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1.
A comparative analysis of the efficacy and safety of paricalcitol versus other vitamin D receptor activators in patients undergoing hemodialysis: A systematic review and meta-analysis of 15 randomized controlled trials.
Geng, X, Shi, E, Wang, S, Song, Y
PloS one. 2020;(5):e0233705
Abstract
Paricalcitol, a new vitamin D receptor activator (VDRA), is reported to be more effective than other VDRAs in reducing calcium and phosphorus levels in patients undergoing hemodialysis. However, the efficacy and safety of paricalcitol remain controversial. This analysis compares paricalcitol with other VDRAs in patients undergoing hemodialysis. We searched the Cochrane Library, PubMed, EMBASE, Web of Science, and CNKI up to April 22, 2019. Standardized mean difference (SMD), risk ratio (RR) and 95% confidence interval (CI) values were estimated to compare the outcomes of the groups. Two reviewers extracted data and assessed trial quality independently. All statistical analyses were performed using the standard statistical procedures of RevMan 5.2 and Stata 12.0. Fifteen studies (N = 110,544) were included in this meta-analysis. Of these studies, 11 were randomized controlled trials (RCTs) and 4 were non-randomized studies of interventions (NRSIs). Patients receiving paricalcitol experienced better overall survival (OS) than patients receiving other VDRAs, with a pooled hazard ratio of 0.86 (95% CI 0.80-0.91; P < 0.00001). Intact parathyroid hormone (iPTH) levels were significantly reduced in the paricalcitol group compared to the group receiving other VDRAs, with a pooled SMD of -0.53 (95% CI -0.89- -0.16; P = 0.004). There was a significant increase in serum calcium levels from baseline in the paricalcitol group compared to the other VDRAs group when limiting the analysis to RCTs, with a pooled SMD of 2.14 (95% CI 0.90-3.38; P = 0.0007). Changes in serum calcium levels were significantly lower in the paricalcitol group when the analysis was limited to NRSIs, with a pooled SMD of -0.85 (95% CI -1.34--0.35; P = 0.0008). The NSRI analysis also showed a significant reduction in serum phosphorus levels in the paricalcitol group, with a pooled SMD of -0.57 (95% CI -1.00--0.13; P = 0.01). No significant differences were observed in the incidence of hypercalcemia, hyperphosphatemia, or adverse events. Generally, paricalcitol seems superior to other VDRAs in reducing mortality and iPTH levels in patients undergoing hemodialysis. However, the comparative effectiveness of paricalcitol in reducing serum calcium and phosphorus levels needs further exploration. No significant difference was found in the rate of adverse events.
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2.
Conversion of haemodialysis patients from iron sucrose to iron isomaltoside: a real-world experience.
Jesus-Silva, JA, Lamplugh, A, Dhada, S, Burton, JO, Bhandari, S
BMC nephrology. 2020;(1):212
Abstract
BACKGROUND Anaemia is common in haemodialysis (HD) patients and associated with significant morbidity and mortality. Intravenous (IV) iron combined with erythropoiesis-stimulating agents (ESA) is the mainstay treatment of anaemia in these patients. The comparative efficacy and risk of adverse events with IV iron preparations have been assessed in only a few trials. METHODS This was a retrospective observational study in 2 centres designed to compare the safety and efficacy of iron sucrose (IS-Venofer®) versus iron isomaltoside (IIM-Diafer®) in haemodialysis patients. The study included patients currently on dialysis and receiving Venofer who were switched to Diafer® and monitored for at least 12 months for each iron preparation. RESULTS A total of 190 patients were included and had a mean age of 65.8 years (SD ± 15.5). Non-inferiority was confirmed with no change in mean haemoglobin per mg of iron administered over a 12-month period. In total there were 41,295 prescriptions of iron isomaltoside and 14,685 of iron sucrose with no difference in the number of reported adverse events during the study period (7 each, none were severe). There was a statistically significant effect on Hb over time after conversion, including adjustment for multiple comparisons. There were significant improvements in ferritin over time, which remained at 6 months (P < 0.01). The weekly iron dose was similar after adjustment (P = 0.02). The EPO dose did not differ significantly after month 0 in patients switched to IIM. CONCLUSIONS This study demonstrates the comparative safety and efficacy of iron isomaltoside versus iron sucrose, with similar dosing schedules in dialysis patients. Iron isomaltoside is non-inferior to iron sucrose in maintaining Hb in patients on regular haemodialysis/haemodiafiltration with no difference in the number of reported adverse events.
