Regulatory authorities review use of galantamine in mild cognitive impairment

doi:10.1136/bmj.330.7486.276-b

BMJ 2005;330:276 (5 February), doi:10.1136/bmj.330.7486.276-b

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Regulatory authorities review use of galantamine in mild cognitive impairment

London Susan Mayor

Regulatory authorities are reviewing data suggesting that galantamine (Reminyl), a cholinesterase inhibitor licensed for mild to moderate dementia in Alzheimer�s disease, was associated with increased mortality among patients with mild cognitive impairment.

The manufacturer, Johnson & Johnson Pharmaceutical Research & Development, made the announcement last week, following two trials that it conducted. The studies combined included 2048 people aged 50 years and over with mild cognitive impairment (insufficient impairment to be diagnosed as dementia). The participants were randomly assigned to receive 8 mg or 12 mg twice daily galantamine or placebo for 24 months to see if the drug slowed progression to dementia.

Initial results showed more deaths in those treated with the drug (13/1026) than with placebo (2/1022) (hazard ratio for death 4.86 (95% confidence interval 1.76 to 13.40) during the double blind phase of the studies. Causes of death in patients taking galantamine included sudden . . . [Full text of this article]

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