著者
Koichiro Kinugawa Naoki Sato Takayuki Inomata Moriyoshi Yasuda Yoshiyuki Shibasaki Toshiyuki Shimakawa
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.82, no.5, pp.1344-1350, 2018-04-25 (Released:2018-04-25)
参考文献数
16
被引用文献数
13 19

Background:It has been 7 years since tolvaptan was approved in Japan for the indication of heart failure in patients with volume overload; the drug can be used in patients with normonatremia. Hypernatremia was identified as a significant adverse event to be prevented.Methods and Results:We compiled and analyzed data from 3,349 patients over 5 years to identify patients at high risk of hypernatremia with tolvaptan treatment. The incidence of hypernatremia, defined as serum sodium ≥150 mEq/L, was 3.65%. Baseline serum sodium concentrations, serum potassium concentrations, blood urea nitrogen : creatinine ratio, initial tolvaptan dose, and age were identified as risk factors for hypernatremia. A hypernatremia risk score was developed using the odds ratios for these factors. The high-risk population was defined as patients with a risk score ≥17.80.Conclusions:To prevent the occurrence of hypernatremic events in patients taking tolvaptan, we recommend a very low starting dose (i.e., 3.75 mg/day) in patients identified as being at high risk of hypernatremia using our new scoring process.
著者
Hiroyuki Tsutsui Shin-ichi Momomura Akira Yamashina Hiroaki Shimokawa Yasuki Kihara Yoshihiko Saito Nobuhisa Hagiwara Hiroshi Ito Masafumi Yano Kazuhiro Yamamoto Junya Ako Takayuki Inomata Yasushi Sakata Takashi Tanaka Yasushi Kawasaki on behalf of the J-SHIFT Study Investigators
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-19-0227, (Released:2019-08-08)
参考文献数
18
被引用文献数
24 45

Background:Increased heart rate (HR) is an independent risk factor for cardiovascular outcomes in chronic heart failure (HF). Ivabradine, anIfinhibitor, improved outcomes in patients with HF and reduced ejection fraction (HFrEF) in the SHIFT study. We evaluated its efficacy and safety in Japanese HFrEF patients in a randomized, double-blind, placebo-controlled phase III study: the J-SHIFT study. The main objective was to confirm a hazard ratio of <1 in the primary composite endpoint of cardiovascular death or hospital admission for worsening HF.Methods and Results:Patients with NYHA functional class II–IV, left ventricular EF ≤35%, and resting HR ≥75 beats/min in sinus rhythm under optimal medical therapy received ivabradine (n=127) or placebo (n=127). Mean reduction in resting HR was significantly greater in the ivabradine group (15.2 vs. 6.1 beats/min, P<0.0001). However, symptomatic bradycardia did not occur. A total of 26 (20.5%) patients in the ivabradine group and 37 (29.1%) patients in the placebo group had the primary endpoint event (hazard ratio 0.67, 95% CI 0.40–1.11, P=0.1179) during median follow-up of 589 days. Mild phosphenes were reported in 8 (6.3%) patients in the ivabradine group and 4 (3.1%) patients in the placebo group (P=0.3760).Conclusions:The J-SHIFT study supported the efficacy and safety of ivabradine for Japanese HFrEF patients, in accord with the SHIFT study.
著者
Takayuki Inomata Yuki Ikeda Keisuke Kida Yugo Shibagaki Naoki Sato Yuji Kumagai Hisahito Shinagawa Junya Ako Tohru Izumi for the Kanagawa Aquaresis Investigators
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.82, no.1, pp.159-167, 2017-12-25 (Released:2017-12-25)
参考文献数
32
被引用文献数
21 54

