alli Proven to Reduce Visceral Fat, a Dangerous Fat Linked to Many Life-Threatening Diseases, According to New Data Released Today

HONG KONG, Jan. 27 /PRNewswire/ -- New studies show that overweight and obese people using alli® (orlistat 60 mg) with a reduced calorie, lower-fat diet can significantly reduce weight, visceral fat, and waist circumference and therefore may reduce their risk of type 2 diabetes, hypertension, heart disease and stroke(1,2). The studies were presented at the 1st International Congress on Abdominal Obesity in Hong Kong earlier today.

To view the multimedia assets associated with this release, please click:  http://multivu.prnewswire.com/mnr/alli/41873/

alli is the only FDA-approved OTC weight loss aid that is clinically proven to boost weight loss by 50 percent and significantly reduce excess visceral fat(3). Working in the digestive tract, alli prevents about 25 percent of the fat that a person eats from being absorbed(3).

Visceral fat is a dangerous type of fat that surrounds the vital organs in the abdomen and when present in excess disrupts the normal functioning of organs, increasing the risk of life-threatening diseases(4-12). Even modest weight loss can result in significant reductions in visceral fat and substantially improve health(14-17). In fact, when losing weight, visceral fat is among the first fat lost, which is associated with noticeable health benefits such as reductions in total cholesterol and low-density lipoprotein (LDL)(21). This helps reduce the risk of type 2 diabetes, hypertension, heart disease and stroke(4-9). It is these health complications that have a high personal and societal toll and impact in the global obesity epidemic.  

"Although most individuals try to lose weight to improve their appearance, it's important to help them understand that losing excess fat reduces their risks of life-threatening diseases," said Jeanine Albu, M.D., Senior Attending in Medicine, Associate Chief of the Division of Endocrinology, Diabetes and Nutrition and the Chief of the Metabolism and Diabetes Clinic at the St. Luke's-Roosevelt Hospital Center in New York.  

"We need to raise awareness of the direct link between visceral fat on the inside and heart disease and diabetes," said Dr. Albu. "Through healthy eating, keeping active and treatments such as alli, people can lose 5 to 10 percent of total body weight -- including visceral fat -- and achieve and maintain their healthy weight."

In two of the studies presented at the congress, alli was evaluated to determine its effect on excess visceral fat. This new body of evidence proves that alli significantly reduces weight and dangerous visceral fat to help people improve their health(1,2).

The Visceral Fat Imaging Study

The three-month Visceral Fat Imaging Study demonstrated that alli reduced total body weight by 5.6 percent and visceral fat by 10.6 percent versus amounts at the start of the study in overweight and obese adults on a reduced calorie, lower-fat diet (P<0.0225)(1). Carried out at Europe's largest imaging center, the Clinical Imaging Centre in Hammersmith Hospital, UK, the study used MRI technology that showed changes taking place inside people's bodies as they lost weight in a unique way.

Twenty-six study participants were counseled to follow a reduced calorie, lower-fat diet, and then took alli three times per day for 12 weeks. Results also showed that at week 12 alli significantly reduced waist circumference (the measurement around the waistline), the best practical way to assess visceral fat, by 5 cm (2 inches)(1,18-20).

The Visceral Fat Multi-Center Study

In the six-month Visceral Fat Multi-Center Study, overweight and obese adults receiving alli while on a reduced calorie, lower-fat diet had significantly greater improvements in visceral fat than those treated with diet alone(2).

In this study, 123 participants were randomly assigned to receive either alli three times per day or a placebo, along with recommendations to follow a reduced calorie, lower-fat diet, for 24 weeks. At week 24, statistically significant reductions in visceral fat and body weight were observed in both groups; however, the reduction was significantly higher among patients taking alli. Mean reductions in visceral fat were 15.66 percent for alli versus 9.39 percent for placebo (P<0.0001); mean reductions in body weight were 5.96 kg versus 3.91 kg, respectively (P<0.05)(2).

Overweight and obese people enrolled in the Visceral Fat Imaging Study and Visceral Fat Multi-Center Study had a body mass index (BMI) of 25-35 kg/m2, with a waist circumference greater than 88 cm (34.64 inches) for women or 102 cm (40.16 inches) for men at the start of the studies(1,2). Use of alli in both studies was shown to be generally well tolerated and consistent with the known safety profile(1,2).

alli is marketed by GlaxoSmithKline Consumer Healthcare for use by overweight adults along with a reduced calorie, lower-fat diet. People interested in losing weight can access interactive tools, lower-fat recipes, physical activity tips and other useful information for leading a healthy life at www.myalli.com.

*Note to editors

For European interest, since overweight and obese is defined as BMI greater than or equal to 28 kg/m2, post-hoc analysis for BMI greater than or equal to 28 kg/m2 also found reductions in body weight and waist circumference (N=22, P<0.0001 for both) and VAT (N=19, P=0.0336)(2).

