Therapeutic Research

Abstract

Background & Objective：Bixalomer is a non‒absorbable polymer that decreases serum phosphate levels by binding to phosphate in the gastrointestinal tract. In this long‒term post‒marketing surveillance（PMS）, we examined the safety and effectiveness of bixalomer in hyperphosphatemic patients with chronic kidney disease on peritoneal dialysis. Methods：This was a non‒comparative, prospective observational surveillance. The observation period was one year. The main safety endpoint was incidence of adverse drug reaction（ADR）defined as an adverse event for which a causal relationship with bixalomer was not ruled out. The efficacy endpoints included changes in serum phosphate, calcium, and intact parathyroid hormone（iPTH）levels. Results：The safety analysis set included 107 patients, mean age was 61.9 years, and male patients accounted for 68.2％. As for bixalomer use situation, 57.0％ of patients was prescribed initial dose of 1500 mg/day, but 38.3％ of patients had bixalomer with a lower initial dose（＜1500 mg/day）. The ADRs occurred in 21.5％, and the incidence was not higher than that of clinical trials. The most commonly observed ADR was constipation （9.3％）. The ef ficacy analysis set included 106 patients. The 38.1％ and 41.8％ of patients reached the target range of serum phosphate and calcium levels（3.5‒6.0 mg/dL and 8.4‒10.0 mg/dL, respectively）, which are recommended by the Japanese guideline, at the 12 Month and end of treatment（EOT）, respectively. No statistically significant changes from baseline in the iPTH level were observed at the 12 Month and EOT. Conclusions：No new concerns for safety and effectiveness of bixalomer were observed in this PMS conducted in the Japanese real‒world clinical setting.