The effect of orlistat on body weight and coronary heart disease risk profile in obese patients: the Swedish Multimorbidity Study.
OBJECTIVE
To assess the effect of orlistat on body weight and cardiovascular risk amongst obese patients at high coronary risk.


METHODS
After screening, patients entered a two-week single-blind placebo lead-in period, during which they followed a mildly hypocaloric diet, before being randomized to double-blind treatment with either orlistat 120 mg or placebo three times daily, in conjunction with dietary intervention for 1 years.


METHODS
The study was conducted at 33 primary care centres in Sweden.


METHODS
A total of 382 obese adults (body mass index 28-38 kg m-2) with type 2 diabetes, hypercholesterolaemia and/or hypertension were recruited, of whom 376 were randomized to orlistat (n = 190) or placebo (n = 186).


METHODS
Change in body weight, waist and hip circumferences, blood pressure, serum lipid profile, fasting glucose and HbA1c.


RESULTS
After 1 years, mean weight loss was significantly greater with orlistat compared with placebo (5.9% vs. 4.6%; P < 0.05). Moreover, significantly more orlistat-treated patients than placebo recipients maintained weight loss of > or = 5% (54.2% vs. 40.9%; P < 0.001). Orlistat was also associated with significantly greater improvements than placebo in total serum cholesterol (- 3.3% vs. -0.5%; P < 0.05), LDL-cholesterol (- 7.0% vs. -1.1%; P < 0.05), fasting glucose (5.1% vs. -0.1%; P < 0.01) and HbA1c (- 2.7% vs. -0.5%; P < 0.05). Similar results were reported for the subgroup of patients with type 2 diabetes. Orlistat was well tolerated.


CONCLUSIONS
Treatment with orlistat in conjunction with diet promotes significantly greater weight loss and cardiovascular risk factor reduction than diet alone amongst obese patients at high risk of future coronary events.
Lindgärde
F
F
Department of Vascular Disease, Malmö University Hospital, University of Lund, 20502 Malmö, Sweden. folke.lindgarde@medsforsk.mas.lu.se
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D019440:Anti-Obesity Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D016009:Chi-Square Distribution; D004038:Diet, Reducing; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007783:Lactones / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000178:diet therapy / Q000188:drug therapy*; D000077403:Orlistat; D012307:Risk Factors; D018709:Statistics, Nonparametric; D013548:Sweden / Q000453:epidemiology
D019440:Anti-Obesity Agents; D007783:Lactones; D000077403:Orlistat