Treatment with the generic tetracycline drug minocycline produced
fewer cases of MS after six months compared to people given a
placebo. The drug was tested in 142 patients who had shown some
early symptoms, but the disease had not been confirmed.
The benefit was also seen after one year of therapy, but not after
two years, said chief author Dr. Luanne Metz of the University of
Calgary's Hotchkiss Brain Institute.
"We did not have enough patients at 24 months to know whether the
drug was still doing anything or not," she told Reuters Health.
Further tests would be ideal but paying for them will be difficult
because no pharmaceutical company stands to make a lot of money from
this use for the generic drug.
Generally, two out of three patients with the early signs of
multiple sclerosis, known as clinically isolated syndrome, go on to
develop MS within six months. The disease attacks the insulation
protecting the body's nerves.
In the new study, the six-month risk of conversion to MS was 33.4
percent with 100 mg of minocycline twice daily versus 61.0 percent
in the placebo group. When the researchers adjusted for the results
of MRI scans, the odds rose to 43.0 percent with minocycline but
stayed the same with placebo.
Yet after two years, the unadjusted risk was comparable in the two
groups, raising the possibility that the benefit may not last.
The treatment costs about C$600 ($444) per year in Canada versus
C$20,000 to C$40,000 for conventional MS therapy, the researchers
said. The price tag is about three times higher in the United
States. In addition, minocycline therapy can be started rapidly. In
Canada, conventional MS therapy can take months to get approved.
"It's a very inexpensive medication - less than C$2 per day - that
can be initiated immediately," coauthor Wee Yong told Reuters
Health. "We know that time matters in MS. With the passage of time,
the immune insults on the brain continue. I see this as potentially
a game-changer in terms of overcoming the challenges of time against
MS."
In addition, the drug could help patients in areas of the world that
don't have access to the more expensive drugs for multiple
sclerosis, he said.
"Overall, the findings from this trial suggest a potential clinical
benefit of minocycline in early multiple sclerosis, with an effect
size similar to that of existing disease-modifying treatments," said
Drs. Zongqi Xia of the Pittsburgh Institute of Neurodegenerative
Diseases and Robert Friedlander of the University of Pittsburgh
School of Medicine in an editorial in the New England Journal of
Medicine, where the study appears.
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Despite some limitations, including the small size of the study, the
findings "make a compelling case for the further study of the effect
of minocycline in multiple sclerosis," they said. "However, use of
minocycline in multiple sclerosis is not supported until its benefit
can be confirmed in larger long-term clinical trials."
According to the National Multiple Sclerosis Society, people who
experience neurologic symptoms for at least 24 hours and those
symptoms are caused by a inflammation or a loss of myelin in the
central nervous system may - but not always - progress to MS.
The odds are about 60 percent to 80 percent when MRI detects MS-like
brain lesions; about 20 percent when they're not seen.
In the new test, done at 12 Canadian MS clinics, all volunteers had
at least two brains lesions larger than 3 millimeters. The study
team used minocycline because it has anti-inflammatory properties
and, unlike most drugs, it crosses the blood-brain barrier.
Among the minocycline side effects: dizziness (seen 10 times more
often than in the placebo group), rash (which was 5 times more
common) and dental discoloration (seen in 6 of 72 patients but none
in the 70-member placebo group).
Six people in the minocycline group withdrew from the test because
of side effects versus one person in the placebo group.
"Most people stay on it and tolerate it very well," Metz said. Side
effects usually fade over time to the point where "it's tolerated
much like taking a vitamin pill."
SOURCE: http://bit.ly/2qvmaLE New England Journal of Medicine,
online May 31, 2017.
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