RESUMEN
BACKGROUND: The effectiveness and safety of edoxaban for venous thromboembolism (VTE) in unselected real-world patients have not been fully evaluated.MethodsâandâResults: In the Japanese nationwide administrative database, we identified 6,262 VTE patients in whom edoxaban was initiated; these patients were divided into 3 groups based on their index doses: 15 mg/day (n=235), 30 mg/day (n=4,532), and 60 mg/day (n=1,495). We evaluated patient characteristics, recurrent VTEs, and a composite endpoint of intracranial hemorrhage (ICH) and gastrointestinal (GI) bleeding. Patient characteristics among the 15-, 30-, and 60-mg edoxaban groups varied widely regarding several aspects, including age (mean 81.0, 76.2, and 65.0 years, respectively) and body weight (mean 49.5, 51.8, and 70.3 kg, respectively). At 180 days, the cumulative incidence of recurrent VTEs in the 15-, 30-, and 60-mg edoxaban groups was 4.4%, 2.6%, and 1.8%, respectively, whereas that of ICH or GI bleeding was 7.3%, 5.4%, and 3.3%, respectively. Subgroup analyses showed that the cumulative incidence of ICH or GI bleeding in patients in the 15-mg edoxaban group was 3.6% for patients aged ≥80 years, 8.4% for those with a body weight <60 kg, and 31.3% for those with renal dysfunction. CONCLUSIONS: Only a minority of patients with VTEs received a super low dose (15 mg) of edoxaban, and these patients may be at higher risk of bleeding as well as VTE recurrence.
Asunto(s)
Tiazoles , Tromboembolia Venosa , Humanos , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/epidemiología , Piridinas/efectos adversos , Hemorragia Gastrointestinal/inducido químicamente , Hemorragias Intracraneales/inducido químicamente , Peso Corporal , Anticoagulantes/efectos adversos , Inhibidores del Factor Xa/efectos adversosRESUMEN
BACKGROUND: Dental procedures can lead to bacteremia and have been considered a potential risk factor for pyogenic vertebral osteomyelitis (PVO). However, data on the association between dental procedures and PVO are limited. QUESTIONS/PURPOSES: (1) After controlling for relevant confounding variables, are dental procedures associated with an increased risk of PVO? (2) Does antibiotic prophylaxis before dental procedures effectively decrease the risk of PVO? METHODS: A case-crossover study was conducted to investigate the association between dental procedures and PVO using a Japanese claims database. The advantage of this study design is that confounding factors that do not vary over time are automatically adjusted for, because cases act as their own controls. From April 2014 to September 2021, the database included 8414 patients who were hospitalized for PVO. Of these, 50% (4182 of 8414) were excluded because they had not undergone any dental procedures before the index date, a further 0.1% (10 of 8414) were excluded because they were younger than 18 years at the index date, and a further 7% (623 of 8414) were excluded because they did not have at least 20 weeks of continuous enrollment before the index date, leaving 43% (3599 of 8414) eligible for analysis here. The mean age was 77 ± 11 years, and 55% (1985 of 3599) were men. Sixty-five percent (2356 of 3599) of patients had a diagnosis of diabetes mellitus, and 42% (1519 of 3599) of patients had a diagnosis of osteoporosis. We compared the frequency of dental procedures between a 4-week hazard period before the admission date for PVO and two control periods, 9 to 12 weeks and 17 to 20 weeks before the admission date for PVO, within individuals. We calculated odds ratios and 95% confidence intervals using conditional logistic regression analysis. RESULTS: Comparing the hazard and matched control periods within individuals demonstrated that dental procedures were not associated with an increased risk of PVO (OR 0.81 [95% CI 0.72 to 0.92]; p < 0.001). Additional analysis stratified by antibiotic prophylaxis use showed that antibiotic prophylaxis was not associated with a lower OR of developing PVO after dental procedures (with antibiotic prophylaxis: OR 1.11 [95% CI 0.93 to 1.32]; p < 0.26, without antibiotic prophylaxis: OR 0.72 [95% CI 0.63 to 0.83]; p < 0.001). Our sensitivity analyses, in which the exposure assessment interval was extended from 4 to 8 or 12 weeks and exposure was stratified by whether the dental procedure was invasive, demonstrated results that were consistent with our main analysis. CONCLUSION: Dental procedures were not associated with an increased risk of subsequent PVO in this case-crossover study. The effectiveness of antibiotic prophylaxis was not demonstrated in the additional analysis that categorized exposure according to the use of antibiotic prophylaxis. Our results suggest that the association between dental procedures and PVO may have been overestimated. Maintaining good oral hygiene may be important in preventing the development of PVO. The indications for antibiotic prophylaxis before dental procedures should be reconsidered in view of the potential risk of adverse drug reactions to antibiotic prophylaxis and the emergence of drug-resistant pathogens. Larger randomized controlled trials are needed to confirm these findings and assess the role of antibiotic prophylaxis. LEVEL OF EVIDENCE: Level III, therapeutic study.
