title: Long-Term Safety and Efficacy of Bixalomer in Hyperphosphatemic Patients With Chronic Kidney Disease Not on Dialysis.
abstract: Bixalomer, a metal-free, nonabsorbable phosphate binder, is approved in Japan to treat hyperphosphatemia in dialysis patients. Bixalomer is effective and has a favorable safety profile in predialysis patients with hyperphosphatemia. This study examined the long-term effectiveness and safety of bixalomer in predialysis patients with hyperphosphatemia. This was a 48-week, multicenter, open-label, phase 3 study in Japanese predialysis patients with hyperphosphatemia. Patients received bixalomer at an initial dose of 1500 mg/day, which was titrated to a maximum of 7500 mg/day depending on patients' serum phosphorus responses to bixalomer. A total of 105 patients received bixalomer treatment, and 39 completed the study. The most common reason for discontinuation was initiation of dialysis. Mean serum phosphorus concentrations decreased from 5.15 mg/dL at baseline to 4.67 mg/dL at Week 12 and then fluctuated slightly around this level until it reached 4.58 mg/dL at Week 48. The proportion of total patients achieving the target serum phosphorus concentration (≥2.5 to <4.6 mg/dL) increased after treatment to a maximum of 66.2% at Week 20 and subsequently decreased to 51.3% by Week 48. Most adverse events (AEs) occurred in the first 12 weeks of treatment. The incidence of AEs did not increase with long-term treatment. Common AEs reported included nasopharyngitis (29.5%), constipation (19%), and upper respiratory tract inflammation (12.4%). These findings suggest that long-term treatment with bixalomer is effective, well tolerated, and has no new safety concerns. Bixalomer may be an alternative treatment option for the long-term management of hyperphosphatemia in patients with chronic kidney diseases.
authors.affiliation: Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
authors.forename: Tadao
authors.initials: T
authors.lastname: Akizawa
authors.affiliation: Global Development, Astellas Pharma Inc., Tokyo, Japan.
authors.forename: Junko
authors.identifier: http://orcid.org/0000-0003-1635-9408
authors.initials: J
authors.lastname: Tsukada
authors.affiliation: Global Development, Astellas Pharma Inc., Tokyo, Japan.
authors.forename: Chisato
authors.initials: C
authors.lastname: Kameoka
authors.affiliation: Global Development, Astellas Pharma Inc., Tokyo, Japan.
authors.forename: Kentarou
authors.initials: K
authors.lastname: Kuroishi
authors.affiliation: Global Development, Astellas Pharma Inc., Tokyo, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Yamaguchi
mesh_terms: D005260:Female; D006801:Humans; D054559:Hyperphosphatemia / Q000150:complications* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011073:Polyamines / Q000009:adverse effects / Q000627:therapeutic use*; D051436:Renal Insufficiency, Chronic / Q000150:complications*; D013995:Time; D016896:Treatment Outcome
chemical_list: D011073:Polyamines; C000589735:bixalomer
keywords: Bixalomer; Chronic kidney disease; Hyperphosphatemia; Phosphate binder; Predialysis