Hoffmann-La Roche Inc. announced
today that it has submitted a supplemental application to the U.S. Food and
Drug Administration (FDA) for a new indication for its prescription weight
loss medication Xenical® (orlistat) to improve glycemic control when used as
an adjunct to other antidiabetic treatments in overweight or obese patients
with type 2 diabetes.
Xenical, the only non-systemically acting prescription weight loss drug,
is a gastrointestinal lipase inhibitor which prevents one-third of dietary fat
from being absorbed. It received FDA approval in April 1999 for weight loss
and weight maintenance when used in conjunction with a reduced-calorie diet.
If the new indication is approved, Xenical will be the only weight loss drug
indicated for the treatment of type 2 diabetes.
The application for improved glycemic control in type 2 diabetics is
supported by clinical trial data showing that patients treated with Xenical
plus a mildly-reduced calorie diet lost more weight than those patients
treated with placebo plus diet, and also had significantly greater and
sustained decreases in glycosylated hemoglobin (HbA1c) and fasting plasma
glucose (FPG). Decreases in FPG were observed as early as after two weeks of
treatment. In addition, patients with type 2 diabetes treated with Xenical
were able to reduce their daily doses of other antidiabetic medications, such
as sulfonylureas, insulin, and metformin.
"In controlled clinical trials, patients treated with Xenical experienced
significant improvements in a number of cardiovascular risk factors such as
total cholesterol, LDL cholesterol, LDL/HDL ratio and blood pressure in
addition to their improvements in glycemic control and weight loss. It is
clear that the benefits of Xenical extend beyond just weight loss," said
Dr. Henry Solomon, medical director, Roche Pharmaceuticals. "The clinical
trial data are exciting because they show that overweight patients with type 2
diabetes can improve their overall health, reduce their daily dose of diabetes
medication, and control their symptoms with the addition of Xenical to their
diabetes treatment regimen."
The new application is supported by findings from seven large multicenter,
randomized, placebo-controlled trials involving 2,600 patients with type 2
diabetes. Four of the studies were one year in duration.
The clinical studies with Xenical in diabetes have shown:
- -- Xenical patients had clinically significant improvements in blood sugar
- -- More patients treated with Xenical were able to reduce the dose of, or
even discontinue their anti-diabetic medications
- -- Overweight and obese patients with type 2 diabetes taking Xenical lost
up to three times more weight than those on diet alone.
- -- Additional data have also shown that Xenical can improve certain risk
factors for cardiovascular disease, such as total cholesterol levels
and blood pressure in diabetic patients.
Type 2 diabetes can lead to a host of severe complications, including
heart disease, stroke, high blood pressure, blindness, kidney disease, nervous
system damage, and amputation. Obesity is a primary risk factor for type 2
A recent study conducted by the Centers for Disease Control and Prevention
(CDC) found that the incidence of type 2 diabetes among adults has increased
rapidly throughout the 1990's across all regions and demographic groups. In
addition, the prevalence of being severely overweight has increased 57 percent
in the last decade, suggesting that further increases in the prevalence of
type 2 diabetes can be expected.
Xenical is the only non-systemically acting prescription lipase inhibitor
for weight loss, maintenance of lost weight, and the reduction of risk of
weight regain after prior weight loss, when used with a reduced-calorie diet.
Weight loss with Xenical has also resulted in improvements in many
cardiovascular risk factors such as high blood pressure, high cholesterol, and
diabetes, compared to diet alone. The long-term benefits of Xenical on
weight-related illnesses and life expectancy have not been studied.
Xenical is unlike other weight loss medications because it is not an
appetite suppressant. It is the most extensively studied pharmacological
weight management treatment to date with more than 30,000 overweight or obese
patients participating in clinical trials with Xenical.
Xenical patients are eligible to participate in XeniCare, a comprehensive
weight-loss support program. Those participating in the program receive
personal telephone counseling from a registered nurse or dietitian specially
trained to provide weight-loss support. In addition, patients may receive
ongoing information and resources designed to maximize their success.
Since Xenical prevents about one-third of the fat in the food consumed
from being absorbed, patients may experience gas with oily discharge,
increased bowel movements, an urgent need to have them and an inability to
control them, particularly after meals containing more fat than recommended.
In clinical trials, these effects appear to occur less often among Xenical
patients with type 2 diabetes.
Xenical should not be taken if patients are pregnant, nursing, have food
absorption problems or reduced bile flow. If taking cyclosporine, patients
should speak to their doctors before taking Xenical. Xenical reduces the
absorption of some vitamins. Therefore, a daily multivitamin is recommended.