Asunto(s)
Osteomielitis , Osteoporosis , Masculino , Humanos , Anciano , Anciano de 80 o más Años , Femenino , Estudios Cruzados , Osteoporosis/complicaciones , Antibacterianos/efectos adversos , Profilaxis Antibiótica , Osteomielitis/tratamiento farmacológico , OdontologíaRESUMEN
BACKGROUND: Moyamoya disease (MMD) is characterized by progressive stenosis or occlusion of the terminal portions of the bilateral internal carotid arteries. A Japanese survey in 2003 reported an incidence and prevalence of MMD of 0.54 and 6.03 per 100,000 people, respectively, showing an upward trend over previous surveys. An update to these estimates is therefore warranted. Additionally, evidence is lacking on trends in revascularization and antiplatelet therapy in MMD patients. METHODS: We conducted a population-based descriptive study using a Japanese claims database. From fiscal year (FY) 2015 to 2019, we standardized the incidence and prevalence estimates of MMD to the 2015 Japanese census population by age and sex. We also estimated the 1-year cumulative incidence of revascularization among incident MMD patients and the proportion of prevalent MMD patients receiving antiplatelet therapy in each FY. RESULTS: The age-standardized male-to-female ratio of both incident and prevalent MMD patients was approximately 1:2. Standardized incidence and prevalence of MMD per 100,000 population increased slightly from 1.8 to 2.4 and 14.7 to 17.6, respectively. The 1-year cumulative incidence of revascularization among incident MMD patients varied between 21.9 % and 28.9 %. Among prevalent MMD patients, 36.6 % to 39.0 % received antiplatelet therapy. CONCLUSIONS: The incidence and prevalence of MMD in Japan from FY 2015 to 2019 were higher than those estimated in 2003. The trends in revascularization and antiplatelet therapy identified in this study will be useful in further improving the quality of MMD clinical practice.
Asunto(s)
Bases de Datos Factuales , Enfermedad de Moyamoya , Inhibidores de Agregación Plaquetaria , Humanos , Enfermedad de Moyamoya/epidemiología , Enfermedad de Moyamoya/terapia , Enfermedad de Moyamoya/diagnóstico , Enfermedad de Moyamoya/cirugía , Japón/epidemiología , Femenino , Masculino , Incidencia , Prevalencia , Adulto , Persona de Mediana Edad , Niño , Adolescente , Adulto Joven , Inhibidores de Agregación Plaquetaria/uso terapéutico , Preescolar , Factores de Tiempo , Anciano , Lactante , Resultado del Tratamiento , Revascularización Cerebral/tendencias , Recién Nacido , Distribución por Edad , Distribución por SexoRESUMEN
INTRODUCTION: Eldecalcitol (ELD) is an active vitamin D3 analog (AVD) commonly used to treat osteoporosis in Japan. Although routine monitoring of serum calcium levels during ELD therapy is recommended, little is known about the actual frequency and determinants of monitoring. MATERIALS AND METHODS: This was a descriptive cohort study using a Japanese electronic medical records database. We identified osteoporosis patients who initiated treatment with ELD or other AVDs (alfacalcidol and calcitriol) between April 1, 2011 and September 10, 2021. The index date for cohort entry was the first prescription date of ELD or other AVDs. The frequency of serum calcium monitoring was evaluated every 6 months. Determinants of serum calcium monitoring were identified using multivariable logistic regression models. We also calculated the incidence of hypercalcemia and the frequency of serum calcium monitoring within 6 months before hypercalcemia. RESULTS: We identified 12,671 ELD users and 7867 other AVD users. Within 6 months after cohort entry, 45.9% of ELD users and 58.7% of other AVD users underwent serum calcium monitoring. Female sex, no use of systemic corticosteroids, moderate-to-good renal function, treatment in smaller hospitals, and treatment in orthopedic surgery departments were associated with a lower likelihood of receiving serum calcium monitoring during ELD therapy. The incidence of hypercalcemia among ELD users was 6.36 per 100 person-years, with 20.6% of cases not receiving serum calcium monitoring before hypercalcemia. CONCLUSION: Our findings suggest that serum calcium monitoring is not given adequate attention during ELD therapy in routine clinical practice.
