Weight reduction and long-term maintenance after 18 months treatment with orlistat for obesity.
OBJECTIVE
To determine the effect of orlistat on weight reduction and the long-term maintenance of this weight loss when associated with a continuous mildly reduced energy diet.


METHODS
A multicenter, 18-month, double-blind study conducted in 81 hospital centers. Patients were randomized to orlistat 120 mg or placebo three times daily in conjunction with a mildly reduced-energy diet maintained throughout the study.


METHODS
In total, 696 otherwise healthy, overweight patients aged 18-65 y (BMI >or=28 kg/m(2)) were randomized to treatment with orlistat (n=346) or placebo (n=350).


METHODS
Body weight, anthropometry, lipid and glycemic control parameters and blood pressure.


RESULTS
After 18 months, patients treated with orlistat lost significantly more body weight compared with placebo (-6.5+/-0.8 vs -3.0+/-0.8%; P=0.0005). After 12 months, 32.9% of orlistat vs 24.5% of placebo patients lost >or=10% of their initial weight (P=0.04). A significantly greater number of patients receiving orlistat treatment maintained this >or=10% weight loss compared to those receiving placebo (28.1 vs 13.8%; P<0.0001). Compared with placebo, orlistat was associated with a greater decrease in fasting blood glucose (-0.86+/-0.12 vs -0.29+/-0.18 mmol/l; P<0.05) and LDL-cholesterol (-13.0+/-1.3 vs -7.0+/-1.3%; P<0.001).


CONCLUSIONS
A clinically meaningful reduction in body weight and the maintenance of this weight loss is achievable with orlistat treatment and dietary restriction over a period of 18 months. This weight loss resulted in an improvement in risk factors for coronary heart disease.
Krempf
M
M
CHU Hôtel-Dieu, Service d'Endocrinologie-Nutrition, Nantes, France. mkemppf@sante.univ-nantes.fr
Louvet
J-P
JP
Allanic
H
H
Miloradovich
T
T
Joubert
J-M
JM
Attali
J-R
JR
D000293:Adolescent; D000328:Adult; D000368:Aged; D019440:Anti-Obesity Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D002149:Energy Intake; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D007783:Lactones / Q000009:adverse effects / Q000627:therapeutic use*; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy*; D000077403:Orlistat; D012307:Risk Factors; D016896:Treatment Outcome; D015431:Weight Loss
D019440:Anti-Obesity Agents; D007783:Lactones; D000077403:Orlistat