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Article ; Online: Safety and effectiveness of empagliflozin in clinical practice as monotherapy or with other glucose-lowering drugs in Japanese patients with type 2 diabetes: subgroup analysis of a 3-year post-marketing surveillance study.

Kaku, Kohei / Nakayama, Yayoi / Yabuuchi, Junko / Naito, Yusuke / Kanasaki, Keizo

2023 Volume 22, Issue 9, Page(s) 819–832

Abstract: Background: Sodium-glucose co-transporter-2 (SGLT2) inhibitors such as empagliflozin are increasingly prescribed as initial glucose-lowering drugs for type 2 diabetes (T2D), based on their cardiorenal benefits. However, information regarding the safety ... ...

Abstract	Background: Sodium-glucose co-transporter-2 (SGLT2) inhibitors such as empagliflozin are increasingly prescribed as initial glucose-lowering drugs for type 2 diabetes (T2D), based on their cardiorenal benefits. However, information regarding the safety and the effectiveness of monotherapy with SGLT2 inhibitors in routine clinical practice is limited. Research design and methods: We analyzed data from a prospective, 3-year, post-marketing surveillance study of empagliflozin in Japan. We evaluated adverse drug reactions (ADRs) (the primary endpoint) and glycemic effectiveness with or without other glucose-lowering drugs. Results: 7931 T2D patients were treated with empagliflozin. At baseline, mean age was 58.7 years, 63.0% were male, and 1835 (23.14%) were not receiving other glucose-lowering drugs. ADRs occurred in 141 (7.68%) and 875 (14.62%) patients initiating empagliflozin as monotherapy or combination therapy, respectively. The most frequent ADRs of special interest with empagliflozin as monotherapy or combination therapy were urinary tract infections (0.82% and 1.14% of patients, respectively) and excessive/frequent urination (0.65%, 1.50%). At last observation, glycated hemoglobin level was reduced by a mean of 0.78% with empagliflozin monotherapy (from baseline mean of 7.55%) and 0.74% with combination therapy (baseline 8.16%). Conclusions: Empagliflozin is well tolerated and effective in clinical practice in Japan when initiated as monotherapy or combination therapy.
MeSH term(s)	Humans ; Male ; Middle Aged ; Female ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/epidemiology ; Glucose ; Hypoglycemic Agents ; Prospective Studies ; East Asian People ; Glycated Hemoglobin ; Sodium-Glucose Transporter 2 Inhibitors ; Benzhydryl Compounds/adverse effects ; Drug-Related Side Effects and Adverse Reactions ; Product Surveillance, Postmarketing ; Blood Glucose
Chemical Substances	empagliflozin (HDC1R2M35U) ; Glucose (IY9XDZ35W2) ; Hypoglycemic Agents ; Glycated Hemoglobin ; Sodium-Glucose Transporter 2 Inhibitors ; Benzhydryl Compounds ; Blood Glucose
Language	English
Publishing date	2023-05-29
Publishing country	England
Document type	Journal Article
ZDB-ID	2088728-0
ISSN	1744-764X ; 1474-0338
ISSN (online)	1744-764X
ISSN	1474-0338
DOI	10.1080/14740338.2023.2213477
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Article ; Online: Unusual abdominal gas after an acute lumbar compression fracture.

Maeda, Sayako / Miyahara, Mizuki / Yabuuchi, Junko / Makiishi, Tetsuya

Internal medicine (Tokyo, Japan)

2014 Volume 53, Issue 21, Page(s) 2565–2566

MeSH term(s)	Acute Disease ; Aged, 80 and over ; Diagnosis, Differential ; Fatal Outcome ; Fractures, Compression/complications ; Fractures, Compression/diagnosis ; Humans ; Lumbar Vertebrae/injuries ; Male ; Pneumoperitoneum/diagnosis ; Pneumoperitoneum/etiology ; Spinal Fractures/complications ; Spinal Fractures/diagnosis ; Tomography, X-Ray Computed
Language	English
Publishing date	2014-11-01
Publishing country	Japan
Document type	Case Reports ; Journal Article
ZDB-ID	32371-8
ISSN	1349-7235 ; 0021-5120 ; 0918-2918
ISSN (online)	1349-7235
ISSN	0021-5120 ; 0918-2918
DOI	10.2169/internalmedicine.53.3028
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Article ; Online: Characteristics of Patients and Their Ascites Who Underwent Repeated Cell-Free and Concentrated Ascites Reinfusion Therapy.

