Effects of orlistat on obesity-related diseases - a six-month randomized trial.
OBJECTIVE
To assess the effect of orlistat on body weight and concomitant diseases in patients with body mass index (BMI) of > 28 kg/m2 and poorly controlled type 2 diabetes, hypertension or hypercholesterolaemia.


METHODS
This trial was a six-month, randomized, double-blind, placebo-controlled study of orlistat 120 mg three times daily plus a mildly reduced-calorie diet. 1004 obese patients (BMI 28-40 kg/m2) were included by 253 private endocrinologists and received orlistat (n = 499) or placebo (n = 505). Patients were stratified by concomitant disorder (type 2 diabetes, n = 193; hypertension, n = 614; hypercholesterolaemia, n = 197). Body weight, anthropometry, lipid and glycaemic control parameters and blood pressure.


RESULTS
After six months, orlistat produced a significantly greater weight loss than placebo in type 2 diabetes (-4.2% vs. -1.4%), hypertension (-6.2% vs. -1.9%) and hypercholesterolaemia (-5.5% vs. -2.3%) groups (p < 0.0001 for all). There was a greater decrease in HbA(1c) in the type 2 diabetes group (-0.54 vs. -0.18%; p = 0.002) and low-density lipoprotein (LDL)-cholesterol in the hypercholesterolaemia group (-11.7% vs. -4.5%; p = 0.004) with orlistat vs. placebo. Early weight loss (> or = 5% at 12 weeks) was associated with the highest weight loss in each group, and the highest decreases in HbA1c, LDL-cholesterol and diastolic blood pressure in patients with type 2 diabetes, hypercholesterolaemia and hypertension, respectively, at six months. The incidence of adverse events was similar for orlistat and placebo, except for certain generally well-tolerated gastrointestinal events that were more common with orlistat.


CONCLUSIONS
Orlistat plus a mildly reduced-calorie diet produced clinically meaningful weight loss and improvements in risk factors in overweight and obese patients with poorly controlled type 2 diabetes, hypertension or hypercholesterolaemia.
Guy-Grand
B
B
Service de Nutrition, Hotel-Dieu, Paris, France. bernard.guy-grand@htd.ap-hop-paris.fr
Drouin
P
P
Eschwège
E
E
Gin
H
H
Joubert
J-M
JM
Valensi
P
P
D000368:Aged; D001281:Atrial Fibrillation / Q000150:complications / Q000453:epidemiology*; D003430:Cross-Sectional Studies; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000453:epidemiology*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000453:epidemiology*; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D015995:Prevalence; D018570:Risk Assessment; D013548:Sweden / Q000453:epidemiology