Asunto(s)
Hipercalcemia , Osteoporosis , Humanos , Femenino , Calcio , Hipercalcemia/tratamiento farmacológico , Hipercalcemia/inducido químicamente , Estudios de Cohortes , Densidad Ósea , Vitamina D , Osteoporosis/tratamiento farmacológico , Osteoporosis/inducido químicamenteRESUMEN
BACKGROUND: Microendoscopic discectomy for lumbar disc herniation has been shown to be as effective as traditional microdiscectomy or open discectomy in terms of clinical outcomes such as pain relief, and it is less invasive. Nevertheless, the reoperation rate for microendoscopic discectomy compared with microdiscectomy or open discectomy remains unclear, possibly due to difficulties in conducting follow-up of sufficient duration and in obtaining information about reoperation in other facilities. QUESTIONS/PURPOSES: (1) What is the rate of reoperation after microendoscopic discectomy for primary lumbar disc herniation on a large scale at a median of 4 years postoperatively? (2) Is there any difference in revision rate at a median of 4 years and within 90 days postoperatively based on surgical method? METHODS: We conducted a retrospective, comparative study of adult patients who underwent microendoscopic discectomy or microdiscectomy or open discectomy for lumbar disc herniation from April 2008 to October 2017 and who were followed until October 2020 using a commercially available administrative claims database from JMDC Inc. This claims-based database provided information on individual patients collected across multiple hospitals, which improved the accuracy of postoperative reoperation rates. We included 3961 patients who received microendoscopic discectomy or microdiscectomy or open discectomy between April 2008 and October 2017 in the JMDC claims database. After applying exclusion criteria, 50% (1968 of 3961) of patients were eligible for this study. Propensity score-weighted analyses were conducted in 646 patients in the microendoscopic discectomy group and in 1322 in the microdiscectomy or open discectomy group, with a median (IQR) of 4 years (3 to 6) of follow-up in both groups. Mean patient age was 42 ± 12 years in the microendoscopic discectomy group and 43 ± 12 years in the microdiscectomy or open discectomy group. Males accounted for 78% (505 of 646) of patients in the microendoscopic discectomy group and 79% (1050 of 1322) of patients in microdiscectomy or open discectomy group. The proportion of patients with diabetes mellitus in the microendoscopic discectomy group (10% [64 of 646]) was less than in the microdiscectomy or open discectomy group (15% [195 of 1322]). The primary outcome was Kaplan-Meier survivorship free from any type of additional lumbar spine surgery at a median of 4 years after the index surgery. The secondary outcome was survival probability using the Kaplan-Meier method with endpoints of any type of reoperation within 90 days after the index surgery. To determine which procedure had the higher revision rate, we conducted propensity score overlap weighting analysis, which controlled for potential confounding variables such as age, sex, comorbidities, and type of hospital as well as Cox proportional hazard models to estimate HRs and 95% confidence intervals (CIs). RESULTS: The 5-year cumulative reoperation rate was 12% (95% CI 9% to 15%) in the microendoscopic discectomy group and 7% (95% CI 6% to 9%) in the microdiscectomy or open discectomy group. After controlling for potentially confounding variables like age, sex, and diabetes mellitus, the microendoscopic discectomy group had a higher reoperation risk than the microdiscectomy or open discectomy group (weighted HR 1.57 [95% CI 1.14 to 2.16]; p = 0.004). Within 90 days of the index surgery, after controlling for potentially confounding variables like age, sex, and diabetes mellitus, we found no difference between the microendoscopic discectomy group and microdiscectomy or open discectomy group in terms of risk of reoperation (weighted HR 1.38 [95% CI 0.68 to 2.79]; p = 0.38). CONCLUSION: Given the higher reoperation risk with microendoscopic discectomy compared with microdiscectomy or open discectomy at a median of 4 years of follow-up, surgeons should select microdiscectomy or open discectomy, despite the current popularity of microendoscopic discectomy. The revision risk of microendoscopic discectomy compared with microdiscectomy or open discectomy in the long term remains unclear. Future large, prospective, multicenter cohort studies with long-term follow-up are needed to confirm the association between microendoscopic discectomy and risk of reoperation. LEVEL OF EVIDENCE: Level â ¢, therapeutic study.
Asunto(s)
Desplazamiento del Disco Intervertebral , Adulto , Masculino , Humanos , Persona de Mediana Edad , Reoperación , Estudios Retrospectivos , Estudios Prospectivos , Resultado del Tratamiento , Vértebras Lumbares/cirugía , Discectomía/métodos , Endoscopía/métodosRESUMEN
BACKGROUND: Although the risk of dental procedures as a cause of bacteremia has been recognized, evidence regarding the association between dental procedures and late periprosthetic joint infection (LPJI) is scarce. We sought to determine whether dental procedures are associated with an increased risk of LPJI. METHODS: The study was conducted under a case-crossover design using a large claims database in Japan. We identified adult patients who had undergone dental procedures and were hospitalized for LPJI between April 2014 and September 2021. Exposure to dental procedures was assessed during a case period of 1-4 weeks, with two control periods of 9-12 weeks and 17-20 weeks, preceding LPJI hospital admission. Conditional logistic regression models were used to calculate the odds ratios (ORs) and 95% confidence intervals (CIs) of LPJI associated with dental procedures in the case period compared with the two control periods. RESULTS: In total, 241 patients with LPJI were included in the case-crossover study. At least one dental procedure was performed in 46 patients (19.1%) in the hazard period and in 75 patients (31.1%) in the control periods. The OR for LPJI with dental procedures was 0.96 (95% CI, 0.61-1.53; p = 0.88). Findings were robust in several sensitivity analyses, including stratification by whether the dental procedure included antibiotic prophylaxis. CONCLUSIONS: This study suggests that dental procedures are not associated with increased risk of LPJI, and will raise questions about the recommendation for antibiotic prophylaxis before dental procedures.
