文献一覧: Norikazu Yamada (著者)

47 0 0 0 OA Mortality-associated Risk Factors in Hospitalized COVID-19 Patients in Japan: Findings of the CLOT-COVID Study

著者: Makoto Takeyama Sen Yachi Yuji Nishimoto Ichizo Tsujino Junichi Nakamura Naoto Yamamoto Hiroko Nakata Satoshi Ikeda Michihisa Umetsu Shizu Aikawa Hiroya Hayashi Hirono Satokawa Yoshinori Okuno Eriko Iwata Yoshito Ogihara Nobutaka Ikeda Akane Kondo Takehisa Iwai Norikazu Yamada Tomohiro Ogawa Takao Kobayashi Makoto Mo Yugo Yamashita
出版者: Japan Epidemiological Association
雑誌: Journal of Epidemiology (ISSN:09175040)
巻号頁・発行日: pp.JE20220201, (Released:2022-11-12)
参考文献数: 53
被引用文献数: 2 2

Background: Reports of mortality-associated risk factors in patients with the novel coronavirus disease 2019 (COVID-19) are limited.Methods: We evaluated the clinical features that were associated with mortality among patients who died during hospitalization (n = 158) and those who were alive at discharge (n = 2,736) from the large-scale, multicenter, retrospective, observational cohort CLOT-COVID study, which enrolled consecutively hospitalized COVID-19 patients from 16 centers in Japan from April to September 2021. Data from 2,894 hospitalized COVID-19 participants of the CLOT-COVID study were analyzed in this study.Results: Patients who died were older (71.1 years vs 51.6 years, P < 0.001), had higher median D-dimer values on admission (1.7 µg/mL vs 0.8 µg/mL, P < 0.001), and had more comorbidities. On admission, the patients who died had more severe COVID-19 than did those who survived (mild: 16% vs 63%, moderate: 47% vs 31%, and severe: 37% vs 6.2%, P < 0.001). In patients who died, the incidence of thrombosis and major bleeding during hospitalization was significantly higher than that in those who survived (thrombosis: 8.2% vs 1.5%, P < 0.001; major bleeding: 12.7% vs 1.4%, P < 0.001). Multivariable logistic regression analysis revealed that age >70 years, high D-dimer values on admission, heart disease, active cancer, higher COVID-19 severity on admission, and development of major bleeding during hospitalization were independently associated with a higher mortality risk.Conclusion: This large-scale observational study in Japan identified several independent risk factors for mortality in hospitalized patients with COVID-19 that could facilitate appropriate risk stratification of patients with COVID-19.

2023-11-10 01:08:36
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5 0 0 0 OA Safety and Effectiveness of Edoxaban in Japanese Venous Thromboembolism Patients ― Final Analysis of One-Year Follow-up Data From a Japanese Postmarketing Observational Study (ETNA-VTE-Japan) ―

著者: Mashio Nakamura Norikazu Yamada Tomohiko Asamura Kazuhito Shiosakai Kazuhiro Uchino
出版者: The Japanese Circulation Society
雑誌: Circulation Reports (ISSN:24340790)
巻号頁・発行日: vol.2, no.3, pp.192-202, 2020-03-10 (Released:2020-03-10)
参考文献数: 24
被引用文献数: 10 11

Background:ETNA-VTE-Japan is a prospective, observational study conducted as part of a postmarketing study regarding the safety and effectiveness of edoxaban in Japanese patients with venous thromboembolism (VTE). The results of the final analysis of data collected at 1 year are presented.Methods and Results:A total of 1,732 patients were included in this study. The safety and effectiveness were evaluated in 1,702 patients (safety analysis set; SAS) and in 1,698 patients (effectiveness analysis set). In the SAS, 39.4% of patients were aged ≥75 years, 58.2% had body weight ≤60 kg, and 22.2% had creatinine clearance <50 mL/min. Approximately 90% of patients received a dose recommended on the package insert. A total of 46.1% of patients continued treatment for 1 year, with mean and median treatment periods of 235.8 and 263.0 days, respectively. The incidence of bleeding adverse events (AE) was 10.3%; major bleeding, 2.6%; and VTE recurrence, 1.8%. The risk factor commonly associated with bleeding AE and VTE recurrence was cancer. The safety and effectiveness profiles of edoxaban in patients receiving the appropriate low dose (30 mg/day), generally used in patients with high bleeding risk, were similar to those for the appropriate standard dose (60 mg/day).Conclusions:At 1 year of treatment, there were no major concerns regarding the safety and effectiveness of edoxaban in Japanese patients with VTE.

