Download Rimonabant, a novel drug for the treatment of

Rimonabant, a novel drug for the treatment of cardiometabolic
risk factors in patients with obesity or overweight with diabetes
type 2 and/or dyslipidemia, have been approved in Argentina
Both obese and overweighted persons with associated diabetes and/or
dyslipidemia will be able to receive it as a supplement to diet and physical activity.
Clinical studies with more than 6,600 patients have shown its safety and efficacy.
Buenos Aires, October 24th, 2006.- Sanofi-aventis communicated that the
National Drug, Food and Medical Technology Administration (ANMAT) approved
rimonabant (Acomplia®) marketing, the first of a new class of drugs known as
“CB1 antagonists”. This drug is indicated for the treatment of obese (BMI* ≥ 30
kg/m2) or overweighted (BMI* ≥ 27 kg/m2) patients with associated cardiometabolic risk factors (type 2 diabetes and/or dyslipidemia), as a supplement to
diet and physical activity.
More than 6,600 patients were included in the RIO (Rimonabant In Obesity)
clinical trials (5000 treated with rimonabant and 1600 with placebo).
Clinical studies in patients with overweight or obesity, many of whom also had
other cardiometabolic risk factors, as type 2 diabetes, low HDL cholesterol
(“good” cholesterol), or increased triglycerides, shown that those receiving
rimonabant 20 mg achieved a significant weight reduction as compared with
those treated with placebo 1,2,3,4; this effect was sustained for 2 years 3.
Waist circumference was also significantly reduced in patients treated with
rimonabant 20 mg as compared with placebo, in addition to improvement in
HbA1c (a measurement of diabetes control) 1, HDL cholesterol and triglycerides
1,2,3,4
. It is worth mentioning that about half of the observed improvement in HbA1c,
HDL cholesterol and triglycerides in patients receiving rimonabant exceeded that
expected for weight loss only. 5
Side effects reported with rimonabant were usually mild and transient and were
mainly observed during the first year. The most common side effects resulting in
discontinuation were: nausea, mood changes, anxiety and vertigo. 3
Cardiometabolic risk represents the probability of developing type 2 diabetes
and/or cardiovascular diseases. The most important risk factors, in addition to
abdominal obesity, are high LDL cholesterol or “bad” cholesterol, hypertension,
hyperglycemia, insulin resistance, low HDL cholesterol, increased triglycerides,
and increased inflammatory markers as adiponectin and RCP (reactive C
protein).
Rimonabant is the first CB1 antagonist in its class, discovered and developed by
sanofi-aventis.
This kind of therapies always requires a change in life style, based on a healthy diet
and an increase in physical activity.
AR RIM 061003
Increased waist circumference increases the risk of developing coronary
artery disease
Not all fats are the same. The critical factor is the body region where their excess
is accumulated. For instance, patients with a higher waist circumference have a
higher risk of suffering coronary artery disease 8. Scientists have discovered that
abdominal obesity causes a great number of substances that negatively affect
blood glucose, blood lipids and blood pressure.
In order to identify patients at risk easily, waist circumference should be regularly
measured. With more than 88 cm in females and 102 cm in males, the risk of type
2 diabetes or cardiovascular diseases increases. 6,7
Specialist’s opinions:
Dr. Mónica Katz
•
Specialist in Nutrition and Director of the Master in Nutrition, Favaloro
University
“This drug decreases weight, reduces waist circumference and increases
adiponectin, a protective substance. The benefit was sustained after two years of
follow-up”.
“Current greatest challenge is to attempt a comprehensive approach of
cardiometabolic risk. The central point is intraabdominal or visceral fat, which has
demonstrated to be a true endocrine organ producing substances that increase
risk. This fat easily measured by means of the waist circumference, a marker that
makes risk tangible”.
“The fact that one every four persons have abdominal obesity causes concern.
Those with abdominal obesity and other clinical forms of cardiometabolic risk
factors (insulin-resistance, dislipidemia, type 2 diabetes or metabolic syndrome)
will obtain the maximum benefit from this drug”.
About ACOMPLIA®
ACOMPLIA® works by selectively blocking CB1 receptors found in the brain and in
peripheral organs important in glucose and lipid (or fat) metabolism, including
adipose tissue, the liver, gastrointestinal tract and muscle. CB1 receptor blockade
with ACOMPLIA® acts to decrease the overactivity of the endocannabinoid
system (EC system).The EC system is a recently characterised physiological
system that includes receptors such as the CB1 receptor, and it is believed to play
an important role in regulating body weight and in controlling energy balance, as
well as glucose and lipid metabolism.
About sanofi-aventis
Sanofi-aventis is the world’s third largest pharmaceutical company, ranking
number one in Europe. Backed by a world-class R&D organisation, sanofi-aventis is
developing leading positions in seven major therapeutic areas: cardiovascular,
thrombosis, oncology, metabolic diseases, central nervous system, internal medicine
and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY).
AR RIM 061003
References
* BMI: body mass index.
1. Scheen et al Rimonbant in patient with type 2 diabetes: results from RIO-diabetes,
presented at ADA 2005
2. Deprés J-P et al. Effects of rimonabant on metabolic risk factors in overweight
patients with dyslipidaemia. NEJM 2005; 353: 2121-2134
3. Pi-Sunyer X et al. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight
and cardiometabolic risk factors in overweight or obese patients. RIO-North America:
A randomised controlled trial. JAMA 2006; 295:761-775.
4. Van Gaal L et al. Effects of the cannabinoid – 1 – receptor blocker rimonabant on
weight reduction and cardiovascular risk factors in overweight patients: 1-year
experience from the RIO – Europe study. Lancet 2005; 365: 1389 – 1397.
5. Información para prescripción aprobada por disposición n° 5524 (21 Sept. 2006)
6. NHANES 1999 – 2000. The epidemiology of abdominal obesity and of associated comorbidities. Available at: http://www.cdc.gov.nchs/nhanes. Data downloaded
September 2004 using SAS software (data on file)
7. Sharma AM. Adipose tissue: a mediator of cardiovascular risk. International Journal of
Obesity (2002) 26, Suppl. 4, S4-S7
8. Hans-Ulrich Wittchen et al. International day for the Evaluation of Abdominal obesity:
rationale and design of a primary care study on the prevalence of abdominal obesity
and associated factors in 63 countries. European Heart Journal Supplements (2006)
8 (Supplement B), B26-B33.
ACOMPLIA®: for further information see the attached Press Pack
Press contact:
Sanofi-aventis
Dr. Cristian Von Schulz - Hausmann
Tel. (011) 4732-5000 Int. 5366
[email protected]
AR RIM 061003