Title of article :
Therapeutic efficacy of a biosimilar epoetin alfa in hemodialysis patients
Author/Authors :
harzallah, a. department of internal medicine a,charles nicolle hospital, Tunisia , zouaghi, k. department of internal medicine a,charles nicolle hospital, Tunisia , dridi, a. department of internal medicine a,charles nicolle hospital, Tunisia , boubaker, k. department of internal medicine a,charles nicolle hospital, Tunisia , beji, s. department of internal medicine a,charles nicolle hospital, Tunisia , ayari, m. department of internal medicine a,charles nicolle hospital, Tunisia , el younsi, f. department of internal medicine a,charles nicolle hospital, Tunisia , moussa, f.b. department of internal medicine a,charles nicolle hospital, Tunisia , kheder, a. department of internal medicine a,charles nicolle hospital, Tunisia
From page :
78
To page :
82
Abstract :
Anemia is a frequent complication in patients with chronic kidney disease. However,human recombinant erythropoietin (rHu-EPO) has revolutionized the management of anemia in chronically dialyzed patients. Epomax ® is a new rHu-EPO alfa manufactured in Tunisia (Medis Laboratories). The aim of this study was to evaluate the efficacy and tolerance of Epomax ® in chronic hemodialysis (HD) patients in a phase-III,multicenter,clinical trial. Fiftythree HD patients (mean age 47.7 ± 13 years) who received a stable dose of rHu-EPO (Hemax ®,a rHu-EPO alfa manufactured by Biosidus Laboratories) subcutaneously were switched to Epomax ® via the same route of administration. At baseline,the mean systolic pressure was 132 ± 18 mm Hg and the mean diastolic pressure was 79 ± 8 mm Hg. The mean blood hemoglobin was 10.2 g/dL and the median ferritin level was 667 ng/mL. After a follow-up of 43 days,the mean blood hemoglobin was 10.5 g/dL under the effect of Epomax ® . There was no significant difference in the mean hemoglobin levels between the treatments with both drugs. Few adverse events were reported during the study. We conclude that Epomax ® was effective at maintaining the hemoglobin levels at target concentrations and was well tolerated in HD patients.
Journal title :
Saudi Journal of Kidney Diseases and Transplantation
Journal title :
Saudi Journal of Kidney Diseases and Transplantation
Record number :
2521329
Link To Document :
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