RESUMEN
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.
Asunto(s)
Revisión de Utilización de Seguros , Humanos , Registros Electrónicos de Salud , Japón/epidemiología , Farmacoepidemiología , InvestigaciónRESUMEN
BACKGROUND: Evidence for the risk and incidence of anticonvulsant-induced Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in Japan is scarce. METHODS: We conducted a matched case-control study using a large-scale Japanese claims database. SJS/TEN cases were identified using a claims-based algorithm developed in a previous study (sensitivity 76.9%, specificity 99.0%). Conditional logistic regression with Firth's bias correction to address an issue of rare events was used to estimate odds ratios (ORs) for SJS/TEN for each anticonvulsant use (90 days before the index date) versus non-use. 90-day cumulative incidence of SJS/TEN per 100,000 new users was calculated for 33 anticonvulsants. Causality between anticonvulsant use and SJS/TEN in each exposed case was assessed using the algorithm of drug causality for epidermal necrolysis (ALDEN) score. RESULTS: From 5,114,492 subjects, we selected 71 SJS/TEN cases and 284 controls. We observed significantly increased ORs for SJS/TEN among new users of carbamazepine (OR 68.00) and lamotrigine (OR 36.00) with ALDEN scores of "probable" or higher. Cumulative incidence of SJS/TEN was 93.83 for carbamazepine and 84.33 for lamotrigine. One case newly exposed to phenytoin which developed SJS/TEN was rated "unlikely" in ALDEN causality, resulting in cumulative incidence of 66.27. Cumulative incidence of SJS/TEN was 25.23 for levetiracetam, 7.52 for clonazepam, and 1.23 for diazepam, but their ALDEN scores were "very unlikely". CONCLUSIONS: This study is the first to document the differential risk of SJS/TEN for anticonvulsants in a real-world setting in Japan. Exposure to carbamazepine and lamotrigine was associated with an increased risk of SJS/TEN.
Asunto(s)
Anticonvulsivantes/efectos adversos , Carbamazepina/efectos adversos , Lamotrigina/efectos adversos , Síndrome de Stevens-Johnson/epidemiología , Adulto , Estudios de Casos y Controles , Clonazepam/efectos adversos , Estudios de Cohortes , Diazepam/efectos adversos , Femenino , Humanos , Incidencia , Japón/epidemiología , Levetiracetam/efectos adversos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Fenitoína/efectos adversos , Factores de Riesgo , Síndrome de Stevens-Johnson/etiologíaRESUMEN
BACKGROUND: The Japanese Ministry of Health, Labour and Welfare introduced Specific Health Checkups (SHC) to identify individuals at risk of metabolic syndrome (MS). This study aimed to describe the SHC database developed by the Japan Medical Data Center Co., Ltd. (JMDC) as a means of exploring lifestyle behaviors and lifestyle diseases among working generations. METHODS: We conducted a retrospective, cross-sectional study of employees and their families using the JMDC-SHC database to describe the prevalence of lifestyle behaviors (smoking, exercise, dietary habits, drinking habits, and sleeping) and lifestyle diseases (MS, hypertension, dyslipidemia, and diabetes mellitus). Results were compared with data from the 2015 National Health and Nutrition Survey (NHNS) in Japan as a benchmark. RESULTS: All 646,869 enrollees in the JMDC-SHC database were included, of whom 66.5% were men. Age ranged from 40-74 years. Compared with the results of the NHNS, the JMDC-SHC subjects were younger and had fewer MS components and a lower prevalence of diabetes and hypertension. Subjects in their 40s were most likely to have unhealthy lifestyle behaviors in all age groups (eg, smoking: 41.0% in men and 10.2% in women). The SHC group had more favorable behaviors overall, but underweight was more prevalent in the SHC females. CONCLUSIONS: The JMDC-SHC population showed different lifestyle and lifestyle disease profiles to the NHNS population, probably due to its different age, gender, and employment distributions. Development of healthcare policies and plans for working generations would benefit from the selection of an age- and employment-appropriate database.
