Efficacy and safety of sucroferric oxyhydroxide in the treatment of hyperphosphataemia in chronic kidney disease in Asturias. FOSFASTUR study

J Emilio Sanchez-Alvarez; Elena Astudillo Cortés; Miguel Seras Mozas; Raúl García Castro; Carlos Miguel Hidalgo Ordoñez; Ana Cristina Andrade López; Catalina Ulloa Clavijo; Anna Gallardo Pérez; Carmen Rodríguez Suarez

doi:10.1016/j.nefroe.2021.02.005

Efficacy and safety of sucroferric oxyhydroxide in the treatment of hyperphosphataemia in chronic kidney disease in Asturias. FOSFASTUR study

Nefrologia (Engl Ed). 2021 Jan-Feb;41(1):45-52. doi: 10.1016/j.nefroe.2021.02.005. Epub 2021 Mar 1.

Authors

J Emilio Sanchez-Alvarez¹, Elena Astudillo Cortés², Miguel Seras Mozas³, Raúl García Castro⁴, Carlos Miguel Hidalgo Ordoñez⁵, Ana Cristina Andrade López⁶, Catalina Ulloa Clavijo⁶, Anna Gallardo Pérez³, Carmen Rodríguez Suarez⁶

Affiliations

¹ Servicio de Nefrología, Hospital Universitario de Cabueñes, Gijón, Asturias, Spain. Electronic address: jesastur@hotmail.com.
² Servicio de Otorrinolaringologia, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain.
³ Servicio de Nefrología, Hospital Universitario San Agustin, Avilés, Asturias, Spain.
⁴ Servicio de Nefrología, Fundación Hospital de Jove, Gijón, Asturias Spain.
⁵ Servicio de Nefrología, Hospital Vital Álvarez Buylla, Mieres, Asturias, Spain.
⁶ Servicio de Nefrología, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain.

PMID: 36165361
DOI: 10.1016/j.nefroe.2021.02.005

Abstract

Alterations in bone and mineral metabolism are very common in chronic kidney disease (CKD). The increase in phosphate levels leads to bone disease, risk of calcification and greater mortality, so any strategy aimed at reducing them should be welcomed. The latest drug incorporated into the therapeutic arsenal to treat hyperphosphataemia in CKD is Sucroferric Oxyhydroxide (SFO).

Objective: To analyse the efficacy and safety of OSF in three cohorts of patients, one with advanced chronic kidney disease not on dialysis (CKD-NoD), another on peritoneal dialysis (PD) and the last on haemodialysis (HD), followed for six months.

Methods: A prospective, observational, multicentre study in clinical practice. Clinical and epidemiological variables were analysed. The evolution of parameters relating to alterations in bone and mineral metabolism and anaemia was analysed.

Results: Eighty-five patients were included in the study (62 ± 12 years, 64% male, 34% diabetic), 25 with CKD-NoD, 25 on PD and lastly, 35 on HD. In 66 patients (78%), SFO was the first phosphate binder; in the other 19, SFO replaced a previous phosphate binder due to poor tolerance or efficacy. The initial dose of SFO was 964 ± 323 mg/day. Overall, serum phosphate levels saw a significant reduction at three months of treatment (19.6%, P < 0.001). There were no differences in the efficacy of the drug when the different populations analysed were compared. Over the course of the study, there were no changes to levels of calcium, PTHi, ferritin, or the transferrin and haemoglobin saturation indices, although there was a tendency for the last two to increase. Twelve patients (14%) withdrew from follow-up, ten due to gastrointestinal adverse effects (primarily diarrhoea) and two were lost to follow-up (kidney transplant). The mean dose of the drug that the patients received increased over time, up to 1147 ± 371 mg/day.

Conclusions: SFO is an effective option for the treatment of hyperphosphataemia in patients with CKD both in the advanced phases of the disease and on dialysis. We found similar efficacy across the three groups analysed. The higher their baseline phosphate level, the greater the reduction in the serum levels. A notable reduction in phosphate levels can be achieved with doses of around 1000 mg/day. Diarrhoea was the most common side effect, although it generally was not significant.

Keywords: Captores de fósforo; Diálisis peritoneal; Haemodialysis; Hemodiálisis; Hiperfosforemia; Hyperphosphataemia; Oxidróxido sucroférrico; Peritoneal dialysis; Phosphate binders; Sucroferric oxyhydroxide.