New Obesity Treatment Option For NHS Patients As It Emerges Public Want Doctors To Help Obese Patients Lose Weight, UK

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Primary Care / General Practice
Article Date: 02 Jul 2008 - 3:00 PDT

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The National Institute for Health and Clinical Excellence (NICE) has issued new guidance recommending use of Acomplia® (rimonabant) in England and Wales, within its licensed indications, as an adjunct to diet and exercise for adults who are obese or overweight and who have had an inadequate response to, are intolerant of or are contraindicated to other anti-obesity agents that have previously been reviewed by NICE.

With the growing problem of obesity requiring urgent action1 and few treatments currently available being suitable for all patients2, a further treatment alternative will be of considerable benefit to healthcare professionals.

In clinical trials in obese and overweight patients, many of whom had associated risk factors such as type 2 diabetes, Acomplia® was shown to help people to not only lose weight but also to improve their cardiovascular risk profile above and beyond that expected from weight loss alone. 3,4,5,6 Among patients with type 2 diabetes not currently treated with anti-diabetic medicines, those given Acomplia® experienced significant improvements in weight and blood sugar control as well as other risk factors such as HDL-cholesterol (good cholesterol) and triglycerides compared to those on placebo.7

The NICE guidance on Acomplia® comes as new national survey data released today shows that three quarters of Britons think GPs should help obese patients lose weight, if they are at risk of associated diseases and have already unsuccessfully tried diet and exercise.8 The survey of 1007 people, conducted by TNS on behalf of sanofi-aventis, also reveals that if people wanted to lose weight to improve their health they would be more likely to turn to their GP for practical help than to a slimming club, family, friends, websites, diet books and online groups.8

Obesity is a serious medical condition linked to the development of type 2 diabetes and heart disease.9 It is estimated that 47% of type 2 diabetes cases in England can be directly attributed to obesity9 and around 35,000 deaths each year are linked to diabetes.10 The cost to the NHS of treating heart disease attributable to obesity has been estimated at £261.7 million9 and cardiovascular disease is the country's biggest killer11 claiming 208,000 lives annually.12

Rates of obesity in England have more than trebled in the last two decades and the total socioeconomic cost of obesity and overweight and the conditions that it causes is estimated to be up to £7.4 billion per year.13 The recent government-sponsored Foresight report also revealed that if current trends continue by 2050 about 60% of men and 50% of women in the UK will be obese.14

Dr David Haslam, Clinical Director of the National Obesity Forum welcomed the new NICE guidance.

He said: "Obesity is a chronic disease that places a significant burden on society as well as an individual, so it is vital GPs have a full range of options to help treat obese and overweight patients especially those with associated risk factors such as type 2 diabetes. Trials show that Acomplia®, in addition to diet and physical activity, provides clinically meaningful weight loss and improvements in related risk factors, such as better blood sugar control. Today's new guidance from NICE is of real benefit to doctors trying to manage this growing group of patients. It is also clear from this new survey that people want GPs to be able to help people who have already unsuccessfully tried diet and exercise and whose weight is putting them at risk of disease. We therefore look forward to NHS trusts providing the funding within three months to implement this guidance, as they are obliged to do, so this treatment option can be made available for all patients who could benefit from it."

Nigel Brooksby, managing director of sanofi-aventis UK, said: "We are proud to have been able to bring this innovative first in-class treatment to the UK. We are delighted NICE has recognised the role Acomplia® can play in helping healthcare professionals manage obese and overweight patients. We now look forward to working in partnership with the NHS to support the implementation of this guidance."

Since January 2002, the NHS has been legally obliged to provide funding and resources in England and Wales for medicines and treatments recommended by NICE's technology appraisal guidance. This means that when NICE recommends a technology, the NHS must ensure it is available to those people it could help, normally within 3 months of the guidance being issued.15

The survey was conducted by market research agency TNS on behalf of sanofi-aventis. It involved a sample of 1007 GB adults aged 16-64, weighted to represent the adult population of Great Britain aged 16-64, and was conducted over the internet from 24th - 26th July 2007.

- 1007 people were asked how much they agreed or disagreed that GPs have a duty to help people lose weight if their obesity puts them at higher risk of associated diseases and if they have already unsuccessfully tried diet and exercise - 76 % agreed (31% agreed strongly, 45% agreed), 17% neither agreed nor disagreed, 5% disagreed, 2% disagreed strongly.

•-1007 people were asked if they wanted to lose weight to improve their health who or what would they turn to for practical help - 46% said they would turn to their GP, 34% to a slimming club, 32% to family, 30% friends, 27% websites, 26% diet books and 10% online groups 10% said "other", 9% said "none of the above".

About rimonabant (Acomplia ®)

ACOMPLIA® (rimonabant) is approved in the European Union as an adjunct to diet and exercise for the treatment of obese patients (BMI ≥ 30/m2) or overweight patients (BMI > 27kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1).1 ACOMPLIA® (rimonabant) is contraindicated in lactating patients or patients with hypersensitivity to the active substance or to any of the excipients, with ongoing major depressive illness and/or ongoing antidepressive treatment. In pivotal clinical trials lasting up to two years, rimonabant significantly reduced body weight and waist circumference, a measure of intra-abdominal fat. In addition rimonabant also improved glycemic control, 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). Rimonabant has been approved for prescribing in 56 countries.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY). http://www.sanofi-aventis.co.uk

Forward Looking Statements

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References

1. NICE Press Release 2006/057: New NICE guideline calls for urgent action to stem the rising tide of obesity in England and Wales

2. NICE's Appraisal consultation document on Rimonabant for the treatment of overweight and obese patients December 2007: Non manufacturer submissions; Association of British Clinical Diabetologists' Professional Organisation Statement. Available here.

3. Scheen AJ et al. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet 2006; 368: 1660-1672

4. Després J-P et al. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidaemia. NEJM. 2005; 353: 2121-2134

5. Pi-Sunyer FX 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

6. Acomplia® Summary of product characteristics

7. Rosenstock et al. HbA1c reductions plus weight loss and improved lipid profile with rimonabant in overweight/obese drug-naive type 2 diabetes: the SERENADE trial in patients with BMI >27 kg/m2 Diabetologia 2007; 50: [Suppl1]: 345

8. Data on file; NPR 08/1184

9. National Audit Office - Tackling Obesity In England: Available here [last accessed May 08]

10. British Heart Foundation website: Mortality from Diabetes: Available here [last accessed May 2008]

11. British Heart Foundation website: Mortality: Available here [last accessed May 2008]

12. British Heart Foundation website: Numbers dying from CHD and CVD. Available here [last accessed May 2008]

13. House of Commons - Health Committee. Report on Obesity 2004

14. Foresight Report. October 2007 Tackling Obesities: Future Choices - Modelling Future Trends in Obesity and the Impact on Health 2nd Edition. Available here [last accessed May 2008]

15. NICE website: Available here. [last accessed May 2008]

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