著者

Yugo Yamashita Toshiki Fukasawa Chikashi Takeda Masato Takeuchi Koh Ono Koji Kawakami

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-23-0818, (Released:2023-12-23)

参考文献数

34

被引用文献数

1

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Background: The effectiveness and safety of edoxaban for venous thromboembolism (VTE) in unselected real-world patients have not been fully evaluated.Methods and Results: 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.

著者

Jia GUAN Shiro TANAKA Shuhei YAMADA Izumi SATO Koji KAWAKAMI

出版者

Japanese Society for Pharmacoepidemiology

雑誌

薬剤疫学 (ISSN:13420445)

巻号頁・発行日

pp.25.e2, (Released:2020-07-15)

参考文献数

32

被引用文献数

1 1

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Objective: To describe the treatment patterns and time to next treatment (TTNT) in newly diagnosed multiple myeloma patients (MM) using a large-scale claims database in Japan.Design: Cohort studyMethods: The patients with newly diagnosed MM from 2008 to 2015 were classified into two groups: age <65 years, and age ≥65 years. Specific regimens and general regimens were identified with a complex algorithm considering interval of no therapy, additional and discontinued agents. Correspondingly, TTNT between the first- and second-line were measured among non-transplant patients with Kaplan-Meier method.Results: A total of 425 patients were eligible to participate in the analysis. The most common regimen for the treatment of MM was bortezomib-based regimens (52.9% in the first-line, 28.2% in later lines), followed by melphalan-prednisolone (27.1% in the first-line, 12.9% in later lines) and lenalidomide-based regimens (4.7% in the first-line, 26.1% in later lines). TTNT between the first- and second-line was 11.4 months and was seen to vary greatly with each regimen. A statistically longer TTNT was observed in subgroups of patients aged 65 years or over compared with patients aged younger than 65 years, but no statistical difference was found between conventional therapy and novel therapy.Conclusion: Based on the data from the study, patients with MM were commonly treated with novel agent-based regimens, especially bortezomib-based regimens. Between the first- and second-line therapies a relatively short TTNT was observed, indicating that therapies in clinical practice poorly complied with treatment guidelines.

著者

Fumiko Ono Shiro Tanaka Yoko M. Nakao Koji Kawakami

出版者

日本循環器学会

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-17-0547, (Released:2017-09-07)

参考文献数

23

被引用文献数

8

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Background:The European Society of Cardiology recommends a risk-based antithrombotic strategy for patients with atrial fibrillation (AF) who undergo percutaneous coronary intervention (PCI) based on CHA2DS2-VASc and HAS-BLED scores. However, because it is unclear if that strategy can be generalized to Asians, we aimed to describe antithrombotic therapies among Japanese patients.Methods and Results:Using a nationwide claims database in Japan, this retrospective cohort study identified AF patients who underwent PCI from April 1, 2014 to March 31, 2015. The primary outcome was utilization of anticoagulant and antiplatelet agents before PCI, at discharge, and 6, 9, and 12 months after PCI. The secondary outcome was incidence of stroke after PCI. We identified 10,862 patients and 87.5% of them had high CHA2DS2-VASc and HAS-BLED scores. There were no significant differences in antithrombotic therapies across the risk strata. More than 30% of patients at high risk of thrombosis did not receive oral anticoagulant prescriptions at discharge. The hazard ratio of incidence of stroke in patients with prior stroke compared with patients without prior stroke was 9.09 (95% confidence interval 7.86–10.50, P<0.01).Conclusions:Among Japanese AF patients who underwent PCI, prescriptions for antiplatelet agents were more common than those for anticoagulant agents. The majority of study participants were classified as high risk, suggesting a need for a new risk classification that reflects the risk profiles of Japanese patients.

