Low-Dose Orlistat Provides Significant Weight Loss And Multiple Health Benefits

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Clinical Trials / Drug Trials
Article Date: 08 Sep 2006 - 0:00 PDT

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Low-dose orlistat (60 mg) along with a reduced-calorie diet provides meaningful weight loss and improves cholesterol and blood pressure levels in overweight and obese individuals, according to findings presented today at the 2006 International Congress on Obesity (ICO) in Sydney, Australia.

Three double-blind, placebo-controlled clinical studies of 1,729 subjects showed that in conjunction with a reduced-calorie diet, orlistat 60 mg results in greater weight loss and reductions in BMI scores and waist-to-hip ratios when compared to diet alone. At both 6 months and 12 months, significantly more orlistat 60 mg users lost 5 percent or more of their baseline body weight compared to the diet alone group. Orlistat 60 mg users also showed decreases in total cholesterol, LDL cholesterol, and systolic and diastolic blood pressure levels when compared to placebo.

"The relationship between obesity and the development of medical conditions such as high cholesterol and elevated blood pressure is well established," said lead investigator Vidhu Bansal, PharmD, Director of Medical Affairs, GlaxoSmithKline Consumer Healthcare. "These findings provide further support that a lower dose of orlistat can not only effectively help individuals lose weight, but reduce risk factors associated with co-morbid diseases and improve health overall."

Orlistat prevents the absorption of approximately 25 percent of the 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. The studies also showed that low-dose orlistat (60 mg) provides better tolerability compared to the 120 mg (prescription Xenical(R)) dose. Users in the 60 mg group experienced fewer treatment effects overall and were less likely to experience these effects in the first month of treatment. In these studies, only 3.2 percent of participants in the 60 mg group dropped out of the studies as a result of gastrointestinal treatment effects compared to 5.4 percent in the 120 mg group.

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. More than 25 million people in 145 countries have used orlistat.

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 6 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.(1,2) Overweight and obesity are associated with an increased risk of developing health problems such as hypertension, type 2 diabetes and heart disease.(3) Factors that can contribute to overweight include an abundance of high-calorie foods, low levels of physical activity, behavior, environment, and genetics.(4) Multiple studies have shown that a modest reduction in weight improves health outcomes significantly in overweight or obese patients.(5)

About GlaxoSmithKline Consumer Healthcare

GSK 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(R), NicoDerm(R) CQ and Commit(R) as well as many medicine cabinet staples, including Abreva(R), Aquafresh(R), Sensodyne(R) and Tums(R).

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 US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, 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 the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report 2004.

(1) Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA 2002;288:1723-1727.
(2) 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.
(3) Centers for Disease Control and Prevention: "Overweight and Obesity." http://www.cdc.gov/nccdphp/dnpa/obesity/. Accessed 12/22/05.
(4) 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.
(5) Hauptman J, Lucas C, Baldrin MN, Collins H, Segal K. "Orlistat in the long-term treatment of obesity in primary care settings." Archives of Family Medicine 9:160-167.

GlaxoSmithKline Consumer Healthcare
http://www.gsk.com