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      Characteristics of Patients Who Achieve Serum Phosphorus Control on Sucroferric Oxyhydroxide or Sevelamer Carbonate: A post hoc Analysis of a Phase 3 Study

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          Abstract

          Introduction: Control of hyperphosphatemia in patients on dialysis remains a major challenge. Objective: This study evaluated predictors of serum phosphorus (sP) control among dialysis patients treated with noncalcium, oral phosphate binder therapy in a phase 3 clinical trial. Methods: Post hoc analyses were performed using data for patients with hyperphosphatemia who received 52 weeks of treatment with sucroferric oxyhydroxide (SFOH) or sevelamer carbonate (sevelamer). Patients were categorized into those who achieved sP control ( n = 302; defined as sP ≤ 5.5 mg/dL at week 52), and those with uncontrolled sP ( n = 195; sP >5.5 mg/dL at week 52). Because SFOH and sevelamer have previously demonstrated similar effects on chronic kidney disease-mineral-bone disorder parameters in this study, the treatment groups were pooled. Results: Average age at baseline was higher among sP-controlled versus sP-uncontrolled patients (56.9 vs. 53.4 years; p = 0.005). Baseline sP levels were significantly lower among sP-controlled versus sP-uncontrolled patients (7.30 vs. 7.85 mg/dL; p < 0.001), and sP reductions from baseline were significantly greater in the sP-controlled group (−2.89 vs. −0.99 mg/dL at week 52; p < 0.001). Logistic regression analysis identified higher baseline sP levels (odds ratio [OR] = 0.86, 95% confidence interval [CI]: 0.765–0.960), no concomitant active vitamin D therapy use (OR = 0.51, 95% CI: 0.328–0.804), and higher body mass index at baseline (OR = 0.96, 95% CI: 0.937–0.992) as significant predictors of uncontrolled sP. Conclusion: This analysis indicates that sP control may be more challenging in younger patients with high sP levels. Closer monitoring and management of serum phosphorus levels may be required in this population.

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          Most cited references 13

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          A systematic review of the prevalence and determinants of nonadherence to phosphate binding medication in patients with end-stage renal disease

          Background Cardiovascular events are the leading cause of death in end stage renal disease (ESRD). Adherence to phosphate binding medication plays a vital role in reducing serum phosphorus and associated cardiovascular risk. This poses a challenge for patients as the regimen is often complex and there may be no noticeable impact of adherence on symptoms. There is a need to establish the level of nonadherence to phosphate binding medication in renal dialysis patients and identify the factors associated with it. Methods The online databases PsycINFO, Medline, Embase and CINAHL were searched for quantitative studies exploring predictors of nonadherence to phosphate binding medication in ESRD. Rates and predictors of nonadherence were extracted from the papers. Results Thirty four studies met the inclusion criteria. There was wide variation in reported rates of non-adherence (22–74% patients nonadherent, mean 51%). This can be partially attributed to differences in the way adherence has been defined and measured. Demographic and clinical predictors of nonadherence were most frequently assessed but only younger age was consistently associated with nonadherence. In contrast psychosocial variables (e.g. patients' beliefs about medication, social support, personality characteristics) were less frequently assessed but were more likely to be associated with nonadherence. Conclusion Nonadherence to phosphate binding medication appears to be prevalent in ESRD. Several potentially modifiable psychosocial factors were identified as predictors of nonadherence. There is a need for further, high-quality research to explore these factors in more detail, with the aim of informing the design of an intervention to facilitate adherence.
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            Long-term effects of the iron-based phosphate binder, sucroferric oxyhydroxide, in dialysis patients