著者

Aki Kuwauchi Satomi Yoshida Shiro Tanaka Sachiko Tanaka Chikashi Takeda Hiroshi Yonekura Isao Nahara Koji Kawakami

出版者

Society for Clinical Epidemiology

雑誌

Annals of Clinical Epidemiology (ISSN:24344338)

巻号頁・発行日

pp.22011, (Released:2022-03-11)

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BackgroundThe controversy concerning the benefits of pulmonary artery catheter (PAC)-based hemodynamic monitoring in cardiac surgeries has not been adequately addressed. This study aims to compare the all-cause mortality between the PAC with venous oxygen saturation monitoring and the Vigileo/FloTrac (FloTrac) system with central venous oxygen saturation monitoring in cardiac surgeries.MethodsThis nationwide retrospective study includes adult patients who underwent elective cardiac surgeries between April 2010 and October 2014, based on the Japanese health insurance claims database. The main outcome was 30-day all-cause mortality. Propensity scores (PS) were used to adjust for the confounding factors. Treatment effects were estimated using multivariable logistic regression analysis, including PS.ResultsA total of 5,838 patients were included in this study. The crude 30-day mortality rates were 2.4% (8/334) and 1.7% (96/5,504) in the FloTrac and PAC groups, respectively. After PS matching, the ORs for 30-day all-cause mortality, in-hospital mortality after PAC placement (vs. FloTrac) were 0.36 (95% CI: 0.05 – 2.37; p= 0.28) and 0.59 (95% CI: 0.16 – 2.20; p= 0.43), respectively. The amount of dobutamine was larger in the PAC group (281±31 mg vs 155±19 mg; p <0.001). There were no significant differences in the amounts of other inotropes, the volume of fluids, or blood transfusions.ConclusionsThe association between PAC (with venous oxygen saturation monitoring) and mortality in patients who underwent elective cardiac surgeries was unclear compared to FloTrac (with central venous oxygen saturation monitoring). Additional investigation is needed to evaluate the benefits of PAC-specific hemodynamic parameters in this population.

著者

Aki Kuwauchi Satomi Yoshida Chikashi Takeda Yugo Yamashita Takeshi Kimura Masato Takeuchi Koji Kawakami

出版者

Japan Epidemiological Association

雑誌

Journal of Epidemiology (ISSN:09175040)

巻号頁・発行日

pp.JE20220360, (Released:2023-04-22)

参考文献数

27

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BackgroundAcute pulmonary embolism (PE) is a life-threatening in-hospital complication. Recently, several studies have reported the clinical characteristics of PE among Japanese patients using the diagnostic procedure combination (DPC)/per diem payment system database. However, the validity of PE identification algorithms for Japanese administrative data is not yet clear. The purpose of this study was to evaluate the validity of using DPC data to identify acute PE inpatients.MethodsThe reference standard was symptomatic/asymptomatic PE patients included in the COntemporary ManageMent AND outcomes in patients with Venous ThromboEmbolism (COMMAND VTE) registry, which is a cohort study of acute symptomatic venous thromboembolism (VTE) patients in Japan. The validation cohort included all patients discharged from the 6 hospitals included in both the registry and DPC database. The identification algorithms comprised diagnosis, anticoagulation therapy, thrombolysis therapy, and inferior vena cava filter placement. Each algorithm’s sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were estimated.ResultsA total of 43.4% of the validation cohort was female, with a mean age of 67.3 years. The diagnosis-based algorithm showed a sensitivity of 90.2% (222/246, 95% CI; 85.8–93.6), a specificity of 99.8% (228,485/229,027, 95% CI; 99.7–99.8), a PPV of 29.1% (222/764, 95% CI; 25.9–32.4) and an NPV of 99.9% (228,485/229,509, 95% CI; 99.9–99.9) for identifying symptomatic/asymptomatic PE. Additionally, 94.6% (159/168, 95% CI; 90.1–97.5) of symptomatic PE patients were identified by the diagnosis-based algorithm.ConclusionsThe diagnosis-based algorithm may be a relatively sensitive method for identifying acute PE inpatients in the Japanese DPC database.

