Medical Inspection – Health Blog

The effectiveness of Atomoxetine generic in the treatment of ADHD was established in six randomized, double-blind, placebo-controlled studies in children, adolescents, and adults who met the criteria for ADHD, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Of these six studies, four were used to assess the drug’s clinical efficacy in children and adolescents and two of the studies were used to evaluate its efficacy in adults.

Michelson et al

A randomized, placebo-controlled, dose-response study involved 297 children (212 boys and 85 girls) with ADHD, as defined by DSMIV. Ages ranged from 8 to 18 years. Patient characteristics are detailed in Table 2.

Table 2   Patient Characteristics in Trials of Atomoxetine for Attention-Deficit/Hyperactivity Disorder

Atomoxetine was dosed on a weight-adjusted basis at 0.5, 1.2, or 1.8 mg/kg per day for eight weeks. Parent and investigator rating scales were used to assess ADHD symptoms, affective symptoms, and social and family functioning.

After an initial 12- to 18-day evaluation and medication washout period, patients were randomly assigned to receive one to three doses of atomoxetine (see earlier) or a placebo for eight weeks. Of these groups, 84 patients received placebo, 44 patients received atomoxetine 0.5 mg/kg per day, 84 patients received atomoxetine 1.2 mg/kg per day, and 85 patients received atomoxetine 1.8 mg/kg per day. cialis canadian pharmacy

At baseline evaluations, symptoms were rated as moderate to severe for most children. At endpoint evaluations, doses of atomoxetine 1.2 and 1.8 mg/kg per day were consistently associated with greater improvement in ADHD symptoms, compared with doses of placebo (P < .001 for pairwise comparisons of each active treatment dose to placebo). The dose of 0.5 mg/kg per day was associated with an efficacy that was intermedi­children and adolescents with ADHD, aged 6 to 16 years, received six weeks of ate between placebo and the two higher doses (Table 3).

Table 3 Efficacy of Atomoxetine in Attention-Deficit/Hyperactivity Disorder

Michelson et al In another double-blind study, 171 treatment with either once-daily atom-oxetine or placebo. Atomoxetine was given as a single dose in the morning, according to body weight, and was titrated according to clinical response, up to a maximum dose of 1.5 mg/kg per day. The mean final daily dose of atom-oxetine was 1.3 mg/kg per day.

After six weeks with either once-daily dosing of atomoxetine or placebo, investigator, parent, and teacher ratings showed better outcomes in the atomox-etine group than in the placebo group, as measured on the ADHD rating scale. The treatment effect size was similar to that reported in the previous studies of twice-daily atomoxetine dosing. buy antibiotics in canada

Table 4 Demographics and Baseline Characteristics of Patients with Attention-Deficit/Hyperactivity Disorder

The rate of patient dropout from the study resulting from adverse events was less than 3% for both treatment groups, and the investigators reported no serious safety concerns. This outcome was surprising because the half-life of atomoxetine was only about four hours. Although ratings in patient diaries suggested that drug-specific effects were sustained late in the day, the authors noted that the results must be interpreted cautiously because the instrument is new and its psychometric characteristics and reliability warrant further study.

Kratochvil and Heiligenstein

After an evaluation and drug washout period, patients were randomly selected to receive open-label treatment with either atomoxetine or methylphenidate for 10 weeks along with weekly medical visits. Sample size and power computations were performed to answer questions specific to the relapse-prevention portion of the study. kamagra soft tablets

The primary measure of symptom response was the investigator-rated ADHD rating scale, an 18-item instrument in which each item corresponded to one of the 18 DSM-IV symptom criteria for ADHD, based on an interview with a parent. Patient demographics and base­line characteristics for this study are shown in Table 4.

Table 5 Symptom Severity Outcomes in Patients with Attention-Deficit/Hyperactivity Disorder

The prospective, randomized, open-label trial involved 228 patients (184 received atomoxetine, and 44 received methylphenidate) to compare the two drugs in the treatment of ADHD using the ADHD-IV rating scale (see Table 4). At endpoint evaluations, outcomes on most measures were similar in the atom-oxetine and the methylphenidate groups for both parent-rated and investigator-rated scales. Reduction of symptoms was similar in both treatment groups for hyperactive-impulsive domains as well as for inattentive domains, as measured by the Hyperactivity/Impulsivity sub-scale and the Inattention subscale of the ADHD rating scale (Table 5) (see next page).

COST

The standard dosing frequency of atomoxetine, as recommended by the manufacturer, is twice daily. According to this standard, therefore, the cost of 60 10- and 18-mg tablets would be $187.89. The cost of 60 25-mg, 40-mg, and 60-mg tablets would be $214.49. Because sequential refills can be prescribed, monthly doctor visits for schedule II medication refills can be avoided. A cost comparison of common ADHD treatment options is shown in Table 6 (see next page).
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SUMMARY

Atomoxetine’s effectiveness in the treatment of children, adolescents, and adults with ADHD has been demonstrated by data from six placebo-controlled clinical studies.More than 4,000 patients have taken atomoxetine in all completed and ongoing clinical trials, some for as long as 2.5 years.

Table 6 Costs of Common Treatments for Attention-Deficit/ Hyperactivity Disorder

Atomoxetine is the first treatment for ADHD that has been approved by the FDA and that is not a stimulant under the Controlled Substances Act. Having a noncontrolled option such as atomoxe-tine has the potential to reduce prescription difficulties for patients, families, and physicians by offering the convenience of phone-in refills and samples.

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