Xenical Twice As Effective As
Diet Alone
May l9, 1997.
Xenical:
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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
