For horses already
suffering from EPM, a drug once thought to hold out great hope to people
with AIDS for treatment of a protozoan?caused diarrhea may prove effective
in the treatment of EPM.
The drug, nitazoxanide,
has been studied by scientists in association with Blue Ridge Pharmaceuticals
(BRP) in Greensboro, North Carolina. BRP is awaiting US Food & Drug Administration
approval for use of the drug in horses.
"We're in the review
process," said Scott Moffitt, BRP's director of equine marketing. The
federal review process for a new drug can be lengthy and is unpredictable
in any case, but in this case the process has been more complex, he said.
"Particularly with
an emerging disease like this, there are more questions than there are
answers, and it makes it more difficult for everybody," said Moffitt.
Nitazoxanide is used
in Mexico and Mali to treat cryptosporidial diarrhea in individuals with
advanced HIV disease. Cryptosporidium parvum is a protozoan parasite that
is very difficult to eliminate once it becomes "interiorized" in the cell
walls of the intestine.
According to documents
on file with the US FDA, nitazoxanide has broad?spectrum activity against
a host of bacteria and parasites such as nematodes, cestodes, and trematodes.
The application by Unimed Pharmaceuticals to have nitazoxanide (NTZ) approved
for use in AIDS patients was rejected in 1998 after the company failed
to produce sufficient data of placebo?controlled studies on the drug's
efficacy.
Clara K. Fenger, DVM,
PhD, of Equine Internal Medicine Consulting in Georgetown, Kentucky, reported
on one study at the American Association of Veterinary Parasitologists
Association meeting last year. Dr. Fenger could not be reached for comment.
In Fenger's study,
the researchers conducted two field trials of the drug. Horses enrolled
in the clinical trial had to show significant asymmetric ataxia (lack
of coordination on one side, for example, grade 2?4) three positive Western
Blot tests for cerebrospinal fluid (see story, page 2) for EPM from at
least two laboratories, complete blood count and chemistry profile, and
a normal physical examination other than neurological signs.
All horses in the
trial received 24 mg/kg NTZ orally once a day for five days, followed
by 50 mg/kg NTZ orally once a day for another 23 days.
Of 63 horses that
completed the trial, 70 percent (or 44) showed improvement in neurological
signs. Thirteen percent (eight horses) had a negative CSF Western blot
test at completion. By the 85 day cut?off, three horses had relapsed.
In the broader field
trial, 23 horses completed the trial, with 21 showing improvement by the
end of the trial.
Side effects of the
drug reported for this last trial included fever (15 horses), increased
digital pulse (four horses), temporary worsening of neurologic signs (four
horses), and colic (one horse).
"No side effects were
severe, or persisted beyond several days," according to the researchers.
More information on
EPM is available in International Equine Science's 16-page report on the
disease. The report covers the latest research on causes, prevention,
and treatment of EPM and costs $14.95 plus $2.00 S&H.
This article originally
appeared in the February 2001 issue of International Equine Science. IES,
an eight-page newsletter, provides the latest scientific information on
the athletic horse - an advertising-free and quick-to-read monthly update
on equine research. www.equinescience.com (802)888-6189.
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