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Article ; Online: Long-term outcome and risk factors associated with events in patients with atrial fibrillation treated with oral anticoagulants: The ASSAF-K registry.

Hatori, Yutaka / Sakai, Hiroyuki / Hatori, Nobuo / Kunishima, Tomoyuki / Namiki, Atsuo / Shimizu, Makoto / Toyosaki, Nobuo / Kuwajima, Masaomi / Sato, Naoki

Journal of cardiology

2022 Volume 81, Issue 4, Page(s) 385–389

Abstract: Background: Oral anticoagulant therapy for atrial fibrillation (AF) has changed dramatically. Direct oral anticoagulant (DOAC) therapy is administered by general practitioners and specialists. However, the beneficial long-term effects and safety of ... ...

Abstract	Background: Oral anticoagulant therapy for atrial fibrillation (AF) has changed dramatically. Direct oral anticoagulant (DOAC) therapy is administered by general practitioners and specialists. However, the beneficial long-term effects and safety of DOACs have not been well investigated in real-world clinical practice. Methods: The ASSAF-K (a study of the safety and efficacy of OAC therapy in the treatment of AF in Kanagawa), a prospective, multi-center, observational study, was conducted to clarify patient characteristics, status of OAC treatment, long-term outcomes, and adverse events, including cerebrovascular disease, bleeding, and death. Results: A total of 4014 patients were enrolled (hospital: 2500 cases; clinic: 1514 cases). The number of patients in the final dataset was 3367 (mean age, 72.6 ± 10.0 years; males, 66.3 %). CHA Conclusions: This multi-center registry demonstrated the long-term outcome in patients with AF treated with and without OACs and suggests that DOAC therapy is safe and beneficial in hospitals and clinics.
MeSH term(s)	Male ; Humans ; Middle Aged ; Aged ; Aged, 80 and over ; Warfarin/therapeutic use ; Atrial Fibrillation/complications ; Atrial Fibrillation/drug therapy ; Atrial Fibrillation/chemically induced ; Prospective Studies ; Anticoagulants/therapeutic use ; Hemorrhage/chemically induced ; Hemorrhage/epidemiology ; Hemorrhage/complications ; Stroke/epidemiology ; Stroke/etiology ; Stroke/prevention & control ; Risk Factors ; Registries ; Administration, Oral
Chemical Substances	Warfarin (5Q7ZVV76EI) ; Anticoagulants
Language	English
Publishing date	2022-09-13
Publishing country	Netherlands
Document type	Observational Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639364-0
ISSN	1876-4738 ; 0386-2887 ; 0914-5087
ISSN (online)	1876-4738
ISSN	0386-2887 ; 0914-5087
DOI	10.1016/j.jjcc.2022.08.012
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Zs.A 1794: Show issues

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Article ; Online: The Proportion of Long-term Response to Anti-N IgG Antibody after 12 Months for COVID-19 Subclinical Infections and a Longitudinal Survey for COVID-19 Subclinical Infections in 2021.

Matsuba, Ikuro / Takuma, Tetsuo / Hatori, Nobuo / Takai, Masahiko / Watanabe, Yoshiyuki / Takada, Nobukazu / Kishi, Satoru / Matsuzawa, Yoko / Nishikawa, Tetsuo / Kunishima, Tomoyuki / Degawa, Hisakazu / Nishikawa, Masanori / Ono, Yoshiaki / Miyakawa, Masaaki / Hatori, Yutaka / Kanamori, Akira

Internal medicine (Tokyo, Japan)

2022 Volume 61, Issue 20, Page(s) 3053–3062

Abstract: Objective To examine the continuation of antibody prevalence status after 12 months and background factors in antibody-positive subjects following asymptomatic infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods We ... ...

