OBJECTIVE: This study aimed to assess the safety and effectiveness of subcutaneous (SC) Epoetin alfa in the treatment of Filipino patients with anemia associated with chronic renal failure.
METHODS: This is a prospective, observational, multicenter study on chronic renal failure patients with anemia for whom Epoetin alfa SC is indicated. Each patient was followed-up according to the frequency deemed appropriate by the physician for a period of 6 months. Data were collected using a case-report form which is filled-up by the investigator based on available data in the patient records. Patient characteristics were analyzed descriptively. The frequency and description of adverse events were obtained. Baseline and endstudy hemoglobin and hematocrit levels were compared inferentially. Monitoring for antibody-mediated pure red cell aplasia (PRCA) was given special focus.
RESULTS: A total of 458 patients were enrolled in the study with an average age 52.8 ± 16.9 years and a slight male predominance (57.8% male). Among patients with primary renal diseases, the most common diagnosis was chronic glumerulonephritis (31.0%), followed by diabetic nephropathy (14.4%) and hypertension (10.0%). Around two-thirds (66.2%) of the patients were on dialysis, while the rest were in the pre-dialysis stage. Most patients had concomitant disease conditions with hypertension (57.9%) and diabetes mellitus (27.1%) being the most common. Most patients also had multiple concomitant medications. Significant improvements inhemoglobin (mean increase 0.8 ± 2.3 mg/dL from 9.66 at baseline; p value at < 0.0001) and hematocrit (mean increase 2.4 ± 6.9% from 28.91% at baseline; p value at <0.0001) levels were observed. A total of 16.6% of the patients experienced non-serious adverse events, with fatigue being the most common, and all of these were resolved during the study. Less than 5% of the patients had serious adverse events leading to mortality, which were all assessed by the investigators as not related to Epoetin alfa. There was no reported suspected loss ofeffect among the subjects indicating no incident PRCA.
CONCLUSION: Subcutaneously administered Epoetin alfa was effective in significantly increasing hemoglobin and hematocrit in chronic kidney disease patients with anemia. The drug is also safe and well tolerated, with no new safety issue identified, and no incident case of PRCA.