Camacho TR, Lago AA, González PM, Parada TMG

Language: Spanish
References: 12
Page: 437-448
PDF size: 503.68 Kb.

ABSTRACT

Background: In Mexico the prevalence of overweight and obesity have reached epidemic proportions have increased to the point of costs care for health problems associated with the impact of overweight and obesity.
Objective: assess efficacy and safety of Orlistat 60 mg three times daily, with low calorie diet and exercise vs. placebo, diet and exercise.
Material and method: A placebo controlled, double blind, randomized and longitudinal (12 week) study; 240 patients of both genders, over 18 years of age, with body mass index (BMI) between 25 and 34.9 kg/m² were included. Variables of efficacy: 1) ≥10% reduction in weight and BMI; 2) Reduction or maintenance of cholesterol and triglycerides; 3) ≥10% reduction of body fat by bioelectric impedance. Safety variable: evaluation of adverse events (AE).
One hundred and nineteen subjects were randomized in group A (orlistat) and 121 in group B (placebo); 105 subjects in group A and 95 in group B finished, and were considered for the variables of efficacy; all 240 subjects were taken into account to assess safety.
Results: ≥10% weight and BMI reduction: group A 34.29%; group B 8.42%, (p≤0.0001). ≤10% reduction of body fat with bioelectric impedance: group A 70.19%; group B 28.42% (p≤0.0001). Reduction of triglycerides: group A dropped 18.45 mg/dL (p=0.008); in group B the difference was -3.22 mg/dL (gain) (p= 0.6041). Reduction of cholesterol: group A dropped 19.87 mg/dL (p= ‹0.0001); group B dropped 9.75 mg/dL (p=0.0040). AEs with frequency ≥10% in group A were steatorrhea, diarrhea, fatty rectal drip, and meteorism.
Conclusion: The goal of losing ≥10% of weight or body fat was greater for subjects in group A and combined with diet and exercise proved to be more effective and safe and much faster.

REFERENCES

1. Informe público europeo de evaluación (EPAR) de orlistat GSK. Resumen de las características del producto. European Medicines Agency, EMEA/H/C/854, 2007. Vínculo de Internet http://www.emea.europa.eu/humandocs/PDFs/EPAR/orlistatgsk/H-854-PI-es.pdf

2. Amy M, Heck J, Yanovski A, Calis KA. Orlistat, a new lipase inhibitor for the management of obesity. Pharmacotherapy 2000;20(3):270-279.

3. Anghelescu I, Klawe C & Benkert O. Orlistat in the treatment of psychopharmacologically induced weight gain (letter). J Clin Psychopharmacol 2000;20(6):716-717.

4. Gokcel A, Gumurdulu Y, Karakose H, et al. Evaluation of the safety and efficacy of sibutramine, orlistat and metformin in the treatment of obesity. Diabetes Obes Metab 2002;4:49-55.

5. Guerciolini R. Mode of action of orlistat. Int J Obesity 1997;21(suppl 3):S12-S23.

6. Guzelhan C, Odink J, Niestijl JJ, et al. Influence of dietary composition on the inhibition of fat absorption by orlistat. J Int Med Res 1994;22:255-265.

7. Hartmann D, Hussain Y, Guzelhan C, et al. Effect on dietary fat absorption of orlistat, administered at different times relative to meal intake. Br J Clin Pharmacol 1993;36:266-270.

8. 8. Hill JO, Hauptman J, Anderson JW, et al Orlistat, a lipase inhibitor, for weight maintenance after conventional dieting: a 1-y study. Am J Clin Nutr 1999;69:1108-1116.

9. Hollander PA, Elbein SC, Hirsch IB, et al. Role of orlistat in the treatment of obese patients with type 2 diabetes. Diabetes Care 1998; 21(8):1288-1294.

10. Hussain Y, Guzelhan C, Odink J, et al. Comparison of the inhibition of dietary fat absorption by full versus divided doses of orlistat. J Clin Pharmacol 1994; 34:1121-1125.

11. Persson M, Vitols S, Yue QY. Orlistat associated with hypertension. BMJ 2000; 321(7253):87.

12. Tonstad S, Pometta D, Erkelens DW, et al. The effect of the gastrointestinal lipase inhibitor, orlistat, on serum lipids and lipoproteins in patients with primary hyperlipidaemia. Eur J Clin Pharmacol 1994;46:405-410.