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DGReview
Long-term Galantamine Shows Continued Safety, Efficacy in Patients with Vascular Dementia or Alzheimer's Disease with Cerebrovascular Disease
A DGReview of :"Long-term safety and cognitive effects of galantamine in the treatment of probable vascular dementia or Alzheimer's disease with cerebrovascular disease"
European Journal of Neurology
12/19/2003
By Deanna M Green, PhD
Long-term use of galantamine is safe and prolongs maintenance of cognitive function in patients with vascular dementia (VaD) or Alzheimer's disease (AD) with cerebrovascular disease (CVD), say researchers.
Alexander F Kurz, MD, at the Technische Universitaet Munchen, Munich, Germany, and colleagues evaluated the safety and cognitive effects of longer-term use of galantamine, a new acetylcholinesterase inhibitors (AChEIs), in patients with VaD or AD with CVD.
The study included 326 patients who had completed a 12 month trial of galantamine treatment and entered the current open-label extension trial where they received galantamine (12 mg twice daily) for 24 months. An interim analysis of cognitive ability was assessed using the AD Assessment Scale (ADAS)-cog/11 in the 248 patients who completed the first year of the study.
The most common adverse events were depression (12.6%), agitation (11.7%) and insomnia (10.1%). The authors note that these events are "characteristic of those expected for an elderly population with dementia." The incidence of nausea and vomiting declined significantly since the initial study and affected only 5.9% and 2.3%, respectively.
Serious adverse events were reported in 31% of patients, with the most frequent being pneumonia (6%) and injury (5%). No deaths occurred due to galantamine treatment.
Cognitive function deteriorated by only 2.8 points on the ADAS-cog/11 from pre-galantamine treatment to 24 months of treatment. Moreover, less deterioration occurred in patients who had received galantamine the longest (2.7 vs. 3.1 points initial placebo group).
Superior maintenance of cognitive ability was observed in patients with VaD than in those with AD with CVD (0.8 vs. 4.4, respectively). Furthermore, baseline levels were maintained for about 21 months in VaD patients and for 12 months in AD plus CVD patients.
Eur J Neurol 2003 Nov;10:6:633-40.
"Long-term safety and cognitive effects of galantamine in the treatment of probable vascular dementia or Alzheimer's disease with cerebrovascular disease"
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