Follow-Up Study I data indicate that children who continue to take hydroxyurea have statistically lower rates of pain crises requiring emergency room visits, episodic transfusions, and hospital admissions for any reason when compared to those taking placebo. These clinical benefits are similar to those demonstrated by the drug in BABY HUG, the results of which were published earlier this year and are consistent with previously published trials that detail the therapy's benefits in older children and adults.
"Our study data reveal not only that the clinical benefits of hydroxyurea continue with ongoing administration, but also the wide acceptance of the treatment by the families of our patients, demonstrated by the high percentage of families that continued their children on hydroxyurea after the randomized trial ended," said lead author Zora R. Rogers, MD, Professor of Pediatrics at UT Southwestern Medical Center Dallas and Clinical Director of the Bone Marrow Failure and General Hematology Program at Children's Medical Center Dallas. "Analysis of growth and development assessments obtained in the Follow-Up Study along with these clinical results will further enhance our understanding of the benefits of the use of starting hydroxyurea in children with sickle cell disease at a very young age."
The BABY HUG Follow-Up Study I is funded by the National Heart, Lung, and Blood Institute (NHLBI) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Dr. Rogers will present this study in an oral presentation on Sunday, December 11, at 4:30 p.m. PST at the Manchester Grand Hyatt in the Elizabeth Ballroom AB.
Genotoxicity Associated with Hydroxyurea Exposure in Infants with Sickle Cell Anemia: Results From the BABY-HUG Phase III Clinical Trial [Abstract 8]
Using data from the larg
|SOURCE American Society of Hematology|
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