Asunto(s)
Bases de Datos Factuales , Planes de Asistencia Médica para Empleados , Estilo de Vida , Síndrome Metabólico/epidemiología , Adulto , Anciano , Consumo de Bebidas Alcohólicas/epidemiología , Estudios Transversales , Diabetes Mellitus/epidemiología , Dislipidemias/epidemiología , Ejercicio Físico , Conducta Alimentaria , Femenino , Humanos , Hipertensión/epidemiología , Japón/epidemiología , Masculino , Persona de Mediana Edad , Encuestas Nutricionales , Prevalencia , Estudios Retrospectivos , Medición de Riesgo , Sueño , Fumar/epidemiologíaRESUMEN
Background: Despite recent evidence of remaining possibility that early initiation of xanthine oxidase inhibitors (XOIs) is beneficial in renoprognosis for patients with stage 2 or less chronic kidney disease (CKD), no evidence is available regarding the difference in renoprognosis based on serum uric acid (sUA) levels at the initiation of XOIs among patients with preserved kidney function. Methods: New XOI initiators were divided into quartiles based on baseline sUA. Primary outcome was the composite incidence of a significant estimated glomerular filtration rate (eGFR) decline (≥40% decline in eGFR from baseline or development of eGFR <30 mL/1.73 m2/min) or all-cause death within 5 years. Results: After excluding inapplicable patients, 1170 XOI initiators were analyzed (mean ± standard deviation age: 68 ± 14.3 years; sUA: 10.6 ± 1.15 mg/dL). On overall median [interquartile range (IQR)] follow-up of 824 (342, 1576) days, incidence rate of the primary outcome was 287 per 1000 person-years for 5 years. Although the nonadjusted model showed a dose-response association between baseline sUA level and the outcome, the adjusted model showed no significant association. Adjusted hazard ratios (95% confidence interval) of the second, third, and fourth quartiles of baseline sUA with the composite outcome within 5 years compared to the first quartile were 1.00 (0.78, 1.29), 1.00 (0.80, 1.30), and 1.02 (0.80, 1.32), respectively. Conclusions: Early initiation of XOIs did not predict a significant benefit on renoprognosis even among the population with preserved kidney function. The validity of initiating XOIs with the aim of improving renoprognosis based on sUA is questionable.
Asunto(s)
Hiperuricemia , Insuficiencia Renal Crónica , Humanos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Ácido Úrico , Xantina Oxidasa , Hiperuricemia/epidemiología , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/tratamiento farmacológico , Tasa de Filtración Glomerular , RiñónRESUMEN
OBJECTIVE: To investigate the association between atomoxetine or methylphenidate use and arrhythmia, heart failure (HF), stroke, and myocardial infarction (MI) in attention-deficit/hyperactivity disorder (ADHD) patients mainly focused on the people of working age. METHODS: In a self-controlled case series study using a Japanese claims database, we identified events of arrhythmia, HF, stroke, and MI among 15,472 atomoxetine new users and 12,059 methylphenidate new users. Adjusted incidence rate ratios (aIRRs) of outcome events were estimated using multivariable conditional Poisson regression. RESULTS: An increased risk of arrhythmia was observed during the first 7 days after the initial atomoxetine exposure (aIRR 6.22, 95% CI [1.90, 20.35]) and in the subsequent exposure (3.23, [1.58, 6.64]). No association was found between methylphenidate exposure and arrhythmia, nor between atomoxetine or methylphenidate exposure and HF. The limited number of stroke and MI cases prevented thorough analysis. CONCLUSIONS: Clinicians should consider monitoring for arrhythmia after patients initiating or re-initiating atomoxetine.
