Paris, September 19, 2007
Contact: Ingrid Goerg-Armbrecht tel +33 6 86 05 66 88
Rimonabant effectively reduces
visceral fat in the obese patient
as confirmed by abdominal
computer tomography (CT) scan
The first direct evidence of the effects of Acomplia® (rimonabant) in significantly reducing human visceral fat
(the metabolically active fat wrapped around the body’s vital organs in the abdomen, such as liver, pancreas) is
being presented today at the 43rd Annual Meeting of the European Association for the Study of Diabetes
The visceral fat area was significantly more reduced with rimonabant 20mg (-40.6cm2) than with placebo
(-20.3cm2); (p< 0.0001).
Visceral fat is a cardio-metabolic risk factor in Japanese patients as it is in the global studies. Visceral fat
accumulation has been shown to correlate with a number of other cardio-metabolic risk factors, such as
dyslipidemia, insulin resistance, hyperinsulinaemia, glucose intolerance and type 2 diabetes.
526 obese Japanese patients (BMI equal or greater than 25 kg/m2) with associated cardio-metabolic risk
factors from 73 centres were exposed for this double-blind, placebo-controlled parallel-group 6-month study
duration, to determine the effective dose of rimonabant (5, 10 and 20mg) on body weight and multiple cardio-
metabolic risk factors. The inclusion criteria included at least 2 of the following cardiometobolic risk factors:
impaired glucose tolerance, type 2 diabetes, dyslipidemia (hypertriglyceridemia and/or low HDL-
cholesterolemia) or hypertension.
The primary endpoint was reduction in body weight. Important secondary endpoints included percentage of
patients responders on body weight, waist circumference, visceral fat area (VFA) assessed by CT scan, HDL-
cholesterol, and triglycerides. Rimonabant 20 mg demonstrated significant improvement on all these endpoints
from baseline to six months compared to the placebo arm.
Rimonabant 20mg demonstrated a favorable safety profile with a discontinuation rate from treatment due to
adverse events higher with placebo (7.6%) versus rimonabant 20 mg (4.5%). Overall more than 86 percent of
the patients completed treatment.
The rimonabant 20mg dose is being studied in 3 ongoing phase III clinical trials in Japan.
About intra-abdominal fat
Obesity is traditionally determined by an indirect measure, the BMI (body mass index). The BMI does not take
into account type and distribution of adipose tissue. Two types of adipose tissue exist in the human body,
characterised by anatomical and metabolic differences:
Subcutaneous fat, located directly under the skin contains small insulin-sensitive adipocytes (fat cells), while the
visceral fat (inter-abdominal adipose tissue), wrapped around the organs in the abdomen, contains large insulin-
The visceral fat is the metabolically more active fat. Excess visceral fat, present in patients with abdominal
obesity, leads to metabolic imbalance, such as lipid disorders, insulin resistance and type 2 diabetes, factors
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leading to cardio-metabolic disease. Waist circumference is used in daily practice to determine the presence of
abdominal obesity. To directly quantify the visceral fat one applies an imaging technique, the computer
tomography. This method was integrated in the trial presented today, to study the direct effect of rimonabant on
this dangerous body fat.
Acomplia® (rimonabant) is approved in 42 countries. In the European Union, Acomplia® (rimonabant) is
approved for the treatment of obese patients (BMI equal to or greater than 30kg/m2), or those overweight (BMI
greater than 27 kg/m2) with associated risk factors such as Type 2 diabetes or dyslipidemia, in conjunction with
diet and physical exercise (see section 5.1).
In pivotal clinical trials lasting up to two years, rimonabant significantly reduced body weight and waist
circumference, a measure of intra-abdominal fat. Rimonabant also improved blood glucose levels, HDL,
triglycerides (fats in the blood), and insulin sensitivity.
The most common adverse events associated with rimonabant were consistent across studies and included
gastrointestinal (nausea, vomiting, diarrhea), nervous system (headache, dizziness, paresthesia/
hypoesthesia/dysesthesia) and psychiatric disorders (anxiety, insomnia, depressed mood and depression).
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medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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