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April 1, 2007 — The U.S.
Food and Drug Establishment (FDA) and Ortho-McNeil Neurologics, Inc,
have notified healthcare professionals via graphic symbol regarding the
results of two clinical trials of galantamine hydrobromide (Reminyl) in
patients with mild cognitive hurt (MCI), according to an preparation
sent day from MedWatch, the FDA’s condition content and adverse
physical phenomenon reporting promulgation.
Galantamine is not approved by the FDA for use in this reading.

In
the two randomized, two-year trials, deathrate was significantly higher
in patients receiving galantamine (13 of 1,026) compared with vesper (1
of 1,022).
Although the deaths were attributed to a show of causes associated with
advanced age, half of the deaths in the galantamine radical appeared to
effect from vascular causes such as myocardial infarction, stroking,
and sudden end.

According
to the graphic symbol, the significant change in rate between the two
groups is highly discrepant with other studies of galantamine.

In
the MCI studies, the deathrate rate in the medication grouping was
markedly lower than that observed in trials involving Alzheimer’s
disease (AD) or other dementias (rate per 1,000 bod geezerhood, 0.7 vs
22 - 61).
Although the glimepiride  rate in the galantamine abstract entity was
similarly decreased (rate per 1,000 person-years, 10.2 vs 23 -31), the
FDA notes that the individual difference of opinion was much less.

Furthermore,
data pooled from the studies of AD and other dementias (n = 6,000)
showed that the impermanency rate in the medicinal drug groups
numerically exceeded that of the galantamine groups, whereas in the MCI
studies no deaths occurred in the medication grouping after six months.

Galantamine
is indicated for the idiom of mild to moderate AD.
Individuals with MCI generally demonstrate isolated module
stultification greater than that expected for their age and grade of
activity but do not meet the flow diagnostic criteria for AD.
Commendation for galantamine use in patients with MCI is not beingness
sought.

This is a part of article FDA Cautions Against Use of Reminyl for Mild Cognitive Impairment. Taken from "Generic Amaryl (Glimepiride) Information" Information Blog

Labels: pharmacology

# posted by Haig Aglaia @ 5:46 AM