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Sucroferric oxyhydroxide

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https://www.readbyqxmd.com/read/28587714/real-world-effectiveness-of-sucroferric-oxyhydroxide-in-patients-on-chronic-hemodialysis-a-retrospective-analysis-of-pharmacy-data%C3%A2
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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...
February 23, 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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
https://www.readbyqxmd.com/read/26893577/phosphate-binders-for-the-treatment-of-chronic-kidney-disease-role-of-iron-oxyhydroxide
#14
REVIEW
Valeria Cernaro, Domenico Santoro, Antonio Lacquaniti, Giuseppe Costantino, Luca Visconti, Antoine Buemi, Michele Buemi
Chronic kidney disease-mineral bone disorder is frequent in patients with renal failure. It is characterized by abnormalities in mineral and bone metabolism with resulting hyperphosphatemia, low serum vitamin D, secondary hyperparathyroidism, altered bone morphology and strength, higher risk of bone fractures, and development of vascular or other soft tissue calcifications. Besides the recommendation to reduce phosphorus dietary intake, many drugs are currently available for the treatment of calcium/phosphate imbalance...
2016: International Journal of Nephrology and Renovascular Disease
https://www.readbyqxmd.com/read/26800972/phosphate-binders-in-chronic-kidney-disease-a-systematic-review-of-recent-data
#15
REVIEW
Jürgen Floege
Hyperphosphatemia is common in chronic kidney disease (CKD) and is treated by dietary measures, dialysis techniques and/or phosphate binders. For the present review PubMed was searched for new publications on phosphate binders appearing between January 2010 and October 2015. This review summarizes the latest information on non-pharmacological measures and their problems in lowering phosphate in CKD patients, effects of phosphate binders on morbidity and mortality, adherence to phosphate binder therapy as well as new information on specific aspects of the various phosphate binders on the market: calcium acetate, calcium carbonate, magnesium-containing phosphate binders, polymeric phosphate binders (sevelamer, bixalomer, colestilan), lanthanum carbonate, ferric citrate, sucroferric oxyhydroxide, aluminum-containing phosphate binders, and new compounds in development...
June 2016: Journal of Nephrology
https://www.readbyqxmd.com/read/26572591/iron-based-phosphate-binders-a-new-element-in-management-of-hyperphosphatemia
#16
REVIEW
Amy Barton Pai, Soo Min Jang, Nicole Wegrzyn
INTRODUCTION: Management of serum phosphorus in patients with chronic kidney disease remains a significant clinical challenge. A pivotal component of the clinical approach to maintaining serum phosphorus concentrations towards the normal range is the use of phosphate binding agents in addition to comprehensive dietary counseling. The available agents work similarly by capitalizing on a cation within the agent to bind negatively charged phosphorus, forming an insoluble complex and reducing ingested phosphorus absorption...
2016: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/26334991/cost-effectiveness-of-sucroferric-oxyhydroxide-compared-with-sevelamer-carbonate-in-the-treatment-of-hyperphosphataemia-in-patients-receiving-dialysis-from-the-perspective-of-the-national-health-service-in-scotland
#17
Florian S Gutzwiller, Alena M Pfeil, Zanfina Ademi, Patricia R Blank, Peter G Braunhofer, Thomas D Szucs, Matthias Schwenkglenks
BACKGROUND: Hyperphosphataemia is common and harmful in patients receiving dialysis. Treatment options include noncalcium-based phosphate binders such as sevelamer carbonate (SC) and sucroferric oxyhydroxide (PA21). OBJECTIVE: The aim of this study was to determine the health economic impact of PA21-based strategies compared with SC-based strategies, from the perspective of the Scottish National Health Service (NHS). METHODS: A Markov model was constructed based on data from a randomised clinical trial comparing PA21 and SC...
December 2015: PharmacoEconomics
https://www.readbyqxmd.com/read/26293683/novel-iron-containing-phosphate-binders-for-treatment-of-hyperphosphatemia
#18
REVIEW
Holger Schmid, Stephan R Lederer
INTRODUCTION: Hyperphosphatemia is a frequent complication of chronic kidney disease and is associated with increased mortality. Despite side effects, risk of accumulation and high costs, phosphate binders (PBs) have become the crucial cornerstone of therapy. The iron-containing PB sucroferric oxyhydroxide (SO) and ferric citrate hydrate (FCH) have entered the market and other candidates are prior market entry. AREAS COVERED: A literature search was performed using MEDLINE and EMBASE databases to identify references on iron-containing PB with particular regard to efficacy, safety and potential benefits...
2015: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/26221597/effects-of-sucroferric-oxyhydroxide-compared-to-lanthanum-carbonate-and-sevelamer-carbonate-on-phosphate-homeostasis-and-vascular-calcifications-in-a-rat-model-of-chronic-kidney-failure
#19
COMPARATIVE STUDY
Olivier Phan, Marc Maillard, Hartmut H Malluche, Jean-Christophe Stehle, Felix Funk, Michel Burnier
Elevated serum phosphorus, calcium, and fibroblast growth factor 23 (FGF23) levels are associated with cardiovascular disease in chronic renal disease. This study evaluated the effects of sucroferric oxyhydroxide (PA21), a new iron-based phosphate binder, versus lanthanum carbonate (La) and sevelamer carbonate (Se), on serum FGF23, phosphorus, calcium, and intact parathyroid hormone (iPTH) concentrations, and the development of vascular calcification in adenine-induced chronic renal failure (CRF) rats. After induction of CRF, renal function was significantly impaired in all groups: uremic rats developed severe hyperphosphatemia, and serum iPTH increased significantly...
2015: BioMed Research International
https://www.readbyqxmd.com/read/26050119/novel-iron-based-phosphate-binders-in-patients-with-chronic-kidney-disease
#20
REVIEW
Hitesh H Shah, Azzour D Hazzan, Steven Fishbane
PURPOSE OF REVIEW: Management of hyperphosphatemia remains an integral component in the care of patients with chronic kidney disease on dialysis. In addition to dietary restriction and dialysis, oral phosphate binders remain a key strategy in the control of serum phosphorus levels in this population. We review two new oral phosphate binders that are currently marketed in the United States. RECENT FINDINGS: Sucroferric oxyhydroxide was approved by the U.S. Food and Drug Administration (FDA) in November 2013...
July 2015: Current Opinion in Nephrology and Hypertension
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