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Diabetes Care 30:27-32, 2007
DOI: 10.2337/dc06-0210
© 2007 by the American Diabetes Association
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Clinical Care/Education/Nutrition
Original Article

Effect of Orlistat on Weight Regain and Cardiovascular Risk Factors Following a Very-Low-Energy Diet in Abdominally Obese Patients

A 3-year randomized, placebo-controlled study

Bjørn Richelsen, MD, PHD1, Serena Tonstad, MD, PHD2, Stephan Rössner, MD, PHD3, Søren Toubro, MD4, Leo Niskanen, MD, PHD5, Steen Madsbad, MD, PHD6, Pertti Mustajoki, MD7 and Aila Rissanen, MD, PHD8

1 Department of Endocrinology and Metabolism, Aarhus University Hospital, Aarhus, Denmark
2 Clinic for Preventive Medicine, Ullevål Hospital, Oslo, Norway
3 Department of Obesity, University Clinic, Huddinge Hospital, Huddinge, Sweden
4 Institute of Human Nutrition, Copenhagen, Denmark
5 Department of Medicine, Kuopio University Hospital, Kuopio, Finland
6 Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark
7 Peijas Hospital, Helsinki University Central Hospital, Helsinki, Finland
8 Obesity Research Unit, Helsinki University Central Hospital, Helsinki, Finland

Address correspondence and reprint requests to Bjørn Richelsen, MD, Professor, Department of Endocrinology and Metabolism C, Aarhus University Hospital, Aarhus Sygehus, Tage Hansensgade 2, DK-8000 Aarhus C, Denmark. E-mail: bjoern.richelsen{at}as.aaa.dk

OBJECTIVE—To investigate the efficacy of orlistat on the maintenance of weight loss over 3 years following a major weight loss induced by very-low-energy diet (VLED) in obese patients with metabolic risk factors such as dyslipidemia, impaired fasting glucose, and diet-treated type 2 diabetes.

RESEARCH DESIGN AND METHODS—Initially, weight loss was induced by an 8-week VLED (600–800 kcal/day) in 383 patients with a mean BMI of 37.5 kg/m2 (range 30.0–45.2). Those who lost ≥5% of their body weight (309 of 383 patients) were then randomized to receive lifestyle counseling for 3 years together with either orlistat 120 mg t.i.d. or matching placebo capsules. Primary end points were the maintenance of ≥5% weight loss after 3 years. Additionally, differences in the development of type 2 diabetes between orlistat and placebo were analyzed.

RESULTS—The VLED induced a mean weight loss of 14.4 ± 2..0 kg among the subsequently randomized patients. The mean weight gain after 3 years was lower with orlistat than with placebo (4.6 ± 8.6 vs. 7.0 ± 7.1 kg; P < 0.02). The number of participants who achieved ≥5% weight loss also favored orlistat (67 vs. 56%; P = 0.037). Waist circumference was significantly more reduced in the orlistat group (P < 0.05), but no other differences in the risk factors were observed between the two groups. The incidences of new cases of type 2 diabetes were significantly reduced in the orlistat group (8 cases out of 153 subjects) versus placebo (17 cases out of 156 subjects) (P = 0.041).

CONCLUSIONS—The addition of orlistat to lifestyle intervention was associated with maintenance of an extra 2.4 kg weight loss after VLED for up to 3 years in obese subjects. The combination of orlistat and lifestyle intervention was associated with a reduced occurrence of type 2 diabetes.

Abbreviations: VLED, very-low-energy diet • XENDOS, XENical in the Prevention of Diabetes in Obese Subjects


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