The researchers found that both groups experienced a decrease in BMI up to week 12, thereafter stabilizing with orlistat but increasing beyond baseline with placebo. At the end of the study, BMI had decreased by 0.55 with orlistat, and had increased by 0.31 with placebo; weight had increased 0.53 kg. with orlistat and 3.14 kg. with placebo. At the study's end, 15.7 percent of the placebo group compared to 26.5 percent of orlistat patients had a five percent or higher decrease in BMI, and 4.5 percent of the placebo group and 13.3 percent of the orlistat group had a ten percent or higher decrease in BMI.
Waist circumference also decreased in the orlistat group by 1.33 cm (.52 inches) and increased by .12 cm (.047 inches) in the placebo group. Mild to moderate gastrointestinal tract adverse effects (such as nausea, fatty/oily stools, and abdominal pain) occurred in 9 percent to 50 percent of the orlistat group, and one percent to 13 percent of the placebo group.
"We conclude that treatment with 120 mg of orlistat three times daily for 52 weeks, in conjunction with a reduced-calorie diet, exercise, and behavioral modification, statistically significantly improves weight management in obese adolescent participants," the authors write. "This effect is probably due to the decrease in the absorption of fat and its associated calories."
(JAMA. 2005; 293:2873 - 2883. Available pre-embargo to the media at www.jamamedia.org.)
Editor's Notes: This study was funded by F. Hoffmann-La Roche Ltd. Dr. Chanoine has received honoraria from Hoffmann-La Roche for speakers presentations. No other authors reported financial disclosures.
Editorial: Pharmacotherapy for Adolescent Obesity - A Weighty Issue
In an accompanying editorial, Alain Joffe, M.D., M.P.H., from Johns Hopkin
Contact: Jean Pierre Chanoine, M.D., Ph.D.
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