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CANCUN, MEXICO November 11, 1997
Clinical data presented today at the North American Association
for the Study of
Obesity (NAASO) Annual Meeting show that Hoffman-La Roche’s
Xenical®
(orlistat) may be effective for the long-term management of obesity.
Researchers presented results from several abstracts on Xenical,
which is being
investigated to promote weight loss, weight maintenance and reduction
in the risk
of weight regain and to improve obesity-related disease factors
when compared
to diet alone.
Approximately 58 million, or one-third of American adults are
overweight or
obese. Among adults, the incidence of obesity has increased from
25 to 32
percent in the last 10 years. Obesity is second only to smoking
as a cause of
preventable death in the US, and is a major contributing factor
to serious medical
conditions such as diabetes, hypertension and other cardiovascular
diseases.
Xenical is the first of a new class of non-systemic anti-obesity
drugs called lipase
inhibitors which act in the gastrointestinal tract to prevent
the absorption of fat by
about 30 percent. Drugs in this class do not achieve their effect
through brain
chemistry. Roche originally submitted a New Drug Application (NDA)
for Xenical
in 1996. An FDA Advisory Committee unanimously recommended approval
of
Xenical on May 14, 1997. Roche later withdrew its original NDA
to conduct further
analyses of data at the request of the FDA. Hoffmann-La Roche
expects to
resubmit the NDA for Xenical within a few days.
In a poster presentation, John Foreyt, PhD, Baylor College
of Medicine reported
that after one year, patients taking Xenical 120 mg in conjunction
with a mildly
hypocaloric diet lost significantly more weight than those taking
placebo in
conjunction with a similar diet (57 percent of patients treated
with Xenical lost
more than five percent of their initial weight vs. 34 percent
of patients taking
placebo).
During the second year, significantly less weight was regained
in those patients
who continued taking Xenical than in patients who switched to
placebo (35
percent vs. 63 percent regain of lost weight). Xenical also reduced
total
cholesterol and LDL cholesterol levels, as well as mean systolic
and diastolic
blood pressure, compared to diet alone.
The clinical trial showed that Xenical was well-tolerated.
The most common side
effects reported were non-systemic and primarily gastrointestinal.
These effects
generally occurred early in treatment and were self-limited and
of short duration in
most cases.
In a poster presented by James Anderson, MD, chief of the endocrine-metabolic
section at the VA Medical Center, Lexington, KY, 729 obese patients
who had
lost more than eight percent of their initial body weight after
24 weeks on a
hypocaloric diet, were randomized to receive Xenical 120 mg tid,
60 mg tid, 30
mg tid or placebo in conjunction with a diet designed to help
prevent weight
regain rather than promote weight loss.
After one year of treatment the amount of weight regain was
significantly less in
the Xenical 120 mg group than in the placebo (32 percent regain
vs. 56 percent
with placebo). Furthermore, patients taking Xenical 120 mg experienced
significant reductions in total cholesterol and LDL-cholesterol
levels compared to
diet alone.
The clinical trial showed that Xenical was well-tolerated.
The most common side
effects reported were non-systemic and primarily gastrointestinal.
These effects
generally occurred early in treatment and were self-limited and
of short duration in
most cases.
A one-year study of weight loss and glycemic control in type
2 diabetics following
orlistat (xenical) treatment, was presented by David Kelley, MD,
associate
director of the metabolism and body composition research core
at the University
of Pittsburgh Obesity and Nutrition Research Center. This study
examined the
efficacy of Xenical in patients with Type 2 diabetes taking sulfonylureas
(medications used to control glucose levels) -- a patient group
in which it is
typically difficult to achieve sustained weight loss.
Results show that patients taking Xenical lost significantly
more weight than in
those treated with placebo. After one year of treatment, HbA1c
levels decreased
in the Xenical group but increased in the placebo group. Sulfonylurea
doses were
reduced 23 percent in the Xenical group versus nine percent in
placebo. In
addition, more than twice as many Xenical patients lost greater
than five percent
of initial body weight (49 percent on Xenical versus 23 percent
on placebo).
Patients treated with Xenical also showed a significant decrease
in total
cholesterol and LDL cholesterol compared to diet alone. The clinical
trial showed
that Xenical was well-tolerated. The most common side effects
reported were
non-systemic and primarily gastrointestinal. These effects generally
occurred
early in treatment and were self-limited and of short duration
in most cases.
The impact of Xenical treatment on quality of life was examined
in research
presented by Susan Mathias, MPH, senior analyst at the Technology
Assessment
Research Group. Results of this study show patients taking Xenical
120mg tid for
up to two years reported a greater decline in overweight distress,
more
satisfaction with treatment and slightly improved depression than
patients
receiving placebo. Data was obtained through a new health-related
quality of life
(HRQoL) measure and an obesity-specific health state preference
assessment.
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