United States of America - The prescribing information for galantamine hydrobromide (Reminyl®) has been updated to reflect the results of two investigational studies in individuals with mild cognitive impairment. Galantamine is approved only for the treatment of mild to moderate Alzheimer disease. No indication is being sought for the treatment of individuals with mild cognitive impairment.
In two randomized, placebo-controlled trials of two years duration in subjects with mild cognitive impairment (MCI), a total of 13 subjects on galantamine and one subject on placebo died. The deaths were due to various causes which could be expected in an elderly population; about half of the galantamine deaths appeared to result from various vascular causes (myocardial infarction, stroke, and sudden death).
Although the difference in mortality between galantamine and placebo-treated groups in these two studies was significant, the results are highly discrepant with other studies of galantamine. Specifically, in these two MCI studies, the mortality rate in the placebo-treated subjects was markedly lower than the rate in placebo-treated patients in trials of galantamine in Alzheimer disease or other dementias.
Although the mortality rate in the galantamine treated MCI subjects was also lower than that observed in galantamine treated patients in Alzheimer disease and other dementia trials, the relative difference was much less. When the Alzheimer disease and other dementia studies were pooled, the mortality rate in the placebo group numerically exceeded that in the galantamine group. Furthermore, in the MCI studies, no subjects in the placebo group died after 6 months, a highly unexpected finding in this population. Individuals with mild cognitive impairment demonstrate isolated memory impairment greater than expected for their age and education, but do not meet current diagnostic criteria for Alzheimer disease.
Reference: Communication from Ortho-McNeil Neurologics on 31 March 2005. http://www.fda.gov/medwatch