Efficacy of rimonabant in obese patients with binge eating disorder

Z. Pataky; C. Gasteyger; O. Ziegler; A. Rissanen; C. Hanotin; A. Golay

doi:10.1055/s-0032-1329957

Experimental and Clinical Endocrinology & Diabetes, Table of Contents

Exp Clin Endocrinol Diabetes 2013; 121(01): 20-26
DOI: 10.1055/s-0032-1329957

Article

Efficacy of rimonabant in obese patients with binge eating disorder

Z. Pataky

¹Department of Community Medicine, Service of Therapeutic Education for Chronic Diseases, World Health Organization Collaborating Centre, University Hospitals of Geneva, Geneva, Switzerland

,

C. Gasteyger

¹Department of Community Medicine, Service of Therapeutic Education for Chronic Diseases, World Health Organization Collaborating Centre, University Hospitals of Geneva, Geneva, Switzerland

,

O. Ziegler

²Department of Diabetes, Metabolic and Nutritional Diseases, Jeanne d'Arc Hospital, Nancy University Hospitals, Nancy, France

,

A. Rissanen

³Obesity Research Unit, Helsinki University Central Hospital, Helsinki, Finland

,

C. Hanotin

⁴Sanofi-Aventis, Paris, France

,

A. Golay

¹Department of Community Medicine, Service of Therapeutic Education for Chronic Diseases, World Health Organization Collaborating Centre, University Hospitals of Geneva, Geneva, Switzerland

› Author Affiliations

Abstract

In obesity, a dysregulation of the endocannabinoid system has been shown. The endocannabinoid receptor blockage by rimonabant demonstrated interesting metabolic effects. However, the role of rimonabant in weight loss of patients with binge eating disorder has not been investigated. Thus, our aim was to evaluate the effects of rimonabant on body weight in obese patients with binge eating disorders.

This multicenter, randomized, double-blind, placebo-controlled study included 289 obese subjects (age 18–70 years, body mass index 30–45 kg/m²) with binge eating disorders. Subjects were randomized (1:1) to receive rimonabant 20 mg/day or placebo for 6 months. In total, 289 participants (age: 43.2±10.5 yrs, 91% of women) were randomized. The completer rate was similar (71%) in both treatment and placebo groups. Participants treated with rimonabant lost 4.7±5.2% of their initial body weight, vs. 0.4±4.5% in the placebo group (difference between both groups: 4.4±0.6 kg, p<0.0001). The rimonabant group showed a greater reduction on the binge eating scale total score (mean±SD − 40.9±35.2%) vs. placebo ( − 29.9±34.6%, p=0.02). The incidence of treatment emergent adverse events was comparable in both the rimonabant (82.5%) and placebo (76.0%) group. Discontinuations due to treatment emergent adverse events occurred in 13.3% rimonabant-treated vs. 6.2% placebo-treated participants.

In conclusion, this is the only randomised, placebo-controlled, double-blind trial having assessed the effect of rimonabant in patients with binge eating disorders. The rimonabant treatment reduced body weight significantly more than placebo in obese subjects with binge eating.

