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Data Show Xenical Improves Glucose And Lipid Levels In Diabetics
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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