Background:Although diuretic resistance leading to residual congestion is a known predictor of a poorer heart failure (HF) prognosis, better therapeutic strategies for effective and safe decongestion have not been established.Methods and Results:In this study, 81 HF patients with fluid retention (despite taking ≥40 mg/day furosemide (FUR)), with an estimated glomerular filtration rate <45 mL/min/1.73 m2, were randomized into 2 groups and administered either ≤15 mg/day additive tolvaptan (TLV) or ≤40 mg/day increased FUR for 7 days. Changes in urine volume between baseline and mean urine volume during treatment were significantly higher in the TLV than FUR group (P=0.0003). Although there was no significant decrease in body weight or improved signs and symptoms of congestion between the 2 groups, the increase in serum creatinine on Day 7 from baseline was significantly smaller in the TLV than FUR group (P=0.038). Multiple logistic regression analysis revealed that additive TLV (odds ratio 0.157, 95% confidence interval 0.043–0.605, P=0.001) was an independent clinical factor for improved renal function during treatment compared with increased FUR.Conclusions:In HF patients with residual congestion and renal dysfunction refractory to standard therapy, additive TLV increased urine volume without further renal impairment compared with patients who received an increased dose of FUR.
著者
Mayu Yazaki Takeru Nabeta Takayuki Inomata Kenji Maemura Takumi Ooki Teppei Fujita Yuichiro Iida Yuki Ikeda Shunsuke Ishii Takashi Naruke Junya Ako
出版者
The Japanese Circulation Society
雑誌
Circulation Reports (ISSN:24340790)
巻号頁・発行日
vol.2, no.1, pp.51-59, 2020-01-10 (Released:2020-01-10)
参考文献数
35
被引用文献数
1

Background:In patients with heart failure (HF), discontinued medical therapy because of adverse events (AE) is associated with high mortality. Patients with type 2 diabetes mellitus (T2DM) treated with sodium-glucose co-transporter 2 inhibitors (SGLT2i) have a lower risk of HF, but AE sometimes occur with the introduction of SGLT2i. In order to use SGLT2i safely in patients with HF, we investigated factors associated with AE following the introduction of SGLT2i.Methods and Results:AE were defined as hypotension or an increase in serum creatinine ≥0.3 mg/dL by the fifth day after SGLT2i introduction. Sixty-four hospitalized patients with HF and T2DM treated with an SGLT2i were enrolled in this study. Patients were divided into 2 groups: with AE (n=13, 20.3%) and without (n=51, 79.7%). On logistic regression analysis, female sex, hemoglobin ≥15.2 g/dL, serum creatinine ≥1.05 mg/dL, and cardiac index on echocardiography ≤2.15 L/min/m2, were significantly associated with AE. A scoring system was constructed to predict AE according to significant variables (area under the receiver operating characteristic curve, 0.83; P<0.001) and the cut-off point was 2 points.Conclusions:Female sex, hemoconcentration, kidney injury, and low cardiac output were associated with AE at SGLT2i initiation in patients with HF. Using this scoring system, introduction of SGLT2i could be done safely in patients with HF.
著者
Takayuki Inomata Yuki Ikeda Keisuke Kida Yugo Shibagaki Naoki Sato Yuji Kumagai Hisahito Shinagawa Junya Ako Tohru Izumi for the Kanagawa Aquaresis Investigators
出版者
日本循環器学会
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-17-0179, (Released:2017-08-22)
参考文献数
32
被引用文献数
54

Background:Although diuretic resistance leading to residual congestion is a known predictor of a poorer heart failure (HF) prognosis, better therapeutic strategies for effective and safe decongestion have not been established.Methods and Results:In this study, 81 HF patients with fluid retention (despite taking ≥40 mg/day furosemide (FUR)), with an estimated glomerular filtration rate <45 mL/min/1.73 m2, were randomized into 2 groups and administered either ≤15 mg/day additive tolvaptan (TLV) or ≤40 mg/day increased FUR for 7 days. Changes in urine volume between baseline and mean urine volume during treatment were significantly higher in the TLV than FUR group (P=0.0003). Although there was no significant decrease in body weight or improved signs and symptoms of congestion between the 2 groups, the increase in serum creatinine on Day 7 from baseline was significantly smaller in the TLV than FUR group (P=0.038). Multiple logistic regression analysis revealed that additive TLV (odds ratio 0.157, 95% confidence interval 0.043–0.605, P=0.001) was an independent clinical factor for improved renal function during treatment compared with increased FUR.Conclusions:In HF patients with residual congestion and renal dysfunction refractory to standard therapy, additive TLV increased urine volume without further renal impairment compared with patients who received an increased dose of FUR.
著者
Naoki Kubota Kazuyuki Ozaki Takumi Akiyama Yuzo Washiyama Shintaro Yoneyama Takeshi Okubo Ryutaro Ikegami Makoto Hoyano Takao Yanagawa Naohito Tanabe Takayuki Inomata
出版者
The Japanese Circulation Society
雑誌
Circulation Reports (ISSN:24340790)
巻号頁・発行日
vol.4, no.8, pp.363-370, 2022-08-10 (Released:2022-08-10)
参考文献数
16
被引用文献数
4

