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Sucroferric oxyhydroxide

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https://www.readbyqxmd.com/read/29656600/long-term-efficacy-and-safety-of-sucroferric-oxyhydroxide-in-african-american-dialysis-patients
#1
Stuart M Sprague, Markus Ketteler, Adrian C Covic, Jürgen Floege, Viatcheslav Rakov, Sebastian Walpen, Anjay Rastogi
INTRODUCTION: Sucroferric oxyhydroxide (SFOH) is a non-calcium, iron-based phosphate binder that demonstrated sustained serum phosphorus (sP) control, good tolerability, and lower pill burden, vs. sevelamer carbonate ("sevelamer"), in a Phase 3 study conducted in dialysis patients with hyperphosphatemia. This analysis evaluates the efficacy and safety of SFOH and sevelamer among African American (AA) patients participating in the trial. METHODS: Post hoc analysis of a 24-week, Phase 3, open-label trial (NCT01324128) and its 28-week extension study (NCT01464190)...
April 15, 2018: Hemodialysis International
https://www.readbyqxmd.com/read/29536389/rationale-design-and-characteristics-of-a-trial-to-evaluate-the-new-phosphate-iron-based-binder-sucroferric-oxyhydroxide-in-dialysis-patients-with-the-goal-of-advancing-the-practice-of-e-b-m-episode
#2
Yoshitaka Isaka, Hideki Fujii, Yoshihiro Tsujimoto, Satoshi Teramukai, Takayuki Hamano
BACKGROUND: In dialysis patients, mortality risk due to cardiovascular diseases is remarkably high and prognosis is poor; coronary artery calcification is considered one of the major contributing factors. It is known that hyperphosphatemia is associated with coronary artery calcification. Therefore, controlling serum phosphate level and thereby mitigating vascular calcification could improve the poor prognosis of dialysis patients. However, the optimal phosphate level in dialysis patients remains unknown; hence, this study was planned to compare the effects of two types of non-calcium-based phosphate binders, and examine the effect of strict control of phosphate on coronary artery calcification...
March 13, 2018: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/29514139/real-world-scenario-improvements-in-serum-phosphorus-levels-and-pill-burden-in-peritoneal-dialysis-patients-treated-with-sucroferric-oxyhydroxide
#3
Kamyar Kalantar-Zadeh, Vidhya Parameswaran, Linda H Ficociello, Ludmila Anderson, Norma J Ofsthun, Christopher Kwoh, Claudy Mullon, Robert J Kossmann, Daniel W Coyne
BACKGROUND: A database analysis was conducted to assess the effectiveness of sucroferric oxyhydroxide (SO) on lowering serum phosphorus and phosphate binder (PB) pill burden among adult peritoneal dialysis (PD) patients prescribed SO as part of routine care. METHODS: Adult PD patients (n = 258) prescribed SO through a renal pharmacy service were analyzed. Baseline was 3 months before SO prescription. SO-treated follow-up was for 6 months or until either a new PB was prescribed, SO was not refilled, PD modality changed, or patient was discharged...
March 7, 2018: American Journal of Nephrology
https://www.readbyqxmd.com/read/29479762/influence-of-ph-and-phosphate-concentration-on-the-phosphate-binding-capacity-of-five-contemporary-binders-an-in-vitro-study
#4
Stefan P Schumacher, L J Schurgers, G Vervloet Marc, Aegida Neradova
INTRODUCTION: Hyperphosphatemia is associated with increased mortality and morbidity in end stage renal disease. Despite phosphate binder therapy, a large proportion of patients does not reach the treatment target. In five contemporary binders we explored the influence of pH and phosphate concentration on phosphate binding. . This interaction could be of relevance in clinical practice. METHODS: Phosphate binding was quantified in vitro in 25 ml of purified water containing phosphate concentrations of 10, 15 and 20 mM and baseline pH values of 3...
February 26, 2018: Nephrology
https://www.readbyqxmd.com/read/29415929/-pharmacological-pharmaceutical-and-clinical-profiles-of-sucroferric-oxyhydroxide-p-tol%C3%A2-chewable-tab-250%C3%A2-mg-500%C3%A2-mg-a-therapeutic-agent-for-hyperphosphatemia
#5
Satoshi Tatemichi, Fumiaki Nakagaki, Shoichi Yoshioka, Natsuko Shichiri
Sucroferric oxyhydroxide (P-TOL® chewable tablets, 250 and 500 mg) is a phosphate binder for oral use; it is composed of polynuclear iron (III)-oxyhydroxide, sucrose, and starches, and is currently indicated for alleviating hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The results of non-clinical pharmacological studies have suggested that P-TOL consistently decreases serum phosphorus levels in the aqueous environment at pH levels similar to those in the gastrointestinal tract, thereby suppressing the progression of secondary hyperparathyroidism, aberrant calcification, and abnormal bone metabolism associated with hyperphosphatemia...
