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Azuma A.,Nippon Medical School | Taguchi Y.,Tenri Hospital | Ogura T.,Kanagawa Cardiovascular and Respiratory Center | Ebina M.,Tohoku University | And 8 more authors.
Respiratory Research | Year: 2011

Background: A phase III trial in Japan showed that pirfenidone is effective for idiopathic pulmonary fibrosis (IPF). To find out which patients specifically benefit from pirfenidone, we analyzed in an exploratory manner the data from the phase III trial.Methods: The patients in the phase III trial were stratified by baseline percentage predicted vital capacity (%VC), arterial oxygen partial pressure (PaO2), and the lowest oxygen saturation by pulse oximetry (SpO2) during the 6-minute steady-state exercise test (6MET). In the subpopulations, changes in VC and subjective symptoms (cough and dyspnea on the Fletcher, Hugh-Jones [F, H-J] Classification scale) were evaluated in patients treated with high-dose (1800 mg/day) pirfenidone, low-dose (1200 mg/day) pirfenidone, and placebo at week 52.Results: Significant efficacy of pirfenidone in reducing the decline in VC could be seen in a subpopulation having %VC ≥ 70% and SpO2 < 90% at baseline. This favorable effect was accompanied by categorical change in VC and progression-free survival time. In the subpopulation, pirfenidone significantly suppressed cough and dyspnea.Conclusions: IPF patients having %VC ≥ 70% and SpO2 < 90% at baseline will most likely benefit from pirfenidone when evaluated using changes in VC (and %VC), and cough and dyspnea symptoms. This subpopulation could expect to benefit most from pirfenidone treatment.Trial Registration: This clinical trial was registered with the Japan Pharmaceutical Information Center (JAPIC) on September 13th, 2005 (Registration Number: JAPICCTI-050121). © 2011 Azuma et al; licensee BioMed Central Ltd.


Taniguchi H.,Tosei General Hospital | Kondoh Y.,Tosei General Hospital | Ebina M.,Tohoku University | Azuma A.,Nippon Medical School | And 9 more authors.
Respiratory Research | Year: 2011

Background: Our phase III clinical trial of pirfenidone for patients with idiopathic pulmonary fibrosis (IPF) revealed the efficacy in reducing the decline of vital capacity (VC) and increasing the progression-free survival (PFS) time by pirfenidone. Recently, marginal decline in forced VC (FVC) has been reported to be associated with poor outcome in IPF. We sought to evaluate the efficacy of pirfenidone from the aspects of 5% change in VC.Methods: Improvement ratings based on 5% change in absolute VC, i.e., "improved (VC ≥ 5% increase)", "stable (VC < 5% change)", and "worsened (VC ≥ 5% decrease)" at month 3, 6, 9 and 12 were compared between high-dose pirfenidone (1800 mg/day; n = 108) and placebo (n = 104) groups, and (high-dose and low-dose (1200 mg/day; n = 55)) pirfenidone (n = 163) and placebo groups. PFS times with defining the disease progression as death or a ≥ 5% decline in VC were also compared between high-dose pirfenidone and placebo groups, and low-dose pirfenidone and placebo groups. Furthermore, considering "worsened" and "non-worsened (improved and stable)" of the ratings at months 3 and 12 as "positive" and "negative", respectively, and the positive and negative predictive values of the ratings were calculated in each group.Results: In the comparison of the improvement ratings, the statistically significant differences were clearly revealed at months 3, 6, 9, and 12 between pirfenidone and placebo groups. Risk reductions by pirfenidone to placebo were approximately 35% over the study period. In the comparison of the PFS times, statistically significant difference was also observed between pirfenidone and placebo groups. The positive/negative predictive values in placebo and pirfenidone groups were 86.1%/50.8% and 87.1%/71.7%, respectively. Further, the baseline characteristics of patients worsened at month 3 had generally severe impairment, and their clinical outcomes including mortality were also significantly worsened after 1 year.Conclusions: The efficacy of pirfenidone in Japanese phase III trial was supported by the rating of 5% decline in VC, and the VC changes at month 3 may be used as a prognostic factor of IPF.Trial Registration: This clinical trial was registered with the Japan Pharmaceutical Information Center (JAPIC) on September 13th, 2005 (Registration Number: JAPICCTI-050121). © 2011 Taniguchi et al; licensee BioMed Central Ltd.


