American Neurological Association: Methylphenidate Alone Still Best for Attention-Deficit/Hyperactivity Disorder
Speaker: Donna Palumbo, PhD, Association Professor of Neurology and Pediatrics, University of Rochester Medical Center, and Director, Strong Neurology ADHD Program, Strong Memorial Hospital, Rochester, NY.
Results from the Clonidine in ADHD Treatment (CAT) trial indicated that methylphenidate (Ritalin®, Novartis)—but not clonidine (Datapres®, Boehringer-Ingelheim)—offered the best combination of benefits and the fewest adverse effects in patients with attention-deficit/hyperactivity disorder (ADHD), whether the medications were administered separately or together.
The use of clonidine alone or together with methylphenidate is becoming more common in the treatment of ADHD, but few safety and efficacy data are available. To better guide physicians and parents in making more informed treatment choices, the CAT trial was designed.
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The multicenter, double-blind, placebo-controlled study involved 122 children (98 boys and 24 girls, 7 to 12 years of age) with ADHD. The children were randomly assigned to receive clonidine, methylphenidate, a combination of the two drugs, or placebo, according to a 2 x 2 factorial design, over a 16-week study period.
The primary outcome measure was the change from baseline to 16 weeks in scores from the Conner’s Abbreviated Symptom Questionnaire for Teachers (ASQ-T) for ADHD. The researchers used a number of other outcome measures for ADHD, including the ASQ-Parent, Conner’s Continuous Performance Test, and direct classroom observations. Adverse effects were carefully monitored.
On the ASQ-T, children receiving methylphenidate, whether alone or in combination with clonidine, performed better than those not taking methylphenidate and better than those taking clonidine alone or placebo. Overall, they experienced the greatest benefits, the smallest number of side effects, and the most improvement in ADHD symptoms.
Children receiving clonidine, either alone or in combination with methylphenidate, performed better than those not receiving clonidine and better than those taking methylphenidate or placebo, although this effect was small and not statistically significant. Thus, clonidine alone did not improve ASQ-T scores.
The combination of the two active drugs demonstrated only marginal improvement in ASQ-T scores but with significantly more sedation. Sedation was reported more frequently among children receiving clonidine (38%) than among those not receiving it (7%). The medications were otherwise well tolerated. In general, sedation did not result in any child being withdrawn from the study.
Intramuscular Olanzapine Relieves Agitation in Schizophrenia or Bipolar Mania
Speaker: Leslie S. Zun, MD, MBA, Chairman and Professor, Department of Emergency Medicine, Chicago Medical School at Rosaline Franklin University of Medicine and Science, and Mount Sinai Hospital, Chicago, Illinois.
An intramuscular (IM) injection of olanzapine (Eli Lilly), an atypical (second-generation) antipsychotic agent indicated for patients with schizophrenia, significantly reduced moderate-to-severe symptoms of agitation in schizophrenia and bipolar mania within 30 minutes of injection, when compared with placebo.
Initially, two randomized trials were conducted to compare treatments for resolution of severe agitation symptoms in mentally disturbed patients. In one study, 311 agitated patients with schizophrenia were randomly assigned to receive, in a 2:2:1 fashion, IM haloperidol (Haldol®, Ortho-McNeil), or IM placebo.
In the second study, 3,201 agitated patients with bipolar mania were randomly selected to receive, also in a 2:1:1 fashion, IM olanzapine, IM lorazepam (Ativa®, Wyeth), or IM placebo. In a post hoc analysis, the investigators examined data on the frequency of patients experiencing a reduction of agitation from baseline moderate-to-extreme ratings on Cor-rigan Agitated Behavior Scale items and Positive and Negative Symptom Scale-Excitement Component (PANSS-EC) measurement scale items within 30 minutes after the IM injection.
In the patients with bipolar mania, “violence” that was rated as moderate to severe at the baseline was significantly reduced in 11 of 12 patients (90.9%) treated, versus four of 16 patients (25%) taking placebo. However, violence was not significantly reduced with lorazepam compared with placebo.
In agitated schizophrenic patients, “explosive anger” that was rated as moderate to severe at the baseline was significantly reduced in 31 of 40 olanzapine-treated patients (77.4%) versus 15 of 38 placebo patients (40%) and in 20 of 22 haloperi-dol-treated patients (90.9%) versus six of 15 placebo patients (40%). No significant difference was observed between the two active treatments.
Duloxetine for Rapid Pain Relief in Diabetic Peripheral Neuropathy
Speaker: Joel Raskin, MD, Medical Advisor, Eli Lilly, Indianapolis, Indiana.
Three randomized studies indicate that oral duloxetine (Eli Lilly), a selective serotonin and nor-epinephrine reuptake inhibitor (SSNRI), may have significant value in relieving diabetic peripheral neuropathic pain (DPNP).
Patients with DPNP of six months or more in duration, but who were not depressed, were enrolled in three 12-week studies.
- In study 1, 457 patients received once daily, 60 mg once daily, 60 mg twice daily, or placebo.
- In study 2, 334 patients were given duloxetine 60 mg once daily, duloxetine 60 mg twice daily, or placebo.
- In study 3, 348 patients were given duloxetine 60 mg once daily, duloxetine 60 mg twice daily, or placebo.
The primary outcome measure in all three studies was the weekly mean score for 24-hour average pain severity. Results from the three studies were comparable.
Duloxetine 60 mg once daily and 60 mg twice daily demonstrated a significant treatment effect on DPNP and a rapid onset of action. Within the first week of treatment, there was a significant difference shown with placebo on 24-hour average pain severity scores. Most secondary pain measurements confirmed these findings.
Whereas duloxetine 60 mg once daily and 60 mg twice daily demonstrated similar efficacy in most measures, the 60-mg, twice-daily dose demonstrated significantly more improvements on some McGill Pain Questionnaire items. A variety of health outcome measures, including the Clinical Global Impression-Severity Scale and the Patients’ Global Impression-Improvement Scale showed the superiority of both 60-mg, once-daily and 60-mg, twice-daily doses of duloxetine canadian over placebo. The active drug was safely administered and well tolerated and showed no adverse effects on diabetic control.