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Sucroferric Oxyhydroxide As Part of Combination Phosphate Binder Therapy Among Hemodialysis Patients

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Sucroferric Oxyhydroxide As Part of Combination Phosphate Binder Therapy Among Hemodialysis Patients Original Investigation Sucroferric Oxyhydroxide as Part of Combination Phosphate Binder Therapy among Hemodialysis Patients Donald A. Molony,1 Vidhya Parameswaran,2 Linda H. Ficociello,2 Claudy Mullon,2 and Robert J. Kossmann2 Abstract Background Combination therapy with multiple phosphate binders is prescribed to reduce elevated serum phosphorus (sP) concentrations among patients on maintenance hemodialysis. Sucroferric oxyhydroxide (SO), an iron-based phosphate binder, has demonstrated efficacy at reducing sP while also being associated with a low pill burden. Whereas the effects of SO monotherapy have been well characterized in clinical trials and observational cohorts, little is known about the effects of SO-containing combination therapy. Methods Patients on hemodialysis (N5234) at Fresenius Kidney Care (FKC) who received $120 days of uninterrupted phosphate binder combination therapy with SO were included in this retrospective study. Patient data were censored after SO discontinuation, end of care at FKC, or completion of 12 months of follow-up. Quarterly (Q) changes in phosphate binder pill burden, mean sP, and proportion of patients achieving National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-KDOQI)–recommended sP levels (#5.5 mg/dl) were compared between baseline (2Q1) and follow-up (Q1–Q4). Results Phosphate binder combination therapy with SO was associated with significant increase in the proportion of patients with sP #5.5 mg/dl (from 19% at baseline to up to 40% at follow-up; P,0.001) and reduction in sP at all postbaseline time points (from 6.7 mg/dl to 6.2–6.3 mg/dl; P,0.001). Patients on calcium acetate (N554) and sevelamer (N594) who added SO therapy at follow-up resulted in a $250% increase in patients achieving sP #5.5 mg/dl (all P,0.001). Whereas mean phosphate binder pill burden increased with initiation of phosphate binder combination therapy with SO (15.8 pills/d at Q1 versus 12.3 pills/d at 2Q1), continued use of SO was associated with down-titration of non-SO phosphate binders such that, by Q4, mean total PB pill burden reduced to 12.3 pills/d. Conclusions For patients on hemodialysis with uncontrolled hyperphosphatemia, combination therapy with SO may allow for sustained improvements in sP control without adversely affecting phosphate binder pill burden. KIDNEY360 1: 263–272, 2020. doi: https://doi.org/10.34067/KID.0000332019 Introduction Prospective observational data collected as part of CKD is associated with disturbances in phosphorus COSMOS (the Current management Of Secondary homeostasis. In early stages of disease, compensatory hyperparathyroidism: a Multicentre Observational mechanisms can maintain physiologic phosphorus lev- Study) support efforts to lower elevated sP concentra- els (1,2). Compensatory mechanisms include increases tions in patients on HD (11). In COSMOS, a survival in phosphatonins such as fibroblast growth factor-23 benefit was observed among patients on HD with that directly reduce renal phosphate reabsorption and elevated baseline sP levels (i.e., .5.2 mg/dl [mean, also result in reductions in active vitamin D; the latter 6.5 mg/dl]) who demonstrated reductions in sP con- reduces phosphorus absorption from the gastrointes- centrations during follow-up. Strategies to lower sP in tinal tract and tubular reabsorption of filtered phos- patients on HD include restriction of dietary phosphate phorus by the kidney (3,4). As kidney function declines while ensuring adequate intake of protein and avoid- and compensatory mechanisms—in particular renal ance of malnutrition (12,13), adjustments in the HD excretion of phosphorus—are significantly impaired, prescription (12,14), and pharmacotherapy with phos- overt hyperphosphatemia can develop and is often phate binders (PBs) to reduce intestinal phosphate evident in later stages of CKD (i.e., stages 4 and 5) absorption (2). (5). High serum phosphorus (sP) levels have been asso- National Kidney Foundation Kidney Disease Out- ciated with adverse outcomes in the setting of ESKD, comes Quality Initiative guidelines recommend mainte- including increased risk of cardiovascular events and nance of sP between 3.5 and 5.5 mg/dl in patients on reduced survival, particularly among populations on dialysis (15). Because of a lack of data from randomized hemodialysis (HD) (6–10). controlled trials, recommendations regarding specific 1Division of Renal Diseases and Hypertension, Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School University of Texas, Houston, Texas; and 2Fresenius Medical Care Renal Therapies Group, Waltham, Massachusetts Correspondence: Dr. Donald A. Molony, Division