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THREE STUDIES PRESENTED AT AMERICAN DIABETES ASSOCIATION MEETING SUGGEST WEIGHT LOSS WITH XENICAL (orlistat) PROVIDES ADDITIONAL BENEFITS FOR TYPE 2 DIABETES PATIENTS WHEN COMBINED WITH CURRENT THERAPIESThe prescription weight-loss medication Xenical® (orlistat) is effective in helping to control blood glucose and insulin resistance in patients with type 2 diabetes, according to three studies being presented at the 62nd annual meeting of the American Diabetes Association. The studies examined the efficacy of Xenical in patients with type 2 diabetes, looking at its impact on body weight, insulin resistance, HbA1c levels (a measure of blood sugar), fasting plasma glucose and waist circumference – all important outcome measures in this patient population.Three separate studies presented by Jaime A. Davidson, M.D., F.A.C.P., F.A.C.E., Ralph DeFronzo, M.D, and Aila Raissanen, M.D., Ph.D. respectively, assessed data from a pool of 2,550 patients in seven double-blind, placebo-controlled trials of Xenical in overweight patients (body mass index = 28-43 kg/m2) with type 2 diabetes. All study participants were placed on a mildly reduced calorie diet (500-600 calorie deficit per day) and all were on a variety of anti-diabetes treatments (metformin, sulfonylureas and/or insulin). All subjects were randomized to receive either Xenical 120 mg three times per day with meals or placebo. "This collection of data provides strong support for the use of Xenical plus diet in conjunction with diabetes treatments in overweight or obese patients with type 2 diabetes," said Dr. Davidson, an endocrinologist at Medical City Dallas Hospital and clinical associate professor of medicine at the University of Texas Southwestern Medical School, who presented one of the studies. "Xenical, when combined with a moderate diet, appears to be a valuable tool with benefits on body weight, glycemic control and waist circumference – all endpoints that matter in this patient population." The first study, presented Saturday by Dr. Davidson, was a pooled analysis of seven multicenter, double-blind, placebo controlled studies that evaluated the efficacy of Xenical plus diet in patients who had baseline HbA1c levels of ³ 8%. Mean baseline HbA1c levels for patients in this study were 9.3%. At the 24- and 52-week endpoints, there was a significantly greater reduction in HbA1c in the Xenical plus diet group compared to the placebo plus diet group (-0.99% vs. -0.52%). In addition, a significantly higher proportion of Xenical-treated patients had a 0.5% or greater decrease in HbA1c levels compared to placebo treated patients (63.9% vs. 49%). Similarly, 46.9% of patients in the Xenical plus diet group had a 1% or greater reduction in HbA1c compared to 33.5% in the placebo plus diet group. When assessing fasting plasma glucose levels, researchers saw, on average, a 1.83 mmol/L decrease in the Xenical plus diet group compared to an average decrease of 0.75 mmol/L in the placebo plus diet group. Waist circumference decreased nearly twice as much, on average, in patients treated with Xenical plus diet compared to placebo plus diet (4.00 cm vs. 2.02 cm). On Monday, Ralph DeFronzo, M.D., professor of medicine and chief of the Diabetes Division at the University of Texas Health Science Center at San Antonio, is presenting a retrospective analysis of pooled data that examines the effects of Xenical in patients at five different baseline HbA1c levels (falling on a continuum between ³ 7% and ³ 11%.) The research found that HbA1c levels decreased from baseline in both the placebo- and Xenical-treated groups. However, on average, patients receiving Xenical plus diet had significantly larger decreases in HbA1c than patients on placebo plus diet. In addition, patients with lower starting HbA1c levels experienced the greatest relative benefit from treatment with Xenical. For example, in patients with baseline HbA1c levels of ³ 7% or ³ 8%, the mean reduction in HbA1c was twice as great in the Xenical plus diet group compared to placebo plus diet. Conversely, patients with a baseline HbA1c of 11% (the highest baseline levels) saw an average benefit of 2.2% when treated with Xenical plus diet compared to 1.5% when treated with placebo plus diet – a relative advantage of 46% for the Xenical group. Mean weight loss was also significantly greater in the Xenical treatment group compared to placebo. In a third study, being presented Monday by Aila Rissanen, M.D., Ph.D., professor at Helsinki University Hospital, Finland, researchers used a retrospective analysis of pooled data from seven multicenter, double-blind, placebo controlled studies to look specifically at the effect of Xenical plus diet on insulin resistance in type 2 diabetes patients with baseline HbA1c levels ³ 8%. Data demonstrated that Xenical plus diet significantly reduced insulin resistance, as measured by the homeostatic model assessment (HOMA) method, compared to placebo plus diet. Overall, patients receiving Xenical plus diet and another diabetes medication (either metformin, sulfonylureas and/or insulin) saw a 1.61-point reduction on the HOMA insulin resistance index. Patients in the control group achieved, on average, a 0.41-point reduction on the HOMA index. In addition, the benefits of Xenical treatment were consistent regardless of which anti-diabetes therapy patients were receiving. Patients receiving Xenical plus diet and metformin saw a 1.58-point decrease on the HOMA index, on average, and patients receiving Xenical plus diet and a sulfonylurea saw an average 1.68-point decrease on the HOMA index. About Xenical Approved in April 1999 for weight loss, maintenance of lost weight, and the reduction of risk of weight regain after prior weight loss when used with a reduced-calorie diet, Xenical is the only non-systemically acting gastrointestinal lipase inhibitor. Its mechanism of action is to prevent one-third of dietary fat from being absorbed. Weight loss with Xenical also has resulted in improvements in many cardiovascular risk factors such as high blood pressure, high cholesterol, and diabetes, compared with diet alone. Xenical has an established safety profile and is the most extensively studied weight management treatment to date. Xenical has been used in two million patients worldwide. The long-term effects of Xenical on morbidity and mortality associated with obesity have not been established. Because Xenical prevents about one-third of the fat in the food consumed from being absorbed, patients may experience gas with oily discharge, increased bowel movements, an urgent need to have them and an inability to control them, particularly after meals containing more fat than recommended. In clinical trials, these effects appear to occur less often among Xenical patients with type 2 diabetes than in patients treated for obesity. Xenical should not be taken if patients are pregnant, nursing, have food absorption problems or reduced bile flow. If taking cyclosporine, patients should speak to their doctors before taking Xenical. Xenical reduces the absorption of some vitamins. Therefore, a daily multivitamin is recommended. |
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