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DALLAS, TX
August 3, 1998
Anti-obesity drug therapy with Hoffmann-La Roche’s Xenical
(orlistat) prevents the
progression of Type II diabetes in obese patients with elevated
glucose levels and
can potentially eliminate the need for sulfonylurea (hypoglycemic)
therapy,
according to a new study published in the current issue of Diabetes
Care.
The study showed that in addition to achieving clinically meaningful
weight loss
and maintenance of weight loss, patients taking orlistat also
showed improved
LDL/HDL ratios and total cholesterol and triglyceride levels for
up to one year.
Furthermore, almost half of orlistat treated patients were able
to decrease their
average dose of oral sulfonylurea medication compared with less
than a third of
placebo-treated patients.
"This study is significant because it shows that Xenical
not only promotes weight
loss but also improves glycemic control and lowers sulfonylurea
dose
requirements in patients with type II diabetes," said Priscilla
Hollander, M.D.,
Ph.D., medical director, Baylor-Ruth Collins Diabetes Center,
at Baylor University
Medical Center in Dallas, the study's lead investigator. "Xenical
also
demonstrates a beneficial effect on lipids independent of what
we would expect
from weight loss alone. This may be related to Xenical's mechanism
of action,
which reduces the absorption of dietary fat."
Xenical represents an entirely new class of drugs called lipase
inhibitors that act
locally in the gastrointestinal tract to prevent the absorption
of a portion of dietary
fat. This randomised, placebo-controlled, multi-centre trial was
conducted at 12
prominent research centres in the U.S. A total of 391 obese men
and women with
type II diabetes being treated with oral sulfonylureas were given
120 mg of orlistat
or placebo three times a day and followed a mildly hypocaloric
diet for one year.
Results indicate that more than twice as many patients in the
Xenical group lost
five percent of initial body weight as compared to patients in
the placebo group.
Furthermore, compared to placebo plus diet modification, patients
receiving
orlistat in conjunction with diet modification showed significant
improvements in
glycemic control and were able to decrease their dosage of oral
sulfonylurea
medication. Xenical treatment also resulted in significantly greater
improvements
than placebo in several lipid parameters.
"While weight loss is almost always recommended as first
line therapy for Type II
diabetes, it is very difficult to achieve and maintain weight
loss in patients on
sulfonylurea medications since these therapies tend to promote
weight gain," Dr.
Hollander said. "Unfortunately, current approaches to weight
loss have been
ineffective in promoting long-term weight loss and improving glycemic
control.
Orlistat is the first pharmacotherapy to be studied in a long-term,
large-scale study
in obese patients with Type II diabetes and it shows great promise
for this patient
population."
The study's authors' point out that while a number of other
pharmacologic agents
have been used in obese patients to promote weight loss, most
of these drugs
act on the central nervous system to suppress appetite. As a result,
in patients
with Type II diabetes, the use of these drugs is strictly regulated.
Obese individuals have a three times greater risk of developing
Type II diabetes
and, of the estimated 15 million Americans who have the disease,
up to 80
percent are overweight or obese. Left untreated in patients with
Type II diabetes,
obesity can lead to many serious and potentially life-threatening
conditions
including heart disease, stroke, kidney failure, impotence, blindness
and nerve
damage.
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