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Sung Min Ko, Chao Zhang, Zhengjia Chen, Luis D'Marco, Antonio Bellasi, Arthur E Stillman, Geoffrey Block, Paolo Raggi
BACKGROUND: In the general population and in hemodialysis patients epicardial adipose tissue (EAT) has been associated with increased mortality and cardiovascular events. Weight loss and lipid lowering therapies reduced EAT in the general population. It is unknown whether sevelamer, a phosphate (Pi) binder that lowers cholesterol and reduces inflammation in dialysis patients also affects EAT progression. METHODS: Post-hoc analysis of a randomized trial of sevelamer (SVL) versus calcium-based Pi binders (CPiB) in incident hemodialysis patients...
October 2016: Journal of Nephrology
Hamid Nasri
INTRODUCTION: Numerous studies have attempted to identify risk factors for mortality and morbidity in maintenance hemodialysis patients. In this study we sought to examine the association of the levels of serum C-reactive protein (CRP) with value of Ca×PO4 product, in stable hemodialysis patients. PATIENTS AND METHODS: Based on the severity of secondary hyperparathyroidism, patients being treated with oral active vitamin D3, calcium carbonate/Renagel tablets at various doses...
2012: Journal of Renal Injury Prevention
Desmond Padhi, Robert Harris, John T Sullivan
BACKGROUND AND OBJECTIVES: Secondary hyperparathyroidism is a common consequence of chronic kidney disease. Cinacalcet (Sensipar(®)) is often prescribed in combination to reduce elevated levels of parathyroid hormone, calcium and phosphorus. The objective of this study was to assess the effects of concomitantly administered therapies of calcium carbonate (CaCO(3); TUMS(®)), sevelamer hydrochloride (HCl; Renagel(®)) and pantoprazole sodium (Protonix(®)) on the pharmacokinetics and safety of cinacalcet in healthy subjects...
August 2014: Clinical Drug Investigation
Caroline M Perry, Greg L Plosker
Sevelamer carbonate (Renvela(®)), a buffered form of sevelamer hydrochloride (Renagel(®)), is an orally administered non-absorbed phosphate-binding anion exchange resin used in the treatment of hyperphosphataemia in chronic kidney disease (CKD). In the EU, sevelamer carbonate is approved in adult CKD patients who require dialysis and in those who do not require dialysis with serum phosphate levels ≥ 1.78 mmol/L, whereas in the USA sevelamer carbonate is approved in adult CKD patients who require dialysis...
May 2014: Drugs
C Tzanno-Martins, B M M Biavo, O Ferreira-Filho, E Ribeiro-Junior, M V S João-Luiz, S Degaspari, C Scavone, E Kawamoto
Sevelamer hydrochloride is an ionic exchange resin with high affinity for phosphate. This phosphate-binding agent has few serious adverse reactions with the advantage of reducing total and low density lipoprotein (LDL) cholesterol levels. However, it is controversial as to whether sevelamer hydrochloride can modulate the inflammatory response via endotoxin reduction. Therefore, a single-center, open-label, prospective and randomized study was performed to compare the clinical efficacy, safety and anti-inflammatory activity of two sevelamer hydrochloride tablet forms a branded tablet form, Renagel (Genzyme manufacturer) and its generic equivalent (EMS manufacturer)...
January 2014: International Journal of Immunopathology and Pharmacology
Jacob Grinfeld, Akimichi Inaba, Alastair J Hutchison
Sevelamer (Renagel and Renvela), is an orally administered weakly basic anion exchange resin that binds dietary phosphate in the gastrointestinal tract, and is approved for use in the US, Europe and many other countries for the treatment of hyperphosphatemia in adult patients on hemodialysis or peritoneal dialysis. Clinical evidence shows that sevelamer is at least as effective as calcium-based oral phosphate binders in controlling serum phosphate, but with a lower incidence of hypercalcemia. Whilst sevelamer hydrochloride is associated with mild acidosis, sevelamer carbonate does not have this drawback...
2010: Open Access Journal of Urology
Benjamin J Swanson, Berkeley N Limketkai, Ta-Chiang Liu, Elizabeth Montgomery, Kamran Nazari, Jason Y Park, William C Santangelo, Michael S Torbenson, Lysandra Voltaggio, Martha M Yearsley, Christina A Arnold
We report the first description of sevelamer crystals (Renagel and Renvela, Genzyme; phosphate-lowering agents) in the gastrointestinal tract. We prospectively collected cases with novel, histologically identical crystals from 4 major academic centers over a 1-year period and studied pertinent clinicopathologic features. Sevelamer usage in the setting of chronic kidney disease was demonstrated in all cases (n=15 total cases, 7 patients). Sites of involvement included the esophagus (n=2), small bowel (n=2), and colon (n=11)...