2023-07-08 20:33:27
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3 0 0 0 OA Efficacy and Safety of Warfarin for the Treatment of Venous Thromboembolism ― A Multicenter Prospective Observational Cohort Study in Japan (AKAFUJI Study) ―

著者: Mashio Nakamura Satoshi Tamaru Shigeki Hirooka Atsushi Hirayama Akihiro Tsuji Mitsuhiro Hirata Mitsuru Munemasa Izumi Nakagawa Masahiro Toshima Hiroaki Shimokawa Yuki Nishimura Toru Ogura Takeshi Yamamoto Hirono Satokawa Toru Obayashi Norikazu Yamada on behalf of the AKAFUJI Study Investigators
出版者: The Japanese Circulation Society
雑誌: Circulation Journal (ISSN:13469843)
巻号頁・発行日: pp.CJ-23-0158, (Released:2023-06-30)
参考文献数: 16
被引用文献数: 1

Background: A large-scale prospective study of the efficacy and safety of warfarin for the treatment of venous thromboembolism (VTE) has not been conducted in Japan. Therefore, we conducted a real-world prospective multicenter observational cohort study (AKAFUJI Study; UMIN000014132) to investigate the efficacy and safety of warfarin for VTE.Methods and Results: Between May 2014 and March 2017, 352 patients (mean [±SD] age 67.7±14.8 years; 57% female) with acute symptomatic/asymptomatic VTE were enrolled; 284 were treated with warfarin. The cumulative incidence of recurrent symptomatic VTE was higher in patients without warfarin than in those treated with warfarin (8.7 vs. 2.2 per 100 person-years, respectively; P=0.018). The cumulative incidence of bleeding complications was not significantly different between the 2 groups. The mean prothrombin time-international normalized ratio (PT-INR) during warfarin on-treatment was <1.5 in 180 patients, 1.5–2.5 in 97 patients, and >2.5 in 6 patients. The incidence of bleeding complications was significantly higher in patients with PT-INR >2.5, whereas the incidence of recurrent VTE was not significantly different between the 3 PT-INR groups. The cumulative incidence of recurrent VTE and bleeding complications did not differ significantly among those in whom VTE was provoked by a transient risk factor, was unprovoked, or was associated with cancer.Conclusions: Warfarin therapy with an appropriate PT-INR according to Japanese guidelines is effective without increasing bleeding complications, regardless of patient characteristics.

2023-07-01 06:01:16
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2 0 0 0 OA Safety Profile and Effectiveness of Rivaroxaban for Patients With Venous Thromboembolism in Japan ― Results From Post-Marketing Surveillance (XASSENT) ―

著者: Ikuo Fukuda Atsushi Hirayama Kazuo Kawasugi Takao Kobayashi Hideaki Maeda Mashio Nakamura Norikazu Yamada Tsubasa Tajima Michiya Tachiiri Yutaka Okayama Toshiyuki Sunaya Kazufumi Hirano Takanori Hayasaki
出版者: The Japanese Circulation Society
雑誌: Circulation Journal (ISSN:13469843)
巻号頁・発行日: pp.CJ-23-0104, (Released:2023-05-27)
参考文献数: 20
被引用文献数: 1

