文献一覧: Ichiro Sakuma (著者)

9 0 0 0 OA Controversies in the 2017 ACC/AHA Hypertension Guidelines: Who Can Be Eligible for Treatments Under the New Guidelines? ― An Asian Perspective ―

著者: Sang-Hyun Ihm George Bakris Ichiro Sakuma Il Suk Sohn Kwang Kon Koh
出版者: The Japanese Circulation Society
雑誌: Circulation Journal (ISSN:13469843)
巻号頁・発行日: pp.CJ-18-1293, (Released:2018-12-29)
参考文献数: 58
被引用文献数: 19

Until the 2017 ACC/AHA Hypertension Guidelines were released, the target blood pressure (BP) for adults with hypertension (HTN) was 140/90 mmHg in most of the guidelines. The new 2018 ESC/ESH, Canadian, Korean, Japan, and Latin American hypertension guidelines have maintained the <140/90 mmHg for the primary target in the general population and encourage reduction to <130/80 if higher risk. This is more in keeping with the 2018 American Diabetes Association guidelines. However, the 2017 ACC/AHA guidelines classify HTN as BP ≥130/80 mmHg and generally recommend target BP levels below 130/80 mmHg for hypertensive patients independently of comorbid disease or age. Although the new guidelines mean that more people (nearly 50% of adults) will be diagnosed with HTN, the cornerstone of therapy is still lifestyle management unless BP cannot be lowered to this level; thus, more people will require BP-lowering medications. To date, there have been many controversies about the definition of HTN and the target BP. Targeting an intensive systolic BP goal can increase the adverse effects of multiple medications and the cardiovascular disease risk by excessively lowering diastolic BP, especially in patients with high risk, including those with diabetes, chronic kidney disease, heart failure, and coronary artery disease, and the elderly. In this review, we discuss these issues, particularly regarding the optimal target BP.

2019-01-23 13:34:38
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7 0 0 0 OA Regulatory Science on AI-based Medical Devices and Systems

著者: Kiyoyuki Chinzei Akinobu Shimizu Kensaku Mori Kanako Harada Hideaki Takeda Makoto Hashizume Mayumi Ishizuka Nobumasa Kato Ryuzo Kawamori Shunei Kyo Kyosuke Nagata Takashi Yamane Ichiro Sakuma Kazuhiko Ohe Mamoru Mitsuishi
出版者: Japanese Society for Medical and Biological Engineering
雑誌: Advanced Biomedical Engineering (ISSN:21875219)
巻号頁・発行日: vol.7, pp.118-123, 2018 (Released:2018-05-24)
参考文献数: 3
被引用文献数: 30

AI-based medical and healthcare devices and systems have unique characteristics including 1) plasticity causing changes in system performance through learning, and need of creating new concepts about the timing of learning and assignment of responsibilities for risk management; 2) unpredictability of system behavior in response to unknown inputs due to the black box characteristics precluding deductive output prediction; and 3) need of assuring the characteristics of datasets to be used for learning and evaluation. The Subcommittee on Artificial Intelligence and its Applications in Medical Field of the Science Board, the Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan, examined “new elements specific to AI” not included in conventional technologies, thereby clarifying the characteristics and risks of AI-based technologies. This paper summarizes the characteristics and clinical positioning of AI medical systems and their applications from the viewpoint of regulatory science, and presents the issues related to the characteristics and reliability of data sets in machine learning.

2018-05-30 15:43:19
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4 0 0 0 OA Risk Profile and 1-Year Outcome of Newly Diagnosed Atrial Fibrillation in Japan ― Insights From GARFIELD-AF ―

著者: Yukihiro Koretsune Takuma Etoh Yousuke Katsuda Tetsuro Suetsugu Kenshi Kumeda Ichiro Sakuma Kenichi Eshima Mitsuhiro Shibuya Shin-ichi Ando Naoto Yokota Shinya Goto Karen S. Pieper Jagan Allu Ajay K. Kakkar for the GARFIELD-AF Investigators
出版者: The Japanese Circulation Society
雑誌: Circulation Journal (ISSN:13469843)
巻号頁・発行日: pp.CJ-18-0655, (Released:2018-12-04)
参考文献数: 20
被引用文献数: 11