Abstract	Objective To examine the continuation of antibody prevalence status after 12 months and background factors in antibody-positive subjects following asymptomatic infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods We initially determined the SARS-CoV-2 anti-nucleocapsid protein immunoglobulin G (anti-N IgG) antibody prevalence in 1,603 patients, doctors, and nurses at 65 medical institutions in Kanagawa Prefecture, Japan. We then obtained consent from 33 of the 39 subjects who tested positive and performed follow-up for 12 months. Results Follow-up for up to 12 months showed that a long-term response of the anti-N IgG antibody could be detected in 6 of the 33 participants (18.2%). The proportions with hypertension, using an angiotensin-receptor blocker, and without a drinking habit were higher among the participants with a long-term anti-N IgG antibody response for up to 12 months than among those without a long-term antibody response. Conclusions The proportion of individuals with subclinical COVID-19 who continuously had a positive result for the anti-N IgG antibody at 12 months was low.
MeSH term(s)	Angiotensin Receptor Antagonists ; Antibodies, Viral/blood ; Asymptomatic Infections/epidemiology ; COVID-19/epidemiology ; COVID-19/immunology ; Coronavirus Nucleocapsid Proteins/immunology ; Humans ; Immunoglobulin G/blood ; Phosphoproteins/immunology ; SARS-CoV-2
Chemical Substances	Angiotensin Receptor Antagonists ; Antibodies, Viral ; Coronavirus Nucleocapsid Proteins ; Immunoglobulin G ; Phosphoproteins ; nucleocapsid phosphoprotein, SARS-CoV-2
Language	English
Publishing date	2022-08-10
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.9628-22
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Zs.A 240: Show issues

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Article ; Online: Heterogeneity assessment of vaccine-induced effects using point-of-care surrogate neutralization test for severe acute respiratory syndrome coronavirus 2.

Watanabe, Yoshiyuki / Matsuba, Ikuro / Watanabe, Karin / Kunishima, Tomoyuki / Takechi, Yukako / Takuma, Tetsuo / Araki, Yasushi / Hirotsu, Nobuo / Sakai, Hiroyuki / Oikawa, Ritsuko / Danno, Hiroki / Fukuda, Masakazu / Futagami, Seiji / Wada, Kota / Yamamoto, Hiroyuki / Itoh, Fumio / Oda, Ichiro / Hatori, Yutaka / Degawa, Hisakazu

Journal of clinical laboratory analysis

2022 Volume 36, Issue 7, Page(s) e24545

Abstract: Introduction: Coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic even after vaccination. We aimed to identify immunological heterogeneity over time in vaccinated healthcare ... ...

Abstract	Introduction: Coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic even after vaccination. We aimed to identify immunological heterogeneity over time in vaccinated healthcare workers using neutralization antibodies and neutralizing activity tests. Methods: Serum samples were collected from 214 healthcare workers before vaccination (pre) and on days 22, 90, and 180 after receiving the first dose of BNT162b2 vaccine (day 0). Neutralization antibody (NAb, SARS-CoV-2 S-RBD IgM/IgG) titers and two kinds of surrogate virus neutralization tests (sVNTs) were analyzed (UMIN000043851). Results: The NAb (SARS-CoV-2 S-RBD IgG) titer peaked on day 90 after vaccination (30,808.0 μg/ml ± 35,211; p < 0.0001) and declined on day 180 (11,678.0 μg/ml ± 33,770.0; p < 0.0001). The neutralizing activity also peaked on day 90 and declined with larger individual differences than those of IgG titer on day 180 (88.9% ± 15.0%, 64.8% ± 23.7%, p < 0.0001). We also found that the results of POCT-sVNT (immunochromatography) were highly correlated with those of conventional sVNT (ELISA). Conclusions: Neutralizing activity is the gold standard for vaccine efficacy evaluation. Our results using conventional sVNT showed large individual differences in neutralizing activity reduction on day 180 (64.8% ± 23.7%), suggesting an association with the difference in vaccine efficacy. POCT-sVNT is rapid and user-friendly; it might be used for triage in homes, isolation facilities, and event venues without restrictions on the medical testing environment.
MeSH term(s)	Antibodies, Viral ; BNT162 Vaccine ; COVID-19/epidemiology ; COVID-19/prevention & control ; Humans ; Immunoglobulin G ; Neutralization Tests ; Point-of-Care Systems ; SARS-CoV-2 ; Vaccines
Chemical Substances	Antibodies, Viral ; Immunoglobulin G ; Vaccines ; BNT162 Vaccine (N38TVC63NU)
Language	English
Publishing date	2022-06-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	645095-7
ISSN	1098-2825 ; 0887-8013
ISSN (online)	1098-2825
ISSN	0887-8013
DOI	10.1002/jcla.24545
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Zs.A 2471: Show issues

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Article ; Online: Time-series transcriptome analysis of peripheral blood mononuclear cells obtained from individuals who received the SARS-CoV-2 mRNA vaccine.