著者

Satomi YOSHIDA Masato TAKEUCHI Sachiko TANAKA-MIZUNO Kayoko MIZUNO Masayuki NAKASHIMA Toshiki FUKASAWA Koji KAWAKAMI

出版者

The Japan Academy

雑誌

Proceedings of the Japan Academy, Series B (ISSN:03862208)

巻号頁・発行日

vol.98, no.10, pp.517-528, 2022-12-09 (Released:2022-12-09)

参考文献数

104

被引用文献数

7

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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.

著者

Koji KAWAKAMI Kenji KOJIMA Ikuyo MAKINO Ikuo KATO Masaharu ONOUE

出版者

Japanese Association for Laboratory Animal Science

雑誌

Experimental Animals (ISSN:13411357)

巻号頁・発行日

vol.56, no.4, pp.301-307, 2007 (Released:2007-07-27)

参考文献数

23

被引用文献数

7 12

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p-Cresol is a metabolite of aromatic amino acid metabolism produced by intestinal microflora, and its formation is influenced by intestinal conditions. Fasting drastically changes intestinal conditions. However, the effect of fasting on p-cresol production is unclear. In this study, serum and cecal p-cresol levels were determined in non-fasted rats and in rats fasting for either 12 or 18 h. Serum p-cresol increased significantly with 12-h fasting (3.44 ± 2.15 nmol/ml; P<0.05) and 18-h fasting (5.40 ± 2.20; P<0.001) as compared to the level in the non-fasted rats (1.02 ± 0.50). Cecal p-cresol levels of the 12-h fasted (272.6 ± 313.2 nmol/cecum) and 18-h fasted rats (436.6 ± 190.8; P<0.01) were higher than those in non-fasted rats (27.1 ± 21.9). The total cecal protein in content did not change with 18-h fasting. However, the cecal protein concentration increased significantly with fasting (P<0.001), and correlated closely with total cecal p-cresol contents (P<0.001). These results indicate that fasting enhances p-cresol production in the rat cecum, resulting in accumulation of serum p-cresol. We presume that the increase in p-cresol produced by fasting is related to the enhancement of bacterial nitrogen metabolism via an increased concentration of endogenous protein in the cecum.

著者

Tomotsugu Seki Masato Takeuchi Shin Kawasoe Kazufumi Takeuchi Ryusuke Miki Kenji Ueshima Koji Kawakami

出版者

Society for Clinical Epidemiology

雑誌

Annals of Clinical Epidemiology (ISSN:24344338)

巻号頁・発行日

vol.3, no.1, pp.10-26, 2021 (Released:2021-01-07)

参考文献数

32

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BACKGROUNDSurvival benefit of outpatient cardiac rehabilitation (CR) after acute myocardial infarction (AMI) has recently been contested under the current real-world clinical practice. We investigated whether outpatient CR was associated with lower mortality and morbidity risks among Japanese AMI patients.METHODSWe analyzed patients who were admitted for AMI and received both percutaneous coronary intervention and inpatient CR from January 2011 to December 2014, using a nationwide administrative database in Japan (final date of follow-up: July 31, 2016). We compared patients who received outpatient CR and who did not, and the primary outcome was a composite of all-cause death and recurrence of AMI after the landmark time-point of day 180 after discharge. We applied Cox proportional hazards model to estimate outcomes, and propensity-score matching was applied to adjust for baseline imbalances.RESULTSA total of 5,654 patients (mean [SD] age, 66.8 [12.4] years; 21.2% female; median follow-up period [IQR] 1.44 [0.87, 2.27] years), 730 (12.9%) participated in outpatient CR at least once within 180 days of discharge. Of 1,458 propensity-score matched patients, outpatient CR participation was associated with lower but statistically non-significant risks among the primary outcome (1.38 vs. 2.12 per 100 patient-years; HR = 0.71; 95%CI, 0.32 to 1.61).CONCLUSIONSAmong Japanese patients who admitted for AMI and received both percutaneous coronary intervention and inpatient CR, outpatient CR was underutilized, and associated with a statistically non-significant mortality and morbidity benefits. Further study is necessary to reaffirm the real-world effectiveness of outpatient CR under the current real-world clinical practice.

