Publisher: Freie Universität Berlin Universitätsbibliothek, Garystr. 39, 14195 Berlin
Types: Doctoral thesis
Subjects: 610 Medizin und Gesundheit, 610 Medical sciences; Medicine
Background: 4 double-blind, placebo-controlled clinical phase III trials of the RIO (Rimona-bant in Obesity)-programme indicated that rimonabant, a selective cannabinoid-1 (CB1) re-ceptor blocker, promoted significant decrease of bodyweight and waist circumference in overweight or obese patients with dyslipidaemia or type 2 diabetes and improvement of insu-lin resistance and lipid and glucose profiles (van Gaal et al., 2005; Deprés et al., 2005; Pi-Sunyer et al., 2006; Scheen et al., 2006).
This analysis of subgroups included in the RIO-Europe study (van Gaal et al., 2005) ad-dressed the efficacy and safety of rimonabant in therapy of obesity over 2 years. In addition to changes of physical parameters like bodyweight and waist circumference as well as lipid and glucose profiles, changes of health-related quality of life and food behaviour were evaluated.
Methods: 42 overweight or obese patients with body-mass index 30 kg/m2 or greater, or body-mass index greater than 27 kg/m2 with treated or untreated hypertension, dyslipidaemia, or both, were randomized to receive placebo (n=9), 5 mg rimonabant (n=17) or 20 mg rimona-bant (n=16) once daily in addition to a hypocaloric diet and advice for physical activity for 2 years from 2001 to 2003 at the St. Hedwig hospital at Berlin. The primary endpoints and effi-cacy measures were changes over one year in body weight and waist circumference as well as in health-related parameters that were assessed by SF36- or IWQOL-Lite-health survey ques-tionnaire.
Results: 38 patients completed the 1 year follow-up. Treatment with 20 mg rimonabant once daily for one year produced significant reduction in body weight (-5,8 kg vs –1,3 kg; p0,05) and in waist circumference (-6,3 cm vs –2,7 cm; p0,0001) as well as improvement of lipid (HDL-cholesterol) and glucose profile (fasting glucose) compared with placebo. Concerning long-term effects, weight loss and reduction of waist circumference achieved during year 1 were maintained during year 2 in patients receiving 20 mg of rimonabant during both years. A greater improvement in general health perception (as assessed by SF 36; p0,05) and in men-tal well-being (p0,01) were recorded at 1 year in the 20 mg/day rimonabant group than in the placebo group.
Health-related quality of life was specifically assessed with IWQOL-Lite questionnaire. Im-provements at 1 year in total IWQOL-Lite score (p0,01), physical functioning (p0,01) and self-esteem (p0,01) were noted in the 20 mg/day rimonabant group. Further improvements at least in tendency were seen for all food behaviour parameters in the 20 mg/day rimonabant group at 1 year (appetite, desire for high fat foods and for sweets).
Conclusions: Selective CB1 blockade with 20 mg rimonabant in combination with diet and exercise over 1 year, promoted modest but sustained reductions in body weight and waist cir-cumference in obese patients and not only favorable changes in cardiometabolic risk factors but also in perception of physical and mental health. The greater drop-out rate after 1 year treatment with placebo (67%) compared to treatment with 20 mg rimonabant (44%) can pos-sibly be explained by patient’s satisfaction that was weight dependent. The trial is limited by only few cases and high drop-out rates. Long-term effects require further study.
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