Journal of medical virology

2023 Volume 95, Issue 6, Page(s) e28884

Abstract: Messenger ribonucleic acid (mRNA) vaccination against coronavirus disease 2019 (COVID-19) is an effective prevention strategy, despite a limited understanding of the molecular mechanisms underlying the host immune system and individual heterogeneity of ... ...

Abstract	Messenger ribonucleic acid (mRNA) vaccination against coronavirus disease 2019 (COVID-19) is an effective prevention strategy, despite a limited understanding of the molecular mechanisms underlying the host immune system and individual heterogeneity of the variable effects of mRNA vaccination. We assessed the time-series changes in the comprehensive gene expression profiles of 200 vaccinated healthcare workers by performing bulk transcriptome and bioinformatics analyses, including dimensionality reduction utilizing the uniform manifold approximation and projection (UMAP) technique. For these analyses, blood samples, including peripheral blood mononuclear cells (PBMCs), were collected from 214 vaccine recipients before vaccination (T1) and on Days 22 (T2, after second dose), 90, 180 (T3, before a booster dose), and 360 (T4, after a booster dose) after receiving the first dose of BNT162b2 vaccine (UMIN000043851). UMAP successfully visualized the main cluster of gene expression at each time point in PBMC samples (T1-T4). Through differentially expressed gene (DEG) analysis, we identified genes that showed fluctuating expression levels and gradual increases in expression levels from T1 to T4, as well as genes with increased expression levels at T4 alone. We also succeeded in dividing these cases into five types based on the changes in gene expression levels. High-throughput and temporal bulk RNA-based transcriptome analysis is a useful approach for inclusive, diverse, and cost-effective large-scale clinical studies.
MeSH term(s)	Humans ; COVID-19 Vaccines ; Transcriptome ; Leukocytes, Mononuclear ; SARS-CoV-2/genetics ; BNT162 Vaccine ; COVID-19/prevention & control ; RNA, Messenger/genetics ; Gene Expression Profiling ; Vaccination ; Antibodies, Viral ; mRNA Vaccines
Chemical Substances	COVID-19 Vaccines ; BNT162 Vaccine ; RNA, Messenger ; Antibodies, Viral
Language	English
Publishing date	2023-05-23
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	752392-0
ISSN	1096-9071 ; 0146-6615
ISSN (online)	1096-9071
ISSN	0146-6615
DOI	10.1002/jmv.28884
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Zs.A 1320: Show issues

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Article ; Online: Study on Continuation of Antibody Prevalence Six Months after Detection of Subclinical Severe Acute Respiratory Syndrome Coronavirus 2 Infections.

Internal medicine (Tokyo, Japan)

2021 Volume 61, Issue 2, Page(s) 159–165

Abstract: Objective To examine the continuation of antibody prevalence and background factors in antibody-positive subjects after asymptomatic infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods A study was carried out to ... ...