Asunto(s)
Trastorno por Déficit de Atención con Hiperactividad , Estimulantes del Sistema Nervioso Central , Metilfenidato , Accidente Cerebrovascular , Humanos , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Trastorno por Déficit de Atención con Hiperactividad/epidemiología , Trastorno por Déficit de Atención con Hiperactividad/inducido químicamente , Metilfenidato/efectos adversos , Clorhidrato de Atomoxetina/efectos adversos , Japón/epidemiología , Estimulantes del Sistema Nervioso Central/efectos adversos , Arritmias Cardíacas/inducido químicamente , Arritmias Cardíacas/tratamiento farmacológico , Accidente Cerebrovascular/inducido químicamente , Accidente Cerebrovascular/tratamiento farmacológico , Inhibidores de Captación Adrenérgica/efectos adversosRESUMEN
STUDY OBJECTIVES: We evaluated the risk of traumatic injury in patients with narcolepsy compared to the general population. METHODS: We conducted a population-based matched cohort study using a Japanese health insurance claims database. For each patient with narcolepsy, up to 5 individuals from the general population without narcolepsy were matched by variables such as sex, age, and cohort entry month. The primary outcome was traumatic injury, and the secondary outcome was fracture. The study population was followed for up to 5 years from the cohort entry date. We estimated crude incidence rates, adjusted incidence rate differences (aIRDs), adjusted hazard ratios (aHRs), and their 95% confidence intervals (CIs) for study outcomes using crude and multivariable Poisson and Cox regression models. RESULTS: We included 2,451 patients with narcolepsy (mean age, 30.3 years; male, 58.0%) and 10,591 matched individuals (mean age, 30.6 years; male, 58.4%). Crude incidence rate of traumatic injury was 11.4 per 100 person-years for patients with narcolepsy compared with 6.2 per 100 person-years for matched individuals (aIRD, 6.2 excess events per 100 person-years [95% CI, 4.9-7.4]; aHR, 1.8 [95% CI, 1.5-2.2]). Crude incidence rate of fracture was 2.3 per 100 person-years for patients with narcolepsy compared with 1.3 per 100 person-years for matched individuals (aIRD, 1.2 excess events per 100 person-years [95% CI, 0.7-1.7]; aHR, 1.7 [95% CI, 1.4-2.1]). CONCLUSIONS: Narcolepsy was associated with increased risk of traumatic injury. For patients with narcolepsy, optimized approaches to injury prevention should be considered.
RESUMEN
OBJECTIVE: We aimed to describe the following in patients with polymyalgia rheumatica (PMR): (1) real-world glucocorticoid (GC) therapy, (2) improvement in inflammatory parameters associated with disease activity (C-reactive protein [CRP] level and erythrocyte sedimentation rate [ESR]), and (3) incidence of GC-related adverse events (AEs). METHODS: A cohort study was conducted using a Japanese electronic medical records database. We included newly diagnosed PMR patients aged≥50years with baseline CRP levels≥10mg/L and/or ESR>30mm/h and an initial GC dose of≥5mg/day. The outcomes were GC dose, inflammatory parameters, and GC-related AEs. RESULTS: A total of 373 PMR patients (mean age, 77.3 years) were analyzed. The median initial GC dose was 15.0mg/day, which gradually decreased to 3.5mg/day by week 52. The median cumulative GC dose at week 52 was 2455.0mg. The median CRP level on day 0 was 64.3mg/L, which decreased during weeks 4-52 (1.4-3.2mg/L). At week 52, 39.0% of patients had a CRP level>3.0mg/L. The cumulative incidence of GC-related AEs at week 52 was 49.0% for osteoporosis, 30.2% for diabetes, 14.9% for hypertension, 12.2% for peptic ulcer, 11.3% for dyslipidemia, 2.9% for glaucoma, and 4.3% for serious infection. The incidence of osteoporosis and diabetes increased with the GC dose. CONCLUSION: The incidence of GC-related AEs was associated with the GC dose in PMR patients. Further research is required to identify treatment strategies that can effectively control PMR disease activity while minimizing GC use.
Asunto(s)
Glucocorticoides , Polimialgia Reumática , Polimialgia Reumática/sangre , Polimialgia Reumática/tratamiento farmacológico , Glucocorticoides/efectos adversos , Glucocorticoides/uso terapéutico , Resultado del Tratamiento , Proteína C-Reactiva/análisis , Humanos , Masculino , Femenino , Anciano , Anciano de 80 o más Años , Sedimentación Sanguínea , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Incidencia , JapónRESUMEN
This study investigated treatment trends and major adverse events in patients hospitalized for osteoporotic vertebral fracture (OVF). The frequency of surgical interventions for OVF increased significantly, but this did not decrease major adverse events. The findings underscore the necessity for reevaluating OVF management strategies. PURPOSE: 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. METHODS: We conducted a cross-sectional descriptive study, using a large Japanese hospital administrative database. The cohort included hospitalized patients aged 65 years 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 30 days of admission. As a secondary outcome, we evaluated the trend in hospitalization costs. RESULTS: The study cohort consisted of 14,714 patients, with a mean age of 82.4 years. 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). CONCLUSION: 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.
