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| |  ECO: Orlistat (Xenical) Plus Reduced Calorie Diet Beneficial For Obese Non-Diabetics By Jill Stein Special to DG News
VIENNA, AUSTRIA -- May 31, 2001 -- Orlistat (Xenical), in combination with a mildly reduced- calorie diet, is an effective and safe treatment for overweight or obese non-diabetics, according to data presented at the 11th European Congress on Obesity (ECO). Professor Hermann Toplak, with the Karl-Franzens University in Graz, Austria, reported that orlistat, used in tandem with a mildly reduced-calorie diet, produced significantly greater improvements in body weight and other anthropometric measurements in overweight or obese patients compared to placebo plus diet. Orlistat was also associated with additional weight loss in patients previously treated with a mildly reduced-calorie diet. Dr. Toplak, who is co-chairman of the ECO meeting, presented in the findings on behalf of the Austrian Orlistat Study Group, comprised of eight sites. The trial in studied overweight or obese (defined as a body mass index (BMI) ranging from 28 to 45 kg/m2) non- diabetic patients from 19 to 65 years of age who first underwent a four- week, single- blind, placebo plus reduced- calorie diet (600 kcal daily deficit, with roughly 30 percent of calories as fat) lead-in period. Those achieving a weight loss of greater than 2 kg were randomized to double-blind treatment with either orlistat, 120 mg, or placebo, TID, plus the reduced-calorie diet for 24 weeks. Patients who completed the double-blind treatment phase could continue with a 24-week open-label orlistat plus diet extension phase. A total of 291 patients entered the lead-in period, of whom 251 were randomized to double-blind treatment (126 received orlistat, and 125 received placebo). Ninety-one patients in the orlistat group and 90 in the placebo group entered the open-label extension phase. During the four-week lead-in period, the mean body weight decreased by 4 kg in both treatment groups, Dr. Toplak said. After randomization, the mean body weight decreased from 100 to 94.2 kg in the orlistat group and from 98 to 94.1 kg in the placebo group. After 24 weeks of double-blind treatment, orlistat produced a significantly greater median weight loss than placebo (4.2 versus 2.4 kg). Marked differences in weight loss occurred between study centers. For example, one study center reported a six-fold greater weight loss with orlistat compared with placebo (12.2 versus 2.2 kg), while another center found only minimal difference (4.4 versus 4. 2 kg). "This may be due to differences in patient management and/or compliance with treatment," Dr. Toplak suggested. More patients in the orlistat group than the placebo group achieved clinically meaningful weight loss of at least five percent (54.1 percent versus 36.8 percent) or at least ten percent (19.8 percent versus 13.2 percent) of their baseline body weight after 24 weeks. Body mass index decreased to a significantly greater extent with orlistat compared with placebo during double-blind treatment. The mean BMI decreased from 35.0 to 33.0 kg/m2 in the orlistat group and from 34.2 to 32.8 in the placebo group. Compared with placebo, treatment with orlistat produced a two-fold greater reduction in waist circumference during double blind treatment (-4 versus -2 cm). Patients treated with orlistat also had greater reductions in subcapsular, triceps, biceps, and supra-iliac skin fold thickness than patients treated with placebo. The median total serum cholesterol and low-density lipoprotein (LDL)- cholesterol levels decreased in the orlistat group and increased in the placebo group after 24 weeks. In the open- label extension phase, patients previously treated with placebo showed a tendency to additional weight loss with orlistat (94.2 kg to 93.2 kg); weight loss was maintained in patients previously treated with orlistat (94.9 kg to 94.6 kg). The study also found that orlistat was well tolerated.
Related Link: Orlistat (Xenical).
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