Abstract	Objective To examine the continuation of antibody prevalence and background factors in antibody-positive subjects after asymptomatic infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods A study was carried out to investigate the SARS-CoV-2 antibody (IgG) prevalence. SARS-CoV-2 antibodies (IgG) were measured and analyzed with immunochromatographic tests. Patients Among 1,603 subjects, comprising patients, physicians, and nurses at 65 medical institutes in Kanagawa, Japan, 39 antibody-positive subjects received follow-up for 6 months. Results Of the 33 subjects who consented to the follow-up (23 patients and 10 medical professionals), continued positivity of IgG antibodies was confirmed in 11 of 32 cases (34.4%) after 2 months, 8 of 33 (24.2%) after 4 months, and 8 of 33 (24.2%) after 6 months. A significant difference was found in the sleeping time, drinking habits, hypertension, and use of angiotensin-receptor blockers on comparing subject background characteristics among three groups: patients with antibody production that continued for six months after the first detection of positivity, patients in whom antibody production stopped at four months, and patients in whom antibody production stopped at two months. Conclusion The continuation rate of IgG antibody prevalence was 24.2% at 6 months after the first detection of antibody positivity in cases with asymptomatic coronavirus disease 2019 (COVID-19) infections. This percentage is low compared with the antibody continuation rate in patients who have recovered from symptomatic COVID-19 infection.
MeSH term(s)	Antibodies, Viral ; COVID-19 ; Humans ; Immunoglobulin G ; Immunoglobulin M ; Prevalence ; SARS-CoV-2
Chemical Substances	Antibodies, Viral ; Immunoglobulin G ; Immunoglobulin M
Language	English
Publishing date	2021-11-06
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.8019-21
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Zs.A 240: Show issues

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Article: Rationale and design of ASSAF-K (A study of the safety and efficacy of anticoagulant therapy in the treatment of atrial fibrillation in Kanagawa).

Hatori, Yutaka / Sakai, Hiroyuki / Kunishima, Tomoyuki / Hatori, Nobuo / Chen, Lin / Ishigami, Tomoaki / Satoh, Naoki

Journal of arrhythmia

2016 Volume 33, Issue 2, Page(s) 111–116

Abstract: Background: Atrial fibrillation (AF) is one of the most prevalent cardiac arrhythmias associated with substantially increased risks of ischemic stroke and thromboembolism. Oral anticoagulants (OACs) are the cornerstone of AF management and effectively ... ...

Abstract	Background: Atrial fibrillation (AF) is one of the most prevalent cardiac arrhythmias associated with substantially increased risks of ischemic stroke and thromboembolism. Oral anticoagulants (OACs) are the cornerstone of AF management and effectively prevent AF-related stroke. As new non-vitamin K antagonist OACs (NOACs) have become available, the landscape of stroke prevention in AF has changed. However, there are considerable gaps between daily clinical practice and current guideline-based recommendations for anticoagulant therapy in Japan. Consequently, little is known about the real-world setting and the current use of NOACs, especially by practitioners in Japan. Methods: We conducted a prospective, observational study in 3847 patients with AF who were enrolled in clinics and hospitals located in Kanagawa Prefecture from September 2013 through March 2015. The participating centers included practitioners (small clinics), medium-sized hospitals, and university hospitals. The primary endpoints were epidemiologic characteristics, status of treatment with anticoagulants and antiplatelet agents, outcomes, and adverse events, including cerebrovascular disease, bleeding, and death. Results: The mean CHADS2 score was 1.81±1.27, the mean CHADS2-Vasc score was 3.02±1.58, and the mean HAS-BLED score was 2.23±1.06, respectively. The usage rate of warfarin was 44.2% overall, and the usage rate of NOACs was 33.5%. Conclusions: The results of the study are expected to serve as the basis for providing clinical practice guidance to healthcare institutions in Japan, with the ultimate goals of better characterizing the appropriate use of OACs and providing clinical decision support to physicians to facilitate the design of appropriate therapeutic strategies and the selection of anticoagulants for the management of AF.
Language	English
Publishing date	2016-08-23
Publishing country	Japan
Document type	Journal Article
ZDB-ID	2696593-8
ISSN	1883-2148 ; 1880-4276
ISSN (online)	1883-2148
ISSN	1880-4276
DOI	10.1016/j.joa.2016.07.008
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Article ; Online: Survey of the current status of subclinical coronavirus disease 2019 (COVID-19).

Matsuba, Ikuro / Hatori, Nobuo / Koido, Norihiko / Watanabe, Yoshiyuki / Ebara, Futoshi / Matsuzawa, Yoko / Nishikawa, Tetsuo / Kunishima, Tomoyuki / Degawa, Hisakazu / Nishikawa, Masanori / Ono, Yoshiaki / Kanamori, Akira

Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy

2020 Volume 26, Issue 12, Page(s) 1294–1300

Abstract: Objectives: We investigated relationships between subclinical COVID-19 (coronavirus disease 2019) and background factors.: Methods: We determined SARS-CoV-2 antibody (IgG) prevalence in 1603 patients, doctors, and nurses in 65 medical institutions in ...

