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Background: Polypharmacy (PP) is common in end-stage chronic renal disease patients largely due to the presence of multiple comorbid conditions. Although PP is potentially harmful, its relationship with mortality and morbidity in hemodialysis patients currently remains unclear. Methods: Study design: cohort study. Setting: participants: one hundred and fifty-two initial hemodialysis patients (male, 88 patients; mean age, 70.3 years) were enrolled between February 2015 and March 2018 at Nobeoka Prefectural Hospital and Chiyoda Hospital. Predictor: patients were divided into 2 groups according to PP (6 or more drug prescriptions or less) during admission and discharge for the initiation of hemodialysis. Outcomes: all-cause mortality and hospitalization during the mean 2.8-year follow-up. Measurements: hazard ratios (HRs) were estimated using Cox's model for the relationships between PP and clinical outcomes and adjusted for potential confounders. The group with 5 or less drug prescriptions was set as a reference. Results: The number of prescribed drugs per patient averaged 7.4 at admission and 7.0 at discharge for initial hemodialysis. One hundred (65.8%) and 94 patients (61.8%) had PP at admission and discharge, respectively. During the follow-up, 20 patients died and 71 were hospitalized. PP at admission did not correlate with outcomes, whereas that at discharge correlated with all-cause hospitalization. Conclusions: PP at discharge may be associated with clinical outcomes. However, it remains unclear whether PP is the direct cause of outcomes or is simply a marker for an increased risk of outcomes. [ABSTRACT FROM AUTHOR]

Background/Aims: Uric acid (UA) levels are affected by changes in dialysis; however, the relationship between the pre- and postdialysis UA difference (UAD) and mortality remains unclear. Methods: A total of 1,073 patients receiving maintenance hemodialysis (HD) were enrolled in this cohort study and followed up for 5 years. Patients were divided into quartile categories according to baseline UAD. Cox's regression analyses were used to investigate the relationship between UAD categories and all-cause and cardiovascular (CV) mortalities while adjusting for potential confounders. Results: A total of 280 patients died of all causes, including 121 CV deaths, during the follow-up. In the analysis for all-cause mortality, hazard ratios were significantly higher in the lowest UAD group (< 4.7 mg/dL) than in the highest UAD group (> 6.2 mg/dL). A correlation was not observed with CV mortality. Conclusion: UAD correlated with all-cause mortality. UAD may be the most appropriate reference for controlling UA in HD patients. [ABSTRACT FROM AUTHOR]

N-terminal-pro-B-type-natriuretic peptide (NT-proBNP) was a predictive marker of cardiovascular disease (CVD)-related death in chronic dialysis patients. NT-proBNP was also correlated with markers of inflammation, malnutrition and protein-energy wasting. We hypothesized whether NT-proBNP was also associated with non-CVD death in chronic dialysis patients. A prospective observational study for incidence of death in chronic dialysis patients was conducted. Prevalent chronic dialysis patients (n = 1310) were enrolled and followed for 24 months. One hundred forty-four deaths were recorded. Area under the curve using ROC analysis for NT-proBNP showed: all causes of death (0.761), CVD-related (0.750), infection and malignancy-related (0.702) and others and unknown (0.745). After adjusting for age, sex, hemodialysis vintage, cardiothoracic ratio, mean pre-dialysis systolic blood pressure, dry weight and basal kidney disease, the hazard ratios (95% confidence intervals) per 1-log NT-proBNP calculated using multivariate Cox analysis were: all causes of death, 3.83 (2.51-5.85); CVD-related, 4.30 (2.12-8.75); infection and malignancy-related, 2.41 (1.17-4.93); and others and unknown origin, 5.63 (2.57-12.37). NT-proBNP was significantly associated not only with CVD-relate but also with non-CVD-related deaths in this population of prevalent chronic dialysis patients. [ABSTRACT FROM AUTHOR]

Background: Although hemoglobin (Hb) levels are affected by a change in the body fluid status, the relationship between Hb levels and mortality while taking interdialytic weight gain (IDWG) at blood sampling into account has not yet been examined in hemodialysis patients. Study design: Cohort study. Setting, Participants: Data from the Miyazaki Dialysis cohort study, including 1375 prevalent hemodialysis patients (median age (interquartile range), 69 (60–77) years, 42.3% female). Predictor: Patients were divided into 5 categories according to baseline Hb levels and two groups based on the median value of IDWG rates at blood sampling at pre-HD on the first dialysis session of the week. Outcomes: All-cause and cardiovascular mortalities during a 3-year follow-up. Measurements: Hazard ratios were estimated using a Cox model for the relationship between Hb categories and mortality, and adjusted for potential confounders such as age, sex, dialysis duration, erythropoiesis-stimulating agent dosage, Kt/V, comorbid conditions, anti-hypertensive drug use, serum albumin, serum C-reactive protein, serum ferritin, and serum intact parathyroid hormone. Patients with Hb levels of 9–9.9 g/dL were set as our reference category. Results: A total of 246 patients (18%) died of all-cause mortality, including 112 cardiovascular deaths. Lower Hb levels (<9.0g/dL) were associated with all-cause mortality (adjusted HRs 2.043 [95% CI, 1.347–3.009]), while Hb levels were not associated with cardiovascular mortality. When patients were divided into two groups using the median value of IDWG rates (high IDWG, ≥5.4% and low IDWG, <5.4%), the correlation between lower Hb levels and all-cause mortality disappeared in high IDWG patients, but was maintained in low IDWG patients (adjusted HRs 3.058 [95% CI,1.575–5.934]). On the other hand, higher Hb levels (≥12g/dL) were associated with cardiovascular mortality in high IDWG patients (adjusted HRs 2.724 [95% CI, 1.010–7.349]), but not in low IDWG patients. Conclusion: In hemodialysis patients, target Hb levels may need to be selected in consideration of IDWG at blood sampling. [ABSTRACT FROM AUTHOR]