November 2013: American Journal of Surgical Pathology
Luis G D'Marco, Antonio Bellasi, Sunjin Kim, Zhengjia Chen, Geoffrey A Block, Paolo Raggi
BACKGROUND: Epicardial adipose tissue (EAT) has been described in the general population as an independent risk marker for incident coronary artery disease. In hemodialysis patients, it correlates with other markers of cardiovascular disease, but it is unknown if it is associated with adverse events. METHODS: post hoc analysis of the Renagel in New Dialysis (RIND) patients study, a randomized trial of sevelamer versus calcium-based phosphate binders in 109 incident hemodialysis patients, followed for all-cause mortality for a median of 49...
October 2013: Nephrology, Dialysis, Transplantation
Sartaj Alam, Asrar Hussain, Rajendra Daiwajna, Jackson Tan
INTRODUCTION: Sevelamer hydrochloride (Renagel) is frequently used as a second-line phosphate binder in patients on renal replacement therapy. Many studies have shown that sevelamer can improve vascular calcification, serum uric acid and low-density lipoprotein (LDL) cholesterol levels. The main objectives of this study were to assess the efficacy of sevelamer against calcium-based phosphate binders, as well as its tolerability and side-effect profile. METHODS: This was a retrospective study that included all patients on renal replacement therapy (between 2008 and 2011) who had previously received calcium-based binders for ≥ 6 months and were subsequently switched to sevelamer...
May 2013: Singapore Medical Journal
Natasa Draca, Ratimir Lazic, Petra Simic, Ivo Dumic-Cule, Ana Tikvica Luetic, Nikica Gabric
Patients with chronic kidney disease (CKD) experience co-morbid illnesses, including cardiovascular disease and retinopathy. Sevelamer hydrochloride (Renagel®); a non-calcium phosphate binder reduces coronary artery and aortic calcification as compared to calcium containing phosphate binders and additionally effects inflammatory biomarkers such as C-reactive protein (CRP), and lowers LDL cholesterol in patients with CKD. Since retinopathy is proven to be associated with increased coronary calcification, shared pathophysiological processes may contribute to both microvascular and macrovascular disease...
April 2013: Medical Hypotheses
Thomas Plagemann, Anne Prenzler, Thomas Mittendorf
Because of an elevated serum phosphate level, patients who suffer from chronic kidney failure frequently tend to have cardiovascular calcification and are therefore exposed to a higher probability of a fatal event. Phosphate binders are able to reduce these negative effects. Currently, there are primarily two groups of phosphate binders (calcium-containing and calcium-free phosphate binders) which are considered to be almost equally effective in terms of binding of free phosphate. There are, however, a few disadvantages of the two groups...
July 20, 2011: Health Economics Review
Ming Zeng, Xiaoyun Wang, Xiaobing Wang, Xiufen Zhao
OBJECTIVE: To investigate the effects of phosphonoformic acid (PFA) and sevelamer hydrochloride (Renagel) on renal type IIa sodium-dependent phosphate cotransporter (NaPi-2) mRNA expression in hyperphosphatemia rats. METHODS: Thirty rats were randomly divided into five groups based on the diet for 2 weeks after 5/6 nephrectomy (Nx): Nx + high-phosphate (HP; 1.2% P) diet; Nx + low-phosphate (LP; 0.2% P) diet; HP + PFA (injected with 0.15 g/kg PFA daily); HP + Saline (injected with the same amount of saline daily); and HP + Renagel (2%) group...
2012: Renal Failure
Nicolas Bertrand, Marc A Gauthier, Céline Bouvet, Pierre Moreau, Anne Petitjean, Jean-Christophe Leroux, Jeanne Leblond
Macromolecular binders consist of polymers, dendrimers, and oligomers with binding properties for endogenous or exogenous substrates. This field, at the frontier of host/guest chemistry and pharmacology, has met a renewed interest in the past decade due to the clinical success of several sequestrants, like sevelamer hydrochloride (Renagel®) or sugammadex (Bridion®). In many instances, multivalent binding by the macromolecular drugs can modify the properties of the substrate, and may prevent it from reaching its site of action and/or trigger a biological response...
October 30, 2011: Journal of Controlled Release: Official Journal of the Controlled Release Society
Qian Zhang, Ming Li, Yanwen Lu, Haiming Li, Yong Gu, Chuanming Hao, Jing Chen
BACKGROUND: Accelerated cardiovascular calcification often occurs in patients with cardiovascular disease who are on hemodialysis. We performed a meta-analysis to compare the effects of sevelamer hydrochloride and calcium-based phosphate binders on coronary artery calcification, C-reactive protein, alkaline phosphatase and intact parathyroid hormone in patients undergoing hemodialysis. METHODS: We used the key words 'sevelamer' and 'Renagel' to retrieve studies from Medline, the Cochrane Library and conference proceedings...