Abstract	Objectives: We investigated relationships between subclinical COVID-19 (coronavirus disease 2019) and background factors. Methods: We determined SARS-CoV-2 antibody (IgG) prevalence in 1603 patients, doctors, and nurses in 65 medical institutions in Kanagawa Prefecture, Japan and investigated their background factors. Antibodies (IgG) against SARS-CoV-2 were analyzed by Immunochromatographic test. Results: The 39 subjects (2.4%) were found to be IgG antibody-positive: 29 in the patient group (2.9%), 10 in the doctor/nurse group (2.0%), and 0 in the control group. After adjustment for age, sex, and the antibody prevalence in the control group, antibody prevalence was 2.7% in the patient group and 2.1% in the doctor/nurse group. There was no significant difference between the antibody-positive subjects and the antibody-negative subjects in any background factors investigated including overseas travel, contact with overseas travelers, presence/absence of infected individuals in the living area, use of trains 5 times a week or more, BCG vaccination, and use of ACE inhibitor and ARB. Conclusions: Antibody prevalence in the present survey at medical institution is higher than that in Tokyo and in Osaka measured by the government suggesting that subclinical infections are occurring more frequently than expected. No background factor that influenced antibody-positive status due to subclinical infection was identified.
MeSH term(s)	Adult ; Aged ; Antibodies, Viral/isolation & purification ; Asymptomatic Infections/epidemiology ; Betacoronavirus/immunology ; COVID-19 ; Chromatography, Affinity ; Coronavirus Infections/epidemiology ; Coronavirus Infections/immunology ; Female ; Humans ; Immunoglobulin G/isolation & purification ; Japan/epidemiology ; Male ; Middle Aged ; Pandemics ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/immunology ; SARS-CoV-2 ; Surveys and Questionnaires
Chemical Substances	Antibodies, Viral ; Immunoglobulin G
Keywords	covid19
Language	English
Publishing date	2020-09-06
Publishing country	Netherlands
Document type	Journal Article ; Multicenter Study
ZDB-ID	1355399-9
ISSN	1437-7780 ; 1341-321X
ISSN (online)	1437-7780
ISSN	1341-321X
DOI	10.1016/j.jiac.2020.09.005
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Zs.A 5236: Show issues

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Article ; Online: Association between acute myocardial infarction-to-cardiac rupture time and in-hospital mortality risk: a retrospective analysis of multicenter registry data from the Cardiovascular Research Consortium-8 Universities (CIRC-8U).

Yoneyama, Kihei / Ishibashi, Yuki / Koeda, Yorihiko / Itoh, Tomonori / Morino, Yoshihiro / Shimohama, Takao / Ako, Junya / Ilari, Yuji / Yoshioka, Koichiro / Kunishima, Tomoyuki / Inami, Shu / Ishikawa, Tetsuya / Sugimura, Hiroyuki / Kozuma, Ken / Sugi, Keiki / Yoshino, Hideaki / Akashi, Yoshihiro J

Heart and vessels

2021 Volume 36, Issue 6, Page(s) 782–789

Abstract: Despite the known association of cardiac rupture with acute myocardial infarction (AMI), it is still unclear whether the clinical characteristics are associated with the risk of in-hospital mortality in patients with AMI complicated by cardiac rupture. ... ...

