THE SAFETY OF TREATMENT WITH RECOMBINANT-HUMAN-ERYTHROPOIETIN IN CLINICAL USE - A REVIEW OF CONTROLLED-STUDIES

Recombinant human erythropoietin (rhEPO) has now been approved for the treatment of renal anemia, anemia of prematurity, cancer-associated a nemia, AIDS-associated anemia and as concomitant treatment for patient s with or without autologous blood donation awaiting elective surgery. The purpose of this review is to provide an overview, based on the re sults of controlled studies, of the anticipated safety profile of rhEP O in various indications and to assess whether treatment with rhEPO in fluences the incidences of certain adverse events in these indications . The anticipated adverse events differ from indication to indication and generally reflect the corresponding underlying illness. With most indications, no relevant differences in the incidences of adverse even ts are observed between rhEPO and placebo-control/patients. Only in th e rhEPO therapy of renal anemia is an increased incidence of hypertens ive events observed in the rhEPO groups, a finding that is not reprodu ced with the other indications. The controlled studies forming the bas is of this review provide no evidence of a relevant increase in the ri sk of thromboembolic events during rhEPO therapy. Overall, it may be s tated that rhEPO treatment, where strictly indicated, is a safe form o f therapy. As with any other treatment, the risk of side effects in ce rtain predisposed patients must also be weighed against the desired cl inical benefits.