Kurashina T.,Jichi Medical University | Nagasaka S.,Jichi Medical University | Watanabe N.,Yodogawa Christian Hospital | Yabe D.,Kansai Electric Power Co. | And 8 more authors.
Journal of Atherosclerosis and Thrombosis | Year: 2014

Aim: Chronic kidney disease (CKD) is associated with cardiovascular events. Tumor necrosis factor (TNF) and/or its receptors have been postulated to be involved in renal pathophysiology. It is unclear whether an increased TNF system activity is present before the development of apparent CKD. Methods: Four hundred and twenty non-diabetic Japanese subjects with an estimated GFR (eGFR) greater than 60 ml/min/1.73 m2 were recruited for measurement of the HbA1c, insulin, TNF system activity (TNF-α, soluble TNF receptor 1 (sTNF-R1) and sTNF-R2) levels and various parameters, including the lipid, high-sensitivity C-reactive protein (hsCRP), high-molecular-weight (HMW) adiponectin and leptin levels. The subjects were stratified according to the eGFR: the G1 level (eGFR ≥90 ml/min/1.73 m2) and the G2 level (90


PubMed | Kanagawa Cardiovascular and Respiratory Center, Hamamatsu University School of Medicine, National Hospital Organization, Enshu Hospital and 4 more.
Type: Journal Article | Journal: The clinical respiratory journal | Year: 2015

Idiopathic pulmonary fibrosis (IPF) is a fatal disorder without specific treatments. Although the efficacy of intravenous immunoglobulin (IVIG) therapy for autoimmune diseases has been reported, that for IPF remains unknown. This study aims to determine the efficacy and safety of IVIG for IPF.In an exploratory, multicenter, non-randomized and prospective trial, patients with progressive IPF were enrolled. Patients were treated with IVIG for five consecutive days (5-day IVIG) or once monthly for five consecutive months (5-month IVIG). Changes in the vital capacity (VC), diffusion capacity of the lung for carbon monoxide (DLCO), 6-min walk test (6MWT) and high-resolution computed tomography (HRCT) findings were evaluated.A total of 10 patients with IPF were treated with IVIG: 6 were in 5-day IVIG and 4 were in 5-month IVIG group. In 5-day IVIG group, the treatment effects were temporal, and physiological and HRCT findings deteriorated in three of six patients. In 5-month IVIG group, changes in %VC, %DLCO and walk distance in 6MWT at 6 months were -0.95.3%, 6.912.6% and 7958m (meanstandard deviation), respectively, and the treatment effects were long lasting. The change in VC 6 months after starting IVIG was smaller than that of 6-12 months after starting IVIG (after cessation of IVIG) (-0.020.15 vs -0.330.14L, P=0.022). Ground glass opacities were diminished in two of four patients. Adverse events were mild and tolerable.This preliminary study shows that once-monthly IVIG treatment may be effective and tolerable in patients with IPF.


Nagayasu S.,Hiroshima University | Suzuki S.,Hiroshima University | Yamashita A.,Hiroshima University | Taniguchi A.,Kyoto Preventive Medical Center | And 7 more authors.
Tobacco Induced Diseases | Year: 2012

