Speaker: Jose Ferreira, MD, Pediatric Epilepsy Neurologist, Pediatric Epilepsy and Neurology Specialists, Tampa, Florida.
Topiramate (Topamax medication, Ortho-McNeil), a broad-spectrum antiepileptic, appears to be efficacious and generally welltolerated in pediatric and adolescent migraine prophylaxis, substantially reducing migraine headache frequency and severity and improving the disability associated with migraine.
Because present-day mainstays of migraine prophylaxis (calcium channel blockers, beta-blockers, antidepressants, and drug divalproex sodium) might have limited efficacy and could be poorly tolerated, and topiramate is known to exhibit several mechanisms of action that contribute to migraine prevention, a retrospective analysis was conducted to determine the efficacy of generic topiramate in the treatment of pediatric and adolescent patients diagnosed with migraine and chronic daily headaches.
A chart review was performed for pediatric and adolescent patients who had been treated with topiramate for migraine. Thirty-four patients (10 male, 24 female), with a mean age of 14 years (range: 8-19 years) had been diagnosed with migraine (16 patients), daily headache (17 patients), and headaches associated with hydrocephalus (1 patient). Most patients had been started with topiramate at a dose of 25 mg/day, which than was increased by 25 mg/week until relief was obtained or the maximum tolerated dose was attained. The mean dose of topiramate canadian therapy was 138 + 85 mg (range: 15-135 mg). Patients kept a headache diary and recorded the frequency and severity of headaches; severity was rated on scale of 1 to 5.
GABA Analog for Painful Diabetic Neuropathy Speaker: Uma Sharma, PhD, Clinical Director for Neuropathic Pain, Pfizer Global Research and Development, Ann Arbor Laboratories, Ann Arbor, Michigan.
Pregabalin 300 mg/day (Pfizer), a structural analog of the neurotransmitter GABA (gamma aminobutyric acid), has been shown to be safe and effective for the treatment of pain associated with diabetic peripheral neuropathy (DPN).
In most patients, DPN is resistant to treatment with simple analgesics and tricyclic antidepressants, anticonvulsants, phe-nothiazines, NSAIDS, and opiates, all of which have been tried with little success. There is, therefore, a need for effective therapy that can relieve the painful symptoms of DPN without risking chemical dependence or affecting glycemic control.
Earlier studies had suggested that generic pregabalin is effective in relieving pain associated with DPN, so a multicenter (23 centers), double-blind, randomized, parallel-group, fixed-dose, placebo-controlled study was carried out to evaluate the efficacy and safety of pregabalin in DPN. A total of 146 patients with DPN of one to five years’ duration were randomized in this trial, consisting of a one-week baseline phase and an eight-week, double-blind, fixed-dose treatment phase in which the patients were randomly assigned to pregabalin 300 mg/day (76 patients) or placebo (70 patients). The primary efficacy parameter was pain, the score being recorded by the patients in a diary using an 11-point numerical rating scale (0 [no pain] – 10 [worst possible pain]). The primary assessment measure was the endpoint mean pain score (mean of last seven diary entries while on study medication). To be randomized, patients had to have a mean pain score of more than 4 on the daily diary during the baseline phase of the study.
Compared to placebo-treated patients, pregabalin-treated patients showed significant improvement in the endpoint mean score, with a 1.47 reduction; efficacy was seen at the first time point (week one). In addition, there was a significantly greater proportion of responders (with at least a 50% reduction in pain from baseline to endpoint) in the pregabalin group (40%) compared to the placebo group (14.5%). Supportive evidence also was seen in the significant improvements on pregabalin versus placebo observed for the Short Forum McGill Pain Questionnaire, Patient and Clinician Global impression of change, SF-36 Health Survey bodily pain domain, and the Profile of Mood States Tension-Anxiety and Total Mood Disturbance subscales. Of particular importance, there is a durability of the analgesic effect over the eight-week double-blind study phase.
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Potassium Channel Blocker for Chronic Motor-Incomplete Spinal Cord Injury
Speaker: Daniel Lammertse, MD, Medical Director, Craig Hospital, Englewood, Colorado.
Fampridine-Sustained Release (SR), an investigational specific blocker of fast-activating neuronal potassium channels in demyelinated axons, was well-tolerated and appears to restore neurologic function, showing statistically significant improvement on Subject Global Impression (SGI) and in bowel function in patients with chronic motor-incomplete spinal cord injury.
In an 11-center, double-blind, placebo-controlled, parallel-group study, a total of 91 patients with traumatic spinal cord injury that had occurred 18 months prior to screening, were randomized to receive fampridine-SR (Acorda Therapeutics, Inc.) 25 mg twice daily, fampridine-SR 40 mg twice daily, or placebo for eight weeks (two-week dose escalation, four-week fixed dose, two-week down titration). Efficacy assessments included weekly measures of spasticity (Ashworth Scale of Rigidity, lower extremity tendon reflex, spasm frequency; SGI; and clinical global impression [CGI]), plus baseline and end-of-study measures (International Index of Erectile Function [IIEF], bowel and bladder questionnaires, Functional Independence Measure [FIM]; and Subject Summary Questionnaire [SSQ] at the end of the meeting). Safety was evaluated from adverse event reports and standard clinical assessments.
Overall, 78% of patients completed the study; the incidence of adverse events and patients discontinuing the study was greatest in the fampridine-SR 40-mg-treated patients. Eleven of the 16 patients who withdrew were in the fampridine-SR 40-mg group. Two outcome measures were statistically significant in favor of fampridine-SR 25 mg: SGI, and number of days with bowel movements. Also, in a subgroup analysis, patients with an Ashworth score greater than median at baseline had significantly reduced spasticity on fampridine-SR 25 mg. Several other outcome measures, which did not achieve statistical significance, favored fampridine-SR 25 mg, including the number of bladder accidents per day, and male sexual functioning.