant correlation between MFS and OS (Pearson's correlation coefficient = 0.62; 95% CI: 0.58-0.65; p < .0001, Spearman's correlation coefficient = 0.62; 95% CI: 0.58-0.65; p < .0001 and Kendall's τ statistic = 0.53; 95% CI: 0.49-0.56; p < .0001). Conclusions: The results of this study indicate a significant correlation between MFS and OS. It may justify the usefulness of MFS as surrogate for OS in nmCRPC.

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