ABSTRACT
INTRODUCTION: Methoxy polyethylene glycol-epoetin ? has been shown to be effective in the treatment of anemia among chronic kidney disease (CKD) patients on dialysis or pre-dialysis. This study evaluated the effectiveness and safety of this drug in the treatment of renal anemia among Filipino patients, demonstrating relevant clinical experiences in drug administration and dose adjustment. METHODS: This was an open-label, one-arm prospective clinical series conducted in five renal clinics in Metro Manila, which enrolled 28 (27 evaluable) CKD patients, 18 years old and above with ESA-naive renal anemia who fulfilled the eligibility criteria. All patients gave their informed consent. The protocol was approved by the Philippine Council for Research & Development-National Ethics Committee. Methoxy polyethylene glycol-epoetin ? was given as a subcutaneous injection beginning at 0.6 ug/kg body weight once every two weeks with dose adjustment (25% increments/decrements per month) to keep hemoglobin at 11 to 12 g/dL (not to exceed 13 g/dL), and then maintained once every four weeks on a dose equal to twice the previous once-everytwo-weeks dose, over a 24-week study period. Data analysis was done using STATA version 10. RESULTS: Across the 24 weeks of methoxy polyethylene glycolepoetin ? treatment, there was a mean increase in hemoglobin of >1.0 g/dL from baseline; >60% of patients achieved hemoglobin levels >11 g/dL starting at week 8 (mean time to first target hemoglobin 5.7 weeks) with variability, no blood transfusion, and mean of 1.52±1.25 SD dose adjustments per patient. The manner of dose adjustment can be the main driver of hemoglobin variability. Common adverse events were sudden rise in blood pressure (6 patients), back pain (3), and fever (3). CONCLUSION: Methoxy polyethylene glycol-epoetin ? administered once monthly after an initial once every two weeks correction phase can improve hemoglobin levels at target 11 to 12 g/dL, with hemoglobin variability and safety events as expected for a CKD population.