Uses
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Alzheimer's Disease
Galantamine hydrobromide is used for the palliative treatment of mild to moderate dementia of the Alzheimer's type (Alzheimer's disease). Efficacy has been demonstrated in 5 randomized, placebo-controlled studies of 3-6 months' duration in patients diagnosed with probable Alzheimer's disease utilizing a dual outcome assessment strategy; 4 of these studies utilized conventional tablets, and 1 study utilized extended-release capsules. Changes in cognitive performance were assessed by various instruments, including the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS cog), and changes in overall clinical effects were assessed using the Clinician's Interview Based Impression of Change that required the use of caregiver information (CIBIC plus). (For additional information on ADAS cog and CIBIC plus, see Uses: Alzheimer's Disease in Donepezil Hydrochloride 12:04.) Overall, galantamine 8-16 mg twice daily (as conventional tablets) was found to be more effective than placebo for improvements in cognitive function and overall clinical status as assessed by the ADAS cog and CIBIC plus scales. In a 6-month study, galantamine 16-24 mg once daily (as extended-release capsules) was as effective as galantamine 8-12 mg twice daily (as conventional tablets) and more effective than placebo in improving cognitive function and overall daily function as assessed by the ADAS cog and Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scales, respectively; however, galantamine extended-release capsules were not more effective than placebo in improving overall clinical status (as assessed by the CIBIC plus scale). In a 6-month extension of a randomized, placebo-controlled study utilizing galantamine conventional tablets, clinical improvements were maintained over a 12-month study period in patients who continued to receive galantamine therapy. However, as with other anticholinesterase inhibitors (e.g., donepezil, tacrine), improvement associated with galantamine therapy was not maintained following discontinuance of the drug, suggesting that galantamine does not alter the underlying disease process of dementia.
For additional information on the management of Alzheimer's disease, .
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Mild Cognitive Impairment
Galantamine has been investigated in patients with mild cognitive impairment who did not meet diagnostic criteria for Alzheimer's disease. However, the incidence of death in patients receiving galantamine was higher than the incidence in those receiving placebo in 2 randomized controlled studies in patients with mild cognitive impairment. (See Mortality under Warning/Precautions: Warnings, in Cautions.) Galantamine is not approved by the US Food and Drug Administration (FDA) for use in patients with mild cognitive impairment who do not have Alzheimer's disease; the manufacturer of galantamine does not intend to seek FDA approval for this indication.