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Sucroferric oxyhydroxide

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https://www.readbyqxmd.com/read/27496336/efficacy-and-safety-of-sucroferric-oxyhydroxide-compared-with-sevelamer-hydrochloride-in-japanese-haemodialysis-patients-with-hyperphosphataemia-a-randomised-open-label-multicentre-12-week-phase-iii-study
#1
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 randomised 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...
August 6, 2016: Nephrology
https://www.readbyqxmd.com/read/27434393/pharmacodynamic-effects-of-sucroferric-oxyhydroxide-and-sevelamer-carbonate-on-vitamin-d-receptor-agonist-bioactivity-in-dialysis-patients
#2
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
#3
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...
July 7, 2016: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/27342579/iron-related-parameters-in-dialysis-patients-treated-with-sucroferric-oxyhydroxide
#4
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...
June 23, 2016: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/26893577/phosphate-binders-for-the-treatment-of-chronic-kidney-disease-role-of-iron-oxyhydroxide
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
https://www.readbyqxmd.com/read/25815172/iron-based-phosphate-binders-do-they-offer-advantages-over-currently-available-phosphate-binders
#12
Armando Luis Negri, Pablo Antonio Ureña Torres
Increased cardiovascular morbidity and mortality has been associated with the hyperphosphatemia seen in patients with end-stage chronic kidney disease (CKD). Oral phosphate binders are prescribed in these patients to prevent intestinal absorption of dietary phosphate and reduce serum phosphate. In prospective observational cohorts they have shown to decrease all-cause and cardiovascular mortality risk. Different problems have been associated with currently available phosphate binders as positive calcium balance and impaired outcomes with calcium-based phosphate binders or increased costs with non-calcium-based phosphate binders...
April 2015: Clinical Kidney Journal
https://www.readbyqxmd.com/read/25761962/sucroferric-oxyhydroxide-a-review-in-hyperphosphataemia-in-chronic-kidney-disease-patients-undergoing-dialysis
#13
REVIEW
Sarah L Greig, Greg L Plosker
Sucroferric oxyhydroxide (Velphoro®), an iron-based oral phosphate binder, is available for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. In a pivotal phase III trial, sucroferric oxyhydroxide 1000-3000 mg/day for 24 weeks was noninferior to sevelamer carbonate 4800-14,400 mg/day with regard to lowering serum phosphorus levels. Additionally, sucroferric oxyhydroxide at maintenance dosages was significantly more effective than low dosage sucroferric oxyhydroxide (250 mg/day) with regard to maintaining controlled serum phosphorus levels during weeks 24-27 of treatment...
April 2015: Drugs
https://www.readbyqxmd.com/read/25691681/long-term-effects-of-the-iron-based-phosphate-binder-sucroferric-oxyhydroxide-in-dialysis-patients
#14
RANDOMIZED CONTROLLED TRIAL
Jürgen Floege, Adrian C Covic, Markus Ketteler, Johannes F E Mann, Anjay Rastogi, Bruce Spinowitz, Edward M F Chong, Sylvain Gaillard, Laura J Lisk, Stuart M Sprague
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...
June 2015: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/25658128/preclinical-pharmacokinetics-pharmacodynamics-and-safety-of-sucroferric-oxyhydroxide
#15
REVIEW
Mario Cozzolino, Felix Funk, Viatcheslav Rakov, Olivier Phan, Isaac Teitelbaum
Sucroferric oxyhydroxide (VELPHORO) is a polynuclear iron-based phosphate binder recently approved for the treatment of hyperphosphataemia in patients with chronic kidney disease (CKD). As a number of the available phosphate binders do not provide the optimal combination of good efficacy, adequate tolerability and low pill burden, sucroferric oxyhydroxide constitutes a promising alternative. Among the attributes of an ideal phosphate binder is minimal absorption and, hence, low risk of systemic toxicity. Accordingly, the iron-releasing properties and absorption, distribution, metabolism and excretion (ADME) profile of sucroferric oxyhydroxide, as well as the possibility of iron accumulation and toxicity, were investigated in a series of preclinical studies...
2014: Current Drug Metabolism
https://www.readbyqxmd.com/read/25450474/a-review-of-sucroferric-oxyhydroxide-for-the-treatment-of-hyperphosphatemia-in-patients-receiving-dialysis
#16
REVIEW
Ava Bousher, Akram Al-Makki, James Sutton, Brian Shepler
PURPOSE: Sucroferric oxyhydroxide is the newest phosphate binder to receive US Food and Drug Administration approval for patients on dialysis. The purpose of this review is to critically evaluate the studies that have been conducted with this medication and determine where it may fit in the clinician's overall treatment plan for hyperphosphatemia in patients with chronic kidney disease. METHODS: Literature searches were performed in the PubMed database and www.ClinicalTrials...
December 1, 2014: Clinical Therapeutics
https://www.readbyqxmd.com/read/25168499/novel-phosphate-binders-plus-%C3%A3-a-change-plus-c-est-la-m%C3%A3%C2%AAme-chose
#17
COMMENT
Alastair J Hutchison
Sucroferric oxyhydroxide is a new calcium-free polynuclear iron(III)-oxyhydroxide compound that binds phosphate by ligand exchange. Floege et al. report equivalent phosphate control with a mean dose of three pills daily compared with eight of sevelamer, and suggest that a reduced pill burden may represent an aid to improved adherence. However, there is still no prospective interventional study to demonstrate that reduction in serum phosphate improves patient outcomes for any oral phosphate binder.
September 2014: Kidney International
https://www.readbyqxmd.com/read/25118800/sucroferric-oxyhydroxide-velphoro-for-hyperphosphatemia
#18
REVIEW
(no author information available yet)
No abstract text is available yet for this article.
August 18, 2014: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/24848754/next-generation-phosphate-binders-focus-on-iron-based-binders
#19
REVIEW
Dimitra Nastou, Beatriz Fernández-Fernández, Usama Elewa, Liliana González-Espinoza, Emilio González-Parra, Maria D Sanchez-Niño, Alberto Ortiz
Phosphate excess is associated with increased mortality in patients with chronic kidney disease (CKD) and has recently been linked to accelerated aging. Oral phosphate binders are prescribed to patients with CKD to prevent absorption of dietary phosphate. Currently available binders have been associated with impaired outcomes (calcium-based binders) or are expensive (non-calcium-based binders). Iron-based phosphate binders represent a new class of phosphate binders. Four iron-based phosphate binders have undergone testing in clinical trials...
June 2014: Drugs
https://www.readbyqxmd.com/read/24715748/conjugated-estrogens-and-bazedoxifene
#20
Dennis J Cada, Danial E Baker
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line...
March 2014: Hospital Pharmacy
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