Treatment Outcomes in African-American Children with ADHD: RESULTS
A total of 1,323 patients were enrolled in this study; of these, 183 were African-American (OROS MPH: n=125, ato-moxetine: n=58). The mean age of the total African-American group was approximately nine years, and most (87%) patients were male (Table 1). The treatment groups were well matched with regard to baseline disease characteristics. Adherence to study medication was high throughout the study and ranged 89. l%-97.9% in both groups. At the end of the study, the mean doses of OROS MPH and atomoxetine were similar between African-American (32.8 ± 10.9 mg, 1.1 ± 0.4 mg/kg, respectively) and non-African-American patients (32.7 ± 12.3 mg, 1.1 ± 0.4 mg/kg, respectively).
Table 1. Demographics and baseline disease characteristics in African-American patients treated with OROS MPH or atomoxetine
| OROS MPH (n=125) |
Atomoxetine (n=58) |
Total (N=183) | |
|
Age (years)* |
8.6 (2.0) |
9.1 (2.2) |
8.8 (2.0) |
| Gender (%)
Male Female |
80 20 |
86 14 |
82 18 |
| Predominant Type (%) Hyperactive-impulsive Inattentive Combined | 12.1 9.8 16.2 | 18.5 8.0 12.0 | 14.1 9.1 14.7 |
|
Family history ot ADHD (%) |
46 |
49 |
47 |
|
Prior treatment for ADHD (%) |
45 |
69 |
52 |
|
Duration of ADHD, mo* |
23.5 (23.5) |
33.2 (28.4) |
27.0 (25.7) |
|
ADHD-RS* |
40.4 (8.3) |
40.9 (8.7) |
40.6 (8.4) |
|
CGI-SI* |
4.9 (1.0) |
4.9 (1.0) |
4.9 (1.0) |
| * Mean values (SD); ADHD: attention-deficit/hyperactivity disorder; ADHD-RS: Attention-Deficit/Hyperactivity Disorder Rating Scale; CGI-SI: Clinical Global Impression-Severity of Illness | |||
Both treatments were associated with significant improvements (P<0.0001) from baseline in total ADHD-RS scores at each week (Figure 1). All changes in the total ADHD-RS were greater in the OROS MPH group compared with the atomoxetine group and, during each successive week of the study, the relative differences in improvement between treatments increased (week 1: difference of 2.3, week 2: difference of 3.1, week 3: difference of 4.5). A significant difference was observed between groups at week 3 (P<0.03). Both treatments were associated with significant improvements (PO.0001) from baseline on the Inattentive Subscale and the Hyperactivity Subscale. However, each week, the OROS MPH group experienced greater improvement in both subscales; during the final week of the study, the improvement on the Inattentive Subscale was significantly greater in the OROS MPH group, compared with the atomoxetine group (P<0.02). In addition, at week 3, a significantly greater number of patients who received OROS MPH experienced ADHD-RS score reductions of >30% or >50% from baseline, compared with the atomoxetine group (>30% reduction: 77.4% vs. 61.1%, respectively, P<0.03; >50% reduction: 58.3% vs. 35.2%, respectively, P<0.006). At week 3, CGI-I scores <2 (i.e., “very much improved” or “much improved”) were observed in a significantly greater number of patients in the OROS MPH group (68.4%), compared with the atomoxetine group (49.1%) (P<0.01). Due to the difficulty in detecting significant differences between two active treatments and the relatively low number of patients available for this sub-analysis (OROS MPH: n=125, atomoxetine: n=58), the differences between the experimental groups did not reach statistical significance until the final week of titration. cialis soft tabs online
Table 2. Summary of treatment-related adverse events in >4% of children with ADHD
|
OROS MPH |
Atomoxetine |
|
|
n(%) |
n(%) |
|
| Upper abdominal pain |
6 (4.8) |
1 (1.7) |
| Decreased appetite |
5 (4.0) |
1 (1.7) |
| Headache |
5 (4.0) |
1 (1.7) |
| Insomnia |
4 (3.2) |
0 |
| Nausea |
1 (0.8) |
2 (3.4) |
| Somnolence |
1 (0.8) |
3 (5.2) |
| Sedation |
0 |
3 (5.2) |
| ADHD: Attention-deficit/hyperactivity disorder | ||
The PSQ data were consistent with those of the investigators and demonstrated a significantly greater improvement of ADHD symptoms in the OROS MPH group (total PSQ score = 19.8), compared with the atomoxetine group (total PSQ score = 23.4) (P<0.009). At the final visit, the percentage of parents stating that their child was doing “better than” or “somewhat better than” before treatment was 85.1% in the OROS MPH group and 63.8% in the atomoxetine group. These data were consistent with the other PSQ ratings. revatio online
Figure 1. Change from baseline in total Attention-Deficit/Hyperactivity Disorder Rating Scale score
The incidence of adverse events was similar between the African-American groups (Table 2). Treatment-related adverse events were reported in 19.2% of the OROS MPH group and in 19% of the atomoxetine group. The most common treatment-related adverse events included abdominal pain, decreased appetite and headache in the OROS MPH group; those in the atomoxetine group included somnolence, sedation and nausea. A slightly greater percentage of patients in the atomoxetine group (1.7%) compared with the OROS MPH group (0.8%) withdrew from the study because of adverse events. One serious adverse event (described as prolonged crying and fears of death for self and family), which resolved upon treatment discontinuation, was reported in a patient who received atomoxetine. No deaths were reported.
dutasteride hair loss