2010: Nephron. Clinical Practice
Magdalene M Assimon, Shaker Mousa, Olfat Shaker, Amy Barton Pai
OBJECTIVE: To review phosphate-binder choice and mortality in hemodialysis patients. DATA SOURCES: A literature search was performed using the PUBMED database to identify clinical trials published from January 1966 through January 2009. Search terms included: sevelamer and mortality, calcium acetate and mortality, and calcium carbonate and mortality. STUDY SELECTION: Clinical trials relating the effect of phosphate-binder choice on cardiovascular disease and mortality in hemodialysis patients, judged to be pertinent by the authors, were selected for discussion...
January 2010: Consultant Pharmacist: the Journal of the American Society of Consultant Pharmacists
Dariusz Runowski, Bozena Jachimiak, Anna Cieślak-Puchalska, Beata Pacanowska, Tomasz Zimoń
UNLABELLED: The aim of study was the estimation of efficacy and safety of sevelamer treatment in children with chronic kidney disease with resistant hyperphsphatemia. MATERIAL AND METHODS: The study group was 7 patients (hemodialysed--2 boys, mean age 7, 7+/-0.1; peritoneal dialysis--5: 3 boys and 2 girls, mean age 5, 6+/-5.0). Sevelamer (Renagel, 800 mg, Genzyme) was used in all patients in mean dosis of 117 mg/kgm.c./d due to lack of effect of the typical treatment (vitamin D, diet, calcium carbonate)...
April 2009: Polski Merkuriusz Lekarski: Organ Polskiego Towarzystwa Lekarskiego
Krista F Huybrechts, J Jaime Caro, Judith A O'Brien
BACKGROUND: Sevelamer hydrochloride (Renagel) binds phosphate in patients with end-stage renal disease without the use of exogenous calcium and may reduce the progression of coronary vascular calcification. This intervention was shown to be cost-effective in the United States. This paper presents the Canadian adaptation. METHODS: A discrete event simulation of the long-term cardiovascular implications of 1 year of phosphate binding in a prevalent hemodialysis population was used to estimate the cost-effectiveness of sevelamer use in Canada based on the demographics, comorbidities, physiological and renal characteristics...
January 2009: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Wajeh Qunibi, Moustafa Moustafa, Larry R Muenz, David Y He, Paul D Kessler, Jose A Diaz-Buxo, Mathew Budoff
BACKGROUND: Previous clinical trials showed that progression of coronary artery calcification (CAC) may be slower in hemodialysis patients treated with sevelamer than those treated with calcium-based phosphate binders. Because sevelamer decreases low-density lipoprotein cholesterol (LDL-C) levels, we hypothesized that intensive lowering of LDL-C levels with atorvastatin in hemodialysis patients treated with calcium acetate would result in CAC progression rates similar to those in sevelamer-treated patients...
June 2008: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
David R Goldsmith, Lesley J Scott, Risto S Cvetković, Greg L Plosker
Sevelamer (Renagel), an orally administered metal-free cationic hydrogel polymer/resin that binds dietary phosphate in the gastrointestinal (GI) tract, is approved for use in the US, Europe and several other countries for the treatment of hyperphosphataemia in adult patients with end-stage renal disease (ESRD) on haemodialysis or peritoneal dialysis.Clinical evidence shows that sevelamer was at least as effective as calcium acetate and calcium carbonate at controlling serum phosphorus, calcium-phosphorus product (Ca x P) and intact parathyroid hormone (iPTH) levels, but generally reduced serum calcium levels to a greater extent and was associated with a lower risk of hypercalcaemic episodes than calcium-based phosphate binders...
2008: Drugs
Matthew J Budoff, Paul Kessler, Yan L Gao, Wajeh Qunibi, Moustafa Moustafa, Song S Mao
RATIONALE AND OBJECTIVES: In the Calcium Acetate Renagel Evaluation (CARE)-2 study, the effects of calcium acetate plus atorvastatin (Lipitor) on the progression of coronary artery calcifications (CACs) are evaluated versus those of Renagel, monitored using dual electron beam tomography (EBT) scans (two scans at study initiation and two at follow up). The aim of this study is to estimate the interscan variation for the Agatston score and for the volume score determined in patients with end-stage renal disease (ESRD) in the CARE-2 study...
January 2008: Academic Radiology
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