A post-marketing surveillance study to evaluate the efficacy and safety of Sevelamer Carbonate in the management of Chronic Kidney Disease related Hyperphosphatemia in the Philippines

ABSTRACT

Introduction@#This is a prospective, post marketing surveillance study that aims to determine the efficacy and safety of sevelamer carbonate in hyperphosphatemic chronic kidney disease (CKD) patients in the Philippines.@*Methods@#Adult CKD patients with serum phosphorous levels >1.78 mmol/L and whose physician had decided to treat with sevelamer carbonate 800 mg were enrolled in the study and followed-up for a minimum of three visits from baseline within a six-month period. The primary endpoint was the change in serum phosphorous levels from baseline to the sixth month. Adverse events were noted and recorded during the treatment period.@*Results@#There were 233 patients included in the study from five centers in Metro Manila from 2010 to 2013. Of the 233 patients, 199 were on chronic dialysis, 33 were not on dialysis, and 1 had no data. There was a statistically significant (P-value <0.0001) reduction in serum phosphorous levels from baseline after treatment with sevelamer carbonate. There were 16 patients reported to have adverse drug reactions, 13 of whom had serious adverse events (SAE) and three were non-serious. Of the 13 patients with SAEs, only one was possibly/probably related to sevelamer carbonate and all three non-SAEs were possibly/definitely related to sevelamer carbonate.@*Conclusion@#The results showed sevelamer carbonate to be effective in lowering serum phosphorous levels and the most common adverse events were related to the gastrointestinal tract (1.4%). There were sixteen patients with adverse events, three of which were non-serious, while 13 were reported to be serious adverse events. Only one was probably related to the drug.