Effects of orlistat on obesity-related diseases - a six-month randomized trial.

Abstract

AIM:

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.

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.

• Authors: B Guy-Grand, P Drouin, E Eschwège, H Gin, J-M Joubert, P Valensi
• Journal: Diabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 6 Issue 5 Pg. 375-83 (Sep 2004) ISSN: 1462-8902 [Print] England
• PMID: 15287931 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2004 Blackwell Publishing Ltd

Topics

• Aged
• Atrial Fibrillation (complications, epidemiology)
• Cross-Sectional Studies
• Diabetes Mellitus, Type 2 (complications, epidemiology)
• Female
• Humans
• Hypertension (complications, epidemiology)
• Insulin Resistance
• Male
• Middle Aged
• Odds Ratio
• Prevalence
• Risk Assessment
• Sweden (epidemiology)