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Unformatted text preview: PLoS Medicine | www.plosmedicine.org 0459 discussion between the clinician and the patient about this possibility” . Two trials, each lasting two years and not yet published, evaluated the effect of galantamine on a total of 2,048 patients with MCI randomized to receive galantamine or placebo [31,32]. Overall, the studies did not show that the drug could improve cognition or delay the conversion to dementia. Increased mortality (mostly due to myocardial infarction and stroke) was observed among patients treated with galantamine compared with patients given placebo. On the basis of these results, the US Food and Drug Administration issued a safety warning concerning galantamine . In these trials, the treatment duration (two years) was longer than that of most previous RCTs on Alzheimer disease (typically only six months). The short trials on Alzheimer disease had shown no increased mortality associated with cholinesterase inhibitors compared with placebo. In clinical practice, though, these drugs would likely be prescribed for several years, and the galantamine trials [31,32] have shown that such prolonged use may be associated with increased mortality. A recent review on clinical trials in MCI concluded that none of the reviewed studies met their primary objectives; that is, none of the trials showed a benefi t of cholinesterase inhibitors in delaying the conversion to dementia or in slowing symptom progression . Conclusion At present, donepezil, galantamine, and rivastigmine are licensed only for the treatment of mild to moderate Alzheimer disease. The treatment effect is modest, and there is evidence of wide variability in the outcomes reported: “some patients will have improved, others stayed the same, while others will have deteriorated. This variance should be comparative in both the treatment and the placebo groups but care should be taken over the interpretation of the mean scores” ....
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This note was uploaded on 10/10/2010 for the course ENG 000121 taught by Professor Mcgrand during the Spring '10 term at Cornell.
- Spring '10