Table 1.
Baseline Characteristics of Hydroxyurea and Placebo Groups
| Baseline Variable | Hydroxyurea (N=96) | Placebo (N=97) |
|---|---|---|
| Age – mo. (mean ± standard deviation) | 13·6±2·7 | 13·5±2·8 |
| Male sex -- no. (%) | 44 (46) | 40 (41) |
| Sickle Cell Disease type -- no. (%) | ||
| Hb SS | 94 (98) | 93 (96) |
| Hb Sβ0thalassaemia | 2 (2) | 4 (4) |
| Hospitalisations before study enrollment -- no. (%) | 65 (68) | 70 (73) |
| Dactylitis before study enrollment -- no. (%) | 31 (33) | 39 (41) |
| Pain events before study enrollment -- no. (%) | 25 (27) | 26 (27) |
| Acute chest syndrome before study enrollment -- no. (%) | 3 (3) | 5 (5) |
| Splenic sequestration before study enrollment -- no. (%) | 5 (5) | 10 (11) |
| Transfusion before study enrollment -- no. (%) | 10 (11) | 17 (18) |
| Primary endpoint measurements: | ||
| Spleen Scan Uptake – no. (%) | ||
| Normal | 8 (8) | 13 (13) |
| Present but decreased | 73 (76) | 72 (74) |
| Absent | 15 (16) | 12 (12) |
| DTPA GFR -- mL/min/1·73m2 (mean±S.D) | 126±39 | 124±30 |
| Haematologic measurements (mean±S.D.): | ||
| Haemoglobin -- g/dL | 9·0±1·3 | 9·2±1·3 |
| HbF -- % | 25·9±8·5 | 26·0±8·5 |
| WBC -- x103/mm3 | 14·3±5·3 | 14·3±5·9 |
| Platelet Count -- x103/mm3 | 365·5±125·2 | 375·0±126·7 |
| Central Nervous System measurements (mean±S.D.): | ||
| TCD TAMM Velocity -- cm/sec | 124±22 | 120±22 |