Ava Bousher1, Akram Al-Makki2, James Sutton2, Brian Shepler3. 1. Purdue University College of Pharmacy, West Lafayette, Indiana. 2. Indiana University Health Arnett Nephrology, Lafayette, Indiana. 3. Purdue University College of Pharmacy, West Lafayette, Indiana. Electronic address: sheplerb@purdue.edu.
Abstract
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.gov using the search terms sucroferric oxyhydroxide, and PA21 phosphate binder. Limits were set to include only clinical trials performed in human subjects. FINDINGS: Four completed clinical trials and 3 ongoing studies were identified. Completed clinical trials included Phase I, Phase II, and Phase III studies that all demonstrated the ability of sucroferric oxyhydroxide to lower serum phosphorus concentrations. One study compared sucroferric oxyhydroxide with sevelamer and reported no statistically significant difference in serum phosphorus-lowering ability. The ongoing trials are evaluating sucroferric oxyhydroxide for long term use, in peritoneal dialysis patients, and compared with calcium-based phosphate binders. IMPLICATIONS: Sucroferric oxyhydroxide is an effective phosphate binder for chronic kidney disease patients receiving hemodialysis and may offer an advantage in terms of pill burden. Gastrointestinal side effects are similar to those of current phosphate binders. Advantages of other phosphate binders (ie, the lipid- and uric acid-lowering abilities of sevelamer) may outweigh the pill burden benefits of sucroferric oxyhydroxide.
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.gov using the search terms sucroferric oxyhydroxide, and PA21 phosphate binder. Limits were set to include only clinical trials performed in human subjects. FINDINGS: Four completed clinical trials and 3 ongoing studies were identified. Completed clinical trials included Phase I, Phase II, and Phase III studies that all demonstrated the ability of sucroferric oxyhydroxide to lower serum phosphorus concentrations. One study compared sucroferric oxyhydroxide with sevelamer and reported no statistically significant difference in serum phosphorus-lowering ability. The ongoing trials are evaluating sucroferric oxyhydroxide for long term use, in peritoneal dialysis patients, and compared with calcium-based phosphate binders. IMPLICATIONS: Sucroferric oxyhydroxide is an effective phosphate binder for chronic kidney diseasepatients receiving hemodialysis and may offer an advantage in terms of pill burden. Gastrointestinal side effects are similar to those of current phosphate binders. Advantages of other phosphate binders (ie, the lipid- and uric acid-lowering abilities of sevelamer) may outweigh the pill burden benefits of sucroferric oxyhydroxide.
Authors: Julia Spoendlin; Julie M Paik; T Tsacogianis; Seoyoung C Kim; Sebastian Schneeweiss; Rishi J Desai Journal: JAMA Intern Med Date: 2019-06-01 Impact factor: 21.873