Maeda, Sayako / Yabuuchi, Junko / Nobuta, Hiroshi / Makiishi, Tetsuya / Hirose, Kunihiko

Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy

2015 Volume 19, Issue 4, Page(s) 342–348

Abstract: Novel cell-free and concentrated ascites reinfusion therapy (KM-CART) is easy to use, safe and applicable for refractory ascites. We can get the full amount of ascites, filtrate, and concentrate in a short time. KM-CART can be applied as palliative care ... ...

Abstract	Novel cell-free and concentrated ascites reinfusion therapy (KM-CART) is easy to use, safe and applicable for refractory ascites. We can get the full amount of ascites, filtrate, and concentrate in a short time. KM-CART can be applied as palliative care for dying patients including patients with massive malignant ascites. Some patients who underwent repeated KM-CART survived longer than those who did not repeat the therapy. The aim of this study was to identify the type of patients with ascites for whom KM-CART would be effective and candidates for repeated KM-CART. In this retrospective cohort observational study, we examined 123 CART processes performed on 58 patients with refractory ascites. Data were collected before and after processing of the ascites. We compared two groups; patients who underwent KM-CART ≥ 5 times and those who underwent this process ≤ 4 times. Age, disease, benign or malignant status of the disease, the amount of ascites, concentrations of total protein (TP) and albumin (Alb) and their amounts in the original ascites and the filtered and concentrated ascitic fluid and the recovery ratio of TP and Alb were determined. No significant difference was observed between the two groups in age, disease, amount of ascites, and the recovery ratio of TP and Alb. Significant differences were observed in the amounts of TP and Alb in the original ascites and the filtered and concentrated ascitic fluid. Patients who underwent KM-CART ≥ 5 times had higher Alb levels in the original ascites than those who underwent this therapy ≤ 4 times. Patients with higher Alb concentrations in the original ascites could be candidates for repeated KM-CART.
MeSH term(s)	Adult ; Aged ; Albumins/metabolism ; Ascites/etiology ; Ascites/mortality ; Ascites/pathology ; Ascites/therapy ; Ascitic Fluid/metabolism ; Ascitic Fluid/pathology ; Equipment Design ; Female ; Filtration/instrumentation ; Filtration/methods ; Humans ; Japan/epidemiology ; Male ; Middle Aged ; Neoplasm Staging ; Neoplasms/complications ; Neoplasms/pathology ; Palliative Care ; Reproducibility of Results ; Retrospective Studies ; Severity of Illness Index ; Survival Analysis ; Treatment Outcome
Chemical Substances	Albumins
Language	English
Publishing date	2015-08
Publishing country	Australia
Document type	Journal Article ; Observational Study
ZDB-ID	2119809-3
ISSN	1744-9987 ; 1091-6660 ; 1744-9979
ISSN (online)	1744-9987
ISSN	1091-6660 ; 1744-9979
DOI	10.1111/1744-9987.12343
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Article ; Online: Association of advanced glycation end products with sarcopenia and frailty in chronic kidney disease.

Yabuuchi, Junko / Ueda, Seiji / Yamagishi, Sho-Ichi / Nohara, Nao / Nagasawa, Hajime / Wakabayashi, Keiichi / Matsui, Takanori / Yuichiro, Higashimoto / Kadoguchi, Tomoyasu / Otsuka, Tomoyuki / Gohda, Tomohito / Suzuki, Yusuke

Scientific reports

2020 Volume 10, Issue 1, Page(s) 17647

Abstract: Prevalence of sarcopenia is high in patients with chronic kidney disease (CKD), especially in those with dialysis. Various pathological conditions related to CKD, such as chronic inflammation, insulin resistance, and endothelial dysfunction, are thought ... ...