Background: We conducted a multicenter prospective cohort study to assess the safety of warfarin therapy in Japanese hemodialysis (HD) patients. Methods: Chronic HD patients on warfarin therapy (warfarin users) were recruited from 111 HD centers in Japan. Two dialysis-vintage-matched warfarin non-users (non-users) were selected from the same HD center as each warfarin user. Clinical data were collected upon registration and every 12 months thereafter for up to 36 months. Results: The final cohort consisted of 365 warfarin users and 692 non-users and was followed for an average of 27.7 months. The mean age of warfarin users (68.8 ± 10.6 years) was significantly higher than that of non-users (66.9 ± 11.0 years, p < 0.001). The analyses by multivariate Cox proportional-hazard models showed that the age [hazard ratio (HR) = 1.07 for each 1-year increase, 95 % confidence interval (CI) 1.05-1.08, p < 0.001] was significantly associated with the death from any cause, but warfarin use (1.08, CI 0.75-1.57, p = 0.68) was not when being adjusted for sex, diabetes mellitus, antiplatelet use, and atrial fibrillation. The risk of composite events, which included death from any cause, stroke, cardiovascular disease, and peripheral arterial disease, was also associated with age but was not associated with warfarin use. Conclusion: The results of this study suggested that warfarin use by HD patients might not be harmful in chronic state, while the safety for the initiation of warfarin therapy in HD patients remained to be determined. [ABSTRACT FROM AUTHOR]

Background/Aims: Predictors including the preventive effects of antiplatelet and anticoagulant drugs on cerebral infarction (CI) events have not yet been clarified in dialysis patients. The aim of the present study was to examine the risk of CI and preventive effects of these drugs in Japanese hemodialysis patients. Methods: Patients receiving maintenance hemodialysis (n=1,551, median age (interquartile range), 69.0 (59.0-78.0) years; 41.5% female) were enrolled in the Miyazaki Dialysis Cohort Study and prospectively followed-up for 3 years. Kaplan-Meier and Cox's regression analyses were used to clarify the risk of CI. Results: Eightyfour patients developed CI at an incidence of 21.5/1000 patients per year. The presence of a previous history of CI, atrial fibrillation (AF), and diabetes mellitus in addition to age were also identified as predictive factors for new CI, whereas no relationship was observed between antiplatelet and/or anticoagulant usage and CI. Furthermore, no significant difference was noted in the frequency of CI events between patients with AF who received warfarin and those who did not. Conclusions: The incidence of CI was higher in dialysis patients with a previous history of CI and AF; however, the preventive effects of antiplatelet/anticoagulant drugs on the development of CI were not evident. [ABSTRACT FROM AUTHOR]

Aim Although infection is the second leading cause of death in maintenance haemodialysis patients, the effects of glycaemic control on infection in diabetic haemodialysis patients have not yet been examined in detail. We examined the relationship between diabetes or glycemic control and infection-related hospitalization (IRH) in haemodialysis patients. Methods Patients receiving maintenance haemodialysis ( n = 1551, 493 diabetic patients) were enrolled in this prospective cohort study in December 2009 and followed-up for 3 years. IRH during the follow-up period was abstracted from medical records. Kaplan- Meier and Cox regression analyses were used to investigate the relationship between diabetes or glycaemic control and IRH. Results The Kaplan-Meier analysis revealed that the risk of IRH was significantly higher in haemodialysis patients with diabetes, particularly in those with poorly controlled HbA1c levels ( HbA1c ≥ 7.0%), than in haemodialysis patients without diabetes. When patients with ≥ HbA1c 7.0% were divided into two groups using a median value of HbA1c, the risk of IRH was significantly higher in those with the poorest glycaemic control ( HbA1c ≥ 7.4%), an older age, or lower albumin levels. The multivariable-adjusted hazard ratio for the risk of IRH was not higher in the second criteria of HbA1c ( HbA1c 7.0-7.3%), but was significantly higher in the group with the poorest glycaemic control ( HbA1c ≥ 7.4%) than in those in the good control criterion ( HbA1c < 7.0%). Conclusions Although diabetes is a risk factor for IRH among maintenance haemodialysis patients, the relationship between glycaemic control and the risk of infection is not linear. Therefore, the risk of infection may increase in a manner that is dependent on the glycaemic control threshold. [ABSTRACT FROM AUTHOR]