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3.
Comparison of zinc acetate hydrate and polaprezinc for zinc deficiency in patients on maintenance hemodialysis: A single-center, open-label, prospective randomized study.
Okamoto, T, Hatakeyama, S, Konishi, S, Okita, K, Tanaka, Y, Imanishi, K, Takashima, T, Saitoh, F, Suzuki, T, Ohyama, C
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. 2020;(5):568-577
Abstract
The efficacy and safety of zinc acetate hydrate (ZAH) for zinc supplementation in patients on maintenance hemodialysis (MHD) remains unknown. In this prospective, single-center, open-label, parallel-group trial for MHD patients with serum zinc level <70 μg/dL, we compared ZAH (zinc; 50 mg/day) and polaprezinc (PPZ; zinc; 34 mg/day) beyond 6-month administration in a 1:1 randomization manner. The ZAH and PPZ groups had 44 and 47 patients, respectively. At 3 months, the change rate of serum zinc levels in the ZAH group was significantly higher than that in the PPZ group. Three months after the study, serum copper levels significantly decreased in the ZAH group, but not in the PPZ group. No significant differences were noted in anemia management in either group. ZAH was superior to PPZ in increasing serum zinc levels. Clinicians should note the stronger decline in serum copper levels when using ZAH for MHD patients.
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4.
Effect of Low-Sodium versus Conventional Sodium Dialysate on Left Ventricular Mass in Home and Self-Care Satellite Facility Hemodialysis Patients: A Randomized Clinical Trial.
Marshall, MR, Vandal, AC, de Zoysa, JR, Gabriel, RS, Haloob, IA, Hood, CJ, Irvine, JH, Matheson, PJ, McGregor, DOR, Rabindranath, KS, et al
Journal of the American Society of Nephrology : JASN. 2020;(5):1078-1091
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Abstract
BACKGROUND Fluid overload in patients undergoing hemodialysis contributes to cardiovascular morbidity and mortality. There is a global trend to lower dialysate sodium with the goal of reducing fluid overload. METHODS To investigate whether lower dialysate sodium during hemodialysis reduces left ventricular mass, we conducted a randomized trial in which patients received either low-sodium dialysate (135 mM) or conventional dialysate (140 mM) for 12 months. We included participants who were aged >18 years old, had a predialysis serum sodium ≥135 mM, and were receiving hemodialysis at home or a self-care satellite facility. Exclusion criteria included hemodialysis frequency >3.5 times per week and use of sodium profiling or hemodiafiltration. The main outcome was left ventricular mass index by cardiac magnetic resonance imaging. RESULTS The 99 participants had a median age of 51 years old; 67 were men, 31 had diabetes mellitus, and 59 had left ventricular hypertrophy. Over 12 months of follow-up, relative to control, a dialysate sodium concentration of 135 mmol/L did not change the left ventricular mass index, despite significant reductions at 6 and 12 months in interdialytic weight gain, in extracellular fluid volume, and in plasma B-type natriuretic peptide concentration (ratio of intervention to control). The intervention increased intradialytic hypotension (odds ratio [OR], 7.5; 95% confidence interval [95% CI], 1.1 to 49.8 at 6 months and OR, 3.6; 95% CI, 0.5 to 28.8 at 12 months). Five participants in the intervention arm could not complete the trial because of hypotension. We found no effect on health-related quality of life measures, perceived thirst or xerostomia, or dietary sodium intake. CONCLUSIONS Dialysate sodium of 135 mmol/L did not reduce left ventricular mass relative to control, despite improving fluid status. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER The Australian New Zealand Clinical Trials Registry, ACTRN12611000975998.
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Association of Hepcidin With Anemia Parameters in Incident Dialysis Patients: Differences Between Dialysis Modalities.
