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University of Kentucky Doctor Presents Findings Regarding New Weight-Loss Medication

PHILADELPHIA, PA -- October 19, 2005 -- A 60 mg low-dose version of the prescription weight-loss medication orlistat (marketed by GlaxoSmithKline as Xenical(R) (120 mg) was found to be safe, effective and tolerable in overweight individuals, according to new data presented today at the 2005 Annual Meeting of NAASO, The Obesity Society in Vancouver, British Columbia.

The study, which compared orlistat 60 mg plus diet to placebo plus diet in patients with a body mass index (BMI) of 25 to 28, demonstrates a statistically significant difference in weight loss. Orlistat patients who completed the four-month treatment period lost 5% of their baseline weight and diet alone lost 3.3%.

The randomized, placebo-controlled, 16-week study was conducted in a primary care setting, offered minimal intervention and was largely self-instructional. Approximately 36% of orlistat users and 28% of the placebo group (who used diet modifications alone) lost more than five% of their initial body weight. Approximately 57% of orlistat users, compared to 42% of the placebo group, lost more than 3% of their initial body weight.

Orlistat patients also demonstrated significant decreases in total cholesterol, LDL cholesterol, systolic and diastolic blood pressure. Safety and tolerability of 60 mg orlistat in this population was similar to that observed in previous studies in a more overweight population.

"Prescription orlistat has been used successfully for years to help obese individuals lose weight and improve their health, so it's exciting to find that a lower dose of orlistat can help those who are overweight with their weight loss efforts," said lead investigator Dr. James Anderson, Professor of Medicine and Clinical Nutrition at the University of Kentucky. "The number of overweight individuals in this country continues to increase each year, and the risk of these folks progressing to obesity - and the resulting more serious medical problems - is significant."

About Orlistat
Prescription orlistat is marketed by GlaxoSmithKline (GSK) as Xenical(R). It is supported by more than 100 clinical studies conducted in more than 30 countries, including a four-year study, the longest study ever of a weight-loss drug. More than 21 million people in 145 countries have used orlistat safely, and it is available without a prescription in several countries.

Xenical(R) (orlistat 120 mg) is non-systemic, and works in the gut by inhibiting the absorption of dietary fat. Non-absorbed fat can lead to some changes in bowel habits. These changes are minimal if the dietary recommendations are followed and generally occur in the first weeks of treatment; however, for some people they may continue for 6 months or longer while on Xenical(R). Patients considering taking Xenical(R) should tell their doctor if they are pregnant, nursing, taking cyclosporine, have food absorption problems or reduced bile flow. A daily multivitamin is recommended because Xenical(R) can reduce the absorption of fat-soluble vitamins.

Currently available in 120 mg dose capsules via prescription, GlaxoSmithKline Consumer Healthcare has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval to market orlistat at the lower 60 mg dose over-the-counter as a weight loss aid.

About Overweight
Currently 65%, or approximately 130 million, U.S. adults are overweight or obese.^{[[i] U.S. Department of Health and Human Services "Statistics Related to Overweight and Obesity."}

http://win.niddk.nih.gov/statistics#preval. Accessed 6.17.05^[i] Overweight is defined as having a body mass index (BMI) ranging from 25.0 to 29.9, and obesity is the diagnosis in individuals with a BMI greater than or equal to 30. Body mass index can be used to screen for both overweight and obesity in adults and is a non-gender specific calculation based on height and weight.^[ii]. Centers for Disease Control and Prevention. "Body Mass Index." http://www.cdc.gov/nccdphp/dnpa/bmi/bmi-adult.htm. Accessed 5.04.05^[ii] Factors that can contribute to overweight include an abundance of high-calorie foods, low levels of physical activity, behavior, environment, and genetics.^[iii] Centers for Disease Control and Prevention. "Overweight and Obesity: Contributing Factors." http://www.cdc.gov/nccdphp/dnpa/obesity/contributing_factors.htm. Accessed 8.01.05.^[iii] Overweight can be associated with an increased risk of developing health problems such as hypertension, type 2 diabetes and heart disease.^[iv] Centers for Disease Control and Prevention. "Overweight and Obesity." http://www.cdc.gov/nccdphp/dnpa/obesity/ Accessed 5.04.05. ^[iv]


SOURCE: GlaxoSmithKline

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