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

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Hyperphosphataemia occurs in patients with chronic kidney disease (CKD) as a result of phosphorus accumulation in the body from dietary phosphate intake and decreasing excretion of phosphorus into the urine. Hyperphosphataemia has been shown to be an independent prognostic factor for mortality.1 For the management of hyperphosphataemia in chronic haemodialysis patients, dietary restriction and the use of phosphate binding agents are recommended in CKD management guidelines both in Japan and internationally.3
The use of phosphate binders is necessary to inhibit the absorption of dietary phosphate from the gastrointestinal tract, because dietary restriction and haemodialysis are not enough to eliminate the phosphorus excess. Four non‐calcium‐containing phosphate binders have been marketed in Japan, because the calcium load during administration of calcium carbonate is of concern.4 Although the use of sevelamer in combination with calcium carbonate was recommended in the first Japanese Mineral and Bone Disorder guideline,6 sevelamer is not widely used in Japan because of frequent gastrointestinal adverse reactions, including constipation and flatulence. In fact, many Japanese haemodialysis patients complain of constipation, in general. Bixalomer and lanthanum were launched after sevelamer; however, these phosphate binders also cause concerns about constipation and lanthanum accumulation with long‐term use, respectively.3 Ferric citrate, an iron‐based phosphate binder, was approved in Japan in 2014.9 Dialysis patients often need to take several medications for the treatment of comorbidities; therefore, a phosphate binder with strong phosphorus absorption potency is required to reduce the tablet intake in dialysis patients. PA21, also known as sucroferric oxyhydroxide, is a novel non‐calcium‐, iron‐based phosphate binder that has already been launched in Europe, the US, and other countries.
The aim of the present study was to investigate the non‐inferiority of PA21 to sevelamer in terms of efficacy and safety after 12 weeks of treatment in Japanese haemodialysis patients with hyperphosphataemia.
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