A 60 mg low-dose version of the prescription weight-loss medication orlistat (marketed by GlaxoSmithKline as Xenical® 120 mg) was found to be safe, effective and tolerable in overweight individuals, according to new data presented today at the 2005 Annual Meeting of NAASO, The Obesity Society in Vancouver, British Columbia.
The study, which compared orlistat 60 mg plus diet to placebo plus diet in patients with a body mass index (BMI) of 25 to 28, demonstrates a statistically significant difference in weight loss. Orlistat patients who completed the four-month treatment period lost 5 percent of their baseline weight and diet alone lost 3.3 percent.The randomized, placebo-controlled, 16-week study was conducted in a primary care setting, offered minimal intervention and was largely self-instructional. Approximately 36 percent of orlistat users and 28 percent of the placebo group (who used diet modifications alone) lost more than five percent of their initial body weight. Approximately 57 percent of orlistat users, compared to 42 percent of the placebo group, lost more than three percent of their initial body weight.
Orlistat patients also demonstrated significant decreases in total cholesterol, LDL cholesterol, systolic and diastolic blood pressure. Safety and tolerability of 60 mg orlistat in this population was similar to that observed in previous studies in a more overweight population.
"Prescription orlistat has been used successfully for years to help obese individuals lose weight and improve their health, so it's exciting to find that a lower dose of orlistat can help those who are overweight with their weight loss efforts," said lead investigator Dr. James Anderson, Professor of Medicine and Clinical Nutrition at the University of Kentucky. "The number of overweight individuals in this country continues to increase each year, and the risk of these folks progressing to obesity - and the resulting more serious medical problems - is significant."