Abstract	Prevalence of sarcopenia is high in patients with chronic kidney disease (CKD), especially in those with dialysis. Various pathological conditions related to CKD, such as chronic inflammation, insulin resistance, and endothelial dysfunction, are thought to be associated with the development and progression of sarcopenia. Advanced glycation end products (AGE), one of the representative uremic toxins, have been shown to contribute to various CKD-associated complications. This study investigated the role of AGE in frailty and sarcopenia in patients and animals with CKD, respectively. In patients undergoing dialysis, serum AGE levels were significantly increased according to the frailty status and inversely associated with physical performance and activity. AGE accumulated in the gastrocnemius muscle of 5/6 nephrectomy mice in association with morphological abnormalities, capillary rarefaction, and mitochondrial dysfunction, all of which were completely inhibited by DNA-aptamer raised against AGE. Our present findings may suggest the pathological role of AGE in sarcopenia and frailty in CKD.
MeSH term(s)	Aged ; Animals ; Blotting, Western ; Exercise ; Female ; Frailty/etiology ; Frailty/metabolism ; Glycation End Products, Advanced/blood ; Glycation End Products, Advanced/metabolism ; Humans ; Male ; Mice ; Mice, Inbred C57BL ; Middle Aged ; Muscle, Skeletal/metabolism ; Renal Insufficiency, Chronic/complications ; Renal Insufficiency, Chronic/metabolism ; Sarcopenia/etiology ; Sarcopenia/metabolism
Chemical Substances	Glycation End Products, Advanced
Language	English
Publishing date	2020-10-19
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-020-74673-x
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Article ; Online: Association of advanced glycation end products with sarcopenia and frailty in chronic kidney disease

Junko Yabuuchi / Seiji Ueda / Sho-ichi Yamagishi / Nao Nohara / Hajime Nagasawa / Keiichi Wakabayashi / Takanori Matsui / Higashimoto Yuichiro / Tomoyasu Kadoguchi / Tomoyuki Otsuka / Tomohito Gohda / Yusuke Suzuki

Scientific Reports, Vol 10, Iss 1, Pp 1-

2020 Volume 12

Abstract: Abstract Prevalence of sarcopenia is high in patients with chronic kidney disease (CKD), especially in those with dialysis. Various pathological conditions related to CKD, such as chronic inflammation, insulin resistance, and endothelial dysfunction, are ...

Abstract	Abstract Prevalence of sarcopenia is high in patients with chronic kidney disease (CKD), especially in those with dialysis. Various pathological conditions related to CKD, such as chronic inflammation, insulin resistance, and endothelial dysfunction, are thought to be associated with the development and progression of sarcopenia. Advanced glycation end products (AGE), one of the representative uremic toxins, have been shown to contribute to various CKD-associated complications. This study investigated the role of AGE in frailty and sarcopenia in patients and animals with CKD, respectively. In patients undergoing dialysis, serum AGE levels were significantly increased according to the frailty status and inversely associated with physical performance and activity. AGE accumulated in the gastrocnemius muscle of 5/6 nephrectomy mice in association with morphological abnormalities, capillary rarefaction, and mitochondrial dysfunction, all of which were completely inhibited by DNA-aptamer raised against AGE. Our present findings may suggest the pathological role of AGE in sarcopenia and frailty in CKD.
Keywords	Medicine ; R ; Science ; Q
Subject code	616
Language	English
Publishing date	2020-10-01T00:00:00Z
Publisher	Nature Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Pharmacokinetic evaluation of liposomal nanoparticle-encapsulated nucleic acid drug: A combined study of dynamic PET imaging and LC/MS/MS analysis

Mukai, Hidefumi / Kentaro Hatanaka / Nobuhiro Yagi / Shota Warashina / Maki Zouda / Maiko Takahashi / Kazuya Narushima / Hayato Yabuuchi / Junko Iwano / Takeshi Kuboyama / Junichi Enokizono / Yasuhiro Wada / Yasuyoshi Watanabe

Journal of controlled release. 2019 Jan. 28, v. 294

2019

Abstract: In vivo biodistribution analyses, especially in tumors, of nucleic acids delivered with nanoparticles are important to develop drug delivery technologies for medical use. We previously developed wrapsome® (WS), an ~100 nm liposomal nanoparticle that can ... ...

