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Study Results Found Low-Dose Orlistat (60 mg) Demonstrates Significant Reduction in LDL Cholesterol While Providing Weight Loss for Up to 2 Years

Results Found Persistent Reduction in LDL-Cholesterol, Independent of Weight Loss and Normalization of LDL Levels After 1 Year

BOSTON, MA, and PITTSBURGH, PA -- October 23, 2006 -- Data presented today at the 2006 Annual Scientific Meeting of NAASO, The Obesity Society, found that low-dose orlistat (60 mg) in conjunction with a reduced-calorie diet, provided significantly greater reductions in LDL cholesterol and weight loss when compared to treatment with placebo and a reduced-calorie diet.

The data demonstrate that the effect of low-dose orlistat on change in LDL cholesterol persisted even after correcting for weight loss, showing the reduction in LDL cholesterol was independent of weight loss. In addition, a significantly greater number of patients with elevated LDL cholesterol levels at baseline had improved LDL cholesterol levels that shifted to a normal range after treatment with low-dose orlistat for 1 year.

The results were based on two multi-center, double-blind, randomized, placebo-controlled clinical trials of 576 patients which were conducted over a 2-year period to compare the differences in weight loss and LDL cholesterol levels of 60 mg orlistat-treated versus placebo-treated subjects, with both groups consuming a reduced-calorie diet. Study results found that approximately 38 percent of orlistat-treated subjects had a favorable shift in their LDL cholesterol level in comparison to 11 percent in the placebo group.

"These study results are significant in showing the added health benefit of taking low-dose orlistat," said Vidhu Bansal, PharmD, Director of Medical Affairs, GlaxoSmithKline Consumer Healthcare. "Because high cholesterol levels are often associated with overweight and obesity, we were excited to see the positive effect low-dose orlistat had. LDL cholesterol levels returned to a normal level after 1 year of taking the medication in a significantly greater number of patients on 60 mg of orlistat with elevated LDL levels at baseline and there was a persistent reduction in LDL cholesterol levels, even after correcting for weight loss."

Additional results showed that during the first year of the study, significantly (P <.001) more subjects (45 percent) treated with orlistat plus a reduced-calorie diet lost at least five percent of their weight from baseline, in comparison to 29 percent treated with placebo plus diet. Orlistat prevents the absorption of approximately 25 percent of fat consumed. As a result of undigested fat passing through the body, users may experience gastrointestinal treatment effects. Reducing dietary fat will decrease the likelihood of experiencing treatment effects with orlistat.

Currently under review by the U.S. Food and Drug Administration (FDA), orlistat 60 mg, which GlaxoSmithKline Consumer Healthcare proposes to market under the brand name alli(TM) (pronounced AL-eye), would be the only FDA-approved weight loss medication available over-the-counter. Alli would be indicated for use by overweight adults along with a reduced-calorie, low-fat diet. Help and advice on adopting a healthy eating plan will be provided in the alli program.

Xenical(R) (orlistat 120 mg capsules) will remain available by prescription for obesity management and for those who should be treated under the care of a physician. Xenical is manufactured by Roche and co-promoted in the U.S. by GlaxoSmithKline Consumer Healthcare.

About Orlistat
The safety and efficacy of orlistat, which has been marketed as a prescription drug in the U.S. since 1999, is supported by more than 100 clinical studies conducted in more than 30 countries, including the four-year landmark XENDOS trial, the longest study ever of a weight loss medicine. There have been more than 25 million patient treatments with orlistat and it is approved in 145 countries.

Orlistat is a weight loss medication that is taken with meals to inhibit the absorption of dietary fat. Orlistat should be used in conjunction with a reduced-calorie diet that contains no more than 30 percent of calories from fat. Following such a diet maximizes weight loss and minimizes unwanted gastrointestinal treatment effects. Prescription orlistat (120 mg) is Xenical. 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 six months or longer while on Xenical. Patients considering taking Xenical 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 can reduce the absorption of fat-soluble vitamins.

About Overweight and Obesity
Currently, approximately 65 percent of U.S. adults are overweight or obese, according to the National Institutes of Health. Research suggests that overweight individuals appear to be on the pathway to obesity.(i,ii) Overweight and obesity are associated with an increased risk of developing health problems such as hypertension, type 2 diabetes and heart disease.(iii) Factors that can contribute to overweight include an abundance of high-calorie foods, low levels of physical activity, behavior, environment, and genetics.(iv) Multiple studies have shown that a modest reduction in weight improves health outcomes significantly in overweight or obese patients.(v,vi)

REFERENCES:
(i) Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA 2002;288:1723-1727.
(ii) McTigue KM, Garrett JM, Popkin BM. The natural history of the development of obesity in a cohort of young US adults between 1981-1998. Ann Intern Med 2002;136:857-864.
(iii) (Centers for Disease Control and Prevention: "Overweight and Obesity." http://www.cdc.gov/nccdphp/dnpa/obesity/. Accessed 12/22/05.
(iv) Centers for Disease Control and Prevention. "Overweight and Obesity: Contributing Factors." http://www.cdc.gov/nccdphp/dnpa/obesity/contributing_factors.htm. Accessed 12/22/05.
(v) Hauptman J, Lucas C, Baldrin MN, Collins H, Segal K. "Orlistat in the long-term treatment of obesity in primary care settings." Arch Fam Med 9:160-167.
(vi) NIH, NHLBI. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults. HHS, PHS; 1998. p. 29-41.


SOURCE: GlaxoSmithKline

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