Trial registration number (clinicaltrials.gov): NCT00481975

Key words

endocannabinoid system - rimonabant - obesity - binge eating disorder

Full Text

References

References
1 Engeli S, Bohnke J, Feldpausch M et al. Activation of the peripheral endocannabinoid system in human obesity. Diabetes 2005; 54: 2838-2843
2 Bluher M, Engeli S, Kloting N et al. Dysregulation of the peripheral and adipose tissue endocannabinoid system in human abdominal obesity. Diabetes 2006; 55: 3053-3060
3 Cote M, Matias I, Lemieux I et al. Circulating endocannabinoid levels, abdominal adiposity and related cardiometabolic risk factors in obese men. Int J Obes (Lond) 2007; 31: 692-699
4 Sipe JC, Scott TM, Murray S et al. Biomarkers of endocannabinoid system activation in severe obesity. PLoS One 2010; 5: e8792
5 Rosenson RS. Role of the endocannabinoid system in abdominal obesity and the implications for cardiovascular risk. Cardiology 2009; 114: 212-225
6 Di Marzo V, Matias I. Endocannabinoid control of food intake and energy balance. Nat Neurosci 2005; 8: 585-589
7 Van Gaal LF, Rissanen AM, Scheen AJ et al. Effects of the cannabinoid-1 receptor blocker rimonabant on weight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet 2005; 365: 1389-1397
8 Pi-Sunyer FX, Aronne LJ, Heshmati HM et al. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized controlled trial. JAMA 2006; 295: 761-775
9 Despres JP, Golay A, Sjostrom L. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. N Engl J Med 2005; 353: 2121-2134
10 Scheen AJ, Finer N, Hollander P et al. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet 2006; 368: 1660-1672
11 Kunnas T, Lahtio R, Kortelainen ML et al. Gln27Glu variant of Beta2-adrenoceptor gene affects male type fat accumulation in women. Lipids Health Dis 2009; 8: 43
12 Silvestri C, Di Marzo V. Second generation CB1 receptor blockers and other inhibitors of peripheral endocannabinoid overactivity and the rationale of their use against metabolic disorders. Expert Opin Investig Drugs 2012;
13 Triay J, Mundi M, Klein S et al. Does rimonabant independently affect free fatty acid and glucose metabolism?. J Clin Endocrinol Metab 2012; 97: 819-827
14 Christou GA, Tellis CC, Elisaf MS et al. The changes in plasma retinol-binding protein 4 levels are associated with those of the apolipoprotein B-containing lipoproteins during dietary and drug treatment. Angiology 2012; 63: 67-75
15 American Psychiatric Association . Diagnostic and Statistical Manual of Mental Disorders (Text Revision). Washington, DC: American Psychiatric Press; 2000
16 Monteleone P, Matias I, Martiadis V et al. Blood levels of the endocannabinoid anandamide are increased in anorexia nervosa and in binge-eating disorder, but not in bulimia nervosa. Neuropsychopharmacology 2005; 30: 1216-1221
17 Williams CM, Kirkham TC. Anandamide induces overeating: mediation by central cannabinoid (CB1) receptors. Psychopharmacology (Berl) 1999; 143: 315-317
18 Jamshidi N, Taylor DA. Anandamide administration into the ventromedial hypothalamus stimulates appetite in rats. Br J Pharmacol 2001; 134: 1151-1154
19 Arias Horcajadas F. Cannabinoids in eating disorders and obesity. Mol Neurobiol 2007; 36: 113-128
20 Parylak SL, Cottone P, Sabino V et al. Effects of CB(1) and CRF(1) receptor antagonists on binge-like eating in rats with limited access to a sweet fat diet: Lack of withdrawal-like responses. Physiol Behav 2012; 107: 231-242
21 de Zwaan M. Binge eating disorder and obesity. Int J Obes Relat Metab Disord 2001; 25 (Suppl. 01) S51-S55
22 Yanovski SZ. Binge eating disorder and obesity in 2003: could treating an eating disorder have a positive effect on the obesity epidemic?. Int J Eat Disord 2003; 34 (Suppl) S117-S120
23 Hodge AM, Zimmet PZ. The epidemiology of obesity. Baillieres Clin Endocrinol Metab 1994; 8: 577-599
24 Pataky Z, Carrard I, Golay A. Psychological factors and weight loss in bariatric surgery. Curr Opin Gastroenterol 2011; 27: 167-173
25 Reas DL, Grilo CM. Review and meta-analysis of pharmacotherapy for binge-eating disorder. Obesity (Silver Spring) 2008; 16: 2024-2038
26 Spitzer RL, Yanovski SZ, Marcus MD. Questionnaire on Eating and Weight Patterns-Revised. Mc Lean, VA: BRS Search Service; 1994
27 Elder KA, Grilo CM, Masheb RM et al. Comparison of two self-report instruments for assessing binge eating in bariatric surgery candidates. Behav Res Ther 2006; 44: 545-560
