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

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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.

著者

Daisuke Sueta Eiichiro Yamamoto Hiroki Usuku Satoru Suzuki Taishi Nakamura Kunihiko Matsui Takaaki Akasaka Kazuhito Shiosakai Kotaro Sugimoto Kenichi Tsujita on behalf of the ESES-LVH Study Investigators

出版者

The Japanese Circulation Society

雑誌

Circulation Reports (ISSN:24340790)

巻号頁・発行日

vol.4, no.2, pp.99-104, 2022-02-10 (Released:2022-02-10)

参考文献数

16

被引用文献数

2

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Background:The complication of left ventricular (LV) hypertrophy (LVH) is associated with increased incidence of major cardiovascular events. Hypertension is an independent risk factor among several factors contributing to the development of LVH, and thus appropriate treatment of both hypertension and LVH reduces the risk of developing heart failure. Mineralocorticoid-receptor blockers (MRBs) have been reported to improve the prognosis of LVH, but use of currently available MRBs is limited by adverse events. Esaxerenone is a novel selective nonsteroidal MRB recently approved for treatment of hypertension. Although the renoprotective effect of esaxerenone has been demonstrated in both preclinical and clinical studies, little data is available in terms of its cardioprotective effects.Methods and Results:This multicenter, open-label, exploratory interventional study was designed to evaluate the safety and efficacy of esaxerenone in combination with renin-angiotensin system (RAS) inhibitors or calcium-channel blockers (CCBs). Eligible criteria are hypertensive patients with LVH, and target blood pressure (BP) not reached with an RAS inhibitor or a CCB. The primary endpoints are change from baseline in seated home BP (early morning systolic/diastolic BPs), and change and %change from baseline in the LV mass index at the end of treatment.Conclusions:This study will provide the first clinical evidence of the antihypertensive effect and safety of esaxerenone in hypertensive patients with LVH.

著者

Masato Nakamura Ken Kozuma Takanari Kitazono Tomoko Iizuka Toru Sekine Kazuhito Shiosakai Isao Usui Seiji Kogure

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-18-0956, (Released:2019-01-24)

参考文献数

19

被引用文献数

10

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Background: A unique dose of prasugrel has been approved exclusively for Japanese patients, but real-world data for prasugrel at that dose in patients with ischemic heart disease (IHD) are limited. Therefore, large-scale, real-world data are needed. Methods and Results: A 2-year observational study of Japanese patients with IHD undergoing percutaneous coronary intervention and being treated with prasugrel to evaluate safety and effectiveness. This report is an interim analysis of data from case report forms (CRFs) after 3 months. CRFs were collected from 4,270 patients, 4,157 of whom were eligible for the safety and effectiveness analysis sets (mean age, 68.3 years; male, 76.5%). The median treatment period was 112 days, and 92.3% of patients continued treatment with prasugrel. The incidence of non-coronary artery bypass grafting-related bleeding adverse events (AEs) was 3.1%, of which Thrombolysis in Myocardial Infarction (TIMI) major and minor bleeding accounted for 0.5% and 0.6%, respectively. The most common bleeding AEs were gastrointestinal disorders, which accounted for 43.2% of the sum of “TIMI major and minor bleeding AEs”. The incidence of major adverse cardiovascular events (MACE) was 1.0%, and the cumulative incidence of MACE was 1.4%. The incidence of stent thrombosis was 0.2%. Conclusions: Interim study results indicated that prasugrel was safe and effective during the early phase of treatment in Japanese patients with IHD in real-world clinical settings.

著者

Masato Nakamura Takanari Kitazono Ken Kozuma Toru Sekine Shinya Nakamura Kazuhito Shiosakai Ayumi Tanabe Tomoko Iizuka

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

vol.84, no.11, pp.1981-1989, 2020-10-23 (Released:2020-10-23)

参考文献数

20

被引用文献数

4

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Background:PRASFIT-Practice II is a postmarketing observational study conducted in 4,155 Japanese patients with ischemic heart disease (IHD) who received long-term prasugrel. The data were used to assess the utility of Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria.Methods and Results:Patients in PRASFIT-practice II were clinically followed for 2 years. The primary endpoint was the cumulative incidence of major adverse cardiovascular events (MACE) and Thrombolysis in Myocardial Infarction (TIMI) major/minor bleeding. Patients were divided into 2 groups based on ARC-HBR criteria (HBR (40.1% of patients) and non-HBR (59.9%)) and the effect of HBR on the primary endpoint was assessed. The median duration of dual antiplatelet therapy with prasugrel was 391.0 days. At 2 years, the cumulative incidence of MACE was 3.3%, and of TIMI major/minor bleeding was 2.7%. At 1 year, MACE and TIMI major/minor bleeding in the HBR group (4.0% and 3.4%, respectively) were higher than that in the non-HBR group (1.3% for both). Landmark analysis at 3 months and 1 year showed that the higher risk of MACE or TIMI major/minor bleeding in the HBR group persisted through 2 years.Conclusions:The results of this study confirmed the safety and effectiveness of long-term treatment with prasugrel, and demonstrated that the ARC-HBR criteria for bleeding risk are applicable in Japanese IHD patients treated with prasugrel.