| |
Prasugrel 5 mg n = 41*
|
Placebo n = 21
|
p value
|
|---|
|
Age (mean, years)
|
32.9
|
31.5
|
0.553
|
|
Female, n (%)
|
21 (51.2)
|
9 (42.9)
|
0.598
|
|
Body Weight (mean, kg)
|
78.3
|
68.6
|
0.021
|
|
Hydroxyurea
|
18
|
9
| |
|
Sickle-cell Genotype, n (%)
| | |
>0.999
|
|
Hb S/ β0 thalassemia
|
2 (5.0)
|
1 (4.8)
| |
|
Hb S/ βthalassemia
|
4 (10.0)
|
2 (9.5)
| |
|
Hb SC
|
10 (25.0)
|
5 (23.8)
| |
|
Hb SS
|
24 (60.0)
|
13 (61.9)
| |
|
Pain Intensity
| | |
0.473
|
|
Mean
|
1.8
|
2.4
| |
|
Minimum
|
0.0
|
0.0
| |
|
Median
|
0.0
|
2.0
| |
|
Maximum
|
9.0
|
7.0
| |
|
Medical History, n (%)
| | | |
|
Vaso-occlusive crisis
|
25 (61.0)
|
12 (57.1)
| |
|
Acute chest syndrome
|
9 (22.0)
|
2 (9.5)
| |
|
Hepatic sequestration
|
0
|
1 (4.8)
| |
|
Splenectomy
|
7 (17.1)
|
5 (23.8)
| |
|
Systemic hypertension
|
11 (26.8)
|
2 (9.5)
| |
|
Pulmonary hypertension
|
7 (17.1)
|
2 (9.5)
| |
|
Renal failure
|
1 (2.4)
|
0
| |
|
Hepatic disease†
|
1 (2.4)
|
0
| |
|
Renal insufficiency
|
0
|
1 (4.8)
| |
|
Laboratory Values, mean (SD)
| | | |
|
Hemoglobin (g/L)
|
10.4 (1.8)
|
9.8 (2.0)
|
0.297
|
|
White Blood Cells (x109/L)
|
8.2 (3.4)
|
8.3 (2.7)
|
0.929
|
|
Platelets (x109/L)
|
310.6 (180.4)
|
340.5 (117.5)
|
0.561
|
- *1 patient was found not to have SCD but to have only β-thalassemia trait.
- †Other than sequestration.