2018: Nihon Yakurigaku Zasshi. Folia Pharmacologica Japonica
https://www.readbyqxmd.com/read/29340330/efficacy-and-safety-of-sucroferric-oxyhydroxide-and-calcium-carbonate-in-hemodialysis-patients
#6
Fumihiko Koiwa, Keitaro Yokoyama, Masafumi Fukagawa, Tadao Akizawa
Introduction: In this phase III, open-label, single-arm, multi-center 12-week study, we evaluated the efficacy and safety of combination therapy with sucroferric oxyhydroxide (PA21) and calcium carbonate for hemodialysis patients with hyperphosphatemia. Methods: We enrolled 35 subjects aged ≥ 20 years with end-stage kidney disease and serum phosphorus 3.5-6.0 mg/dl who were undergoing hemodialysis 3 times weekly and taking calcium carbonate and sevelamer hydrochloride...
January 2018: KI Reports
https://www.readbyqxmd.com/read/29311459/-low-continuity-rate-of-sucroferric-oxyhydroxide-among-japanese-hemodialysis-patients-with-high-phosphate-binder-pill-burden
#7
Satoru Mitsuboshi, Hitoshi Yamada, Kazuhiko Nagai, Hideo Okajima
 This prospective observational study was conducted to evaluate the continuity, efficacy, and tolerability of sucroferric oxyhydroxide (SO) among hemodialysis (HD) patients who switched to SO from sevelamer hydrochloride (SH) or bixalomer (BX). Participants were 9 HD patients in Kaetsu Hospital who had been receiving more than 9 tablets/d of SH or BX and were switched to SO 750 mg/d. All the participants were men. Over a 6-month observational period, 6 of the 9 patients (67%) discontinued SO because of adverse events, including diarrhea, atheroma, and polycythemia...
2018: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28587714/real-world-effectiveness-of-sucroferric-oxyhydroxide-in-patients-on-chronic-hemodialysis-a-retrospective-analysis-of-pharmacy-data
#8
Daniel W Coyne, Linda H Ficociello, Vidhya Parameswaran, Ludmila Anderson, Sharanya Vemula, Norma J Ofsthun, Claudy Mullon, Franklin W Maddux, Robert J Kossmann, Stuart M Sprague
AIMS: Hyperphosphatemia has been associated with an increased risk of mortality in patients with end-stage renal disease. We sought to assess the real-world effectiveness of sucroferric oxyhydroxide (SO), an iron-based phosphate binder (PB), in control of serum phosphorus levels, and to determine the associated pill burden in hemodialysis patients. MATERIALS AND METHODS: Adult, in-center hemodialysis patients first prescribed SO through a renal pharmacy service as part of routine clinical care between April 1, 2014 and March 31, 2015 were included in the analysis...
August 2017: Clinical Nephrology
https://www.readbyqxmd.com/read/28584909/a-review-of-phosphate-binders-in-chronic-kidney-disease-incremental-progress-or-just-higher-costs
#9
REVIEW
Wendy L St Peter, Lori D Wazny, Eric Weinhandl, Katie E Cardone, Joanna Q Hudson
As kidney disease progresses, phosphorus retention also increases, and phosphate binders are used to treat hyperphosphatemia. Clinicians prescribe phosphate binders thinking that reducing total body burden of phosphorus may decrease risks of mineral and bone disorder, fractures, cardiovascular disease, progression of kidney disease, and mortality. Recent meta-analyses suggest that sevelamer use results in lower mortality than use of calcium-containing phosphate binders. However, studies included in meta-analyses show significant heterogeneity, and exclusion or inclusion of specific studies alters results...
