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Weight reduction and long-term maintenance after 18 months treatment with orlistat for obesity

International Journal of Obesity volume 27, pages 591–597 (2003)Cite this article

Abstract

OBJECTIVE: To determine the effect of orlistat on weight reduction and the long-term maintenance of this weight loss when associated with a continuous mildly reduced energy diet.

DESIGN: A multicenter, 18-month, double-blind study conducted in 81 hospital centers. Patients were randomized to orlistat 120 mg or placebo three times daily in conjunction with a mildly reduced-energy diet maintained throughout the study.

SUBJECTS: In total, 696 otherwise healthy, overweight patients aged 18–65 y (BMI ≥28 kg/m2) were randomized to treatment with orlistat (n=346) or placebo (n=350).

MEASUREMENTS: Body weight, anthropometry, lipid and glycemic control parameters and blood pressure.

RESULTS:After 18 months, patients treated with orlistat lost significantly more body weight compared with placebo (−6.5±0.8 vs −3.0±0.8%; P=0.0005). After 12 months, 32.9% of orlistat vs 24.5% of placebo patients lost ≥10% of their initial weight (P=0.04). A significantly greater number of patients receiving orlistat treatment maintained this ≥10% weight loss compared to those receiving placebo (28.1 vs 13.8%; P<0.0001). Compared with placebo, orlistat was associated with a greater decrease in fasting blood glucose (−0.86±0.12 vs −0.29±0.18 mmol/l; P<0.05) and LDL-cholesterol (−13.0±1.3 vs −7.0±1.3%; P<0.001).

CONCLUSION: A clinically meaningful reduction in body weight and the maintenance of this weight loss is achievable with orlistat treatment and dietary restriction over a period of 18 months. This weight loss resulted in an improvement in risk factors for coronary heart disease.

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Acknowledgements

In addition to the authors, the following persons participated in the study:

