Treatment Outcomes in African-American Children with ADHD: DISCUSSION
This was the first randomized study to directly compare OROS MPH and atomoxetine in African-American children. Response in this population was consistent with that observed in the overall population. Both treatments demonstrated significant improvement from baseline; however, improvements noted in the OROS MPH group were consistently greater than those observed in the atomoxetine group. Differences in improvements between the groups were significant at week 3, as measured by total ADHD-RS, the Inattentive Subscale and CGI-I scores. These data suggest that OROS MPH may be more effective than atomoxetine. In addition, it is worthwhile to note that some differences in effectiveness between treatment groups became greater as the study progressed. The reasons for this finding are not known. During a placebo-controlled study of atomoxetine in patients with ADHD, most of the treatment effects were exerted by the third week of treatment, with little additional improvement observed beyond this time period. For this reason, the 21-day treatment period was chosen during the present study. The mean doses of atomoxetine during the placebo-controlled study (1.3 mg/kg/day) and the present study (1.1 mg/kg/day) were similar. According to the product information for atomoxetine, no additional benefits are observed beyond a mean daily dose of 1.2 mg/kg.
Another study done predominately in white children with ADHD compared atomoxetine with an immediate-release formulation of MPH over 10 weeks; comparable outcomes were reported in patients who received either treatment. However, it is not possible to make direct comparisons between that study and the present trial because each was unique in its design and patient population, and each tested a different MPH formulation. Because direct comparative studies are lacking, effect size calculations may be useful in comparing responses to stimulant and nonstimulant treatments evaluated during independent randomized, double-blind, placebo-controlled studies. According to effect size analyses, stimulant treatments, such as OROS MPH, are more likely to be effective in the management of ADHD than nonstimulant treatments. The effect size of long-acting stimulant medications has been reported to be 0.95, whereas that of nonstimulant medications was reported as 0.62. Another study that compared data from large, placebo-controlled studies of patients treated with OROS MPH or atomoxetine found that effect sizes from parent and teacher evaluations in patients treated with OROS MPH were 1.02 and 0.96, respectively, compared with 0.62 and 0.44, respectively, for atomoxetine. In the present study, the difference in effect sizes for OROS MPH and atomoxetine for investigator-rated ADHD-RS in the African-American patients was calculated as 0.59, in favor of OROS MPH over atomoxetine. Differences greater than 0.2 are considered clinically important. buy finasteride online
No significant differences were noted between African Americans and non-African Americans for change from baseline in total ADHD-RS score, Inattentive Subscale or Hyperactivity Subscale scores in patients who received OROS MPH or atomoxetine. This study was not designed prospectively to determine significant differences in effectiveness between African-American patients and the non-African-American population; however, numerically similar improvements were observed between the groups in all outcome measures. Together with findings from other investigators, this implies that the clinical efficacy of ADHD treatment is similar between African-American and white children. One study used data from the highly controlled, double-blind MTA MPH trial to explore the effect of ethnicity or race on clinical outcomes. The study included African Americans and white children who were well matched for treatment, study site and gender. Response to MPH was reported in 76% (28/37) of African-American children and in 78% (29/37) of white children who received medication alone or in combination with behavioral therapy. Of note, the mean final dose of MPH was approximately 50% higher in the African-American group (48.7 mg/day), compared with the white group (32.4 mg/day). The investigators speculated that the need for increased doses in African-American children might be associated with the development of tolerance. However, this hypothesis was negated by the fact that African-American patients who received combined treatment (MPH and behavioral therapy) received MPH doses similar to those given to white patients. generic flomax
Several limitations of this study should be considered. For example, the open-label study design may have caused investigator or patient bias that could have influenced outcomes. In addition, because this study did not include a placebo control group, secular trends cannot be ruled out as an alternative explanation of the changes from baseline. However, the differential effects between the two treatments cause this to be unlikely. A further limitation may be related to the disease characteristics of the treatment groups. Although the severity of ADHD as measured by the ADHD-RS was comparable between the groups at baseline, the duration of ADHD was greater in the atomoxetine group, compared with the OROS MPH group. This is difficult to explain, since the groups were randomized. The brief duration of the study may also be considered a limitation; however, the increased trend over time towards greater symptom improvement in patients who received OROS MPH, compared with that of those who received atomoxetine, suggested the study period was adequate. Still, it is possible that the full effects of atomoxetine are not observed in some patients during a three-week treatment period. Furthermore, the study was not powered prospectively to study the African-American subgroup; therefore, these data should be considered exploratory in nature.
CONCLUSION
Both OROS MPH and atomoxetine demonstrated improvement in baseline symptoms and similar incidences of adverse events in the treatment of ADHD in African-American children. These findings support the use of ADHD treatment in African-American patients with ADHD. The greater response to OROS MPH than atomoxetine at three weeks as reported by parents and investigators suggests that OROS MPH may be more effective than atomoxetine in the treatment of ADHD in African-American children. rimonabant 20mg
Few studies have evaluated the treatment of ADHD in children who are members of minority groups. An early, small study of 11 male African-American adolescents with ADD found that MPH exerted improvement in attention and impulsivity, with a linear dose effect. This small study also found a trend for an increase in side effects with increasing MPH doses, including a mean increase in diastolic blood pressure, which was noted to be within the normal pediatric blood pressure range. Modest increases in blood pressure have also been noted with the use of atomoxetine. Additional long-term studies are therefore warranted to study these treatments in larger populations.