July 2017: Drugs
https://www.readbyqxmd.com/read/28577730/-sucroferric-oxyhydroxide-a-novel-iron-based-phosphate-binder-which-current-use-in-dialysis-patients
#10
Pierre Bataille, Vincent Delattre, Maité Daroux
International guidelines suggest lowering elevated phosphorus level to the normal range in patients on dialysis. Among the phosphate-lowering strategies, phosphate binder is frequently used in addition to dietary phosphate restriction and an adequate dialysis strategy. However, serum phosphate concentration higher than 1.78mmol/L is observed in more than 40% of patients justifying the quest for new drugs. Sucroferric oxyhydroxide is one of the new iron-based agents and is available in France since May 2016...
April 2017: Néphrologie & Thérapeutique
https://www.readbyqxmd.com/read/28550969/long-term-assessment-of-the-safety-and-efficacy-of-pa21-sucroferric-oxyhydroxide-in-japanese-hemodialysis-patients-with-hyperphosphatemia-an-open-label-multicenter-phase-iii-study
#11
Fumihiko Koiwa, Keitaro Yokoyama, Masafumi Fukagawa, Tadao Akizawa
OBJECTIVE: The objective of this article was to assess the safety and efficacy of long-term administration of PA21. DESIGN AND METHODS: Phase III, open-label, long-term study in 15 sites in Japan. SUBJECTS: Japanese hemodialysis patients (N = 161) with hyperphosphatemia aged ≥20 years undergoing stable maintenance hemodialysis 3 times weekly, for ≥12 weeks. INTERVENTION: After a 2-week observation period with their previous hyperphosphatemia therapy, patients began the 52-week treatment with PA21, which was administered orally at an initial dose of 250 mg, 3 times daily, immediately before every meal (dosing range between 750 and 3,000 mg/day)...
May 24, 2017: Journal of Renal Nutrition
https://www.readbyqxmd.com/read/28464802/phosphate-binders-affect-vitamin-k-concentration-by-undesired-binding-an-in-vitro-study
#12
A Neradova, S P Schumacher, I Hubeek, P Lux, L J Schurgers, M G Vervloet
BACKGROUND: Vascular calcification is a major contributing factor to mortality in end stage renal disease (ESRD). Despite the efficacy of phosphate binders to improve hyperphosphatemia, data on vascular calcification are less clear. There seems to be a difference in attenuation or delay in progression between different binders. In this in vitro experiment we tested whether phosphate binders could limit bioavailability of vitamin K2 by undesired binding. Vitamin K-deficiency limits activation of the vascular tissue mineralization inhibitor matrix γ-carboxyglutamate (Gla) protein (MGP) thereby exacerbating vascular calcification...
May 2, 2017: BMC Nephrology
https://www.readbyqxmd.com/read/28339993/one-year-efficacy-and-safety-of-the-iron-based-phosphate-binder-sucroferric-oxyhydroxide-in-patients-on-peritoneal-dialysis
#13
Jürgen Floege, Adrian C Covic, Markus Ketteler, Johannes Mann, Anjay Rastogi, Bruce Spinowitz, Viatcheslav Rakov, Laura J Lisk, Stuart M Sprague
Background: Sucroferric oxyhydroxide is a noncalcium, iron-based phosphate binder that demonstrated sustained serum phosphorus control, good tolerability and lower pill burden compared with sevelamer carbonate (sevelamer) in a Phase 3 study conducted in dialysis patients. This subanalysis examines the efficacy and tolerability of sucroferric oxyhydroxide and sevelamer in the peritoneal dialysis (PD) patient population. Methods: The initial study (NCT01324128) and its extension (NCT01464190) were multicenter, Phase 3, open-label, randomized (2:1), active-controlled trials comparing sucroferric oxyhydroxide (1...
November 1, 2017: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/28248961/effects-of-different-phosphate-lowering-strategies-in-patients-with-ckd-on-laboratory-outcomes-a-systematic-review-and-nma
#14
REVIEW
Nigar Sekercioglu, Argie Angeliki Veroniki, Lehana Thabane, Jason W Busse, Noori Akhtar-Danesh, Alfonso Iorio, Luciane Cruz Lopes, Gordon H Guyatt
BACKGROUND: Chronic kidney disease-mineral and bone disorder (CKD-MBD), a complication of chronic kidney disease, has been linked to reduced quality and length of life. High serum phosphate levels that result from CKD-MBD require phosphate-lowering agents, also known as phosphate binders. The objective of this systematic review is to compare the effects of available phosphate binders on laboratory outcomes in patients with CKD-MBD. METHODS: Data sources included MEDLINE and EMBASE from January 1996 to April 2016, and the Cochrane Register of Controlled Trials up to April 2016...
