- Pharmacoeconomic Review Report: Sucroferric Oxyhydroxide (Velphoro): (Vifor Fresenius Medical Care Renal Pharma Ltd.): Indication: For the control of serum phosphorus levels in adult patients with end-stage renal disease on dialysis [BOOK]
- BOOKCanadian Agency for Drugs and Technologies in Health: Ottawa (ON)
- Sucroferric oxyhydroxide (500 mg; Velphoro) is a non-calcium, iron-based, chewable phosphate binder indicated for the control of serum phosphorus levels in patients with end-stage renal disease (ESRD…
Sucroferric oxyhydroxide (500 mg; Velphoro) is a non-calcium, iron-based, chewable phosphate binder indicated for the control of serum phosphorus levels in patients with end-stage renal disease (ESRD) receiving dialysis. The starting dosage is three tablets per day (1,500 mg iron) administered as one tablet (500 mg iron) three times daily with meals. The dose is titrated up or down in increments of 500 mg iron (one tablet) per day every two to four weeks until an acceptable serum phosphorus level is reached. The submitted price of sucroferric oxyhydroxide is $4.62 per tablet (daily cost: $13.87 to $18.49). The manufacturer submitted a cost-utility analysis comparing sucroferric oxyhydroxide with sevelamer hydrochloride in adult patients with ESRD receiving dialysis. The analysis was conducted over a lifetime time horizon (assumed to be 10 years) from the perspective of the Canadian health care payer.
- Use of Phosphate Binders in End-Stage Renal Disease: An Experience From a Secondary Care Hospital in United Arab Emirates. [Journal Article]
- JPJ Pharm Bioallied Sci 2019 Apr-Jun; 11(2):148-154
- CONCLUSIONS: We observed that hyperphosphatemia and related events in our study population were better controlled by sevelamer per se and combination therapy than calcium carbonate per se. Further large scale, multicenter studies are required to confirm and establish these findings.
- Ischemic Colitis in Association with Sevelamer Crystals. [Case Reports]
- IJIndian J Nephrol 2019 May-Jun; 29(3):191-193
- Sevelamer is an important drug used to lower serum phosphate levels in advanced kidney disease and in patients on dialysis. This drug is generally well tolerated but some patients report mild gastroi…
Sevelamer is an important drug used to lower serum phosphate levels in advanced kidney disease and in patients on dialysis. This drug is generally well tolerated but some patients report mild gastrointestinal distress as a side effect. Although regulatory agencies, such as Food and Drug Administration, list bowel ischemia and necrosis as potential and rare side effects, there are few case reports describing these adverse effects. We present a 35-year-old HIV patient with end-stage renal disease on hemodialysis who developed colonic hemorrhage and perforation. Imaging showed ischemic gangrene of bowel wall. Histopathology was consistent with transmural ischemic necrosis with deposition of fibrin thrombi and sevelamer crystals.
- The Effect of Sevelamer on Serum Levels of Gut-Derived Uremic Toxins: Results from In Vitro Experiments and A Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial. [Journal Article]
- TToxins (Basel) 2019 05 17; 11(5)
- High serum levels of gut-derived uremic toxins, especially p-cresyl sulfate (pCS), indoxyl sulfate (IS) and indole acetic acid (IAA), have been linked to adverse outcomes in patients with chronic kid…
High serum levels of gut-derived uremic toxins, especially p-cresyl sulfate (pCS), indoxyl sulfate (IS) and indole acetic acid (IAA), have been linked to adverse outcomes in patients with chronic kidney disease (CKD). Sevelamer carbonate could represent an interesting option to limit the elevation of gut-derived uremic toxins. The aim of the present study was to evaluate the adsorptive effect of sevelamer carbonate on different gut-derived protein-bound uremic toxins or their precursors in vitro, and its impact on the serum levels of pCS, IS and IAA in patients with CKD stage 3b/4. For the in vitro experiments, IAA, p-cresol (precursor of pCS) and indole (precursor of IS), each at a final concentration of 1 or 10 µg/mL, were incubated in centrifugal 30 kDa filter devices with 3 or 15 mg/mL sevelamer carbonate in phosphate-buffered saline at a pH adjusted to 6 or 8. Then, samples were centrifuged and free uremic toxins in the filtrates were analyzed. As a control experiment, the adsorption of phosphate was also evaluated. Additionally, patients with stage 3b/4 CKD (defined as an eGFR between 15 and 45 mL/min per 1.73 m2) were included in a multicenter, double-blind, placebo-controlled, randomized clinical trial. The participants received either placebo or sevelamer carbonate (4.8 g) three times a day for 12 weeks. The concentrations of the toxins and their precursors were measured using a validated high-performance liquid chromatography method with a diode array detector. In vitro, regardless of the pH and concentration tested, sevelamer carbonate did not show adsorption of indole and p-cresol. Conversely, with 10 µg/mL IAA, use of a high concentration of sevelamer carbonate (15 mg/mL) resulted in a significant toxin adsorption both at pH 8 (mean reduction: 26.3 ± 3.4%) and pH 6 (mean reduction: 38.7 ± 1.7%). In patients with CKD stage 3b/4, a 12-week course of treatment with sevelamer carbonate was not associated with significant decreases in serum pCS, IS and IAA levels (median difference to baseline levels: -0.12, 0.26 and -0.06 µg/mL in the sevelamer group vs. 1.97, 0.38 and 0.05 µg/mL in the placebo group, respectively). Finally, in vitro, sevelamer carbonate was capable of chelating a gut-derived uremic toxin IAA but not p-cresol and indole, the precursors of pCS and IS in the gut. In a well-designed clinical study of patients with stage 3b/4 CKD, a 12-week course of treatment with sevelamer carbonate was not associated with significant changes in the serum concentrations of pCS, IS and IAA.
