American Neurological Association: Sustained-Release Fampridine Improves Impressions in Multiple Sclerosis
Sustained-Release Fampridine Improves Impressions in Multiple Sclerosis
Speaker: Andrew Goodman, MD, Associate Professor of Neurology, Chief, Neuroimmunology Unit, and Director, Multiple Sclerosis Unit, Department of Neurology, University of Rochester Medical Center, Rochester, New York.
Response to fampridine-SR (Acorda Therapeutics), an investigational, oral sustained-release formulation of 4-aminopyridine (4-AP), in patients with multiple sclerosis (MS), as measured by consistent improvement of walking speed on the Timed 25-Foot Walk (T25-FW) test, identifies a meaningful change that positively affects patients’ impressions of their ambulatory disability.
A 24-center, double blind, placebo-controlled trial enrolled 206 patients with MS. The patients were randomly assigned to receive either fampridine-SR (10 mg, 15 mg, or 20 mg twice daily) or placebo, over a 14-week treatment period.
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Among the 205 intent-to-treat patients, 62 patients experienced consistent improvements in walking speed during at least three of four visits during treatment that was faster than the maximum speed during the five “off-drug” visits. Response rates were higher in all fampridine-SR groups: 35% with 10 mg, 36% with 15 mg, 39% with 20 mg, and 9% with placebo. Consistent improvement in walking speed was significantly associated with improved Subjects’ Global Impression Questionnaire scores and 12-item Multiple Sclerosis Walking Scale (MSW5-12) scores. This indicates that consistent improvement in walking speed on the Timed Walk associated with this treatment is clinically meaningful to the patient.
Six Months of Memantine Helps Alzheimer’s Disease
Speaker: Rachel S. Doody, MD, PhD, Professor in Alzheimer’s Disease Research, Department of Neurology, and Director, Alzheimer’s Disease Research Center, Baylor College of Medicine, Houston, Texas.
Six months of treatment with memantine (Namenda®, Forest Laboratories, Inc.) offers a valuable therapeutic approach for patients with mild-to-severe Alzheimer’s disease (AD).
Evidence of this efficacy was reached from a meta-analysis of data from six large-scale, placebo-controlled trials (five American, one European). These encompassed 2,312 outpatients with either mild-to-moderate AD or moderate-to-severe AD who received memantine for six months. A meta-analysis such as this applies procedures to the treatment effects from individual trials to allow a quantitative evaluation of the treatment effect across trials. Unlike a pooled analysis, a metaanalysis recognizes that the subjects come from different trials and considers the heterogeneity between trials.
The investigators concluded that memantine over a six-month period resulted in a statistically significant benefit over placebo in cognition, function, and global status in patients with mild-to-severe AD.
Trials of patients with moderate-to-severe AD revealed statistically significant benefits over placebo on cognition, function, behavior, and global status.
Trials of patients with mild-to-moderate AD showed positive effects on cognition and global status. Rates of discontinuation and adverse effects from memantine treatment were similar to those reported for placebo.