Effect of orlistat on weight regain and cardiovascular risk factors following a very-low-energy diet in abdominally obese patients: a 3-year randomized, placebo-controlled study.
OBJECTIVE
To investigate the efficacy of orlistat on the maintenance of weight loss over 3 years following a major weight loss induced by very-low-energy diet (VLED) in obese patients with metabolic risk factors such as dyslipidemia, impaired fasting glucose, and diet-treated type 2 diabetes.


METHODS
Initially, weight loss was induced by an 8-week VLED (600-800 kcal/day) in 383 patients with a mean BMI of 37.5 kg/m(2) (range 30.0-45.2). Those who lost > or = 5% of their body weight (309 of 383 patients) were then randomized to receive lifestyle counseling for 3 years together with either orlistat 120 mg t.i.d. or matching placebo capsules. Primary end points were the maintenance of > or = 5% weight loss after 3 years. Additionally, differences in the development of type 2 diabetes between orlistat and placebo were analyzed.


RESULTS
The VLED induced a mean weight loss of 14.4 +/- 2.0 kg among the subsequently randomized patients. The mean weight gain after 3 years was lower with orlistat than with placebo (4.6 +/- 8.6 vs. 7.0 +/- 7.1 kg; P < 0.02). The number of participants who achieved > or =5% weight loss also favored orlistat (67 vs. 56%; P = 0.037). Waist circumference was significantly more reduced in the orlistat group (P < 0.05), but no other differences in the risk factors were observed between the two groups. The incidences of new cases of type 2 diabetes were significantly reduced in the orlistat group (8 cases out of 153 subjects) versus placebo (17 cases out of 156 subjects) (P = 0.041).


CONCLUSIONS
The addition of orlistat to lifestyle intervention was associated with maintenance of an extra 2.4 kg weight loss after VLED for up to 3 years in obese subjects. The combination of orlistat and lifestyle intervention was associated with a reduced occurrence of type 2 diabetes.
Richelsen
Bjørn
B
Department of Endocrinology and Metabolism, Aarhus University Hospital, Aarhus, Denmark. bjoern.richelsen@as.aaa.dk
Tonstad
Serena
S
Rössner
Stephan
S
Toubro
Søren
S
Niskanen
Leo
L
Madsbad
Steen
S
Mustajoki
Pertti
P
Rissanen
Aila
A
D000328:Adult; D000368:Aged; D019440:Anti-Obesity Agents / Q000627:therapeutic use*; D015992:Body Mass Index; D049628:Body Size; D003131:Combined Modality Therapy; D048909:Diabetes Complications / Q000097:blood / Q000503:physiopathology; D004038:Diet, Reducing; D005260:Female; D018149:Glucose Intolerance / Q000150:complications; D006801:Humans; D007783:Lactones / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000178:diet therapy / Q000188:drug therapy*; D000077403:Orlistat; D010919:Placebos; D015430:Weight Gain / Q000187:drug effects*
D019440:Anti-Obesity Agents; D007783:Lactones; D010919:Placebos; D000077403:Orlistat