Background: The incidence of venous thromboembolism (VTE; pulmonary embolism [PE] and/or deep vein thrombosis [DVT]) in Japan is increasing, but relatively small numbers of patients from Japan have been included in studies investigating rivaroxaban (a direct factor Xa inhibitor) for the treatment of VTE and preventing its recurrence.Methods and Results: An open-label, prospective, observational study (XASSENT [NCT02558465]) investigated the safety profile and effectiveness of rivaroxaban for ≤2 years in the treatment of VTE and prevention of its recurrence in Japanese clinical practice. Primary outcomes were major bleeding and symptomatic recurrent VTE. Statistical analyses were exploratory and descriptive. Overall, 2,540 patients were enrolled (safety analysis population [SAP], n=2,387; effectiveness analysis population [EAP], n=2,386). In the SAP, >80% of patients received the approved rivaroxaban dose, the mean (standard deviation) age was 66.6 (15.0) years, ≈74% were >50 kg, and 43% had a creatinine clearance ≥80 mL/min. PE+DVT, PE only, and DVT only were reported in 42%, 8%, and 50% of patients, respectively, and active cancer in 17% of patients. Major bleeding was reported in 69 patients (2.89%; 3.60%/patient-year; SAP) and symptomatic PE/DVT recurrence in 26 patients (1.09%; 1.36%/patient-year; EAP) during the treatment period.Conclusions: XASSENT provided information on the expected proportions of bleeding and VTE recurrence during rivaroxaban treatment in Japanese clinical practice; no new concerns of safety or effectiveness were found.

2023-05-29 19:02:42
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2 0 0 0 OA Incidence and Clinical Features of Venous Thromboembolism in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19) in Japan

著者: Yugo Yamashita Yuuki Maruyama Hirono Satokawa Yuji Nishimoto Ichizo Tsujino Hideki Sakashita Hiroko Nakata Yoshinori Okuno Yoshito Ogihara Sen Yachi Naoki Toya Masami Shingaki Satoshi Ikeda Naoto Yamamoto Shizu Aikawa Nobutaka Ikeda Hiroya Hayashi Shingo Ishiguro Eriko Iwata Michihisa Umetsu Akane Kondo Takehisa Iwai Takao Kobayashi Makoto Mo Norikazu Yamada on behalf of the Taskforce of VTE and COVID-19 in Japan Study
出版者: The Japanese Circulation Society
雑誌: Circulation Journal (ISSN:13469843)
巻号頁・発行日: pp.CJ-21-0169, (Released:2021-05-20)
参考文献数: 33
被引用文献数: 30

Background:Coronavirus disease 2019 (COVID-19) reportedly causes venous thromboembolism (VTE), but the status of this complication in Japan was unclear.Methods and Results:The VTE and COVID-19 in Japan Study is a retrospective, multicenter cohort study enrolling hospitalized patients with COVID-19 who were evaluated with contrast-enhanced computed tomography (CT) examination at 22 centers in Japan between March 2020 and October 2020. Among 1,236 patients with COVID-19, 45 (3.6%) were evaluated with contrast-enhanced CT examination. VTE events occurred in 10 patients (22.2%), and the incidence of VTE in mild, moderate, and severe COVID-19 was 0%, 11.8%, and 40.0%, respectively. COVID-19 patients with VTE showed a higher body weight (81.6 vs. 64.0 kg, P=0.005) and body mass index (26.9 vs. 23.2 kg/m2, P=0.04), and a higher proportion had a severe status for COVID-19 compared with those without. There was no significant difference in the proportion of patients alive at discharge between patients with and without VTE (80.0% vs. 88.6%, P=0.48). Among 8 pulmonary embolism (PE) patients, all were low-risk PE.Conclusions:Among a relatively small number of patients undergoing contrast-enhanced CT examination in Japanese real-world clinical practice, there were no VTE patients among those with mild COVID-19, but the incidence of VTE seemed to be relatively high among severe COVID-19 patients, although all PE events were low-risk without significant effect on mortality risk.

2021-06-08 06:42:17
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1 0 0 0 OA Mortality-associated Risk Factors in Hospitalized COVID-19 Patients in Japan: Findings of the CLOT-COVID Study

著者: Makoto Takeyama Sen Yachi Yuji Nishimoto Ichizo Tsujino Junichi Nakamura Naoto Yamamoto Hiroko Nakata Satoshi Ikeda Michihisa Umetsu Shizu Aikawa Hiroya Hayashi Hirono Satokawa Yoshinori Okuno Eriko Iwata Yoshito Ogihara Nobutaka Ikeda Akane Kondo Takehisa Iwai Norikazu Yamada Tomohiro Ogawa Takao Kobayashi Makoto Mo Yugo Yamashita
出版者: Japan Epidemiological Association
雑誌: Journal of Epidemiology (ISSN:09175040)
巻号頁・発行日: vol.33, no.3, pp.150-157, 2023-03-05 (Released:2023-03-05)
参考文献数: 53
被引用文献数: 2