of Renal Diseases and Hypertension, McGovern Medical School University of Texas, 6431 Fannin Street, MSB 5.134, Houston, TX 77030. Email: [email protected] www.kidney360.org Vol 1 April, 2020 Copyright © 2020 by the American Society of Nephrology 263 264 KIDNEY360 clinical approaches are largely absent from the guidelines. efficacy of such dosing strategies have not been rigorously Observational studies, however, demonstrate that prescribed studied in clinical trials. Nonetheless, combination PB ther- PB therapy is associated with a survival benefitamongpatients apy is used in clinical practice and has been associated with on HD (16–18). Presently, more than three quarters of patients a survival benefit in COSMOS (18,33,34). This retrospective on HD in the United States are prescribed PBs, but .40% have analysis aimed to examine the effects of SO among patients sP levels .5.5 mg/dl (19,20), and approximately 17% have sP on HD when prescribed with other PBs for up to 1 year. concentrations .7.0 mg/dl (20). According to Sekar et al. (21), PB selection should be individualized to the needs of the patient and should con- Materials and Methods sider the patient’s metabolic profile (e.g., iron and calcium Study Design stores), safety, pill burden, and cost. Pill burden and its poten- This retrospective cohort study used de-identified data tial effect on adherence may be particularly relevant for extracted from the Fresenius pharmacy (FreseniusRx) data- patients on HD because of the high rates of polypharmacy base. All adult, in-center patients on HD prescribed SO in in this population (22,23). Sucroferric oxyhydroxide (SO) is an combination with other PB(s) for at least 120 days of therapy effective, iron-based PB approved for the control of sP in as part of routine care at Fresenius Kidney Care (FKC) patients with CKD on dialysis with demonstrated effectiveness facilities between April 1, 2014 and April 1, 2015 were at a lower pill burden in randomized controlled trials with SO included in this analysis (Figure 1). SO is an iron-based monotherapy (24–29). The effectiveness of SO monotherapy PB with a recommended starting dose of three pills per day has also been assessed in retrospective studies examining the (administered as one pill three times daily with meals) “real-world” effects of starting, or switching to, SO therapy indicated for the control of sP levels in patients with CKD (30–32). In these analyses, improvements in sP, reductions in on dialysis. pill burden, and improved adherence have been reported. Eligible non-SO PBs included calcium acetate, lanthanum Combination therapy with PBs is not currently addressed carbonate, sevelamer carbonate, and sevelamer hydrochlo- within evidence-based recommendations and the safety and ride. Calcium carbonate as a PB was not included because we Adult, HD patients at FKC facilities who received ≥ 30 days of SO + non-SO PB prescriptions between April 1, 2014 - April 1, 2015 n = 456 Patients with ≥ 120 days of PB Patients with < 120 days of PB combination therapy (SO + non-SO PB) combination therapy (SO + non-SO PB) Study Cohort Excluded n = 234 n = 222 Discharged Switched from Completed follow-up Discontinued Switched from from FKC* or (SO + non-SO PB) through Q4 follow-up prior to Q4 (SO + non-SO PB) disenrolled to SO Completers Non-completers to non-SO PB(s) from FreseniusRx monotherapy n = 134 n = 100 n = 147 n = 49 n = 26 (SO + non-SO PB) Discharged from FKC* Non-SO PB Non-SO PB throughout or disenrolled monotherapy polytherapy follow-up from FreseniusRx n=95 n=52 n = 76 n = 33 Switched from Switched from (SO + non-SO PB) (SO + non-SO PB) to SO monotherapy to non-SO PB(s) n = 58 n = 67 Non-SO PB Non-SO PB monotherapy polytherapy n=61 n=6 Figure 1. | Patient dispositionflow chart detailing patients in the overall study cohort (n5234) with subgroups and patients excluded from the overall study cohort but included in sensitivity analyses (n5222). *Reasons for discharge from Fresenius Kidney Care (FKC) included transplantation, transfer to non-FKC facilities, withdrawal from dialysis, or death. FreseniusRx, Fresenius specialty pharmacy; HD, hemodialysis; PB, phosphate binder; Q, quarter; SO, sucroferric oxyhydroxide. KIDNEY360 1: 263–272, April, 2020 Combination Phosphate Binder Therapy with Sucroferric Oxyhydroxide, Molony et al. 265 were unable to track prescriptions as it is available over the and the first 120 days of follow-up (months 11, 12, 13, and counter. Treatment periods were defined quarterly (Q) as 14) were evaluated. baseline (2Q1; 3 months before SO prescription) and follow- Blood samples were drawn, generally on the same day of up (Q1 through Q4; up to 12 months of SO prescription; each week, using standardized methods at FKC facilities and Figure 2). Treatment data were censored if (1)patients analyzed at Spectra Laboratories (Rockleigh, New Jersey). All
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