Background: The correlation between the Japanese version of high bleeding risk (J-HBR) criteria and the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score is unknown, as is the relationship of both risk scores with ischemic events.Methods and Results: This study enrolled 842 patients who underwent percutaneous coronary intervention (PCI) between January 2016 and December 2020. The 2 bleeding risk scores at the time of PCI and the subsequent risk of bleeding and ischemic events over a 1-year follow-up were examined. The J-HBR score was significantly correlated with the PRECISE-DAPT score (r=0.731, P<0.001). However, 1 year after PCI, the J-HBR was not significantly associated with the incidence of major bleeding and ischemic events (log-rank, P=0.058 and P=0.351, respectively), whereas the PRECISE-DAPT score predicted both the incidence of major bleeding and ischemic events (log-rank, P=0.006 and P=0.019, respectively). According to receiver operating characteristic curve analysis, a J-HBR score ≥1.5 was significantly associated with a higher cumulative incidence of major bleeding, but not ischemic events (log-rank, P=0.004 and P=0.513, respectively).Conclusions: The J-HBR score is highly correlated with the PRECISE-DAPT score. A J-HBR score ≥1.5 can identify high bleeding risk patients without an increased risk of ischemic events.
著者
Jin Endo Motoaki Sano Yasuhiro Izumiya Kenichi Tsujita Kazufumi Nakamura Nobuhiro Tahara Koichiro Kuwahara Takayuki Inomata Mitsuharu Ueda Yoshiki Sekijima Yukio Ando Hiroyuki Tsutsui Mitsuaki Isobe Keiichi Fukuda
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-19-0811, (Released:2019-11-16)
参考文献数
4
被引用文献数
18

Transthyretin cardiac amyloidosis is a progressive and life-threating disease that is significantly underdiagnosed, and the actual number of patients with the disease is presently unknown. Accumulation of wild-type transthyretin-derived amyloid in the heart is a common finding in very elderly patients. Recent clinical trials demonstrated that tafamidis reduced all-cause death and the number of cardiovascular hospitalizations when compared with placebo. The Japanese Ministry of Health, Labour and Welfare approved tafamidis (Vyndaqel®, Pfizer Inc.) for the treatment of cardiomyopathy caused by both wild-type and mutated transthyretin-derived amyloidoses. This scientific statement on transthyretin-derived cardiac amyloidosis summarizes the conditions for reimbursement of the cost of tafamidis therapy, and the institutional and physician requirements for the introduction of tafamidis.
著者
Koichiro Kinugawa Naoki Sato Takayuki Inomata Moriyoshi Yasuda Toshiyuki Shimakawa Yasuhiko Fukuta
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-19-0158, (Released:2019-05-22)
参考文献数
26
被引用文献数
19

Background:In Japan, tolvaptan is indicated for patients with heart failure and volume overload who have inadequate response to other diuretics. In contrast to the USA and Europe, tolvaptan can be used in Japan in patients with normal sodium levels.Methods and Results:In this multicenter, non-interventional, post-marketing surveillance study, prospective data from 3,349 patients treated with tolvaptan over a 5-year period were analyzed to identify benefits and risks. By Day 2 of treatment, 76.9% of evaluable patients had an increase in baseline 24-h urine volume (tolvaptan responders). Mean change in body weight was similar between 7.5 mg and 15 mg dosage groups (−3.6±3.9 kg and −3.7±4.0 kg, respectively). Improvement or disappearance rates for congestive symptoms from baseline to Day 14 ranged from 77.7% for lower limb edema to 51.1% for 3rd sound. Adverse drug reactions were reported in 18.1% of patients, most frequently thirst (8.4%). No case of central pontine myelinolysis was reported. All-cause mortality was significantly lower in patients with improved sodium concentration and increased 24-h urine volume.Conclusions:The effectiveness and safety of tolvaptan in real-world clinical settings was confirmed in this large-scale analysis. The 7.5-mg dose was equally as effective as the 15-mg dose and had a better safety profile. Improvements in all-cause mortality were suggested in tolvaptan responders.