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Long-Term Galantamine Therapy Safe, Effective for Dementia Patients

Galantamine produces long-term benefits and is well tolerated in patients with vascular dementia (VaD) and Alzheimer's disease (AD) with cerebrovascular disease (CVD), according to a new study.

Primarily associated with the elderly, dementia is a growing concern as a large proportion of the population ages. While AD and VaD are the most common types of dementia, epidemiologic evidence suggests that many dementia patients have both AD and CVD, otherwise known as mixed dementia.

Because cholinergic dysfunction is involved in both AD and mixed dementia, use of acetylcholinesterase (AChE) inhibitors in the treatment of dementia is a developing area of research. Galantamine, an AChE inhibitor and allosteric nicotinic modulator, has shown broad clinical benefit in mild to moderate dementia cases.

In an open-label extension of a 6-month double-blind study of galantamine, Timo Erkinjuntti, MD, of the Department of Clinical Neurosciences, Helsinki University Central Hospital, Helsinki, Finland, and colleagues evaluated the long-term efficacy and safety profile of galantamine in VaD or mixed dementia patients.

The study population consisted of 459 patients previously randomised to receive galantamine 24 mg/d or placebo in a double-blind study phase. Patients in both treatment groups received open label treatment (164 placebo/galantamine, 295 galantamine/galantamine) for 6 months.

The primary efficacy measure was change in cognition, based on scores on the standard11-item Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog/11). Secondary measures included changes in functional ability based on the Disability Assessment for Dementia (DAD), and behaviour based on the Neuropsychiatric Inventory (NPI). Safety and tolerability were also monitored.

Approximately 81.5% of patients completed the study (120 placebo/galantamine, 254 galantamine/galantamine). Principle reasons for discontinuation included adverse events (32 patients), withdrawn consent (6 patients), death unrelated to treatment (2 patients), and non-compliance (2 patients).

In the previous 6-month double-blind study phase, patients receiving placebo worsened significantly from baseline in ADAS-cog/11 scores while patients receiving galantamine improved significantly. At the end of the open-label extension (study month 12), both treatment groups improved from baseline in ADAS-cog/11 scores (-0.3 point placebo/galantamine [95% CI, -1.64 to 1.06], -0.9 point galantamine/galantamine [95% CI, -1.73 to 0.03]).

Alternatively, DAD scores suggested that functional ability at month 12 had deteriorated from baseline and month 6 in both treatment groups, although greater change occurred in patients receiving placebo in the double-blind phase.

Total NPI scores at month 12 did not differ significantly from baseline in either treatment group, indicating that galantamine treatment prevented new behavioural symptoms.

Overall, researchers concluded that cognitive function and behavior were maintained for 12 months with galantamine, and significant benefits were seen in terms of functional ability. The majority of patients benefited from galantamine treatment, regardless of diagnosis (VaD or mixed dementia).
Clin Ther 2003 Jun;25:6:1765-82. "An open-label extension trial of galantamine in patients with probable vascular dementia and mixed dementia"

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