Abstract	In vivo biodistribution analyses, especially in tumors, of nucleic acids delivered with nanoparticles are important to develop drug delivery technologies for medical use. We previously developed wrapsome® (WS), an ~100 nm liposomal nanoparticle that can encapsulate siRNA, and reported that WS accumulates in tumors in vivo and inhibits their growth by an enhanced permeability and retention effect. In the present study, we evaluated the pharmacokinetics of nucleic acid-containing nanoparticles by combining dynamic positron emission tomography (PET) imaging and liquid chromatography-tandem mass spectrometry (LC/MS/MS) analysis. An 18-mer phosphorothioate oligodeoxynucleotide (ODN), trabedersen, was used as a model drug and was encapsulated in WS. Dynamic PET imaging and time-activity curve analysis of WS-encapsulated 64Cu-labeled ODNs administered to mice with MIA PaCa-2 subcutaneous xenograft tumors showed tumor accumulation (~3% injected dose per gram (%ID/g)) and liver accumulation (~30 %ID/g) at 24 h. Under these conditions, LC/MS/MS analysis showed that the level of intact ODNs was 1.62 %ID/g in the tumor and 1.70 %ID/g in the liver. From these pharmacokinetic data, the intact/accumulated ODN ratios were calculated using the following equation: intact/accumulated ODN ratio (%) = %ID/g LC/MS/MS, tissue, mean/%ID/g PET, tissue, mean × 100. Interestingly, the ratios for the tumor and kidney were maintained at 20–50% over 48 h after administration of the WS-encapsulated form. In contrast, the ratio for the liver rapidly decreased at 24 h, showing the same pattern as that for naked ODN. These different patterns indicate that WS effectively protected the ODN in the tumor and kidney, but protected it less efficiently in the liver. A combined approach of dynamic PET imaging and LC/MS/MS analysis will assist the development of nanoparticle-encapsulated nucleic acid drugs, such as those using WSs, to determine their detailed pharmacokinetics.
Keywords	drugs ; equations ; image analysis ; kidneys ; liquid chromatography ; liver ; mice ; nanoparticles ; neoplasms ; oligodeoxyribonucleotides ; permeability ; pharmacokinetics ; positron-emission tomography ; small interfering RNA ; tandem mass spectrometry
Language	English
Dates of publication	2019-0128
Size	p. 185-194.
Publishing place	Elsevier B.V.
Document type	Article
ZDB-ID	632533-6
ISSN	1873-4995 ; 0168-3659
ISSN (online)	1873-4995
ISSN	0168-3659
DOI	10.1016/j.jconrel.2018.12.006
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Pharmacokinetic evaluation of liposomal nanoparticle-encapsulated nucleic acid drug: A combined study of dynamic PET imaging and LC/MS/MS analysis.

Mukai, Hidefumi / Hatanaka, Kentaro / Yagi, Nobuhiro / Warashina, Shota / Zouda, Maki / Takahashi, Maiko / Narushima, Kazuya / Yabuuchi, Hayato / Iwano, Junko / Kuboyama, Takeshi / Enokizono, Junichi / Wada, Yasuhiro / Watanabe, Yasuyoshi

Journal of controlled release : official journal of the Controlled Release Society

