title: Therapeutic efficacy of a biosimilar epoetin alfa in hemodialysis patients.
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.
authors.affiliation: Department of Internal Medicine A, Charles Nicolle Hospital, Tunis, Tunisia.
authors.forename: Amel
authors.initials: A
authors.lastname: Harzallah
authors.forename: Karim
authors.initials: K
authors.lastname: Zouaghi
authors.forename: Afef
authors.initials: A
authors.lastname: Dridi
authors.forename: Karima
authors.initials: K
authors.lastname: Boubaker
authors.forename: Soumaya
authors.initials: S
authors.lastname: Beji
authors.forename: Mohamed
authors.initials: M
authors.lastname: Ayari
authors.forename: Fethi
authors.initials: F
authors.lastname: El Younsi
authors.forename: Fatma Ben
authors.initials: FB
authors.lastname: Moussa
authors.forename: Adel
authors.initials: A
authors.lastname: Kheder
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D001794:Blood Pressure; D057915:Drug Substitution; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D005260:Female; D006397:Hematinics / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000628:therapy; D013810:Therapeutic Equivalency; D014416:Tunisia
chemical_list: D059451:Biosimilar Pharmaceuticals; D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa