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Fat-Blocking Drug Xenical (Orlistat) May Prevent Some Type 2 Diabetes
NEW YORK, NY -- May 8, 2000 -- In the first demonstration of the prevention of diabetes through modest long-term weight loss, a study led by a researcher at St. Luke's-Roosevelt Hospital Center has concluded that the fat- blocking drug Xenical (orlistat) can help to reverse high blood sugar and even prevent type 2 diabetes in obese individuals.
The report by a team headed by Steven B. Heymsfield, MD, Deputy Director of the New York Obesity Research Center at St. Luke's-Roosevelt, appears in today's issue of the Archives of Internal Medicine.
"People with obesity are at an increased risk for diabetes and the serious health risks that accompany diabetes," said Dr. Heymsfield. "We found that weight loss with Xenical may be an important addition to dietary and lifestyle interventions in reducing the risk of diabetes."
Dr. Heymsfield and his colleagues analyzed data from three large multicenter clinical trials involving a total of 675 obese patients. They concluded that the addition of Xenical to a conventional weight loss regimen significantly improved blood sugar tolerance and diminished the rate of progression to the development of abnormal blood sugar tolerance and adult- onset diabetes.
"This study demonstrates that by partially blocking fat absorption with Xenical, sustained weight loss was produced in obese subjects, leading to significant improvement in blood sugar and insulin metabolism, hopefully delaying or preventing diabetes," Dr. Heymsfield said.
As noted in the study:
-- More than half of Americans are overweight or obese.
-- Twenty percent of Americans are classified as obese (BMI greater than or equal to 30).
-- More than 16.6 million Americans have diabetes, 12 million of them being overweight or obese with type 2 diabetes.
-- More than 30 million Americans have abnormal blood sugar tolerance, which frequently leads to type 2 diabetes.
-- An estimated 80 million people had diabetes worldwide in 1990 and that number is believed to have doubled in the past decade.
Three two-year clinical trials were conducted at 39 research centers in the United States and Europe. The three studies enrolled a total of 675 obese adults. All participants were randomized to receive either placebo or treatment with Xenical (120 mg) three times a day for two years. Patients were given a standard, three-hour sugar tolerance test (a standard diagnostic test for diabetes).
In all three studies, the patients treated with Xenical lost more weight and demonstrated better blood sugar control than those who received placebo, and they showed improved serum insulin levels as well. Among participants already on their way to becoming diabetic, nearly three-quarters (71.6 percent) of the subjects treated with Xenical converted their blood sugar from abnormal to normal, compared with fewer than half (49.1 percent) of those receiving placebo. And more than twice as many patients receiving placebo became diabetic (7.6 percent) compared to the group treated with Xenical, where only 3 percent became diabetic.
The researchers noted that the lowering of serum insulin levels may be clinically important since earlier studies have linked serum insulin levels to coronary heart disease risk and hypertension. The study was supported by a research grant from Hoffmann-La Roche Inc.
Xenical, the only fat-blocking prescription medication approved by the FDA, acts in the gastrointestinal tract to prevent the absorption of dietary fat by approximately one-third. The drug is prescribed in conjunction with a reduced-calorie diet for obesity management, including weight loss, weight maintenance and to reduce the risk for weight regain after prior weight loss.
The New York Obesity Research Center is renowned for its innovative programs and pioneering research into many areas of nutrition, metabolism and body composition. The Center's major focus is to identify the causes and optimal treatment for obesity.
The Center includes six core laboratories, a clinical research ward, two training grants, support for pilot and feasibility projects, and an ambulatory research clinic. St. Luke's-Roosevelt's best known research is in the areas of endocrinology, nutrition, obesity and body composition.
Related Links: Xenical (orlistat) and Hoffmann-La Roche Inc.
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