2018 Volume 294, Page(s) 185–194

Abstract	In vivo biodistribution analyses, especially in tumors, of nucleic acids delivered with nanoparticles are important to develop drug delivery technologies for medical use. We previously developed wrapsome® (WS), an ~100 nm liposomal nanoparticle that can encapsulate siRNA, and reported that WS accumulates in tumors in vivo and inhibits their growth by an enhanced permeability and retention effect. In the present study, we evaluated the pharmacokinetics of nucleic acid-containing nanoparticles by combining dynamic positron emission tomography (PET) imaging and liquid chromatography-tandem mass spectrometry (LC/MS/MS) analysis. An 18-mer phosphorothioate oligodeoxynucleotide (ODN), trabedersen, was used as a model drug and was encapsulated in WS. Dynamic PET imaging and time-activity curve analysis of WS-encapsulated
MeSH term(s)	Animals ; Cell Line, Tumor ; Chromatography, Liquid ; Female ; Humans ; Liposomes ; Mice ; Nanoparticles/administration & dosage ; Neoplasms/diagnostic imaging ; Neoplasms/metabolism ; Oligonucleotides/administration & dosage ; Oligonucleotides/pharmacokinetics ; Positron-Emission Tomography ; Tandem Mass Spectrometry ; Tissue Distribution
Chemical Substances	Liposomes ; Oligonucleotides
Language	English
Publishing date	2018-12-07
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	632533-6
ISSN	1873-4995 ; 0168-3659
ISSN (online)	1873-4995
ISSN	0168-3659
DOI	10.1016/j.jconrel.2018.12.006
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Article ; Online: Long-term Low-density Lipoprotein Apheresis in a Patient with Refractory Idiopathic Membranous Glomerulonephritis.

Yabuuchi, Junko / Suwabe, Tatsuya / Mizuno, Hiroki / Ueno, Toshiharu / Hoshino, Junichi / Sekine, Akinari / Kawada, Masahiro / Yamanouchi, Masayuki / Hayami, Noriko / Hiramatsu, Rikako / Hasegawa, Eiko / Sawa, Naoki / Takaichi, Kenmei / Fujii, Takeshi / Ohashi, Kenichi / Ubara, Yoshifumi

Internal medicine (Tokyo, Japan)

2017 Volume 56, Issue 12, Page(s) 1543–1547

Abstract: A 61-year-old Japanese man developed nephrotic syndrome (NS) due to idiopathic membranous glomerulonephritis (MGN). He received immunosuppressive therapy for two years, including prednisolone, cyclophosphamide, and cyclosporine A, but the NS persisted. ... ...

Abstract	A 61-year-old Japanese man developed nephrotic syndrome (NS) due to idiopathic membranous glomerulonephritis (MGN). He received immunosuppressive therapy for two years, including prednisolone, cyclophosphamide, and cyclosporine A, but the NS persisted. Low-density lipoprotein apheresis (LDL-A) was initiated at a frequency of twice a month and continued for 9 years (203 sessions in total). His proteinuria reduced to less than 1 g daily after 9 years. LDL-A was stopped, and the NS has not relapsed for five years. This case suggests that long-term LDL-A therapy may be a treatment option for idiopathic MGN refractory to immunosuppressive therapy or short-term LDL-A.
Language	English
Publishing date	2017
Publishing country	Japan
Document type	Journal Article
ZDB-ID	32371-8
ISSN	1349-7235 ; 0021-5120 ; 0918-2918
ISSN (online)	1349-7235
ISSN	0021-5120 ; 0918-2918
DOI	10.2169/internalmedicine.56.8081
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Article: Renal histology and MRI in a 25-year-old Japanese man with nephronophthisis 4 .

Takada, Daisuke / Sekine, Akinari / Yabuuchi, Junko / Kogure, Yuta / Ueno, Toshiharu / Yamanouchi, Masayuki / Sumida, Keiichi / Suwabe, Tatsuya / Hayami, Noriko / Hoshino, Junichi / Takaichi, Kenmei / Kinowaki, Keiichi / Fujii, Takeshi / Ohashi, Kenichi / Mori, Takayasu / Sohara, Eisei / Uchida, Shinichi / Ubara, Yoshifumi

Clinical nephrology

2018 Volume 89, Issue 3, Page(s) 223–228

Abstract: We investigated a 25-year-old Japanese man who had polycystic kidneys and end-stage renal failure without a positive family history. Ultrasonography revealed enlarged kidneys with increased echogenicity and multiple cystic lesions. MRI showed replacement ...

