HEALTH
A novel experimental treatment showed promise in a small study for
helping certain diabetics retain some ability to make insulin,
potentially lessening their need for shots of the hormone to regulate
blood sugar levels.
But the experiment raised safety concerns: Most who got the treatment
had side effects that researchers said were temporary, but that
theoretically might increase their risk of a blood disorder later on.
Nevertheless, the Juvenile Diabetes Research Foundation, which funded
the work, considered the results encouraging enough to plan future
large-scale studies, which would be needed before the experimental drug
might be available.
"The results are very promising. There are not many instances where you
can stop an autoimmune disease in its tracks," said Dr. Richard Insel,
the foundation's executive vice president for research.
Results were published in Thursday's New England Journal of Medicine.
More than 18 million people in the United State have diabetes. The vast
majority have Type 2, which is linked to obesity and occurs when the
body can't effectively use the insulin it makes.
The new study involved the other 5 percent to 10 percent of diabetics
who have Type 1, which occurs when the body's immune system attacks and
destroys insulin-producing cells in the pancreas. They must get insulin
through shots or a pump.
Researchers led by Dr. Lucienne Chatenoud of Necker Hospital in Paris
tested the novel approach on 80 newly diagnosed diabetics who still had
some insulin function left. The patients were given an experimental drug
called anti-CD3 antibody to prevent the immune system attack.
Half of the patients received it and the other half got a dummy drug for
a week after they were diagnosed as diabetics. Both groups also got at
least three insulin shots a day to control blood sugar.
After 11/2 years, the placebo group lost an average one-third of its
insulin production ability and needed 50 percent more insulin in shots
to regulate blood sugar. The group that got the drug, on the other hand,
lowered insulin dependence by 12 percent and increased insulin-making
capability. The drug worked best in patients who still had about half of
their insulin function remaining.
However, nearly all the people who took the drug had symptoms of
mononucleosis, a white-blood-cell disorder caused by a virus, and
flulike symptoms including fever and headache.
Researchers said the side effects were minor and short-lived. But Dr.
Ake Lernmark, a professor of medicine at the University of Washington,
Seattle, wrote in an accompanying editorial that more research is needed
to address the drug's safety.
Lernmark, who had no role in the study, also noted that the drug's
benefits might be limited in patients who already have greater insulin
function than typical Type 1 patients. Most Type 1 diabetics are
diagnosed when they have already lost 90 percent of their insulin-making
ability.
The federal government is currently supporting two studies of the drug
in Type 1 patients, said Dr. Judith Fradkin of the National Institute of
Diabetes and Digestive and Kidney Diseases.
Several of the researchers in the study reported getting consulting fees
and holding stocks options from TolerRx Inc., a Cambridge, Mass., firm
that developed the drug.
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