New data from a Phase III study of a proprietary formulation of memantine HCl (Namenda®) found that patients treated with the 28 mg once-daily extended-release formulation experienced statistically significant benefits in cognitive ability and clinical global status and significant improvements in verbal fluency and behavioral symptoms, compared with those treated with placebo. The randomized, double-blind, multicenter, placebo-controlled study evaluated the efficacy, safety, and tolerability of the new formulation in 677 out-patients with moderate to severe Alzheimer’s disease currently treated with a cholinesterase inhibitor. The results were presented at the 2008 Alzheimer’s Association International Conference on Alzheimer’s Disease.
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Patients in the 24-week study were randomly assigned to receive either 28 mg per day of memantine extended release or placebo. The primary endpoints evaluated were change from baseline on the Severe Impairment Battery (SIB) and the Clinician’s Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus) rating at week 24. The study showed statistically significant higher cognitive abilities, as measured by the SIB, and clinical global status, as measured by the CIBIC-Plus, in patients treated with memantine 28 mg extended release compared with those taking placebo (p = 0.001 for SIB and p = 0.008 for CIBIC-Plus, both using the predefined last observation carried forward analyses).
Additional assessments were conducted to evaluate change in behavior from baseline using the Neuropsychiatric Inventory (NPI) at 24 weeks and change in verbal fluency from baseline using the Verbal (Semantic) Fluency Test at 24 weeks. Memantine provided significant benefits over placebo (p = 0.005 for NPI and p = 0.004 for verbal fluency). Measurement of daily living activities using the 19-item AD Cooperative Study-Activities of Daily Living scale demonstrated maintenance of function during the study period, but this was not significantly different from placebo (p = 0.18).
The study also showed that the once-daily formulation was well tolerated. The most common adverse events occurring at a higher rate than placebo were dizziness, diarrhea, and headache.
Source.“New Data Highlight Positive Results of Namenda® memantine HCl) Once-Daily Extended-Release Formulation.” (2008, July 30). Retrieved August 1, 2008, from http://www.medicalnewstoday.com/articles/116705.php.
To address the Centers for Medicare & Medicaid Services’ new policy regarding facility-acquired pressure ulcers, which goes into effect on October 1 of this year, Medline Industries, Inc. has created the Pressure Ulcer Prevention Program. This money-back guaranteed product bundle includes:
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For more information, call 1-800-MEDLINE or access http://www.medline.com.
Source.“Medline’s Pressure Ulcer Prevention Program Addresses New CMS Deadline of October 1, 2008.” (2008, May 29). Retrieved July 11, 2008, from http://www.tradingmarkets.com/.site/news/Stock%20News/1632079/.…