In: Main7 Apr 2010
Atomoxetine Benefits Attention-Deficit/Hyperactivity Disorder and Comorbid Tourette Syndrome
Speaker: Thomas J. Spencer, MD, Associate Professor, Department of Psychiatry, Harvard Medical School, and Assistant Director, Pediatric Psychopharmacology Clinic, Department of Pediatric Psychopharmacology, Massachusetts General Hospital, Boston, Massachusetts
Atomoxetine (Lilly), a nonstimulant indicated for attention-deficit/hyperactivity disorder (ADHD), has been shown to be safe, well tolerated, and effective for children with ADHD and comorbid Tourette syndrome by treating ADHD symptoms without exacerbating tic symptoms. Because the psychostimulants traditionally used to treat ADHD sometimes trigger or worsen motor or vocal tics in patients with ADHD and Tourette syndrome, a study was performed to examine the change in severity of tics and symptoms of ADHD during.
Initially, 148 ADHD patients were assigned to treatment; 117 of these patients also had Tourette syndrome. All of these children, 7 to 17 years of age, were entered into a two-week screening and washout period, followed by an 18-week, double-blind, placebo-controlled, acute-treatment phase. They were randomly assigned to receive atomoxetine 0.5 to 1.5 mg/kg per day or placebo twice daily for up to 18 weeks.
Results were based on an a priori-defined secondary analysis of the subgroup of 117 ADHD patients meeting the full criteria of Tourette syndrome. Atomoxetine significantly decreased symptoms of ADHD in patients with Tourette syndrome. These patients showed significant improvement in the ADHD Rating Scale total scores and in CGI overall severity scores. Viagra Online Canadian Pharmacy
No worsening of tics was observed with atomoxetine; in fact, this agent appeared to have a beneficial effect on tic severity and was associated with a greater reduction in tic severity at the endpoint compared with placebo. Such reductions were measured by total scores on the Yale Global Tic Severity Scale and by CGI Severity of Tic/Neurological Symptoms Scale scores, but not by total scores on the Tic Symptom Self-Report.
Atomoxetine was generally well tolerated, although patients taking this drug experienced greater increases in pulse rate, decreased body weight, and treatment-related decreased appetite and nausea. No other clinically relevant treatment-related adverse events were seen for any other vital signs, laboratory parameters, or electrocardiographic measures.
Pregabalin Relieves Neuropathy and Neuralgia
Speaker: Russell Portenoy, MD, Chairman, Department of Pain Medicine and Palliative Care, Beth Israel Medical Center, New York, New York
A number of short-term, randomized clinical trials have shown that pregabalin (Pfizer), an anticonvulsant used to relieve seizures and nerve pain, has a rapid onset of effect in painful diabetic peripheral neuropathy (DPN) and post-herpetic neuralgia (PHN), often by the second day of treatment.
To describe the time to onset and the duration of analgesia during studies of pregabalin for peripheral neuropathic pain, investigators evaluated data from seven placebo-controlled, short-term, randomized, controlled trials (five to 13 weeks in length) and four open-label extension trials (two years in duration). A total of 1,543 patients (940 taking pregabalin and 603 taking placebo) were enrolled. Patients with DPN received pregabalin 300 or 600 mg daily or placebo. Patients with PHN received day, 300 mg/day, or 600 mg/day or placebo.
In the open-label extension studies, 444 patients received flexible dosing, and pain data were reported for 251 patients. The time of onset was defined by the first day on which numeric daily pain scores (ranging from 0 to 10) were significantly lower than placebo on two consecutive days.
In nine of 11 study arms in the trials that demonstrated significant efficacy at the endpoint, the onset of analgesia occurred on the first or second day of treatment. In these nine treatment arms, the therapeutic effect, as measured by daily pain scores on the first confirmed day of response, ranged from -0.70 (P = .004) to -1.40 (P < .001) in the patients with DPN and from -0.45 (P= .036) to -0.66 (P= .004) in those with PHN.
For patients in the open-label extension studies, pain remained consistent from the first quarter to the two-year follow-up, and there were no clinically meaningful variations in mean dosage of pregabalin during this period.
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