A clinical trial assessing the safety and efficacy of the CB1R inverse agonist taranabant in obese and overweight patients: Low-dose study

International Journal of Obesity

Volumn 34, Issue 8, 2010, Pages 1243-1254

  Proietto, J ^a   Rissanen, A ^b   Harp, J B ^c   Erondu, N ^c   Yu, Q ^c   Suryawanshi, S ^c   Jones, M E ^c   Johnson Levonas, A O ^c   Heymsfield, S B ^c   Kaufman, K D ^c   Amatruda, J M ^c  

^a UNIVERSITY OF MELBOURNE   (Australia)

^b HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^c MERCK RESEARCH LABORATORIES   (United States)

Author keywords

cannabinoid 1 receptor; endocannabinoid; randomized clinical trial

Indexed keywords

GLUCOSE; LIPID; PLACEBO; TARANABANT; TRIACYLGLYCEROL;

ADULT; AGGRESSION; ANGER; ANXIETY DISORDER; ARTHRALGIA; ARTICLE; BACKACHE; BODY FAT; BODY MASS; BODY WEIGHT; BRONCHITIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; FLUSHING; GASTROENTERITIS; GLUCOSE BLOOD LEVEL; HEADACHE; HOT FLUSH; HUMAN; INFLUENZA; INSOMNIA; IRRITABILITY; LIPID BLOOD LEVEL; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MOOD DISORDER; NAUSEA; OBESITY; OBSERVATIONAL STUDY; POSITIONAL DIZZINESS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE BLIND PROCEDURE; SINUSITIS; TRIACYLGLYCEROL BLOOD LEVEL; UPPER RESPIRATORY TRACT INFECTION; WAIST CIRCUMFERENCE; WEIGHT REDUCTION;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; AMIDES; ANTI-OBESITY AGENTS; BODY WEIGHT; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; OBESITY; PYRIDINES; QUESTIONNAIRES; RECEPTOR, CANNABINOID, CB1; WEIGHT LOSS; YOUNG ADULT;

EID: 77955472298     PISSN: 03070565     EISSN: 14765497     Source Type: Journal    
DOI: 10.1038/ijo.2010.38     Document Type: Article

References (22)

1. Clinical guidelines on the identification, evaluation treatment of overweight obesity in adultsFthe evidence report national institutes of health. Obes Res 1998; 6 (Suppl 2): 51S-209S.
2. WHO. Obesity:preventing and managing the global epidemic. Report of a WHO consultant. World Health Organ Tech Rep Ser 2000 2008; 894: 1-253.
3. Bray GA. Medical Mangement of Obesity. In: Bray GA, Bouchard C. (eds). Handbook of Obesity: Clinical Applications. Informa Healthcare: New York, NY, 2008. pp 227-484.
4. Li Z, Maglione M, Tu W, Mojica W, Arterburn D, Shugarman LR et al. Meta-analysis: pharmacologic treatment of obesity. Ann Intern Med 2005; 142: 532-546.
5. 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.
6. Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin J, Rosenstock J. 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.
7. Rucker D, Padwal R, Li SK, Curioni C, Lau DC. Long term pharmacotherapy for obesity and overweight: updated meta-analysis. BMJ 2007; 335: 1194-1199.
8. Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet 2006; 368: 1660-1672.
9. Van Gaal LF, Rissanen AM, Scheen AJ, Ziegler O, Rossner S. 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. (Pubitemid 40523733)
10. Van Gaal LF, Scheen AJ, Rissanen AM, Rossner S, Hanotin C, Ziegler O. Long-term effect of CB1 blockade with rimonabant on cardiometabolic risk factors: two year results from the RIO-Europe Study. Eur Heart J 2008; 29: 1761-1771.
11. Addy C, Wright H, Van Laere K, Gantz I, Erondu N, Musser BJ et al. The acyclic CB1R inverse agonist taranabant mediates weight loss by increasing energy expenditure and decreasing caloric intake. Cell Metab 2008; 7: 68-78.
12. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001; 16: 606-613.
13. Addy C, Cote J, Li S, Agrawal N, Majumdar A, Li H et al. Taranbant plasma concentrations are increased when co-administered with ketoconazole or ditiazem. Obesity, Program Abstract Supplement 2007; A147.
14. Keller SD, Bayliss MS, Ware Jr JE, Hsu MA, Damiano AM, Goss TF. Comparison of responses to SF-36volume: health survey questions with one-week and four-week recall periods. Health Serv Res 1997; 32: 367-384.
15. Kolotkin RL, Crosby RD, Kosloski KD, Williams GR. Development of a brief measure to assess quality of life in obesity. Obes Res 2001; 9: 102-111.
16. Wechsler D. WAIS-III WMS-III Technical Manual. The Psychological Corporations, Harcout Brace and Company: San Antonia, TX, 1997.
17. McNair DM, Lorr M, Droppleman LF. Manual for the Profile of Mood States (POMS). Educational and Industrial Testing Service: San Diego, CA, 1971.
18. Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. primary care evaluation of mental disorders patient health questionnaire. JAMA 1999; 282: 1737-1744
19. Department of Health Human Services Public Health Service Food Drug Administration Center for Drug Evaluation Research Memorandum N12. Overview for December Meeting of Psycho-pharmacologic Drug Advisory Committee (PDAC) Appendix 2 Request to SponsorsFAdvice for the pharmaceutical industry in exploring their placebo-controlled clinical trials databases for suicidality and preparing data sets for analysis by FDA. http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006- 4272b1-01-FDA. pdf 2006; 128-137.
20. Posner K, Oquendo MA, Gould M, Stanley B, Davies M. Columbia classification algorithm of suicide assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Am J Psychiatry 2007; 164: 1035-1043.
21. Katz A, Nambi SS, Mather K, Baron AD, Follmann DA, Sullivan G et al. Quantitative insulin sensitivity check index: a simple, accurate method for assessing insulin sensitivity in humans. J Clin Endocrinol Metab 2000; 85/7: 2402-2410.
22. Aronne LJ, Tonstad S, Moreno M, Gantz I, Erondu N, Suryawanshi S et al. A clinical trial assessing the safety and efficacy of taranabant, a CB1R inverse agonist, in obese and overweight patients: a high-dose study. Int J Obesity 2010 (in press).