Objective To study the efficacy of orlistat, as an adjunct to dietary modif
ication, in weight reduction and modification of cardiovascular risk factor
s in obese patients after 1 year of treatment.
Design A total of 3132 obese patients (body mass index 28-43 kg/m(2)) were
evaluated in an analysis of pooled data from five randomized, double-blind,
placebo-controlled trials of orlistat in conjunction with a hypocaloric di
et. Ail studies included a 4-week, single-blind, placebo lead-in period dur
ing which patients followed a mildly hypocaloric diet, after which they wer
e randomized to double-blind treatment with orlistat 120 mg three times a d
ay (tid) or placebo for 1 year.
Results After 1 year, orlistat 120 mg tid produced significantly more weigh
t loss than placebo (9.2% vs 5.8%; P< 0.001). Furthermore, a greater propor
tion of orlistat-treated patients lost >5% or >10% of their initial body we
ight compared to placebo (69.6% vs 51.9%; P< 0.001 and 42.1% vs 22.7%; P< 0
.001, respectively). Improvements in cardiovascular risk factors were obser
ved during a 4-week placebo lead-in period. However, following randomizatio
n, orlistat-treated patients had significantly greater improvements than pl
acebo-treated patients in several lipid parameters including total choleste
rol, low-density lipoprotein-cholesterol, triglycerides, and apolipoprotein
B. In addition, orlistat had a beneficial effect on oral glucose tolerance
tests status, waist circumference and systolic and diastolic blood pressur
e. Orlistat was well tolerated and had a similar safety profile to placebo.
I Hypertens 1998, 16:2013-2017 (C) 1998 Lippincott Williams & Wilkins.