Background: The effect of smoking on leptin regulation is controversial. Smoking may induce low-grade inflammation. Recent series of studies indicated the critical role of macrophage migration in the establishment of adipose tissue inflammation. In this study, we aimed to see the effects of smoking and inflammation on leptin regulation both at cellular and epidemiological levels. Methods. We compared the concentration of inflammatory markers and serum leptin levels among Japanese male subjects. Additionally, leptin and intercellular adhesion molecule (ICAM) -1 gene expression was assessed in adipocytes co-cultured with or without macrophages in the presence or absence of nicotine and/or lipopolysaccharide (LPS). Results: In subjects with BMI below 25 kg/m 2, both WBC counts and soluble-ICAM-1 levels are significantly higher in smokers than in non-smokers. However, leptin concentration did not differ according to smoking status. However, in subjects with BMI over 25 kg/m 2, smokers exhibited significantly lower serum leptin level as well as higher WBC counts and s-ICAM-1 concentration as compared with non-smokers. Leptin gene expression was markedly suppressed in adipocytes co-cultured with macrophages than in adipocyte culture alone. Furthermore, nicotine further suppressed leptin gene expression. ICAM-1 gene expression was markedly up-regulated in adipocytes co-cultured with macrophages when stimulated with LPS. Conclusions: Adipose tissue inflammation appears to down-regulate leptin expression in adipose tissues. Nicotine further suppresses leptin expression. Thus, both smoking and inflammation may diminish leptin effect in obese subjects. Therefore, obese, but not normal weight, smokers might be more resistant to weight loss than non-smokers. © 2012 Nagayasu et al; licensee BioMed Central Ltd.


PubMed | Saiseikai Noe Hospital, Kyoto Institute of Health Science, Okayama Prefectural University, St Lukes International Hospital and 3 more.
Type: | Journal: Journal of diabetes research | Year: 2016

To investigate the characteristics of isolated impaired glucose tolerance (IGT) and isolated impaired fasting glucose (IFG), we analyzed the factors responsible for elevation of 2-hour postchallenge plasma glucose (2 h PG) and fasting plasma glucose (FPG) levels.We investigated the relationship between 2 h PG and FPG levels who underwent 75 g OGTT in 5620 Japanese subjects at initial examination for medical check-up. We compared clinical characteristics between isolated IGT and isolated IFG and analyzed the relationships of 2 h PG and FPG with clinical characteristics, the indices of insulin secretory capacity, and insulin sensitivity.In a comparison between isolated IGT and isolated IFG, insulinogenic index was lower in isolated IGT than that of isolated IFG (0.43 0.34 versus 0.50 0.47, resp.; p < 0.01). ISI composite was lower in isolated IFG than that of isolated IGT (6.87 3.38 versus 7.98 4.03, resp.; p < 0.0001). In isolated IGT group, insulinogenic index showed a significant correlation with 2 h PG (r = -0.245, p < 0.0001) and had the strongest correlation with 2 h PG ( = -0.290). In isolated IFG group, ISI composite showed a significant correlation with FPG (r = -0.162, p < 0.0001) and had the strongest correlation with FPG ( = -0.214).We have elucidated that decreased early-phase insulin secretion is the most important factor responsible for elevation of 2 h PG levels in isolated IGT subjects, and decreased insulin sensitivity is the most important factor responsible for elevation of FPG levels in isolated IFG subjects.


Nakai Y.,Kyoto Institute of Health science | Nin K.,Kyoto University | Fukushima M.,Okayama Prefectural University | Nakamura K.,Otemon Gakuin University | And 4 more authors.
European Eating Disorders Review | Year: 2014

The aim of the present study was to provide normative data for the Eating Disorder Examination Questionnaire (EDE-Q) among undergraduate Japanese women and to compare these data to norms obtained from previous studies. Undergraduate Japanese women (n = 289), aged 18-24 years, were administered the EDE-Q. The mean global score in the present study was 1.55 (SD = 1.03). Japanese women reported significantly higher scores of shape concern and weight concern in spite of lower body mass index but a significantly lower score of restraint, compared with women in other normative studies. There were significant differences with respect to the occurrence of some specific eating disorder behaviours between Japanese women and women in the previous studies. Differences in normative data for the EDE-Q between young Japanese women and young women in the previous studies suggest that there may be certain cultural differences in eating disorder psychopathology. Copyright © 2014 John Wiley & Sons, Ltd and Eating Disorders Association.