著者

Shinako Inaida Kousuke Kanemoto Shiro Tanaka Yoko Gouji Tomohiro Oshima Riki Matsumoto Akio Ikeda Koji Kawakami

出版者

JAPAN EPILEPSY SOCIETY

雑誌

Epilepsy & Seizure (ISSN:18825567)

巻号頁・発行日

vol.10, no.1, pp.73-86, 2018 (Released:2018-09-08)

参考文献数

35

被引用文献数

3

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Purpose: Psychogenic non-epileptic seizures (PNES) are psychogenic disorders that often resemble epileptic seizures. Herein, we describe the recent clinical trends of PNES by using the data from a large, claims-based Japanese database obtained from the Japan Medical Data Center.Methods: A 10-year epidemiological study of patients of all ages with newly diagnosed PNES was conducted. Data were extracted using the International Classification of Diseases 10th Revision (ICD-10) diagnostic codes. Prevalence in new epilepsy patients and period of the diagnostic delay of PNES after epilepsy diagnosis were retrieved from the data. The study endpoint was change in frequency of hospital visits. Data of 413 patients with PNES were retrieved using the criterion of “PNES diagnosis after epilepsy diagnosis.”Results: The highest PNES prevalence in new epilepsy patients was observed in the 40-49 year age group (4.3%) for males, and in the 30-39 age group (4.9%) for females. The ratio of the prevalence in males to that in females was 1:2 for 0-9, 10-19, and >60 age groups, and 1:1 for the other age groups. A significant and positive correlation was found between the frequency of hospital visits and duration of the diagnostic delay of PNES. After PNES diagnosis, the average number of monthly hospital visits decreased over time.Discussion: The differences in the duration of diagnostic delay of PNES among cases and also a decrease in the frequency of hospital visits after PNES diagnosis highlight the importance of early differentiation between epilepsy and PNES.

著者

Shin Kawasoe Kazuki Ide Tomoko Usui Takuro Kubozono Shiro Yoshifuku Hironori Miyahara Shigeho Maenohara Mitsuru Ohishi Koji Kawakami

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-18-0607, (Released:2018-09-27)

参考文献数

26

被引用文献数

7

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Background: The independent role of serum triglyceride (TG) levels as a cardiovascular risk factor is still not elucidated. We aimed to investigate if the effect of TG on arterial stiffness is influenced by the serum level of low-density lipoprotein cholesterol (LDL-C). Methods and Results: We studied 11,640 subjects who underwent health checkups. They were stratified into 4 groups according to LDL-C level (≤79, 80–119, 120–159, and ≥160 mg/dL). Arterial stiffness was evaluated by brachial-ankle pulse wave velocity (baPWV). In each group, univariate and multivariete logistic regression analyses were performed to investigate the association between high TG (≥150 mg/dL) and high baPWV (>1,400 cm/s). In the univarite analysis, high TG was significantly associated with high baPWV in LDL-C <79 mg/dL (OR, 3.611, 95% CI, 2.475–5.337; P<0.0001) and 80–119 mg/dL (OR, 1.881; 95% CI, 1.602–2.210; P<0.0001), but not in LDL-C 120–159 mg/dL and ≥160 mg/dL. In the multivariate analysis, high TG was significantly associated with high baPWV in LDL-C ≤79 mg/dL (OR, 2.558; 95% CI, 1.348–4.914; P=0.0040) and LDL-C 80–119 mg/dL (OR, 1.677; 95% CI, 1.315–2.140; P<0.0001), but not in LDL-C 120–159 mg/dL and ≥160 mg/dL. Conclusions: High TG and increased arterial stiffness showed an independent relationship in a Japanese general population with LDL-C ≤119 mg/dL. TG-lowering therapy might be an additional therapeutic consideration in these subjects.