Abstract	Despite the known association of cardiac rupture with acute myocardial infarction (AMI), it is still unclear whether the clinical characteristics are associated with the risk of in-hospital mortality in patients with AMI complicated by cardiac rupture. The purpose of this study was to investigate the association between the time of cardiac rupture occurrence and the risk of in-hospital mortality after AMI. We conducted a retrospective analysis of multicenter registry data from eight medical universities in Eastern Japan. From 10,278 consecutive patients with AMI, we included 183 patients who had cardiac rupture after AMI, and examined the incidence of in-hospital deaths during a median follow-up of 26 days. Patients were stratified into three groups according to the AMI-to-cardiac rupture time, namely the > 24-h group (n = 111), 24-48-h group (n = 20), and < 48-h group (n = 52). Cox proportional hazards regression analysis was used to estimate the hazard ratio (HR) and the confidence interval (CI) for in-hospital mortality. Around 87 (48%) patients experienced in-hospital death and 126 (67%) underwent a cardiac surgery. Multivariable Cox regression analysis revealed a non-linear association across the three groups for mortality (HR [CI]; < 24 h: 1.0, reference; 24-48 h: 0.73 [0.27-1.86]; > 48 h: 2.25 [1.22-4.15]) after adjustments for age, sex, Killip classification, percutaneous coronary intervention, blood pressure, creatinine, peak creatine kinase myocardial band fraction, left ventricular ejection fraction, and type of rupture. Cardiac surgery was independently associated with a reduction in the HR of mortality (HR [CI]: 0.27 [0.12-0.61]) and attenuated the association between the three AMI-to-cardiac rupture time categories and mortality (statistically non-significant) in the Cox model. These data suggest that the AMI-to-cardiac rupture time contributes significantly to the risk of in-hospital mortality; however, rapid diagnosis and prompt surgical interventions are crucial for improving outcomes in patients with cardiac rupture after AMI.
MeSH term(s)	Aged ; Biomedical Research ; Female ; Follow-Up Studies ; Heart Rupture, Post-Infarction/diagnosis ; Heart Rupture, Post-Infarction/epidemiology ; Heart Rupture, Post-Infarction/physiopathology ; Hospital Mortality/trends ; Humans ; Incidence ; Japan/epidemiology ; Male ; Myocardial Infarction/diagnosis ; Myocardial Infarction/mortality ; Registries ; Retrospective Studies ; Risk Assessment/methods ; Risk Factors ; Stroke Volume/physiology ; Survival Rate/trends ; Time Factors ; Universities
Language	English
Publishing date	2021-01-16
Publishing country	Japan
Document type	Journal Article ; Multicenter Study
ZDB-ID	89678-0
ISSN	1615-2573 ; 0910-8327 ; 0935-736X
ISSN (online)	1615-2573
ISSN	0910-8327 ; 0935-736X
DOI	10.1007/s00380-020-01762-2
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Zs.A 2049: Show issues

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Article: Effects of sitagliptin on coronary atherosclerosis in patients with type 2 diabetes-A serial integrated backscatter-intravascular ultrasound study.

Nozue, Tsuyoshi / Fukui, Kazuki / Koyama, Yutaka / Fujii, Hiroyuki / Kunishima, Tomoyuki / Hikita, Hiroyuki / Hibi, Kiyoshi / Miyazawa, Akiyoshi / Michishita, Ichiro

American journal of cardiovascular disease

2016 Volume 6, Issue 4, Page(s) 153–162

Abstract: Dipeptidyl peptidase-4 (DPP-4) inhibitors have demonstrated anti-inflammatory and anti-atherogenic effects in an animal model. However, the clinical usefulness of DPP-4 inhibitors, particularly its effects on coronary atherosclerosis, has not been ... ...

Abstract	Dipeptidyl peptidase-4 (DPP-4) inhibitors have demonstrated anti-inflammatory and anti-atherogenic effects in an animal model. However, the clinical usefulness of DPP-4 inhibitors, particularly its effects on coronary atherosclerosis, has not been evaluated thus far. Therefore, in this study, we evaluated the effects of sitagliptin, a DPP-4 inhibitor, on coronary atherosclerosis using integrated backscatter (IB)-intravascular ultrasound (IVUS) in patients with type 2 diabetes. This trial was a prospective, open-labeled, randomized, multicenter study. Twenty-eight patients with type 2 diabetes who underwent elective percutaneous coronary intervention (PCI) were randomly assigned to either the sitagliptin group (group S) or the control group (group C). Non-PCI lesions were evaluated using IB-IVUS at the time of PCI and at the 48-week follow-up. The primary endpoint was the percentage change in plaque volume measured using grayscale IVUS, and the secondary endpoint was changes in plaque composition evaluated using IB-IVUS. Grayscale IVUS analysis demonstrated that plaque volume tended to decrease in both groups (group S: -1.7±8.5%; group C: -3.2±12.2%), but a between-group difference was not observed. A decrease in the lipid plaque volume (group S: from 200.1±116.2 to 179.8±121.0 mm
Language	English
Publishing date	2016-11-30
Publishing country	United States
Document type	Journal Article
ZDB-ID	2616844-3
ISSN	2160-200X
ISSN	2160-200X
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Article ; Online: Effects of sitagliptin on coronary atherosclerosis evaluated using integrated backscatter intravascular ultrasound in patients with type 2 diabetes: rationale and design of the TRUST study.

