Context Orlistat, a gastrointestinal lipase inhibitor that reduces dietary fat absorption by approximately 30%, may promote weight loss and reduce cardiovascular risk factors.
Objective To test the hypothesis that orlistat combined with dietary intervention is more effective than placebo plus diet for weight loss and maintenance over 2 years.
Design Randomized, double-blind, placebo-controlled study conducted from October 1992 to October 1995.
Setting and Participants Obese adults (body mass index [weight in kilograms divided by the square of height in meters], 30-43 kg/m2) evaluated at 18 US research centers.
Intervention Subjects received placebo plus a controlled-energy diet during a 4-week lead-in.
On study day 1, the diet was continued and subjects were randomized to receive placebo 3 times a day or orlistat, 120 mg 3 times a day, for 52 weeks.
After 52 weeks, subjects began a weight-maintenance diet, and the placebo group (n=133) continued to receive placebo and orlistat-treated subjects were rerandomized to receive placebo 3 times a day (n=138), orlistat, 60 mg (n=152) or 120 mg (n=153) 3 times a day, for an additional 52 weeks.
Main Outcome Measures Body weight change and changes in blood pressure and serum lipid, glucose, and insulin levels.
Results A total of 1187 subjects entered the protocol, and 892 were randomly assigned on day 1 to double-blind treatment. (...)
Mots-clés Pascal : Obésité, Randomisation, Essai thérapeutique contrôlé, Orlistat, Facteur risque, Réduction chimique, Perte poids, Association, Traitement diététique, Evaluation, Homme, Etats Unis, Amérique du Nord, Amérique, Etat nutritionnel, Trouble nutrition, Hypolipémiant, Métabolisme pathologie, Prévention
Mots-clés Pascal anglais : Obesity, Randomization, Controlled therapeutic trial, Orlistat, Risk factor, Chemical reduction, Weight loss, Association, Diet therapy, Evaluation, Human, United States, North America, America, Nutritional status, Nutrition disorder, Antilipemic agent, Metabolic diseases, Prevention
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0096036
Code Inist : 002B02N. Création : 31/05/1999.