Lim, JH, Park, YW, Lee, SH, Do, JY, Kim, SH, Han, S, Jung, HY, Choi, JY, Cho, JH, Kim, CD, et al
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. 2020;(1):4-16
Abstract
Hepcidin's relationships with other variables are unclear. We evaluated associations of serum hepcidin with clinical parameters in ESRD patients. Ninety-nine incident dialysis patients, including 57 on peritoneal dialysis (PD) and 42 on HD, were prospectively followed for 6 months. Serum hepcidin levels significantly increased during initial 6 months of dialysis. In the multivariate regression model, independent predictors of serum hepcidin levels in ESRD patients before maintenance dialysis were interleukin-6, ferritin, phosphate, iron, and aspartate transaminase. Six months after initiating dialysis, serum hepcidin levels were independently predicted by ferritin, total iron binding capacity (TIBC), and aspartate transaminase in all patients, whereas by ferritin and TIBC in PD patients, and ferritin, TIBC, and 24-h urine volume in HD patients. Serum hepcidin levels are differentially associated with anemia parameters in PD compared with HD patients. Urine volume was an independent predictor of hepcidin levels in early HD patients.
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Effect of Sheng Xue Ning Tablets on Renal Anemia in Patients Subject to Maintenance Hemodialysis and Safety Evaluation: A Multi-setting Prospective Randomized Study.
Tang, XJ, Rong, S, Mei, CL, Ni, ZH, Jiang, GR, Yuan, WJ, Wang, NS, Guo, ZY, Ma, J, Yan, HD, et al
Current medical science. 2020;(2):327-331
Abstract
This study compared Sheng Xue Ning (SXN) tablets with ferrous succinate (FS) tablets in terms of their efficacy for the treatment of iron-deficient renal anemia and safety in patients subject to maintenance hemodialysis (MHD). A total of 94 patients undergoing MHD were randomly assigned to an experiment group (receiving oral SXN tablets, SXN group) and a control group (orally given FS tablets, FS group) and followed up for 12 weeks. Erythropoietin (EPO) was used in both groups. The efficacy was assessed by detecting the subsequent changes in hemoglobin (Hb), serum iron (SI), SF and transferrin saturation (TSAT). At the 12th week, Hb and TSAT levels in both groups were significantly increased compared to those in the screening period (P<0.05). However, no significant difference in Hb and TSAT was found between the two groups. The average weekly EPO dosage used was lower in SXN group than in FS group (P<0.05) at the 10th week and the 12th week. Our study showed that SXN tablets can effectively ameliorate renal anemia and keep iron metabolism stable in MHD patients, and its efficacy is virtually close to that of FS tablets. Meanwhile, SXN tablets can reduce the dosage of EPO and have a good safety profile.
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Comparison of Adequacy of Dialysis between Single-use and Reused Hemodialyzers in Patients on Maintenance Hemodialysis.
Hamid, A, Dhrolia, MF, Imtiaz, S, Qureshi, R, Ahmad, A
Journal of the College of Physicians and Surgeons--Pakistan : JCPSP. 2019;(8):720-723
Abstract
OBJECTIVE To compare adequacy of dialysis between single-use and reused dialyzer in order to ascertain whether reuse of dialyzers provides adequate dialysis and thereby enable provision of effective yet affordable renal replacement therapy in resource-limited countries. STUDY DESIGN Observational cross-sectional study. PLACE AND DURATION OF STUDY Department of Nephrology, The Kidney Centre, Postgraduate Training Institute (TKC-PGTI), Karachi, from December 2017 to February 2018. METHODOLOGY Equal number of patients on thrice weekly hemodialysis with either single-use (group A; n=33) or reuse (group B; n=33) dialyzer for at least six months were reviewed. Both groups were compared for dialysis adequacy measured as urea reduction ratio (URR); as well as adequacy of patient care in terms of anemia, bone-mineral control and nutritional status. Serum hemoglobin and erythropoietin stimulating agent (ESA) dose were taken as markers for anemia management, serum calcium, phosphate and intact parathyroid hormone (iPTH) for bone-mineral control and serum albumin as index for nutritional status. RESULTS The mean age of patients in Group A was 51.36 +13.9 years and in Group B was 54.78 +15.4 years. Female to male ratio was 1.75:1. The mean number of dialyzer reused in group B was 47.5±27.8. There was no significant difference between the study groups in terms of URR (p=0.362), hemoglobin (p=0.347), ESA dose (p-=0.556), serum calcium, phosphorus and iPTH (p=0.868, p=0.138 and p=0.323, respectively), and serum albumin (p=0.777). All the parameters were in accordance with KDOQI guidelines. CONCLUSION Reuse of dialyzer does not affect dialysis efficiency. Adequate dialysis therapy can be provided economically through reprocessed dialyzers in at least resource-poor countries.
