DUBLIN, Ireland, November 1 /PRNewswire/ -- Sanofi-aventis Ireland Ltd. announced today, that ACOMPLIA(R) (rimonabant20mg/day), is available from today, 1st November 2006.
ACOMPLIA(R) is the first in a new class of drugs that targetcardiometabolic risk factors such as abdominal obesity, insulin resistance,cholesterol and elevated triglycerides(i). It is licensed for use as anadjunct to diet and exercise for the treatment of obese patients (BMI greaterthan or equal to 30kg/m2), or overweight patients (BMI >27kg/m2) withassociated risk factors, such as type 2 diabetes or dyslipidaemia(1).
Ireland is the third country in the world to have launchedACOMPLIA(R) and the treatment has been welcomed by physicians across thecountry.
"Rimonabant (Acomplia) addresses the multiple cardiometabolicrisk factors that put patients at risk for cardiovascular disease and type 2diabetes" said Dr. Seamus Sreenan, Consultant Endocrinologist, ConnollyHospital, Blanchardstown, Dublin 15. He continued "ACOMPLIA(R) is animportant advancement which will offer benefits beyond current treatments forindividual risk factors such as blood pressure, cholesterol and diabetes andI applaud the foresight of early access to this valuable medicine forpatients in Ireland".
Obesity is typically measured by Body Mass Index (BMI - weightin kg divided by height in metres squared) but recent findings have shownthat abdominal obesity, commonly referred to as 'fat around the middle' is amuch better determinant of cardiometabolic risk i.e. the risk of developingcardiovascular disease and type 2 diabetes(2,3).
Recent results from the IDEA study (International Day for theEvaluation of Abdominal Obesity), a 63 country study including Ireland,confirmed that the Irish population are at high cardiometabolic risk with44.1% of Irish women and 32.0% of Irish men considered to have a high waistcircumference according to the NCEP ATP III Guidelines (>88cm /> 35 inchesfor a woman and >102 cm or >40 inches for a man).(4,5,6)
In fact, over a quarter of Irish men (25.9%) and a fifth ofIrish women (22.9%) can be classified as clinically obese (BMI greater thanor equal to 30 kg/m2)(4).
Dr. Sreenan stressed "Acomplia is an innovative medicine butit is not a lifestyle drug therapy and those likely to gain most benefit willbe patients presenting with a high waist circumference, who also havediabetes and/or dyslipidemia".
The approval of ACOMPLIA(R) was based on comprehensiveefficacy and safety data, including data from the RIO clinical trialprogramme which involved more than 6,600 patients worldwide, of which over 4,500 were studied for up to two years.
Results from the RIO programme demonstrated that oneACOMPLIA(R) 20 mg tablet taken every day significantly decreased weight andwaist circumference, HbA1c, and triglycerides and increased HDL-cholesterollevels - the 'good cholesterol. Importantly the license granted states thatan estimated 50% of the observed improvements in HbA1c, HDL-cholesterol andtriglycerides were beyond that expected from weight loss alone.(1)
Last week saw the Lancet published the RIO-Diabetes Study results, whichshowed that Rimonabant (Acomplia) significantly improved weight, blood sugarlevels and other cardiometabolic Risk Factors in People with Type 2Diabetes(12) .
i) More about Cardiometabolic Disease
Global cardiometabolic risk represents the overall risk ofdeveloping type 2 diabetes and/or cardiovascular disease and is due to acluster of modifiable risk factors. Cardiometabolic risk factors includeclassical risk factors such as high LDL-cholesterol levels, hypertension andhyperglycaemia and emerging risk factors closely related to abdominal obesity(especially intra-abdominal adiposity), such as insulin resistance, lowHDL-cholesterol, high triglyceride levels, and inflammatory markers such asadiponectin and CRP (C-reactive protein)(7).
More about ACOMPLIA(R)
ACOMPLIA(R) works by selectively blocking CB1 receptors foundin the brain and in peripheral organs important in glucose and lipid (or fat)metabolism, including adipose tissue, the liver, gastrointestinal tract andmuscle(8) . CB1 receptor blockade with ACOMPLIA(R) acts to decrease theoveractivity of the endocannabinoid system (EC system)(9,10) . The EC system isa recently characterised physiological system that includes receptors such asthe CB1 receptor, and it is believed to play an important role in regulatingbody weight and in controlling energy balance, as well as glucose and lipidmetabolism(11).
Safety and Tolerability
ACOMPLIA(R) 20mg has been evaluated for safety in over 6,300patients. In placebo controlled studies the discontinuation rate due toadverse reactions was 15.7% for patients receiving ACOMPLIA(R). The mostcommon adverse events resulting in discontinuation were nausea, moodalteration with depressive disorders, anxiety and dizziness.(1)
ACOMPLIA(R) should not be initiated in patients with hepaticor renal impairment or patients with uncontrolled serious psychiatricillnesses such as major depression1
About sanofi-aventis
Sanofi-aventis is the world's third largest pharmaceuticalcompany, ranking number one in Europe. Backed by a world-class R&Dorganisation, sanofi-aventis is developing leading positions in seven majortherapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases,central nervous system, internal medicine and vaccines. Sanofi-aventis islisted in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
1. Acomplia Summary of Product Characteristics
2. Yusuf S, Hawken S, Ôunpuu S, Dans T, Avezum A, Lanas F et al., Effectof potentially modifiable risk factors associated with myocardial infarctionin 52 countries (the INTERHEART study): case control study. The Lancet. 2004;364: 937-952.
3. Castro JP, El-Atat FA, McFarlane SI, Aneja A, Sowers JR.Cardiometabolic Syndrome: Pathophysiology And Treatment. Curr Hypertens Rep.2003; 5: 393-401.
4 Data on File. The IDEA study 2005
5. NCEP ATP III Guidelines
6. Haffner S on behalf of the IDEA Executive Committee. Waistcircumference and Body Mass Index are both independently associated withcardiovascular disease. The International Day for the Evaluation of AbdominalObesity (IDEA) survey. Abstract presentation at American College ofCardiology's 55th Annual Scientific Session. 2006. vol 47 (4 s uppl 1):358A,ABS 542-6 http://www.theheart.org/article/681953,doc
7. Results of Rio-Diabetes. Data on File
8.Pagotto U. Fighting obesity and associated risk factors by antagonisingcannabinoid type receptors. Lancet. 2005 Apr 16-22;365(9468):1363-64.
9. Van Gaal et al. Effects of the cannabinoid-1 receptor blockerrimonabant on weight reduction and cardiovascular risk factors in overweightpatients: 1-year experience from the RIO-Europe study.Lancet.2005Apr16-22;365(9468):1389-97.
10. Di Marzo V, et al. Leptin-regulated endocannabinoids are involved inmaintaining food intake. Nature. 2001;410:822-825.
11.Di Marzo V / Matias I. Endocannabinoid control of food intake andenergy balance. Nat Neurosci. 2005 May;8(5):585-9. Review
12. Scheen et al. Effect and tolerability of rimonabant in overweight orobese patients with type 2 diabetes : a randomised controlled study. ;www.thelancet.com
sanofi-aventis Ireland Ltd
For further information / to arrange an interview with Dr. Seamus Sreenan please contact: Rachel Mooney, Sanofi-aventis, Tel: +353(0)1-403-5643 / +353(0)87-205-1913, Email: rachel.mooney@sanofi-aventis.com