28 Celio AA, Wilfley DE, Crow SJ et al. A comparison of the binge eating scale, questionnaire for eating and weight patterns-revised, and eating disorder examination questionnaire with instructions with the eating disorder examination in the assessment of binge eating disorder and its symptoms. Int J Eat Disord 2004; 36: 434-444
29 WHO . Obesity: preventing and managing the global epidemic. Report of a WHO consultation on obesity, Geneva, June 3-5, 1997. Geneva: WHO; 1998
30 Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res 1985; 29: 71-83
31 Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults – The Evidence Report. National Institutes of Health. Obes Res 1998; 6 (Suppl. 02) 51S-209S
32 Bobbioni-Harsch E, Pataky Z, Makoundou V et al. From metabolic normality to cardiometabolic risk factors in subjects with obesity. Obesity (Silver Spring) 2012; 20: 2063-2069
33 Arnold LM, McElroy SL, Hudson JI et al. A placebo-controlled, randomized trial of fluoxetine in the treatment of binge-eating disorder. J Clin Psychiatry 2002; 63: 1028-1033
34 Grilo CM, Masheb RM, Wilson GT. Efficacy of cognitive behavioral therapy and fluoxetine for the treatment of binge eating disorder: a randomized double-blind placebo-controlled comparison. Biol Psychiatry 2005; 57: 301-309
35 Devlin MJ, Goldfein JA, Petkova E et al. Cognitive behavioral therapy and fluoxetine as adjuncts to group behavioral therapy for binge eating disorder. Obes Res 2005; 13: 1077-1088
36 Hudson JI, McElroy SL, Raymond NC et al. Fluvoxamine in the treatment of binge-eating disorder: a multicenter placebo-controlled, double-blind trial. Am J Psychiatry 1998; 155: 1756-1762
37 Pearlstein T, Spurell E, Hohlstein LA et al. A double-blind, placebo-controlled trial of fluvoxamine in binge eating disorder: a high placebo response. Arch Womens Ment Health 2003; 6: 147-151
38 McElroy SL, Casuto LS, Nelson EB et al. Placebo-controlled trial of sertraline in the treatment of binge eating disorder. Am J Psychiatry 2000; 157: 1004-1006
39 McElroy SL, Hudson JI, Malhotra S et al. Citalopram in the treatment of binge-eating disorder: a placebo-controlled trial. J Clin Psychiatry 2003; 64: 807-813
40 Grilo CM, Masheb RM, Salant SL. Cognitive behavioral therapy guided self-help and orlistat for the treatment of binge eating disorder: a randomized, double-blind, placebo-controlled trial. Biol Psychiatry 2005; 57: 1193-1201
41 Golay A, Laurent-Jaccard A, Habicht F et al. Effect of orlistat in obese patients with binge eating disorder. Obes Res 2005; 13: 1701-1708
42 Makoundou V, Pataky Z, Bobbioni-Harsch E et al. Multi-factorial approach associated with a new ‘on/off’ Orlistat(R) use in a weight loss maintenance programme: 4 years follow-up. Obes Facts 2011; 4: 191-196
43 Appolinario JC, Bacaltchuk J, Sichieri R et al. A randomized, double-blind, placebo-controlled study of sibutramine in the treatment of binge-eating disorder. Arch Gen Psychiatry 2003; 60: 1109-1116
44 Wilfley DE, Crow SJ, Hudson JI et al. Efficacy of sibutramine for the treatment of binge eating disorder: a randomized multicenter placebo-controlled double-blind study. Am J Psychiatry 2008; 165: 51-58
45 Stunkard A, Berkowitz R, Tanrikut C et al. d-fenfluramine treatment of binge eating disorder. Am J Psychiatry 1996; 153: 1455-1459
46 Claudino AM, de Oliveira IR, Appolinario JC et al. Double-blind, randomized, placebo-controlled trial of topiramate plus cognitive-behavior therapy in binge-eating disorder. J Clin Psychiatry 2007; 68: 1324-1332
47 McElroy SL, Arnold LM, Shapira NA et al. Topiramate in the treatment of binge eating disorder associated with obesity: a randomized, placebo-controlled trial. Am J Psychiatry 2003; 160: 255-261
48 McElroy SL, Hudson JI, Capece JA et al. Topiramate for the treatment of binge eating disorder associated with obesity: a placebo-controlled study. Biol Psychiatry 2007; 61: 1039-1048
49 Brownley KA, Berkman ND, Sedway JA et al. Binge eating disorder treatment: a systematic review of randomized controlled trials. Int J Eat Disord 2007; 40: 337-348
50 Marcus MD, Wing RR, Lamparski DM. Binge eating and dietary restraint in obese patients. Addict Behav 1985; 10: 163-168
51 Friederich HC, Schild S, Wild B et al. Treatment outcome in people with subthreshold compared with full-syndrome binge eating disorder. Obesity (Silver Spring) 2007; 15: 283-287
52 Grilo CM, White MA, Masheb RM. DSM-IV psychiatric disorder comorbidity and its correlates in binge eating disorder. Int J Eat Disord 2009; 42: 228-234