Background/Aims: We investigated the method of switching EPO to CERA that does not cause a decrease in the Hb level. Methods: Fifty EPO-treated patients were randomly divided into two groups in which CERA was administered every two weeks (Q2W) or every four weeks (Q4W). After 8 weeks of treatment, the frequency of administration was changed to Q4W in the former. Follow-up was performed for 24 weeks. Results: There was no difference in the Hb level between the two groups until 6 weeks. In the Q2W group, the Hb maintained a stable level throughout a study period. However, in the Q4W group, the Hb level was significantly lower than in the Q2W group at weeks 9, 11, and 13. Conclusion: EPO switching to CERA without a decrease in the Hb level could be achieved by administering CERA every two weeks, but not every four weeks, for a specific period after switching. © 2014 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Background: Patients on hemodialysis (HD) frequently experience cardiovascular events associated with vascular calcification. We investigated the involvement of osteoprotegerin (OPG), an inhibitor of vascular calcification, in the incidence of cardiovascular events and mortality among new HD patients. Methods: We conducted a prospective cohort study of the association of serum OPG levels with morbidity and mortality in subjects who became new HD patients between June 2000 and May 2006. Results: A total of 99 patients (age 58.9 ± 14.6 years, 65 male, 34 female) were prospectively followed up for 41.5 ± 20.2 months. During this period, 27 patients developed cardiovascular events and 12 died of causes related to cardiovascular disease. When divided into 2 groups according to OPG levels, the high OPG group showed a higher prevalence of cardiovascular morbidity and mortality compared with the low OPG group. Cox’s proportional hazards analysis associated the new onset of cardiovascular events with the high OPG group (HR 2.88, 95% CI 1.09–7.62, p = 0.033). Furthermore, the high OPG group at the start of HD was significantly associated with older age, male gender and a high aortic calcification index. Conclusions: Elevated levels of serum OPG in new HD patients may predict subsequent cardiovascular events. Copyright © 2008 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Background: Hemodialysis (HD) patients often experience cardiovascular events, that might be related to altered calcium–phosphate metabolism, dyslipidemia, and chronic inflammation in addition to hypertension. Sevelamer, a non-calcium-containing phosphate binder, may improve the lipid profile of HD patients. However, the influence of sevelamer on chronic inflammation has not been clarified. Methods: We enrolled 36 maintenance HD patients with a serum calcium (Ca) or phosphate (P) level constantly greater than 9.5 mg/dL and 5.5 mg/dL, respectively. The dose of sevelamer was titrated to achieve a serum Ca and P in the target ranges. The study period was 24 weeks. Patients underwent the following measurements: bone mineral markers, lipids, and a high-sensitivity C-reactive protein (hs-CRP). Results: In the 28 patients who completed the study, sevelamer significantly reduced the mean non-high-density lipoprotein cholesterol (non-HDL-C) level by 15% and 20% ( p [ABSTRACT FROM AUTHOR]

Background: Large amounts of n-3 polyunsaturated fatty acids are known to lower the risk of cardiovascular events (CVE). Serum eicosapentaenoic acid (EPA) / arachidonic acid (AA) ratio may potentially be a predictor of CVE which is the most common cause of death in hemodialysis (HD) patients. Therefore, we estimated the effect of EPA ethyl ester on fatty acid profile in HD patients. Subjects & Methods: Fatty acid profile and high sensitivity CRP (hs-CRP) were measured in 131 patients receiving maintenance HD. Among these, 64 patients (F:M=25:39) with both low EPA/AA ratio (≦0.4) and negative CRP were enrolled in this randomized study (Group A, EPA administrated group, n=30; Group B, EPA non-administrated group, n=34). The mean age of the patients was 66.5 ± 11.9 years old and the duration of HD was 8.4 ± 7.9 years. The serum levels of EPA, AA, docosahexaenoic acid (DHA), and dihomogammalinolenic acid (DHL-A) were measured by gas chromatography (SRL, Tokyo, Japan). Results: The mean levels of EPA/AA ratio, DHA/AA ratio, DHL-A, non HDL-C and GNRI (Geriatric Nutritional Risk Index) were 0.28±0.13, 0.62±0.15, 22.7±8.4 μg/ml, 112.2±31.0 mg/dl and 93.6±5.5, respectively. After one month of treatment with EPA in group A, EPA/AA ratio was significantly increased (0.30±0.15 vs. 0.95±0.45, p<0.0001) and DHL-A significantly decreased (22.7±7.4 vs. 15.7±6.8, p= 0.0003), but DHA/AA ratio, serum non HDL-C and phosphate levels did not change. EPA/AA ratio was significantly higher and DHL-A lower in group A compared with group B after one month of the start of study. Conclusions: Medication of EPA for one month increases EPA/AA ratio, and decreases DHL-A level without the change of serum phosphate level in HD patients with low EPA/AA ratio. [ABSTRACT FROM AUTHOR]