About alli®

alli is the only FDA-approved weight-loss product available to overweight adults, 18 years or older, without a prescription. alli is a clinically-proven product used with a comprehensive individualized action plan. People who use alli can lose 50 percent more weight than diet alone. The alli program encourages gradual weight loss, known by experts as the best way to lose weight. alli (60 mg orlistat capsules) is safe and effective when used as directed.

The alli plan was developed by nutritional and weight management experts who understand the struggle to lose weight. The alli program, which includes a healthy, balanced diet, regular physical activity and alli capsules available in 60-capsule and 90-capsule educational starter packs. alli works by blocking about 25 percent of fat in the foods eaten to reduce the amount of fat and calories absorbed. alli is non-systemic and well-tolerated.

www.myalli.com

About GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. Its more than 30 well-known brands include the leading smoking cessation products, Nicorette®, NicoDerm® CQ and Commit® as well as many medicine cabinet staples, including Aquafresh®, Sensodyne®, Tums® and Breathe Right®.

About GlaxoSmithKline

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.

References:

1. Beaver J, Bell JD, Thomas EL et al. Orlistat 60 mg in conjunction with diet provides significant reduction in visceral adipose tissue. Poster presented at: 1st International Congress on Abdominal Obesity, 2009, Hong Kong.
2. Greenway F, Smith SR, Murray K et al. Orlistat 60 mg demonstrates a significant reduction in visceral adipose tissue at 24 weeks compared with placebo. Poster presented at: 1st International Congress on Abdominal Obesity, 2009, Hong Kong.
3. alli Product Label. GlaxoSmithKline Consumer Health.
4. Wang Y et al. Comparison of abdominal adiposity and overall obesity in predicting risk of type 2 diabetes among men. Am J Clin Nutr. 2005, 81: 555-63.
5. Chan J et al. Obesity, fat distribution, and weight gain as risk factors for clinical diabetes in men. Diabetes Care 1994;17(9): 961-969.
6. Larsson B et al. Abdominal adipose tissue distribution, obesity, and risk of cardiovascular disease and death: 13 year follow-up of participants in the study of men born in 1913. Br Med J. 1984; 288: 1401-4.
7. Sironi AM et al. Visceral Fat in Hypertension: Influence on Insulin Resistance and ß-Cell function. Hypertension 2004 ;44;127–133.
8. Lapidus L et al. Distribution of adipose tissue and risk of cardiovascular disease and death: a 12-year follow-up of participants in the population study of women In Gothenburg, Sweden. Br Med J. 1984; 289: 1257-61.
9. Yusuf S et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet 2004, 364: 937-952.
10. Pouliot MC et al. Visceral obesity in men. Associations with glucose tolerance, plasma insulin, and lipoprotein levels. Diabetes 1992, 41: 826-34.
11. Lean ME. Impairment of health and quality of life in people with large waist circumference. Lancet 1998; 351(9106): 853-6.
12. Mathieu  P et al. Visceral Obesity: The Link Among Inflammation, Hypertension, and Cardiovascular Disease. Hypertension 2009; 53:577-584.
13. Purnell J et al. Effect of Weight Loss with Reduction of Intra-Abdominal Fat on Lipid Metabolism in Older Men. J Clin Endocrinol Metab. 2000; 85: 977–82.
14. Rice B et al. Effects of Aerobic or Resistance Exercise and/or Diet on Glucose Tolerance and Plasma Insulin Levels in Obese Men. Diabetes Care 1999; 22(5): 684-91.
15. Goodpaster B et al. Effects of weight loss on regional fat distribution and insulin sensitivity in obesity. Diabetes 1999; 48: 839-47.
16. Ross R et al. Reduction in Obesity and Related Comorbid Conditions after Diet-Induced Weight Loss or Exercise-Induced Weight Loss in Men A  Randomized, Controlled Trial. Ann Intern Med. 2000; 133: 92-103.
17. Ross A et al. Exercise-Induced Reduction in Obesity and Insulin Resistance in Women: a Randomized Controlled Trial. Obesity Research 2004;12: 789–798.
18. Lean ME, et al. Waist circumference as a measure for indicating need for weight management. British Med J. 1995;311:158-61.
19. Pouliot MC, et al. Waist circumference and abdominal sagittal diameter: best simple anthropometric indexes of abdominal visceral adipose tissue accumulation and related cardiovascular risk in men and women. Am J Cardiol. 1994;73(7):460-8.
20. NHLBI Obesity Education Initiative. The Practical Guide Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. http://www.nhlbi.nih.gov/guidelines/obesity/prctgd_c.pdf. Accessed 02/11/2009.
21. Weight Control Information Network. Statistics Related to Overweight and Obesity. http://www.win.niddk.nih.gov/statistics/index.htm. Accessed 01/08/2010.

SOURCE GlaxoSmithKline Consumer Healthcare