2017: PloS One
https://www.readbyqxmd.com/read/27971356/cost-effectiveness-analysis-of-sucroferric-oxyhydroxide-in-treatment-of-hyperphosphatemia-in-patients-with-chronic-kidney-disease
#15
D Ugrekhelidze, R Yagudina, A Kulikov
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27971351/budget-impact-analysis-of-sucroferric-oxyhydroxide-in-treatment-of-hyperphosphatemia-in-patients-with-chronic-kidney-disease
#16
D Ugrekhelidze, R Yagudina, A Kulikov
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27496336/efficacy-and-safety-of-sucroferric-oxyhydroxide-compared-with-sevelamer-hydrochloride-in-japanese-haemodialysis-patients-with-hyperphosphataemia-a-randomized-open-label-multicentre-12-week-phase-iii-study
#17
RANDOMIZED CONTROLLED TRIAL
Fumihiko Koiwa, Keitaro Yokoyama, Masafumi Fukagawa, Akira Terao, Tadao Akizawa
AIM: We aimed to investigate the non-inferiority of PA21 (sucroferric oxyhydroxide) to sevelamer hydrochloride (sevelamer) in terms of efficacy and safety in Japanese haemodialysis patients with hyperphosphataemia. METHODS: In this Phase III, open-label, multicentre study, 213 haemodialysis patients with hyperphosphataemia were randomized to PA21 or sevelamer treatment for 12 weeks. The primary outcome was adjusted serum phosphorus concentration at the end of treatment; the non-inferiority of PA21 was confirmed if the upper limit of the two-sided 95% confidence interval (CI) is ≤0...
April 2017: Nephrology
https://www.readbyqxmd.com/read/27434393/pharmacodynamic-effects-of-sucroferric-oxyhydroxide-and-sevelamer-carbonate-on-vitamin-d-receptor-agonist-bioactivity-in-dialysis-patients
#18
RANDOMIZED CONTROLLED TRIAL
Stuart M Sprague, Adrian C Covic, Jürgen Floege, Markus Ketteler, Jaco Botha, Edward M Chong, Anjay Rastogi
BACKGROUND: Many patients with chronic kidney disease are prescribed vitamin D receptor agonists (VDRAs) for the management of secondary hyperparathyroidism. Oral phosphate binders may interact with, and potentially reduce the therapeutic activity of, oral VDRAs. This post hoc analysis of a Phase 3 study evaluated the pharmacodynamic effects of the iron-based phosphate binder sucroferric oxyhydroxide (SFOH) and sevelamer (SEV) carbonate on VDRA activity in dialysis patients. METHODS: One thousand and fifty nine patients were randomized to SFOH 1...
2016: American Journal of Nephrology
https://www.readbyqxmd.com/read/27389681/dose-response-efficacy-and-safety-of-pa21-in-japanese-hemodialysis-patients-with-hyperphosphatemia-a-randomized-placebo-controlled-double-blind-phase-ii-study
#19
Fumihiko Koiwa, Akira Terao
BACKGROUND: Hyperphosphatemia is common in chronic kidney disease (CKD) and associated with mortality and morbidity. We aimed to evaluate the dose-dependent efficacy and safety of PA21 (sucroferric oxyhydroxide), an iron-based phosphate binder, in Japanese hemodialysis patients with hyperphosphatemia. METHODS: In this double-blind, multicenter, Phase II study, 183 patients were randomized to placebo or PA21 at doses of 250, 500, 750, or 1000 mg (based on iron content) three times/day for 6 weeks...
June 2017: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/27342579/iron-related-parameters-in-dialysis-patients-treated-with-sucroferric-oxyhydroxide
#20
Adrian C Covic, Jürgen Floege, Markus Ketteler, Stuart M Sprague, Laura Lisk, Viatcheslav Rakov, Anjay Rastogi
Background: Sucroferric oxyhydroxide is a non-calcium, iron-based phosphate binder indicated for the treatment of hyperphosphataemia in adult dialysis patients. This post hoc analysis of a randomized, 24-week Phase 3 study and its 28-week extension was performed to evaluate the long-term effect of sucroferric oxyhydroxide on iron parameters. Methods: A total of 1059 patients were randomized to sucroferric oxyhydroxide 1.0-3.0 g/day (n = 710) or sevelamer carbonate ('sevelamer') 2...
August 1, 2017: Nephrology, Dialysis, Transplantation
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