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Fully closed-loop insulin delivery improves glucose control of inpatients with type 2 diabetes receiving hemodialysis.
Bally, L, Gubler, P, Thabit, H, Hartnell, S, Ruan, Y, Wilinska, ME, Evans, ML, Semmo, M, Vogt, B, Coll, AP, et al
Kidney international. 2019;(3):593-596
Abstract
Inpatient diabetes management of those on hemodialysis poses a major challenge. In a post hoc analysis of a randomized controlled clinical trial, we compared the efficacy of fully automated closed-loop insulin delivery vs. usual care in patients undergoing hemodialysis while in hospital. Compared to control patients receiving conventional subcutaneous insulin therapy, those patients receiving closed-loop insulin delivery significantly increased the proportion of time when a continuous glucose monitor was in the target range of 5.6-10.0 mmol/l by 37.6 percent without increasing the risk of hypoglycemia. Thus, closed-loop insulin delivery offers a novel way to achieve effective and safe glucose control in this vulnerable patient population.
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Influence of Physical Exercise on the Dialytic Adequacy Parameters of Patients on Hemodialysis.
García Testal, A, García Maset, R, Hervás Marín, D, Pérez-Domínguez, B, Royo Maicas, P, Rico Salvador, IS, Meléndez-Oliva, E, Molina Aracil, J, Murgui Chiva, M, Del Pozo Blanco, O, et al
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. 2019;(2):160-166
Abstract
It has been suggested that physical exercise in chronic hemodialysis could improve dialysis dose and reduce postdialysis rebound. A randomized controlled trial was performed to compare a group of patients doing physical exercise during the first 2 h of hemodialysis sessions and another group doing physical exercise at home. The descriptive variables, dialysis doses measured by KtV, and rebounds (urea, creatinine, potassium, phosphorus), were recorded. For 69 patients: the mean KtV was 1.84; the 30-min rebound of creatinine was 32.37%, urea 24.39%, potassium 15.31%, and phosphorus 51.29%. For each patient, the basal measurement was compared with those determined when performing physical exercise; no statistically significant differences were observed between the changes determined to dose and rebound in the group with hemodialysis exercise compared to those of the home exercise group. In conclusion, performing physical exercise during the first 2 hours of hemodialysis sessions neither lowered postdialysis molecules rebound nor improved dialysis dose.
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TRANSITION PERIOD CLINICAL TRAJECTORIES FOR PD VERSUS HD STARTERS.
Maddux, DW, Usvyat, LA, Blanchard, T, Jiao, Y, Kotanko, P, van der Sande, FM, Kooman, JP, Maddux, FW
Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis. 2019;(1):42-50
Abstract
BACKGROUND Peritoneal dialysis (PD) starters generally have a better outcome compared with hemodialysis (HD) starters, perhaps related to treatment characteristics or case mix. We previously showed that pre- and post-dialysis start clinical parameter trajectories are related to outcomes. The aim of this study was to investigate these trajectories in PD and HD starters. METHODS This retrospective observational study analyzing data from the Fresenius Medical Care-chronic kidney disease (CKD) Registry from January 2009 to March 2018 examines trends in key clinical parameters through the transition period covering 12 months before to 12 months after dialysis start in 8,088 HD and 1,015 PD starters. RESULTS Hemodialysis starters differed from PD starters by a significantly greater decline in estimated glomerular filtration rate (eGFR) slope (-0.64 vs -0.45 mL/min/1.73 m2/month) before and higher eGFR (9.85 vs 7.84 mL/min/1.73 m2) at dialysis start. Relatedly, differences in phosphorus (0.07 vs 0.05 mg/dL/month) and hemoglobin (-0.08 vs -0.01 g/dL/month) slopes before the transition to dialysis therapy were observed. After dialysis start, HD starters experienced a greater increase in albumin (0.01 vs 0 g/dL/month) whereas PD starters experienced a decline in serum sodium and higher white blood cell counts compared with HD starters. CONCLUSION For nephrology practice CKD patients, HD and PD starters appear clinically comparable in the year before dialysis start although HD starters exhibit a more rapid pre-dialytic eGFR decline. Ideally, studies comparing incident HD and PD outcomes should also consider CKD eGFR trajectories. In the first dialysis year, divergence occurs in albumin, white blood cell count, sodium and hemoglobin trends, which may be partly treatment-related.