Background: Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective non-interventional study of stroke prevention in patients with newly diagnosed non-valvular AF (NAVF) that is being conducted in 35 countries. Methods and Results: A total of 52,081 patients with a new diagnosis of NVAF were enrolled prospectively in GARFIELD-AF. Of these, 4859 (9.3%) were recruited in Japan (2010–2016). In cohort 1 (2010–2011), few patients were on non-vitamin K antagonist oral anticoagulants (NOAC) globally. From cohort 2 onwards (2011–2016), however, there was a rapid increase in NOAC use around the globe, especially in Japan. By the last year of enrolment (2015–2016), 67.9% of patients in Japan and 43.1% of patients globally were on NOAC±antiplatelet therapy (AP). In Japan and globally, 17.0% and 12.2% of patients, respectively, did not receive stroke prevention treatment. Few patients in Japan (5.7%) received AP only. Compared with the other countries, the unadjusted rates of all-cause mortality and major bleeding were low, while rates of stroke/systemic embolism were similar after 1 year of follow-up. Conclusions: GARFIELD-AF continues to provide important information on the homogeneity and heterogeneity of baseline characteristics and treatment patterns in patients with newly diagnosed NVAF. This diversity reflects the differences in outcomes in Japan compared with the rest of the world.

2019-03-04 02:16:16
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3 0 0 0 OA Residual Coronary Risk Factors Associated With Long-Term Clinical Outcomes in Patients With Coronary Artery Disease Treated With High- vs. Low-Dose Statin Therapy ― REAL-CAD Substudy ―

著者: Takumi Higuma Yoshihiro J. Akashi Yoshihiro Fukumoto Hitoshi Obara Tatsuyuki Kakuma Yasuhide Asaumi Satoshi Yasuda Ichiro Sakuma Hiroyuki Daida Hiroaki Shimokawa Takeshi Kimura Satoshi Iimuro Ryozo Nagai
出版者: The Japanese Circulation Society
雑誌: Circulation Journal (ISSN:13469843)
巻号頁・発行日: pp.CJ-23-0134, (Released:2023-07-21)
参考文献数: 31
被引用文献数: 1

Background: It remains unclear which comorbidities, other than lipid parameters, or combination of comorbidities, best predicts cardiovascular events in patients with known coronary artery disease (CAD) treated with statins. Therefore, we aimed to identify the nonlipid-related prognostic factors and risk stratification of patients with stable CAD enrolled in the REAL-CAD study.Methods and Results: Blood pressure, glucose level, and renal function were considered as risk factors in the 11,141 enrolled patients. The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and unstable angina. The secondary composite endpoint was the primary endpoint and/or coronary revascularization. A significantly worse prognosis at the primary endpoint was observed in the estimated glomerular filtration rate (eGFR) ≤60 group, and the combination of eGFR ≤60 and HbA1c ≥6.0 was the worst (hazard ratio (HR) 1.66; P<0.001). However, even in the eGFR >60 group, systolic blood pressure (SBP) ≥140 mmHg met the secondary endpoint (HR 1.33; P=0.006), and the combination of eGFR ≤60 and HbA1c ≥6.0 was also the worst at the secondary endpoint (HR 1.35; P=0.002).Conclusions: Regarding nonlipid prognostic factors contributing to the incidence of cardiovascular events in statin-treated CAD patients, renal dysfunction was the most significant, followed by poor glucose control and high SBP.

2023-07-22 06:48:44
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1 0 0 0 OA Small Dense Low-Density Lipoprotein Cholesterol and Cardiovascular Risk in Statin-Treated Patients with Coronary Artery Disease

著者: Junnichi Ishii Kosuke Kashiwabara Yukio Ozaki Hiroshi Takahashi Fumihiko Kitagawa Hideto Nishimura Hideki Ishii Satoshi Iimuro Hideki Kawai Takashi Muramatsu Hiroyuki Naruse Hiroshi Iwata Sadako Tanizawa-Motoyama Hiroyasu Ito Eiichi Watanabe Yutaka Matsuyama Yoshihiro Fukumoto Ichiro Sakuma Yoshihisa Nakagawa Kiyoshi Hibi Takafumi Hiro Seiji Hokimoto Katsumi Miyauchi Hiroshi Ohtsu Hideo Izawa Hisao Ogawa Hiroyuki Daida Hiroaki Shimokawa Yasushi Saito Takeshi Kimura Masunori Matsuzaki Ryozo Nagai
出版者: Japan Atherosclerosis Society
雑誌: Journal of Atherosclerosis and Thrombosis (ISSN:13403478)
巻号頁・発行日: vol.29, no.10, pp.1458-1474, 2022-10-01 (Released:2022-10-01)
参考文献数: 33
被引用文献数: 1 11

