Impact of hydroxyurea on clinical events in the BABY HUG trial
| Autor: | Russell E. Ware, Rathi V. Iyer, Bruce W. Thompson, Phillip Seaman, Scott T. Miller, Winfred C. Wang, Beatrice Files, Ofelia A. Alvarez, Jeffrey D. Lebensburger, Zhaoyu Luo, Courtney D. Thornburg, Ram Kalpatthi |
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| Rok vydání: | 2012 |
| Předmět: |
Pediatrics
medicine.medical_specialty Anemia business.industry Immunology Cell Biology Hematology medicine.disease Placebo Biochemistry Asymptomatic Acute chest syndrome Sickle cell anemia law.invention Dactylitis Clinical trial Randomized controlled trial law hemic and lymphatic diseases medicine medicine.symptom business |
| Zdroj: | Blood. 120:4304-4310 |
| ISSN: | 1528-0020 0006-4971 |
| DOI: | 10.1182/blood-2012-03-419879 |
| Popis: | The Pediatric Hydroxyurea Phase 3 Clinical Trial (BABY HUG) was a phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial of hydroxyurea in infants (beginning at 9-18 months of age) with sickle cell anemia. An important secondary objective of this study was to compare clinical events between the hydroxyurea and placebo groups. One hundred and ninety-three subjects were randomized to hydroxyurea (20 mg/kg/d) or placebo; there were 374 patient-years of on-study observation. Hydroxyurea was associated with statistically significantly lower rates of initial and recurrent episodes of pain, dactylitis, acute chest syndrome, and hospitalization; even infants who were asymptomatic at enrollment had less dactylitis as well as fewer hospitalizations and transfusions if treated with hydroxyurea. Despite expected mild myelosuppression, hydroxyurea was not associated with an increased risk of bacteremia or serious infection. These data provide important safety and efficacy information for clinicians considering hydroxyurea therapy for very young children with sickle cell anemia. This clinical trial is registered with the National Institutes of Health (NCT00006400, www.clinicaltrials.gov). |
| Databáze: | OpenAIRE |
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