Nozue, Tsuyoshi / Fukui, Kazuki / Koyama, Yutaka / Fujii, Hiroyuki / Kunishima, Tomoyuki / Hikita, Hiroyuki / Hibi, Kiyoshi / Miyazawa, Akiyoshi / Michishita, Ichiro

Heart and vessels

2016 Volume 31, Issue 5, Page(s) 649–654

Abstract: Patients with diabetes mellitus are at high risk for developing coronary artery disease (CAD), even if they are treated with statins. Several studies have shown the beneficial effects of dipeptidyl peptidase-4 (DPP-4) inhibitors on the cardiovascular ... ...

Abstract	Patients with diabetes mellitus are at high risk for developing coronary artery disease (CAD), even if they are treated with statins. Several studies have shown the beneficial effects of dipeptidyl peptidase-4 (DPP-4) inhibitors on the cardiovascular system in an animal model. However, recent clinical trials using DPP-4 inhibitors have shown that these inhibitors fail to reduce the occurrence of cardiovascular events. Therefore, this study will be performed to evaluate the effects of sitagliptin, a DPP-4 inhibitor, on coronary atherosclerosis in patients with type 2 diabetes. This study will be a prospective, open-label, randomized multicenter trial performed in 6 centers in Japan. Stable CAD patients with type 2 diabetes who have undergone successful percutaneous coronary intervention under integrated backscatter (IB)-intravascular ultrasound (IVUS) guidance will be studied. They will be randomly assigned to either the sitagliptin group or a control group. After 48 weeks' treatment, the IVUS examination will be repeated in the same coronary artery as at baseline. The primary end point will be the percentage change in plaque volume measured using grayscale IVUS from baseline to the 48-week follow-up. This study will be the first multicenter trial to evaluate the effects of a DPP-4 inhibitor on coronary atherosclerosis evaluated using IB-IVUS, and the findings will clarify the anti-atherogenic effects of sitagliptin.
MeSH term(s)	Clinical Protocols ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/etiology ; Coronary Artery Disease/therapy ; Coronary Vessels/diagnostic imaging ; Coronary Vessels/drug effects ; Coronary Vessels/pathology ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/diagnosis ; Diabetes Mellitus, Type 2/drug therapy ; Diabetic Angiopathies/diagnostic imaging ; Diabetic Angiopathies/etiology ; Diabetic Angiopathies/therapy ; Dipeptidyl-Peptidase IV Inhibitors/therapeutic use ; Humans ; Incretins/therapeutic use ; Japan ; Percutaneous Coronary Intervention ; Plaque, Atherosclerotic ; Predictive Value of Tests ; Prospective Studies ; Research Design ; Sitagliptin Phosphate/therapeutic use ; Time Factors ; Treatment Outcome ; Ultrasonography, Interventional/methods
Chemical Substances	Dipeptidyl-Peptidase IV Inhibitors ; Incretins ; Sitagliptin Phosphate (TS63EW8X6F)
Language	English
Publishing date	2016-05
Publishing country	Japan
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	89678-0
ISSN	1615-2573 ; 0910-8327 ; 0935-736X
ISSN (online)	1615-2573
ISSN	0910-8327 ; 0935-736X
DOI	10.1007/s00380-015-0662-4
Database	MEDical Literature Analysis and Retrieval System OnLINE

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