Aim: We investigated the relationship between small dense low-density cholesterol (sdLDL-C) and risk of major adverse cardiovascular events (MACE) in patients treated with high- or low-dose statin therapy.Methods: This was a prospective case-cohort study within the Randomized Evaluation of Aggressive or Moderate Lipid-Lowering Therapy with Pitavastatin in Coronary Artery Disease (REAL-CAD) study, a randomized trial of high- or low-dose (4 or 1 mg/d pitavastatin, respectively) statin therapy, in patients with stable coronary artery disease (CAD). Serum sdLDL-C was determined using an automated homogenous assay at baseline (randomization after a rule-in period, >1 month with 1 mg/d pitavastatin) and 6 months after randomization, in 497 MACE cases, and 1543 participants randomly selected from the REAL-CAD study population.Results: High-dose pitavastatin reduced sdLDL-C by 20% than low-dose pitavastatin (p for interaction <0.001). Among patients receiving low-dose pitavastatin, baseline sdLDL-C demonstrated higher MACE risk independent of LDL-C (hazard ratio [95% confidence interval], 4th versus 1st quartile, 1.67 [1.04–2.68]; p for trend=0.034). High-dose (versus low-dose) pitavastatin reduced MACE risk by 46% in patients in the highest baseline sdLDL-C quartile (>34.3 mg/dL; 0.54 [0.36–0.81]; p=0.003), but increased relative risk by 40% in patients with 1st quartile (≤ 19.5 mg/dL; 1.40 [0.94–2.09]; p=0.099) and did not alter risk in those in 2nd and 3rd quartiles (p for interaction=0.002).Conclusions: These findings associate sdLDL-C and cardiovascular risk, independent of LDL-C, in statin-treated CAD patients. Notably, high-dose statin therapy reduces this risk in those with the highest baseline sdLDL-C.

2023-08-13 21:55:57
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1 0 0 0 OA Low-Density Lipoprotein Cholesterol Levels on Statins and Cardiovascular Event Risk in Stable Coronary Artery Disease ― An Observation From the REAL-CAD Study ―

著者: Toshiaki Toyota Takeshi Morimoto Satoshi Iimuro Retsu Fujita Hiroshi Iwata Katsumi Miyauchi Teruo Inoue Yoshihisa Nakagawa Yosuke Nishihata Hiroyuki Daida Yukio Ozaki Satoru Suwa Ichiro Sakuma Yutaka Furukawa Hiroki Shiomi Hirotoshi Watanabe Kyohei Yamaji Naritatsu Saito Masahiro Natsuaki Yasuo Ohashi Masunori Matsuzaki Ryozo Nagai Takeshi Kimura
出版者: The Japanese Circulation Society
雑誌: Circulation Journal (ISSN:13469843)
巻号頁・発行日: pp.CJ-22-0168, (Released:2022-09-14)
参考文献数: 20

Background: The relationship between very low on-treatment low-density lipoprotein cholesterol (LDL-C) level and cardiovascular event risk is still unclear in patients receiving the same doses of statins.Methods and Results: From the REAL-CAD study comparing high-dose (4 mg/day) with low-dose (1 mg/day) pitavastatin therapy in patients with stable coronary artery disease, 11,105 patients with acceptable statin adherence were divided into 3 groups according to the on-treatment LDL-C level at 6 months (<70 mg/dL, 70–100 mg/dL, and ≥100 mg/dL). The primary outcome measure was a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, or unstable angina requiring emergent admission. The adjusted risks of the LDL-C <70 mg/dL group relative to the LDL-C 70–100 mg/dL group (reference) was not significantly different for the primary outcome measure in both 1 mg/day and 4 mg/day strata (HR 0.84, 95% CI 0.58–1.18, P=0.32, and HR 1.25, 95% CI 0.88–1.79, P=0.22). The adjusted risk of the LDL-C ≥100 mg/dL group relative to the reference group was not significant for the primary outcome measure in the 1 mg/day stratum (HR 0.82, 95% CI 0.60–1.11, P=0.21), whereas it was highly significant in the 4 mg/day stratum (HR 3.32, 95% CI 2.08–5.17, P<0.001).Conclusions: A very low on-treatment LDL-C level (<70 mg/dL) was not associated with lower cardiovascular event risk compared with moderately low on-treatment LDL-C level (70–100 mg/dL) in patients receiving the same doses of statins.

2022-09-14 07:52:16
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1 0 0 0 OA Risk Profile and 1-Year Outcome of Newly Diagnosed Atrial Fibrillation in Japan ― Insights From GARFIELD-AF ―

著者: Yukihiro Koretsune Takuma Etoh Yousuke Katsuda Tetsuro Suetsugu Kenshi Kumeda Ichiro Sakuma Kenichi Eshima Mitsuhiro Shibuya Shin-ichi Ando Naoto Yokota Shinya Goto Karen S. Pieper Jagan Allu Ajay K. Kakkar for the GARFIELD-AF Investigators
出版者: The Japanese Circulation Society
雑誌: Circulation Journal (ISSN:13469843)
巻号頁・発行日: vol.83, no.1, pp.67-74, 2018-12-25 (Released:2018-12-25)
参考文献数: 20
被引用文献数: 11

2019-03-02 15:07:12
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