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Hydroxyurea for treatment of severe sickle cell anemia: a pediatric
clinical trial
A Ferster, C Vermylen, G Cornu, M Buyse, F Corazza, C Devalck, P Fondu, M Toppet and E Sariban
Hemato-Oncology Unit, Hopital Universitaire des Enfants Reine Fabiola,
Brussels, Belgium.
Hydroxyurea (HU) enhances the synthesis of fetal hemoglobin (HbF) and can
improve the clinical course of some adult patients with sickle cell anemia
(SCA). In a randomized trial, we studied the biologic effects and the
clinical benefit of HU in children and young adults with severe SCA.
Twenty-five patients (median age, 9 years) were randomized to receive
either HU (at the initial dosage of 20 mg/kg/d) or a placebo for 6 months
and were then switched to the other arm for the next 6 months. Among the 22
evaluable patients (median age, 8 years), significant increases in HbF and
mean corpuscular volume occurred during the HU treatment period. The white
blood cell and reticulocytes counts decreased significantly, but these
changes were not clinically relevant. Sixteen of 22 patients (73%)
experienced a complete disappearance of events requiring hospitalization.
The number of days of hospitalization as well as the number of
hospitalizations for patients on HU, as compared with those for the
patients receiving placebo, were significantly reduced. We conclude that
treatment with HU in children and young adults is feasible, well-tolerated,
and improves the clinical course of SCA. The long-term effects of HU
require further investigation.
Volume 88,
Issue 6,
pp. 1960-1964,
09/15/1996
Copyright © 1996 by The American Society of Hematology
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