Orlistat, a lipase inhibitor, for weight maintenance after conventional dieting: a 1-y study.
BACKGROUND
Long-term maintenance of weight loss remains a therapeutic challenge in obesity treatment.


OBJECTIVE
This multicenter, double-blind, placebo-controlled study was designed to test the hypothesis that orlistat, a gastrointestinal lipase inhibitor, is significantly more effective than a placebo in preventing weight regain.


METHODS
Obese subjects who lost > or = 8% of their initial body weight during a 6-mo lead-in of a prescribed hypoenergetic diet (4180-kJ/d deficit) with no adjunctive pharmacotherapy were randomly assigned to receive placebo, 30 mg orlistat, 60 mg orlistat, or 120 mg orlistat 3 times daily for 1 y in combination with a maintenance diet to help prevent weight regain. Of 1313 recruited subjects [body mass index (in kg/m2): 28-43], 729 subjects lost > or =8% of their initial body weight during the 6-mo weight-loss lead-in period and were enrolled in the double-blind phase.


RESULTS
After 1 y, subjects treated with 120 mg orlistat 3 times daily regained less weight than did placebo-treated subjects (32.8 +/- 4.5% compared with 58.7 +/- 5.8% regain of lost weight; P < 0.001). Moreover, more subjects in the 120-mg orlistat group than in the placebo group regained < or = 25% of lost weight (47.5% of subjects compared with 29.9%). In addition, orlistat treatment (120 mg 3 times daily) was associated with significantly greater reductions in total and LDL-cholesterol concentrations than was placebo (P < 0.001).


CONCLUSIONS
The use of orlistat during periods of attempted weight maintenance minimizes weight readjustment and facilitates long-term improvement in obesity-related disease risk factors.
Hill
J O
JO
University of Colorado Health Sciences Center, Denver, USA.
Hauptman
J
J
Anderson
J W
JW
Fujioka
K
K
O'Neil
P M
PM
Smith
D K
DK
Zavoral
J H
JH
Aronne
L J
LJ
D000328:Adult; D019440:Anti-Obesity Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001521:Behavior Therapy; D002318:Cardiovascular Diseases / Q000517:prevention & control; D008076:Cholesterol, HDL / Q000097:blood; D004041:Dietary Fats / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007783:Lactones / Q000008:administration & dosage / Q000627:therapeutic use*; D008049:Lipase / Q000037:antagonists & inhibitors*; D008297:Male; D009765:Obesity / Q000178:diet therapy* / Q000188:drug therapy*; D000077403:Orlistat; D012307:Risk Factors; D015431:Weight Loss / Q000187:drug effects
D019440:Anti-Obesity Agents; D008076:Cholesterol, HDL; D004041:Dietary Fats; D004791:Enzyme Inhibitors; D007783:Lactones; D000077403:Orlistat; D008049:Lipase