Orlistat in hypertensive overweight/obese patients: results of a randomized clinical trial.
OBJECTIVE
To assess the effect of orlistat plus diet compared with diet alone in promoting weight loss and blood pressure reduction in hypertensive, overweight/obese patients.


METHODS
A pragmatic randomized, controlled trial.


METHODS
Hypertension clinic of a university hospital.


METHODS
Hypertensive patients aged 18-75 years with a body mass index greater than 25 kg/m(2).


METHODS
Orlistat 360 mg/day combined with a hypocaloric diet (treatment group), or a calorie-restricted diet alone (control group).


METHODS
Primary outcomes were reductions in weight and blood pressure. Secondary outcomes were decreases in lipid and glucose concentrations. A subgroup analysis of the main outcomes among diabetic and non-diabetic patients was also performed.


RESULTS
A total of 204 patients were included in the intention-to-treat analysis. After 12 weeks the orlistat group lost, on average, 3.7 kg and the control group lost 2.0 kg in weight (P < 0.001). Systolic (SBP) and diastolic (DBP) blood pressures decreased by 15.3 and 11.4 mmHg, respectively, in the group given orlistat plus a hypocaloric diet and by 11.6 and 5.2 mmHg, respectively, in the control group given the calorie-restricted diet alone (P = 0.25 and P = 0.0004, respectively). Fasting glucose (0.82 and 0.17 mmol/l, P = 0.01) and total cholesterol (0.85 and 0.56 mmol/l, P = 0.05) were reduced to a greater extent with orlistat than with diet alone. The mean reduction in triglycerides with orlistat plus the hypocaloric diet was 0.75 mmol/l and that in the control group was 0.30 mmol/l (P = 0.28); the increases in high-density lipoprotein cholesterol were 0.05 and 0.00 mmol/l, respectively, in the two groups (P = 0.17). Treatment improved blood pressure and glucose control in the individuals with diabetes, but not in those without diabetes.


CONCLUSIONS
In both groups there was a reduction in weight, blood pressure and metabolic parameters. The orlistat group performed better in reducing weight, DBP, glucose and cholesterol. Results show that even a small reduction in weight helps to control blood pressure and glucose. The cost-benefit of the use of orlistat should be evaluated for hypertensive obese patients.
Hypertension Program, Department of Preventive Medicine, Medical School, University Hospital Clementino Fraga Filho, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. bloch@hucff.ufrj.br
Katia Vergetti
KV
Bloch
Gil Fernando
GF
Salles
Elizabeth Silaid
ES
Muxfeldt
Armando
A
Da Rocha Nogueira
D000368:Aged; D019440:Anti-Obesity Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure; D015992:Body Mass Index; D031204:Caloric Restriction; D002784:Cholesterol / Q000097:blood; D048909:Diabetes Complications; D003920:Diabetes Mellitus / Q000178:diet therapy / Q000188:drug therapy / Q000473:pathology; D003971:Diastole; D005215:Fasting / Q000097:blood; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications* / Q000503:physiopathology; D007783:Lactones / Q000009:adverse effects / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications* / Q000178:diet therapy / Q000188:drug therapy* / Q000473:pathology; D000077403:Orlistat; D013599:Systole; D015431:Weight Loss
D019440:Anti-Obesity Agents; D001786:Blood Glucose; D007783:Lactones; D008055:Lipids; D000077403:Orlistat; D002784:Cholesterol