Atomoxetine versus methylphenidate in paediatric outpatients with attention deficit hyperactivity disorder: a randomized, double-blind comparison trial.

OBJECTIVE: To (i) test whether atomoxetine is non-inferior to methylphenidate in treating symptoms of attention deficit hyperactivity disorder (ADHD) in paediatric patients; and (ii) determine the tolerability of the two drugs. METHOD: This double-blind study was conducted in 6- to 16-year-old outpatients with ADHD (DSM-IV) in China, Korea and Mexico (January-October 2004). Patients were randomly assigned to once-daily atomoxetine (0.8-1.8 mg kg(-1) day(-1); n = 164) or twice-daily methylphenidate (0.2-0.6 mg kg(-1) day(-1); n = 166) for approximately 8 weeks. Primary efficacy assessment was the comparison of response rates (> or =40% reduction from baseline to end point in total score) on the Attention Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and -Scored. Tolerability measures included, but were not limited to, the assessment of treatment-emergent adverse events (TEAEs) and weight. RESULTS: Atomoxetine was non-inferior to methylphenidate in improving ADHD symptoms based on response rates (atomoxetine, 77.4%; methylphenidate, 81.5%; one-sided 95% lower confidence limit = -11.7%, p = 0.404). Treatment-emergent adverse effects experienced significantly more frequently in the atomoxetine group, compared with the methylphenidate group, included anorexia (37.2% vs. 25.3%; p = 0.024), nausea (20.1% vs. 10.2%; p = 0.014), somnolence (26.2% vs. 3.6%; p <0.001), dizziness (15.2% vs. 7.2%; p = 0.024) and vomiting (11.6% vs. 3.6%; p = 0.007), most of which were of mild or moderate severity. Atomoxetine-treated patients experienced a small but significantly greater mean weight loss from baseline to end point than methylphenidate-treated patients (-1.2 kg vs. -0.4 kg; p <0.001). CONCLUSIONS: This study suggests that atomoxetine is non-inferior to methylphenidate in the improvement of ADHD symptoms in paediatric outpatients. Although both of the drugs were well tolerated, atomoxetine was associated with a higher incidence of TEAEs than methylphenidate.

Epidemiological profile of rotavirus infection in the Republic of Korea: results from prospective surveillance in the Jeongeub District, 1 July 2002 through 30 June 2004.

To facilitate future decisions regarding the usefulness of rotavirus vaccines in the Republic of Korea, active surveillance was conducted in a network of clinics, emergency departments, and hospitals serving Jeongeub District, Korea. Children with diarrhea underwent standard clinical evaluations, and stool specimens were collected to test for the presence of rotavirus. Parents were interviewed to collect demographic and family information. From 1 July 2002 through 30 June 2004, a total of 4106 children, representing 1 (50%) of every 2 children <5 years old in the study population, were evaluated for rotavirus diarrhea. Of the 2232 stool specimens obtained throughout the year, 460 (20.6%) were rotavirus positive; however, the monthly prevalence of rotavirus infection peaked at 49.5% in February 2004. Of the 460 rotavirus-positive stool specimens, 366 were obtained from children who visited outpatient clinics, and 94 were obtained from children who were hospitalized. By extrapolating the proportion of rotavirus-positive patients to all children with diarrhea in the surveillance system, we calculate that 882 children in Jeongeub District had rotavirus infection (which would predict that there would be 702 associated clinic visits and 180 hospitalizations). Genotyping of rotavirus strains showed that 39% of strains were type G9P[8], 24% were type G1P[8], 17% were type G3P[8], and 13% were type G2P[4]. The incidence of rotavirus diarrhea peaked at age 13-24 months, and 94% of cases occurred during the first 3 years of life. The annual incidence of all rotavirus disease-associated outcomes was 56.9 cases/1000 children <5 years old (95% confidence interval [CI], 51.9-62.2 cases/1000 children <5 years old). The incidence of rotavirus disease-associated hospitalizations was 11.6 cases/1000 children <5 years old (95% CI, 9.5-14.2 cases/1000 children <5 years old). In Korea, diarrhea is common during childhood, and the incidence of diarrhea due to rotavirus infection suggests that improved programs for the prevention and control of both rotavirus diarrhea and diarrhea due to other causes are needed.