Aboud E (Narbonne), Archambeaud F (Limoges), Babin T (Toulouse), Balarac N (Saint-Laurent Du Var), Barbe P (Toulouse), Baussan V (Toulon), Benatre V (Lyon), Beroud V (Limoges), Beutter D (Vannes), Bex V (Pessac), Bindi P (Verdun), Blaise R (Mulhouse), Blanchard P (Quimper), Blickle J-F (Strasbourg), Boda Buccino M (Nice), Boucherie B (Corbeil-Essonnes), Bouillot P (Nevers), Bourgon C (Lons-Le-Saunier), Boutonnat Y (Nevers), Brac De La Perriere A (Lyon), Brogard J-M (Strasbourg), Brunetiere C (Saint-Nazaire), Brun-Pacaud A (Dijon), Cailleba A (Bayonne), Calazel-Fournier C (Toulouse), Cathelineau G (Paris), Chadenas D (Orléans), Chameau A-M (Saint-Michel), Charpentier G (Corbeil-Essonnes), Chauchard M-C (Toulouse), Chevalier E (Paris), Cirette B (Nevers), Clavel S (Le Creusot), Coffin C (Caen), Colas A-E (Rennes), Courreges J-P (Narbonne), Couturier M (Belfort), Cuny P (Thionville), Cuperlier A (Charleville-Mézières), Dabadie H (Pessac), Davidescu M (Verdun), De Boivilliers F (Montpellier), Dell'isola B (Issy-Les-Moulineaux), Derennes V (Saint-Malo), Devergie B (Creil), Dorey F (Agen), Dougny M (Nevers), Drouin P (Toul), Dubreuil A (Amiens), Dumontier D (Angers), Dusselier L (Metz), Dutour A (Marseille), Duxin C (Vesoul), Estour B (Saint-Etienne), Fayard A (Lille), Fenichel P (Nice), Feraud-Silvestri C (Marseille), Floriot M (Toul), Fontaine G (Toulon), Fontaine P (Lille), Gabreau T (Auxerre), Galinat S (Limoges), Gancel A (Bois-Guillaume), Getin-Bouyer F (Lorient), Gibault T (Créteil), Godeau T (La Rochelle), Goichot B (Strasbourg), Gouet D (La Rochelle), Grunenberger F (Strasbourg), Guillaume V (Marseille), Guillon-Metz F (Caen), Haardt M-J (Paris), Hassler P (Haguenau), Haulot J-P (Tulle), Heim M (Marseille), Hernandez G (Toulouse), Hespel J-P (Rennes), Houque D (Dunkerque), Hubschman B (Arras), Huet D (Paris), Jacquin L (Saint-Etienne), Jaffiol C (Montpellier), Jauffret P (Aix-En-Provence), Khalife S (Belfort), Kharitonnoff T (Tulle), Kuhn J-M (Bois-Guillaume), Lalau J-D (Amiens), Le Devehat C (Nevers), Lemoine A (Nevers), Leroy M (Saint-Benoît La Forêt), Loeb G (Strasbourg), Loison S (Creil), Louis J (Metz), Malinsky M (Thionville), Marcelli J-M (Laon), Marechaud R (Poitiers), Mattei C (Marseille), Mausset J (Limoges), Meyer C (Laval), Monguillon P (Brest), Monnier L-H (Montpellier), Mourlon-Bidaud C (Amiens), Naladon-Chambrier S (Limoges), Narboni G (Besançon), Olivier F (Cahors), Oppert J-M (Paris), Orgiazzi J (Pierre-Bénite), Ortega F (Strasbourg), Ory J-P (Vesoul), Paris-Bockel D (Strasbourg), Perlemuter L (Créteil), Peylhard A-M (Nîmes), Pinel J-C (Nevers), Pinget M (Strasbourg), Pommet-Nicot C (Pierre-Bénite), Potier R (Thionville), Pradignac A (Strasbourg), Prevost G (Lille), Pugeat M (Lyon), Recchi V (Nice), Richard J-L (Le Grau Du Roi), Rieu M (Paris), Riou J-P (Lyon), Rodier M (Nîmes), Roger P (Pessac), Rollin P (Besançon), Roques M (Périgueux), Roux C (Paris), Sadoul J-L (Nice), Sandre-Banon D (Bondy), Schletzer A (Laval), Schlienger J-L (Strasbourg), Schmitt B (Lorient), Semon C (Besançon), Siemen C (Saint-Malo), Slama G (Paris), Stevenard C (Dunkerque), Thevenot A (Pessac), Torremocha F (Poitiers), Vague P (Marseille), Valensi P (Bondy), Vanhoutte C (Nevers), Vannereau D (Le Grau Du Roi), Verlet E (Dunkerque), Vidal E (Limoges), Villard H (Saint-Etienne), Wautelet R (Charleville-Mézières), Winiszewski P (Belfort), Zaïr Y (Nantes), Zerah-Allali V (Caen).

We gratefully acknowledge all dietitians and nurses who helped to conduct this trial and François Montestruc (Biostatistician), Emmanuelle Pines (Drug Safety Physician) and Sophie Vigneron (Clinical Research Associate Coordinator) for their contributions to this study. This study was funded by Roche, Neuilly, France.

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Authors and Affiliations

  1. CHU Hôtel-Dieu, Service d'Endocrinologie-Nutrition, Nantes, France

    M Krempf

  2. CHU Rangueil, Service d'Endocrinologie, Toulouse, France

    J-P Louvet

  3. CHU de Rennes, Service de Diabétologie-Endocrinologie, Rennes, France

    H Allanic

  4. Roche Pharmaceuticals, Neuilly, France

    T Miloradovich & J-M Joubert

  5. Hôpital Jean Verdier, Service de Nutrition-Diabétologie-Endocrinologie, Bondy, France

    J-R Attali

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  1. M Krempf
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  4. T Miloradovich
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Correspondence to M Krempf.

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Krempf, M., Louvet, JP., Allanic, H. et al. Weight reduction and long-term maintenance after 18 months treatment with orlistat for obesity. Int J Obes 27, 591–597 (2003). https://doi.org/10.1038/sj.ijo.0802281

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