Orlistat in the long-term treatment of obesity in primary care settings.
OBJECTIVE
To evaluate the long-term efficacy and tolerability within primary care settings of orlistat, a gastrointestinal lipase inhibitor, for the treatment of obesity.


METHODS
Randomized, double-blind, placebo-controlled, multicenter study.


METHODS
A group of 796 obese patients (body mass index, 30-44 kg/m2), treated with placebo 3 times a day (TID), 60 mg of orlistat TID, or 120 mg of orlistat TID, in conjunction with a reduced-energy diet for the first year and a weight-maintenance diet during the second year.


METHODS
Seventeen primary care centers in the United States.


METHODS
Changes in body weight and obesity-related disease risk factors.


RESULTS
Patients treated with orlistat lost significantly more weight (7.08 +/- 0.54 and 7.94 +/- 0.57 kg for the 60-mg and 120-mg orlistat groups, respectively) than those treated with placebo (4.14 +/- 0.56 kg) in year 1 (P<.001) and sustained more of this weight loss during year 2 (P<.001). More patients treated with orlistat lost 5% or more of their initial weight in year 1 (48.8% and 50.5% of patients in the 60-mg and 120-mg groups, respectively) compared with placebo (30.7%; P<.001), and approximately 34% of patients in the orlistat groups sustained weight loss of 5% or greater over 2 years compared with 24% in the placebo group (P<.001). Orlistat produced greater improvements than placebo in serum lipid levels and blood pressure and was well tolerated, although treatment resulted in a higher incidence of gastrointestinal events.


CONCLUSIONS
This long-term study indicates that orlistat is an effective adjunct to dietary intervention in the treatment of obesity in primary care settings.
Hauptman
J
J
Department of International Clinical Research, Hoffman-LaRoche Inc, Nutley, NJ 07110, USA. jonathan.hauptman@roche.com
Lucas
C
C
Boldrin
M N
MN
Collins
H
H
Segal
K R
KR
D000328:Adult; D019440:Anti-Obesity Agents / Q000627:therapeutic use*; D001786:Blood Glucose / Q000378:metabolism; D001794:Blood Pressure; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007328:Insulin / Q000097:blood; D007783:Lactones / Q000627:therapeutic use*; D008049:Lipase / Q000037:antagonists & inhibitors; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D000077403:Orlistat; D011320:Primary Health Care; D012307:Risk Factors; D016896:Treatment Outcome; D014481:United States; D014815:Vitamins / Q000097:blood; D015431:Weight Loss
D019440:Anti-Obesity Agents; D001786:Blood Glucose; D007328:Insulin; D007783:Lactones; D008055:Lipids; D014815:Vitamins; D000077403:Orlistat; D008049:Lipase