Abstract	We investigated a 25-year-old Japanese man who had polycystic kidneys and end-stage renal failure without a positive family history. Ultrasonography revealed enlarged kidneys with increased echogenicity and multiple cystic lesions. MRI showed replacement of both kidneys by cystic lesions without definite walls. Renal biopsy demonstrated interstitial fibrosis, especially at the corticomedullary junction. The residual tubular system showed starfish-like disruption. Tubules with cystic dilation were mainly the distal loop of Henle and the distal tubules since immunohistochemical staining was positive for cytokeratin 7 (the distal loop of Henle and the distal tubule) and Tamm-Horsfall protein (the distal loop of Henle), while being negative for aquaporin 3 (the collecting duct) and CD10 (proximal tubule). Comprehensive genetic analysis identified compound heterozygous missense mutations of <italic>NPHP4</italic> with autosomal recessive inheritance since his asymptomatic parents each had a single heterozygous missense mutation of <italic>NPHP4</italic>. In conclusion, MRI and immunohistochemical analysis of renal biopsy specimens may be useful for evaluation of this disease. .
MeSH term(s)	Adult ; Humans ; Immunohistochemistry ; Kidney Diseases, Cystic/diagnostic imaging ; Kidney Diseases, Cystic/genetics ; Kidney Diseases, Cystic/pathology ; Kidney Failure, Chronic/diagnostic imaging ; Kidney Failure, Chronic/pathology ; Kidney Tubules/metabolism ; Kidney Tubules/pathology ; Magnetic Resonance Imaging ; Male ; Proteins/genetics
Chemical Substances	NPHP4 protein, human ; Proteins
Language	English
Publishing date	2018-03
Publishing country	Germany
Document type	Case Reports ; Journal Article
ZDB-ID	185101-9
ISSN	0301-0430
ISSN	0301-0430
DOI	10.5414/CN109175
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Article: Immunoglobulin G subclass 3 in ISN/RPL lupus nephritis classification .

Yabuuchi, Junko / Hoshino, Junichi / Mizuno, Hiroki / Ozawa, Yuko / Sekine, Akinari / Kawada, Masahiro / Sumida, Keiichi / Hiramatsu, Rikako / Hayami, Noriko / Yamanouchi, Masayuki / Hasegawa, Eiko / Suwabe, Tatsuya / Sawa, Naoki / Fujii, Takeshi / Ohashi, Kenichi / Takaichi, Kenmei / Ubara, Yoshifumi

Clinical nephrology

2018 Volume 91, Issue 1, Page(s) 32–39

Abstract: Objectives: In lupus nephritis, the immune complex plays a very important role in kidney disease progression, and immunoglobulin G subclass 3 (IgG3) may play an important role in endothelial damage as lupus nephropathy progresses. We evaluated the ... ...

Abstract	Objectives: In lupus nephritis, the immune complex plays a very important role in kidney disease progression, and immunoglobulin G subclass 3 (IgG3) may play an important role in endothelial damage as lupus nephropathy progresses. We evaluated the association between IgG3 positivity and lupus nephritis activity. Materials and methods: We identified 71 biopsies taken from 57 patients who had lupus nephritis with enough tissue to allow light and immunofluorescence microscopy. We compared the intensity of IgG subclass staining (on a scale of 0 - 3+) with IgG subclass dominance among lupus nephritis classes as defined by the ISN/RPS 2003 classification. Results: The proportion of IgG3-positive patients with capillary loop lesion was significantly higher in the class IV group compared with other groups (p < 0.01). Interestingly, in most patients IgG1 was the strongest subclass; in class IV groups, IgG3 was the strongest in 21% of the biopsies. IgG3 deposition in capillary loops was significantly associated with C1q deposition in those loops. According to Kaplan-Meier analysis, renal survival rates in the patients with IgG3 deposition was lower (82.2%) than in patients without IgG3 deposition (93.3%), but the difference was not significant. Conclusion: Our results suggest that capillary loop deposition of IgG3 is associated with disease activity in lupus nephritis. .
MeSH term(s)	Adult ; Female ; Fluorescent Antibody Technique ; Humans ; Immunoglobulin G/immunology ; Kidney/pathology ; Lupus Nephritis/immunology ; Lupus Nephritis/pathology ; Male ; Middle Aged ; Retrospective Studies ; Survival Analysis
Chemical Substances	Immunoglobulin G
Language	English
Publishing date	2018-11-15
Publishing country	Germany
Document type	Journal Article
ZDB-ID	185101-9
ISSN	0301-0430
ISSN	0301-0430
DOI	10.5414/CN109459
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