2023-03-24 12:03:03
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1 0 0 0 OA Effect of Sitagliptin on Coronary Flow Reserve Assessed by Magnetic Resonance Imaging in Type 2 Diabetic Patients With Coronary Artery Disease

著者: Keishi Moriwaki Tetsushiro Takeuchi Naoki Fujimoto Toshiki Sawai Yuichi Sato Naoto Kumagai Jun Masuda Shiro Nakamori Masaki Ishida Norikazu Yamada Mashio Nakamura Hajime Sakuma Masaaki Ito Kaoru Dohi
出版者: The Japanese Circulation Society
雑誌: Circulation Journal (ISSN:13469843)
巻号頁・発行日: pp.CJ-18-0083, (Released:2018-05-12)
参考文献数: 36
被引用文献数: 5

Background:The present study was conducted to assess the cardiovascular effects of dipeptidyl peptidase-4 inhibitors (DPP4i) on coronary flow reserve (CFR), left ventricular (LV) function and endothelial function of the peripheral artery by comparison with those of α-glucosidase inhibitors (αGI) in patients with type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD).Methods and Results:We randomly assigned 30 patients with T2DM and CAD to receive either sitagliptin or voglibose, and 28 patients (age 69±9 years, 75% male, hemoglobin A1c [HbA1c] 6.62±0.48%) completed the study (14 in each group). CFR and LV function, assessed by cardiac magnetic resonance imaging, and endothelial function, assessed by reactive hyperemia peripheral arterial tonometry (RH-PAT), were measured at baseline and 24 weeks after treatment. Clinical and laboratory parameters, including HbA1c level, plasma active glucagon-like peptide-1 concentrations, and biomarkers of inflammation, were unchanged in both groups after 24 weeks of treatment. CFR were unchanged in both the αGI group (3.01±0.98 at baseline and 3.06±0.8 after treatment, P=NS) and the DPP4i group (4.29±2.04 at baseline and 3.63±1.31 after treatment, P=NS), with no interaction effect. LV functional parameters and the reactive hyperemia index also remained unchanged after the 24-week treatment.Conclusions:DPP4i did not improve CFR, LV function or endothelial function of the peripheral artery in patients with relatively well-controlled T2DM and CAD.

2018-05-15 21:26:45
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1 0 0 0 OA A Phase III, Multicenter, Collaborative, Open-Label Clinical Trial of Sildenafil in Japanese Patients With Pulmonary Arterial Hypertension

著者: Tohru Satoh Tsutomu Saji Hiroshi Watanabe Satoshi Ogawa Kazuhiko Takehara Nobuhiro Tanabe Norikazu Yamada Atsushi Yao Katsumasa Miyaji Norifumi Nakanishi Yumiko Suzuki Tadami Fujiwara Takayuki Kuriyama
出版者: The Japanese Circulation Society
雑誌: Circulation Journal (ISSN:13469843)
巻号頁・発行日: vol.75, no.3, pp.677-682, 2011 (Released:2011-02-25)
参考文献数: 28
被引用文献数: 13 11

Background: There is evidence that phosphodiesterase type-5 is effective for the treatment of pulmonary arterial hypertension (PAH). Methods and Results: A phase III, multicenter, open-label clinical trial of sildenafil 20mg t.i.d. was conducted in 21 Japanese patients with PAH to examine its efficacy, safety, and pharmacokinetics. The present trial consisted of a screening period and 12-week treatment. Patients who were enrolled in the present trial increased their 6-min walking distance of administration increased at week 12 by 84.2m from baseline. Hemodynamic parameters (eg, mean pulmonary artery pressure and pulmonary vascular resistance), Borg dyspnea scores, and plasma brain natriuretic peptide concentrations also improved compared to baseline. Most patients improved or sustained WHO functional class. Seven subjects, who were examined for the pharmacokinetics of sildefanil, showed relatively large interindividual variations in the Cmax, AUC0-8, Css,av, and Ctrough of the drug. Any serious adverse events, severe adverse events, and deaths were not observed. Most of events of undeniable causality were mild or moderate in severity. Sildefanil was well tolerated by the subjects. Conclusions: Sildenafil 20mg t.i.d. was effective and safe for Japanese patients with PAH. (Circ J 2011; 75: 677-682)

2011-02-28 00:06:04
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