            Background Hyperphosphatemia necessitates the use of phosphate binders in most dialysis patients. Long-term efficacy and tolerability of the iron-based phosphate binder, sucroferric oxyhydroxide (previously known as PA21), was compared with that of sevelamer carbonate (sevelamer) in an open-label Phase III extension study. Methods In the initial Phase III study, hemo- or peritoneal dialysis patients with hyperphosphatemia were randomized 2:1 to receive sucroferric oxyhydroxide 1.0−3.0 g/day (2−6 tablets/day; n = 710) or sevelamer 2.4−14.4 g/day (3−18 tablets/day; n = 349) for 24 weeks. Eligible patients could enter the 28-week extension study, continuing the same treatment and dose they were receiving at the end of the initial study. Results Overall, 644 patients were available for efficacy analysis (n = 384 sucroferric oxyhydroxide; n = 260 sevelamer). Serum phosphorus concentrations were maintained during the extension study. Mean ± standard deviation (SD) change in serum phosphorus concentrations from extension study baseline to Week 52 end point was 0.02 ± 0.52 mmol/L with sucroferric oxyhydroxide and 0.09 ± 0.58 mmol/L with sevelamer. Mean serum phosphorus concentrations remained within Kidney Disease Outcomes Quality Initiative target range (1.13–1.78 mmol/L) for both treatment groups. Mean (SD) daily tablet number over the 28-week extension study was lower for sucroferric oxyhydroxide (4.0 ± 1.5) versus sevelamer (10.1 ± 6.6). Patient adherence was 86.2% with sucroferric oxyhydroxide versus 76.9% with sevelamer. Mean serum ferritin concentrations increased over the extension study in both treatment groups, but transferrin saturation (TSAT), iron and hemoglobin concentrations were generally stable. Gastrointestinal-related adverse events were similar and occurred early with both treatments, but decreased over time. Conclusions The serum phosphorus-lowering effect of sucroferric oxyhydroxide was maintained over 1 year and associated with a lower pill burden, compared with sevelamer. Sucroferric oxyhydroxide was generally well tolerated long-term and there was no evidence of iron accumulation.
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              Prevention and control of phosphate retention/hyperphosphatemia in CKD-MBD: what is normal, when to start, and how to treat?

              Phosphate retention and, later, hyperphosphatemia are key contributors to chronic kidney disease (CKD)-mineral and bone disorder (MBD). Phosphate homeostatic mechanisms maintain normal phosphorus levels until late-stage CKD, because of early increases in parathyroid hormone (PTH) and fibroblast growth factor-23 (FGF-23). Increased serum phosphorus, and these other mineral abnormalities, individually and collectively contribute to bone disease, vascular calcification, and cardiovascular disease. Earlier phosphate control may, therefore, help reduce the early clinical consequences of CKD-MBD, and help control hyperphosphatemia and secondary hyperparathyroidism in late-stage CKD. Indeed, it is now widely accepted that achieving normal phosphorus levels is associated with distinct clinical benefits. This therapeutic goal is achievable in CKD stages 3 to 5 but more difficult in dialysis patients. Currently, phosphate control is only initiated when hyperphosphatemia occurs, but a potentially beneficial and simple approach may be to intervene earlier, for example, when tubular phosphate reabsorption is substantially diminished. Early CKD-MBD management includes dietary phosphate restriction, phosphate binder therapy, and vitamin D supplementation. Directly treating phosphorus may be the most beneficial approach because this can reduce serum phosphorus, PTH, and FGF-23. This involves dietary measures, but these are not always sufficient, and it can be more effective to also consider phosphate binder use. Vitamin D sterols can improve vitamin D deficiency and PTH levels but may worsen phosphate retention and increase FGF-23 levels, and thus, may also require concomitant phosphate binder therapy. This article discusses when and how to optimize phosphate control to provide the best clinical outcomes in CKD-MBD patients.
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                Author and article information

                Journal
                NEF
                Nephron
                10.1159/issn.1660-8151
                Nephron
                S. Karger AG
                1660-8151
                2235-3186
                2020
                September 2020
                25 June 2020
                : 144
                : 9
                : 428-439
                Affiliations
                aNephrology Clinic and Dialysis and Transplantation Center, Grigore T. Popa University of Medicine and Pharmacy, Iași, Romania
                bNorthShore University Health System, University of Chicago, Pritzker School of Medicine, Evanston, Illinois, USA
                cDivision of Nephrology, University of California, Los Angeles, California, USA
                dDepartment of General Internal Medicine and Nephrology, Robert-Bosch-Krankenhaus, Stuttgart, Germany
                eDepartment of Medical Affairs, Vifor Pharma, Glattbrugg, Switzerland
                fDepartment of Biometrics, Vifor Pharma, Glattbrugg, Switzerland
                gDivision of Nephrology, RWTH University Hospital Aachen, Aachen, Germany
                Author notes
                *Prof. Adrian C. Covic, Nephrology Clinic and Dialysis and Transplantation Center, Grigore T. Popa University of Medicine and Pharmacy, Strada Universității 16, RO–700115 Iași (Romania), accovic@gmail.com
                Article
                507258 Nephron 2020;144:428–439
                10.1159/000507258
                32585670
                The Author(s). Published by S. Karger AG, Basel

                This article is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND). Usage and distribution for commercial purposes as well as any distribution of modified material requires written permission. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                Page count
                Figures: 3, Tables: 3, Pages: 12
                Categories
                Clinical Practice: Research Article

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