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  Vol. 9 No. 2, February 2000 TABLE OF CONTENTS
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Orlistat in the Long-term Treatment of Obesity in Primary Care Settings

Jonathan Hauptman, MD; Charles Lucas, MD; Mark N. Boldrin, MS; Harry Collins, MD
Karen R. Segal, PhD

Arch Fam Med. 2000;9:160-167.

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

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

Participants  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.

Setting  Seventeen primary care centers in the United States.

Main Outcome Measures  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.


for the Orlistat Primary Care Study Group

From Departments of International Clinical Research (Dr Hauptman and Mr Boldrin) and Medical Affairs (Drs Lucas and Segal), Hoffman–LaRoche Inc, Nutley, NJ; and the Edison Medical Group, Edison, NJ (Dr Collins).


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