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| |  Xenical (Orlistat) Improves Glycaemic Control in Overweight Type 2 Diabetics GLASGOW, SCOTLAND -- September 10, 2001 -- Treating type 2 diabetes who are overweight and obese with the weight loss medication, Xenical (orlistat), substantially improves glycaemic control, reduces the need for anti-diabetic medication and helps them lose weight according to new data being presented today at the European Association for the Study of Diabetes (EASD) meeting in Glasgow(1). The results from the first of two studies showed that type 2 diabetes patients treated with Xenical had significantly improved glycaemic control, as shown by significant reductions in HbA]lc, fasting glucose, and post prandial glucose, leading to a reduction in the mean daily dose of anti-diabetic medication (sulphonylureas) required. Furthermore, Xenical was also effective in promoting weight loss: · After one year, people treated with Xenical had lost significantly more weight (5.3kg) than people treated with diet alone (3.4kg) · Significantly more patients achieved clinically meaningful weight loss of at least 5 percent of their initial body weight with Xenical compared with placebo (51.3 percent versus 31.6 percent). · The reduction in waist circumference for patients treated with Xenical was almost two fold greater than for patients treated with placebo alone (average waist size reduction with Xenical was 5.5cm; with placebo, 3cm). The study was conducted by Professor Markolf Hanefeld from the University of Dresden, Germany. Participants (people with obesity and type 2 diabetes) were placed on a mildly reduced-calorie, reduced-fat diet and treated either with Xenical (189 patients) or a placebo (180 patients). "Achieving sufficient weight loss is a vital first step in the treatment of people with type 2 diabetes, although less than 10 percent of people with type 2 diabetes manage to achieve sufficient weight loss through diet alone. Any medication, therefore, which helps people to lose weight, improves blood sugar control, whilst also reducing their need for anti-diabetic medication, is of real value for people who need to control their weight and their type 2 diabetes" commented Professor Hanefeld. The results of Professor Hanefeld’s research are also supported by another study presented today at the EASD meeting. The study, conducted by Professor Alfredo Halpern from Hospital das Clinicas da FMUSP, in Sao Paulo, Brazil, involved 338 patients with type 2 diabetes who were all placed on a mildly calorie-reduced diet. It showed that patients treated with Xenical achieved significantly greater weight loss than patients treated with diet alone (4.2kg versus 2.6kg), and that Xenical treatment is associated with a significant improvement in glycaemic control compared to diet alone, as reflected by greater reductions in HbAlc levels, fasting plasma glucose and postprandial glucose(2). Importantly, the results of both studies also confirm that treatment with Xenical reduces both total and low-density lipoprotein (LDL) cholesterol, as well as blood pressure levels, leading to improved cardiovascular health for obese patients with type 2 diabetes. The data also show Xenical to be well tolerated, with a safety profile similar to placebo. Regulatory authorities are currently reviewing an application for an additional type 2 diabetes indication in Xenical’s licence in the U.S. and Canada, and a variation to include type 2 diabetes in the licence in the European Union. This application is supported by findings from seven large multi-centre trials up to one year in duration involving more than 2,600 patients with type 2 diabetes, which are among the largest and longest for any anti-diabetic drug. Approvals for the change to the Xenical data sheet to reflect type 2 diabetes are expected early next year. Xenical is the only available weight loss medication that works locally in the gut to prevent dietary fat absorption by around 30 percent and effectively promotes weight loss. It is the most extensively studied pharmacological weight management treatment to date, with over 30,000 overweight or obese patients participating in clinical trials with Xenical. It is an effective therapy that not only helps patients lose weight, but also helps them maintain their weight loss. Xenical is well tolerated and unlike other appetite suppressants it does not act on the brain. In clinical trials, people taking Xenical in conjunction with a mildly reduced calorie diet have shown twice as much weight loss as diet alone. Since it was first marketed in 1998, there have been more than nine million patient treatments with Xenical world-wide. Xenical is licensed for weight management in over 100 countries around the world. References: (1) Hanefeld M, Sachse G. "Orlistat promotes weight loss and improves glycaemic control in overweight patients with type 2 diabetes". Poster presented at EASD, Glasgow, 2001. (2) Halpern A, Mancini MC, Suplicy H, Zanella MT et al. "LatinAmerican trial of orlistat for weight loss and improvement in glycaemic profile in obese diabetic patients". Poster presented at EASD, Glasgow 2001. SOURCE: Shire Hall International Related Link: Xenical (orlistat).
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