Safety and tolerability of a multidose formulation of epoetin beta in dialysis patients. Collaborative Study Group

Previous studies in healthy volunteers and renal patients have demonstrated the favorable tolerability of a new multidose formulation of epoetin beta. The aim of this open, multicenter study was to further assess the safety, tolerability and efficacy of this formulation ofepoetin beta in patients with end-stage renal disease (ESRD).

375 adult patients receiving maintenance epoetin therapy for renal anemia were switched to the multidose formulation of epoetin beta for 12 weeks, using the same dosage and route of administration.

Adverse events were experienced by 123 patients (33%), most commonly hypertension (5.6%) and hypotension (4.5%). Few patients (2%) were prematurely withdrawn because of tolerability concerns. No clinically relevant changes in blood pressure or laboratory variables were observed. Compared with baseline, hemoglobin and hematocrit values remained essentially unchanged during treatment with this new formulation of epoetin beta. No changes in iron metabolism parameters were apparent, and nearly all patients (94%) did not require blood transfusions during the study.

The results of this study indicate that the multidose formulation of epoetin beta is safe and well tolerated in patients with ESRD. Moreover, switching patients to this new formulation of epoetin beta does not compromise therapeutic efficacy.