And, two-year treatment of young children with hydroxyurea is not associated with genotoxicity
MONDAY, Dec. 12 (HealthDay News) -- Hydroxyurea can be safely and effectively continued in young children with sickle cell anemia (SCA), and is not associated with a significant increase in genotoxicity, according to two studies being presented at the annual meeting of the American Society of Hematology, held from Dec. 10 to 13 in San Diego.
Zora R. Rogers, M.D., from the University of Texas Southwestern Medical Center in Dallas, and colleagues investigated the clinical benefits of continued hydroxyurea treatment in 163 children (aged 28 to 44 months) with SCA in the Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-Up Study. Hydroxyurea treatment was accepted by 82 percent of participating families at study entry, and was reportedly taken by 68 to 75 percent during each six-month data collection period of the 36-month follow-up. Children who continued taking hydroxyurea had significantly lower rates of pain crises which necessitated emergency room visits, episodic transfusions, and any cause hospital admissions.
Patrick T. McGann, M.D., from the Baylor College of Medicine in Houston, and colleagues investigated whether hydroxyurea treatment caused genotoxic effects in young children with SCA. Data from 193 participants (aged 9 to 18 months) of the BABY HUG trial were analyzed. Participants were randomized to two-year treatment with hydroxyurea or placebo. At the study exit, there was no significant difference between the hydroxyurea and placebo groups in the numbers of chromosome and chromatid breaks, illegitimate VDJ (variable, diverse, and joining) recombination events, and micronuclei-containing early reticulocytes.
"Hydroxyurea treatment in very young patients with SCA was not associated with any significant increases in genotoxicity compared to placebo treatment," McGann and colleagues write.
One of the study authors from the McGann study disclosed financial ties to Litron Laboratories.
Abstract - Rogers
Abstract - McGann