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Effects of orlistat on obesity‐related diseases – a six‐month randomized trial
Author(s) -
GuyGrand B.,
Drouin P.,
Eschwège E.,
Gin H.,
Joubert JM.,
Valensi P.
Publication year - 2004
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1462-8902.2004.00359.x
Subject(s) - orlistat , medicine , placebo , weight loss , type 2 diabetes , lipid profile , blood pressure , body mass index , diabetes mellitus , endocrinology , concomitant , randomized controlled trial , obesity , gastroenterology , cholesterol , alternative medicine , pathology
Aim: To assess the effect of orlistat on body weight and concomitant diseases in patients with body mass index (BMI) of > 28 kg/m 2 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/m 2 ) 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 (≥ 5% at 12 weeks) was associated with the highest weight loss in each group, and the highest decreases in HbA 1c , 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. Conclusion: 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.