DUBLIN, Ireland, June 19, 1997
Results from the first large clinical studies of Xenical (generic
name is orlistat), the
first of a new class of non-systemic anti-obesity medications
demonstrate that the
drug is significantly more effective in weight reduction than
diet alone.
The studies, which were presented today at the 8th European
Congress on
Obesity (ECO), in Dublin, are one and two year efficacy studies
comparing the
use of Xenical 120mg tid, taken with a mildly reduced calorie
diet containing
approximately 30 percent of calories from fat, against placebo
with the same diet.
Results show that three out of four patients taking Xenical
reach a medically
meaningful weight loss. This was twice the loss seen in patients
taking placebo.
According to lead investigator, Professor Stephan Rossner from
the Karolinska
Hospital, Stockholm, "The average patient in the studies
weighed 220 lbs and lost
20 lbs, or about 10 percent of body weight.''
Importantly, he said, most patients managed to maintain their
new weight. Xenical
significantly prevents the regain of the weight lost -- weight
regain being the most
common problem associated with weight loss.
"It may not seem like much, but a five to ten percent
reduction in weight does
significantly reduce the occurrence and severity of obesity related
conditions,
such as hypertension, diabetes and heart disease,'' said Dr. Paul
Whitsitt, an
Oshawa, Ontario, family physician in attendance at ECO. "Therefore,
the focus
should not be on achieving 'ideal' weight, but what weight reduction
is necessary
to make one healthy. Xenical in combination with dietary management
appears to
be a novel approach to achieving these goals.''
In addition, Xenical-treated patients had statistically significant
reductions in
some of the important risk factors that make obesity such a life-threatening
disease. These included significant reductions in total and LDL
cholesterol,
systolic and diastolic blood pressure, and showed improvements
in blood
concentrations of glucose and insulin.
Xenical acts by blocking the action of lipases which normally
break down fat
enabling fat to be absorbed through the intestinal wall. Excess
fat in the diet is a
major cause of obesity. Xenical does not work on the brain to
suppress appetite,
and does not enter the blood stream. In the clinical studies,
Xenical was well
tolerated, and was not associated with any serious medical side
effects.
Xenical has recently been recommended for approval by the U.S.
Food and Drug
Administration's Endocrinology and Metabolic Drugs Advisory Committee
for
long term treatment of obese people (BMI more than 30kg/m2) and
in those with
BMI more than 27kg/m2 who have risk factors. It is currently being
reviewed by the
Health Protection Branch of Health Canada.
Xenical is the product of research by F. Hoffmann-La Roche
Ltd. in Basel,
Switzerland.
Roche Canada is a Mississauga-based pharmaceutical company
with over 500
employees across the country. The company is dedicated to the
research and
development of innovative medicines to help treat human illness.
It is also heavily
involved in the vitamins, fine chemicals and diagnostic equipment
areas.
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