Original Research
Tuesday, October 15, 2024
08:30 AM–10:00 AM
Abstract
Introduction: Hyperphosphatemia is a clinical challenge in children with advanced chronic kidney disease (CKD), due to the limited availability of suitable phosphate binders pediatric dosage forms. A previous study confirmed 14 days stability of an extemporaneous sevelamer hydrochloride 50 mg/ml suspension; however, sevelamer carbonate was not investigated.
Research Question or Hypothesis: Is extemporaneous sevelamer carbonate suspension effective, safe, and palatable in hyperphosphatemic children with advanced CKD.
Study Design: Retrospective cohort study.
Methods: The analysis included pediatric patients (less than 14 years of age at the initiation of sevelamer carbonate 50 mg/ml suspension) with advanced chronic kidney disease and hyperphosphatemia (level of more than 5.5 mg/dl). The suspension was compounded in the pharmacy of the Armed Forces Hospital Southern Region, Saudi Arabia, between January 2018 and March 2024. The preparation method was adapted from the sevelamer hydrochloride study. The outcomes measured included changes in phosphate blood levels after preparation use, reported adverse reactions of the preparation, and palatability of the preparation which was assessed using the five-point hedonic scale.
Results: Fourteen children administered the preparation (mean age 10 years 1.7 months + 3 years 9.6 months), with a median duration of treatment 1.25 months (range 0.5 – 30 months), and an average decline in phosphorus level of 3.5 + 2.57 mg/dl, p < .001. Ten children had normal blood phosphorus levels (71.4 %). Bicarbonate blood levels showed a non-significant increase (mean change 1.3 mmol/L p= 0.2). Five patients (35%) reported nausea or vomiting and one patient reported abdominal pain (7.1%) that improved on the fifth day of therapy. According to the parents of nine children’s feedback, the preparation median palatability score improved from 1 (range 1-3) on the first day of use to 4 (range 3-4) on the fifth day (p = 0.002).
Conclusion: Extemporaneous Sevelamer Carbonate suspension appears to be effective, safe, and palatable in hyperphosphatemic children with advanced CKD.
Presenting Author
Ali Najmi PharmD, BCPPSPharmaceutical care Administration, Armed Forces Hospital southern region
Authors
Khalid Ageeli PharmD
Pharmaceutical Care Administration, Armed forces hospital southern region
Marzog Al Nasser PhD
Pharmaceutical care Administration, Armed Forces Hospital southern region
Ibrahim Alhomood PharmD
Armed Forces Hospital Southern Region
Ali Alhomoud PharmD
Pharmaceutical Care Administration, Armed forces hospitals southern region
Saeed Alshehri MD
Pharmaceutical Care Administration, Armed forces hospitals southern region
Dalia Ballal BPharm, MSc
Pharmaceutical Care Administration, Armed forces hospitals southern region
Ehab Elmongui PharmD, MSc
Medical research institute
Mohammad Zaitoun BSc(Pharm), PharmD, MBA, CPHQ
Armed Forces Hospitals Southern Region