Nakai Y.,Kyoto Institute of Health science | Fukushima M.,Okayama Prefectural University | Taniguchi A.,Kyoto Preventive Medical Center | Nin K.,Kyoto University | Teramukai S.,Kyoto University
European Eating Disorders Review | Year: 2013

Objective The purpose of this study was to compare the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) and the proposed Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnostic criteria in terms of the number of cases of eating disorder not otherwise specified (EDNOS) and to see which diagnostic system can effectively capture variance in psychiatric symptoms in a Japanese sample. Method One thousand and twenty-nine women with an eating disorder (ED) participated in this study. Assessment methods included structured clinical interviews and administration of the Eating Attitudes Test and the Eating Disorder Inventory. Results Relaxing the diagnostic criteria for anorexia nervosa and bulimia nervosa and recognizing binge ED decreased the proportion of EDNOS (from 45.1% to 26.1%). The DSM-5 categorization of patients was better able to capture variance in psychopathology scales. Conclusions The proposed revisions to EDs in the DSM-5 partially reduced reliance on EDNOS. The DSM-5 may differentiate ED groups more effectively than the DSM-IV. © 2012 John Wiley & Sons, Ltd and Eating Disorders Association.


Nakai Y.,Kyoto Institute of Health science | Nin K.,Kyoto University | Teramukai S.,Kanazawa University | Taniguchi A.,Kyoto Preventive Medical Center | And 2 more authors.
International Journal of Eating Disorders | Year: 2014

Objective We examined the existence of nonfat-phobic anorexia nervosa (NFP-AN) and fat-phobic AN, with no evidence of distortions related to body shape and weight (AN-NED), in a Japanese sample and studied eating disorder pathology and psychopathology in NFP-AN and AN-NED. Method The study participants were 200 (52.2%) women with typical AN, 86 (22.5%) women with NFP-AN, and 97 (25.3%) women with AN-NED. Diagnosis of the three types of AN was made by structured clinical interviews. The Eating Attitudes Test (EAT) and the Eating Disorder Inventory (EDI) were administered to all the participants. Results There were significant differences among the three groups in terms of duration of illness, maximum and minimum BMIs and AN subtypes. There was no transition from the NFP-AN and AN-NED groups to the typical AN group during the 2- to 7-year follow-up period. There were significant differences among the three groups in scores of the EAT, the EDI total, and all the subscales of the EDI. Discussion Besides typical AN, there were two types of atypical AN in terms of fat phobia and body image disturbance in this Japanese sample. The findings of the current study suggest that there may be significant differences among the three groups in terms of eating disorder pathology and psychopathology. Copyright © 2013 Wiley Periodicals, Inc.


Nakai Y.,Kyoto Institute of Health science | Nin K.,Kyoto University | Teramukai S.,Kanazawa University | Taniguchi A.,Kyoto Preventive Medical Center | And 2 more authors.
Eating Behaviors | Year: 2013

The purposes of this study were to compare DSM-IV diagnostic criteria and the Broad Categories for the Diagnosis of Eating Disorders (BCD-ED) scheme in terms of the number of cases of Eating Disorder Not Otherwise Specified (EDNOS) and to test which diagnostic tool better captures the variance of psychiatric symptoms in a Japanese sample. One thousand and twenty-nine women with an eating disorder (ED) participated in this study. Assessment methods included structured clinical interviews and administration of the Eating Attitudes Test and the Eating Disorder Inventory. The BCD-ED scheme dramatically decreased the proportion of DSM-IV EDNOS from 45.1% to 1.5%. However, the categorization of patients with the BCD-ED scheme was less able to capture the variance in psychopathology scales than the DSM-IV, suggesting that the BCD-ED scheme may differentiate ED groups less effectively than the DSM-IV. These results suggest that the BCD-ED scheme may have the potential to eliminate the use of DSM-IV EDNOS, but it may have problems capturing the variance of psychiatric symptoms. © 2013 Elsevier Ltd.

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