Low-dose orlistat effects on body weight of mildly to moderately overweight individuals: a 16 week, double-blind, placebo-controlled trial.
BACKGROUND
Lifestyle measures are considered the first line of therapy for treating overweight individuals, but many are unable to achieve a meaningful weight loss.


OBJECTIVE
To determine the efficacy and safety of orlistat 60 mg, given 3 times daily, for weight loss in mildly to moderately overweight individuals.


METHODS
A multicenter, 16 week, randomized, double-blind, placebo-controlled study was conducted in 391 overweight subjects at 20 US centers. The main outcome measure was change in weight from baseline to week 16; secondary measures included changes in body mass index, waist circumference, blood pressure, and fasting lipoprotein and glucose levels.


RESULTS
Subjects in both groups lost weight over the treatment period; however, orlistat-treated subjects lost significantly more weight than placebo-treated subjects beyond 2 weeks of treatment. Weight loss from baseline to week 16 was significantly greater in participants receiving orlistat versus those receiving placebo (3.05 vs 1.90 kg; p < 0.001, intent-to-treat analysis). Orlistat-treated subjects who completed 16 weeks of treatment lost 4.8 +/- 0.35% (mean +/- SE) of baseline weight compared with 3.1 +/- 0.38% for the placebo group (p < 0.001). Orlistat-treated subjects, compared with those receiving placebo, also demonstrated a greater relative reduction in total (-4.4% vs 0.0%; p = 0.004) and low-density lipoprotein cholesterol (-7.2% vs -0.6%; p = 0.005) and both diastolic (-3.9% vs -0.5%; p = 0.001) and systolic blood pressure (-4.7% vs -1.8%; p = 0.004). Both groups showed a similar safety profile; gastrointestinal events were significantly more common in the orlistat-treated subjects.


CONCLUSIONS
The use of orlistat 60 mg by mildly to moderately overweight individuals produced significant weight loss in conjunction with a reduced calorie diet and self-instructional materials. This amount of weight loss was associated with improvements in several weight-related risk factors. Orlistat 60 mg may be a useful adjunct to lifestyle measures and has the potential to contribute significantly to weight and risk factor improvement for overweight individuals.
Anderson
James W
JW
Endocrine Division, University of Kentucky, Lexington, KY 40506-0298, USA. jwandersmd@aol.com
Schwartz
Susan M
SM
Hauptman
Jonathan
J
Boldrin
Mark
M
Rossi
Maureen
M
Bansal
Vidhu
V
Hale
Cecilia A
CA
D000328:Adult; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects* / Q000502:physiology; D004038:Diet, Reducing / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007783:Lactones / Q000008:administration & dosage*; D008019:Life Style; D008297:Male; D008875:Middle Aged; D000077403:Orlistat; D050177:Overweight / Q000187:drug effects* / Q000502:physiology; D013997:Time Factors; D015431:Weight Loss / Q000187:drug effects / Q000502:physiology
D007783:Lactones; D000077403:Orlistat