- Does the Administration of Sevelamer or Nicotinamide Modify Uremic Toxins or Endotoxemia in Chronic Hemodialysis Patients? [Journal Article]
- DDrugs 2019; 79(8):855-862
- CONCLUSIONS: In contrast to sevelamer, nicotinamide did not reduce circulating levels of low-molecular-weight uremic toxins other than phosphate, and neither agent reduced circulating uremic toxins of high-molecular-weight or protein-bound toxins. Sevelamer, but not nicotinamide, reduced serum endotoxin levels. Despite no change in serum C-reactive protein, the endotoxin-lowering effect of sevelamer may help to attenuate the inflammatory status of patients with chronic kidney disease.
- Cardiovascular Outcomes of Calcium-Free vs Calcium-Based Phosphate Binders in Patients 65 Years or Older With End-stage Renal Disease Requiring Hemodialysis. [Journal Article]
- JIMJAMA Intern Med 2019 May 06
- CONCLUSIONS: The results of the study do not suggest increased cardiovascular safety of sevelamer in the routine clinical practice of patients with ESRD compared with calcium acetate; this study's findings suggest that well-designed, long-term, randomized clinical trials are needed.
- Effects of Sevelamer Carbonate in Patients With CKD and Proteinuria: The ANSWER Randomized Trial. [Journal Article]
- AJAm J Kidney Dis 2019 Apr 23
- CONCLUSIONS: Short treatment duration, lower pretreatment proteinuria than expected.3-month sevelamer treatment did not reduce proteinuria in patients with CKD on maximal RAS blockade. Amelioration of inflammation and dyslipidemia with sevelamer treatment raises the possibility that it may confer benefit in patients with CKD beyond reduction of proteinuria.
- Pathology of Resin-Induced Gastrointestinal Damage: Report of 15 Cases and Review of Literature. [Journal Article]
- TPTurk Patoloji Derg 2019 Apr 26
- CONCLUSIONS: Accurate and timely recognition of the resin crystals in biopsy samples with clinical correlation is mandatory to avoid serious complications.
- When acute kidney injury in the intensive care unit is not acute tubular necrosis: A case report of κ-light chain crystalline tubulopathy . [Case Reports]
- CNClin Nephrol 2019; 91(5):311-316
- CONCLUSIONS: This case describes a rare presentation of κ light chain crystalline tubulopathy and illustrates the value of a comprehensive evaluation for acute kidney injury to enable prompt diagnosis and therapy. .
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- Phosphate Binders and Nonphosphate Effects in the Gastrointestinal Tract. [Review]
- JRJ Ren Nutr 2019 Mar 04
- Phosphate binders are commonly prescribed in patients with end-stage kidney disease to prevent and treat hyperphosphatemia. These binders are usually associated with gastrointestinal distress, may bi…
Phosphate binders are commonly prescribed in patients with end-stage kidney disease to prevent and treat hyperphosphatemia. These binders are usually associated with gastrointestinal distress, may bind molecules other than phosphate, and may alter the gut microbiota, altogether having systemic effects unrelated to phosphate control. Sevelamer is the most studied of the available binders for nonphosphate-related effects including binding to bile acids, endotoxins, gut microbiota-derived metabolites, and advanced glycation end products. Other binders (calcium- and noncalcium-based binders) may bind vitamins, such as vitamin K and folic acid. Moreover, the relatively new iron-based phosphate binders may alter the gut microbiota, as some of the iron or organic ligands may be used by the gastrointestinal bacteria. The objective of this narrative review is to provide the current evidence for the nonphosphate effects of phosphate binders on gastrointestinal function, nutrient and molecule binding, and the gut microbiome.