Asunto(s)
Hospitalización , Fracturas Osteoporóticas , Complicaciones Posoperatorias , Fracturas de la Columna Vertebral , Humanos , Masculino , Anciano , Femenino , Anciano de 80 o más Años , Fracturas de la Columna Vertebral/cirugía , Fracturas de la Columna Vertebral/epidemiología , Incidencia , Fracturas Osteoporóticas/cirugía , Fracturas Osteoporóticas/epidemiología , Estudios Transversales , Japón/epidemiología , Hospitalización/estadística & datos numéricos , Complicaciones Posoperatorias/epidemiologíaRESUMEN
BACKGROUND: Understanding the different patterns of adherence to istradefylline treatment is essential to identifying Parkinson's disease (PD) patients who might benefit from targeted interventions. OBJECTIVES: This descriptive study aimed to identify longitudinal istradefylline adherence patterns and to characterize factors associated with them. METHODS: We identified PD patients aged 21-99 years who initiated istradefylline treatment in a Japanese hospital administrative database. Group-based trajectory modeling was used to model the monthly proportion of days covered over time to identify distinct 360-day adherence patterns. Factors associated with each adherence pattern were assessed using univariable multinomial logistic regression models. RESULTS: Of 2088 eligible PD patients, 4 distinct adherence groups were identified: consistently high adherence (56.8%); rapidly declining adherence (25.8%); gradually declining adherence (8.5%); and gradually declining and then recovering adherence (9.0%). Compared to the consistently high adherence group, the other groups had the following characteristics associated with a likelihood of lower adherence: the rapidly declining adherence group received fewer dopamine agonists (63.8% vs. 69.4%), monoamine oxidase B (MAO-B) inhibitors (26.8% vs. 31.6%), and catechol-O-methyl transferase inhibitors (31.6% vs. 37.0%) and had a higher prevalence of anxiety/mood disorders (29.9% vs. 24.6%); the gradually declining adherence group received fewer MAO-B inhibitors (22.5% vs. 31.6%) and amantadine (8.4% vs. 16.1%) and had a higher prevalence of mild cognitive impairment/dementia (27.0% vs. 18.8%); and the declining and then recovering adherence group had a higher prevalence of anxiety/mood disorders (34.2% vs. 24.6%). CONCLUSIONS: Clinicians should be aware of the heterogeneous patterns of adherence to istradefylline.
Asunto(s)
Antiparkinsonianos , Cumplimiento de la Medicación , Enfermedad de Parkinson , Purinas , Humanos , Masculino , Femenino , Enfermedad de Parkinson/tratamiento farmacológico , Persona de Mediana Edad , Anciano , Purinas/uso terapéutico , Cumplimiento de la Medicación/estadística & datos numéricos , Anciano de 80 o más Años , Antiparkinsonianos/uso terapéutico , Adulto , Adulto Joven , Estudios Longitudinales , Japón/epidemiologíaRESUMEN
BACKGROUND: When considering changing hypnotic pharmacotherapy, lemborexant has attracted attention as a candidate due to its effectiveness and safety profile. However, few studies have investigated switching patterns in clinical practice. RESEARCH DESIGN AND METHODS: We conducted a retrospective cohort study using a nationwide claims database. Patients prescribed a single hypnotic who either subsequently switched to (switching cohort) or were additionally prescribed (add-on cohort) lemborexant between July 2020 and December 2021 were identified. Proportion of successful switching was defined as remaining on lemborexant alone or without any hypnotic at six months after lemborexant initiation. RESULTS: Success proportion was 70.1% in the switching cohort (n = 4,861) and 38.6% in the add-on cohort (n = 9,423). In the add-on cohort, success proportion was lower in patients with a hypnotic history of ≥180 days (31.4%) and in patients whose prescribed hypnotic was a benzodiazepine or non-benzodiazepine (31.5% and 37.6%, respectively). CONCLUSION: Proportion of successful switching was higher in patients who switched to lemborexant than in those who added lemborexant as a concomitant treatment. The lower success proportion in the add-on cohort might be related to clinically more severe insomnia, and/or a concomitant prescription of a benzodiazepine or non-benzodiazepine, from which discontinuation may be challenging.
RESUMEN
INTRODUCTION: A safety signal concerning parkinsonism and related movement disorders with gabapentinoids (gabapentin and pregabalin) or tramadol was detected by reviewing individual case reports and data mining in spontaneous report databases. Well-designed pharmacoepidemiological studies are needed to assess the signal. OBJECTIVE: This study aimed to investigate the association of exposure to gabapentinoids or tramadol with the risk of parkinsonism and related movement disorders. METHODS: We conducted a case-crossover study using a Japanese electronic medical records database. Patients with newly diagnosed parkinsonism or related movement disorders between January 1, 2007, and April 14, 2019, were identified. The diagnosis date of outcomes was defined as the index date. We assessed the exposure of each patient to gabapentinoids or tramadol during a 90-day hazard period ending 1 day before the index date and in three 90-day reference periods. Multivariable conditional logistic regression models were employed to estimate adjusted odds ratios (aORs) and 95% confidence intervals (CIs). To confirm the robustness of the primary findings, we also performed sensitivity analyses using a case-case-time-control design, a different time window for hazard and reference periods, a different definition of outcome, and different number of reference periods. RESULTS: A total of 28,972 eligible cases were included in the primary analysis. Exposure to gabapentinoids (aOR, 2.12; 95% CI, 1.73-2.61) and tramadol (aOR, 2.04; 95% CI, 1.57-2.64) was associated with increased risk. Results were consistent across sensitivity analyses. CONCLUSION: Our findings serve as a caution to physicians who prescribe gabapentinoids or tramadol in routine clinical practice.
