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

  1. Bjørn Richelsen, MD, PHD1,
  2. Serena Tonstad, MD, PHD2,
  3. Stephan Rössner, MD, PHD3,
  4. Søren Toubro, MD4,
  5. Leo Niskanen, MD, PHD5,
  6. Steen Madsbad, MD, PHD6,
  7. Pertti Mustajoki, MD7 and
  8. Aila Rissanen, MD, PHD8
  1. 1Department of Endocrinology and Metabolism, Aarhus University Hospital, Aarhus, Denmark
  2. 2Clinic for Preventive Medicine, Ullevål Hospital, Oslo, Norway
  3. 3Department of Obesity, University Clinic, Huddinge Hospital, Huddinge, Sweden
  4. 4Institute of Human Nutrition, Copenhagen, Denmark
  5. 5Department of Medicine, Kuopio University Hospital, Kuopio, Finland
  6. 6Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark
  7. 7Peijas Hospital, Helsinki University Central Hospital, Helsinki, Finland
  8. 8Obesity Research Unit, Helsinki University Central Hospital, Helsinki, Finland
  1. 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

Abstract

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.

Footnotes

  • A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.

    The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact.

    • Accepted September 29, 2006.
    • Received February 24, 2006.
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  1. doi: 10.2337/dc06-0210 Diabetes Care January 2007 vol. 30 no. 1 27-32
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