Asunto(s)
Trastornos Parkinsonianos , Tramadol , Humanos , Tramadol/efectos adversos , Estudios Cruzados , Gabapentina/efectos adversos , Pregabalina/efectos adversos , Trastornos Parkinsonianos/inducido químicamente , Analgésicos Opioides/efectos adversosRESUMEN
BACKGROUND: Evidence is lacking on the association between antibiotic use and risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in Asians. OBJECTIVE: We assessed the risk of SJS/TEN associated with different antibiotic classes in Japanese. METHODS: We conducted a case-crossover study using a claims database. Firth conditional logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) of SJS/TEN associated with antibiotic use in a 56-day hazard period versus 3 control periods. We created 18 cohorts for each antibiotic class and calculated 56-day cumulative incidence per 100,000 new users. The association between antibiotic class and SJS/TEN was also evaluated in each case using the ALgorithm of Drug causality for Epidermal Necrolysis (ALDEN). RESULTS: Our case-crossover study included 170 SJS/TEN cases. Increased ORs were observed for lincomycins (OR, 33.00 [95% CI, 3.74-4332.05]), trimethoprim-sulfamethoxazole (21.20 [6.73-105.98]), penicillins (14.39 [6.95-34.21]), glycopeptides (14.37 [3.17-136.10]), cephalosporins (7.06 [4.25-12.21]), aminoglycosides (6.55 [1.97-26.84]), quinolones (5.98 [3.34-11.20]), fosfomycin (5.40 [1.20-30.97]), carbapenems (5.09 [1.85-15.64]), tetracyclines (4.95 [1.78-15.27]), and macrolides (3.78 [2.13-6.83]). Cumulative incidence of SJS/TEN was 67.4 for trimethoprim-sulfamethoxazole, 86.2 for glycopeptides, and below 10.0 for the others. Despite the high incidence, only 2 cases had a probable causal relationship with glycopeptides. CONCLUSION: Some antibiotic classes, including lincomycins, glycopeptides, aminoglycosides, fosfomycin, and carbapenems, were newly suggested to be associated with risk of SJS/TEN; considered together with the high incidence for trimethoprim-sulfamethoxazole and glycopeptides, these findings warrant caution in clinical practice.
Asunto(s)
Fosfomicina , Síndrome de Stevens-Johnson , Humanos , Síndrome de Stevens-Johnson/epidemiología , Síndrome de Stevens-Johnson/etiología , Antibacterianos/efectos adversos , Estudios Cruzados , Combinación Trimetoprim y Sulfametoxazol , Aminoglicósidos , Carbapenémicos , GlicopéptidosRESUMEN
Objective: We evaluated adherence to and 1-year persistence of two third-generation anti-seizure medications (ASMs), lacosamide and perampanel, in adult patients with focal epilepsy, compared with lamotrigine and levetiracetam. Methods: A cohort study was conducted using a Japanese health insurance claims database (JMDC Inc.). We identified patients with adult-onset focal epilepsy who initiated any of the four ASMs between August 31, 2016, and October 31, 2019. Patients were further classified into ASM-naïve patients initiating any of the four ASMs as first-line treatment, and ASM-experienced patients initiating any of the four ASMs as second- or later-line treatment. Outcomes included adherence (proportion of days covered [PDC], defined as the total number of days covered by ASMs divided by the total number of days in the follow-up period) and 1-year persistence for the four ASMs. Results: We identified 141 lacosamide, 75 perampanel, 80 lamotrigine, and 530 levetiracetam initiators. Among these, the proportion of ASM-naïve patients was highest in the levetiracetam group (60.8%), followed by the lamotrigine (25.0%), lacosamide (20.6%), and perampanel groups (1.3%). Mean PDC (standard deviation) was similar across the four groups, at 0.95 (0.08) for lacosamide, 0.93 (0.12) for perampanel, 0.92 (0.10) for lamotrigine and 0.94 (0.11) for levetiracetam. The proportion of patients persisting with treatment for 1 year was highest in the lacosamide group (73.0%), followed by the levetiracetam (58.3%), lamotrigine (57.5%), and perampanel groups (54.7%). In ASM-naïve patients, adherence and 1-year persistence were almost identical in the lacosamide, lamotrigine, and levetiracetam groups. Results for ASM-experienced patients did not significantly differ from those of all patients. Significance: With regard to adherence and 1-year persistence, lacosamide may be equal to or better than lamotrigine and levetiracetam, especially in patients with experienced ASM, while perampanel may be comparable to lamotrigine and levetiracetam in patients with experienced ASM.