Naltrexone sustained-release/bupropion sustained-release for the management of obesity: Review of the data to date

Drug Design, Development and Therapy

Volumn 8, Issue , 2014, Pages 1419-1427

  Caixàs, Assumpta ^a   Albert, Lara ^a   Capel, Ismael ^a   Rigla, Mercedes ^a  

^a UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

Author keywords

Cancer; Cardiovascular disease; Contrave; Diabetes; Overweight; Weight loss

Indexed keywords

ALPHA INTERMEDIN; AMFEBUTAMONE; AMFEBUTAMONE PLUS NALTREXONE; BETA ENDORPHIN; NALTREXONE; PLACEBO; PROOPIOMELANOCORTIN; ANTIOBESITY AGENT; BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHORIDE DRUG COMBINATION; DRUG COMBINATION;

ABDOMINAL PAIN; APPETITE; BRAIN REGION; CARDIOVASCULAR RESPONSE; CHOLECYSTITIS; CONSTIPATION; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DRUG APPROVAL; DRUG EFFICACY; DRUG MECHANISM; DRUG RESPONSE; DRUG SAFETY; HEADACHE; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HUMAN; NAUSEA; NERVE CELL; NONHUMAN; OBESITY; PHARMACOLOGICAL BLOCKING; PHASE 2 CLINICAL TRIAL (TOPIC); PROTEIN CLEAVAGE; PROTEIN SECRETION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SATIETY; SEIZURE; SMOKING CESSATION; SUSTAINED DRUG RELEASE; SYSTEMATIC REVIEW; SYSTOLIC BLOOD PRESSURE; TINNITUS; TREATMENT DURATION; TREMOR; WEIGHT REDUCTION; XEROSTOMIA; DRUG COMBINATION;

ANTI-OBESITY AGENTS; BUPROPION; DRUG COMBINATIONS; HUMANS; NALTREXONE; OBESITY;

EID: 84908055935     PISSN: None     EISSN: 11778881     Source Type: Journal    
DOI: 10.2147/DDDT.S55587     Document Type: Review

References (66)

1. Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity in the United States, 2009-2010. NCHS Data Brief. 2012;(82):1-8.
2. Finkelstein EA, Khavjou OA, Thompson H, et al. Obesity and severe obesity forecasts through 2030. Am J Prev Med. 2012;42(6):563-570.
3. Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer- and service-specific estimates. Health Aff (Millwood). 2009;28:5w822-5w831.
4. National Heart, Lung and Blood Institute (NHLBI) Obesity Education Initiative Expert Panel on the Identification, Evaluation, and Treatment of Obesity in Adults (US). Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report. Report number 98-4083. Bethesda, MD: NHLBI; 1998. Available from: http://www.ncbi.nlm.nih.gov/books/NBK2003/. Accessed May 15, 2014.
5. Berrington de Gonzalez A, Hartge P, Cerhan JR, et al. Body-mass index and mortality among 1.46 million white adults. N Engl J Med. 2010;363(23):2211-2219.
6. George M, Rajaram M, Shanmugam E. New and emerging drug molecules against obesity. J Cardiovasc Pharmacol Ther. 2014;19(1):65-76.
7. Weight-Control Information Network (WIN). Prescription Medications for the Treatment of Obesity. Bethesda, MD: National Institutes of Health; 2009. Available from: http://www.win.niddk.nih.gov/publications/PDFs/Prescription_Medications.pdf. Accessed May 1, 2014.
8. Rodgers RJ, Tschöp MH, Wilding JP. Anti-obesity drugs: past, present and future. Dis Model Mech. 2012;5(5):621-626.
9. Ling H, Lenz TL, Burns TL, Hilleman DE. Reducing the risk of obesity: defining the role of weight loss drugs. Pharmacotherapy. 2013;33(12):1308-1321.
10. Klonoff DC, Greenway F. Drugs in the pipeline for the obesity market. J Diabetes Sci Technol. 2008;2(5):913-918.
11. Kaplan LM. Pharmacological therapies for obesity. Gastroenterol Clin North Am. 2005;34(1):91-104.
12. Halford JC, Boyland EJ, Blundell JE, Kirkham TC, Harrold JA. Pharmacological management of appetite expression in obesity. Nat Rev Endocrinol. 2010;6(5):255-269.
13. Nathan PJ, O'Neill BV, Napolitano A, Bullmore ET. Neuropsychiatric adverse effects of centrally acting antiobesity drugs. CNS Neurosci Ther. 2011;17(5):490-505.
14. Ioannides-Demos LL, Piccenna L, McNeil JJ. Pharmacotherapies for obesity: past, current, and future therapies. J Obes. 2011;2011:179674.
15. Witkamp RF. Current and future drug targets in weight management. Pharm Res. 2011;28(8):1792-1818.
16. Bray GA, Ryan DH. Drug treatment of obesity. Psychiatr Clin N Am. 2011;34(4):871-880.
17. Hiatt WR, Thomas A, Goldfine AB. What cost weight loss? Circulation. 2012;125(9):1171-1177.
18. Carter R, Mouralidarane A, Ray S, Soeda J, Oben J. Recent advancements in drug treatment of obesity. Clin Med. 2012;12(5):456-460.
19. Derosa G, Maffioli P. Anti-obesity drugs: a review about their effects and their safety. Expert Opin Drug Saf. 2012;11(3):459-471.
20. Chugh PK, Sharma S. Recent advances in the pathophysiology and pharmacological treatment of obesity. J Clin Pharm Ther. 2012;37(5):525-535.
21. Heal DJ, Gosden J, Smith SL. What is the prognosis for new centrally-acting anti-obesity drugs? Neuropharmacology. 2012;63(1):132-146.
22. Ryan DH, Bray GA. Pharmacologic treatment options for obesity: what is old is new again. Curr Hypertens Rep. 2013;15(3):182-189.
23. Boulghassoul-Pietrzykowska N, Franceschelli J, Still C. New medications for obesity management: changing the landscape of obesity treatment. Curr Opin Endocrinol Diabetes Obes. 2013;20(5):407-411.
24. Heal DJ, Gosden J, Smith SL. A review of late-stage CNS drug candidates for the treatment of obesity. Int J Obes (Lond). 2013;37(1):107-117.
25. Howland RH. Therapies for obesity and medication-associated weight gain. J Psychosoc Nurs Ment Health Serv. 2013;51(5):13-16.
26. Rueda-Clausen CF, Padwal RS, Sharma AM. New pharmacological approaches for obesity management. Nat Rev Endocrinol. 2013;9(8):467-478.
27. Clapper JR, Athanacio J, Wittmer C, et al. Effects of amylin and bupropion/naltrexone on food intake and body weight are interactive in rodent models. Eur J Pharmacol. 2013;698(1-3):292-298.
28. Greenway FL, Whitehouse MJ, Guttadauria M, et al. Rational design of a combination medication for the treatment of obesity. Obesity (Silver Spring). 2009;17(1):30-39.
29. Lee MW, Fujioka K. Naltrexone for the treatment of obesity: review and update. Expert Opin Pharmacother. 2009;10(11):1841-1845.
30. Plodkowski RA, Nguyen Q, Sundaram U, Nguyen L, Chau DL, St Jeor S. Bupropion and naltrexone: a review of their use individually and in combination for the treatment of obesity. Expert Opin Pharmacother. 2009;10(6):1069-1081.
31. Greenway FL, Dunayevich E, Tollefson G, et al; NB-201 Study Group. Comparison of combined bupropion and naltrexone therapy for obesity with monotherapy and placebo. J Clin Endocrinol Metab. 2009;94(12):4898-4906.
32. Wilcox CS, Oskooilar N, Erickson JS, et al. An open-label study of naltrexone and bupropion combination therapy for smoking cessation in overweight and obese subjects. Addict Behav. 2010;35(3):229-234.
33. Naltrexone/bupropion: Contrave(R); naltrexone SR/bupropion SR. Drugs R D. 2010;10(1):25-32.
34. Citrome L. Miracle pills for weight loss: what is the number needed to treat, number needed to harm and likelihood to be helped or harmed for naltrexone-bupropion combination? Int J Clin Pract. 2010;64(11):1462-1465.
35. Astrup A. Is cardiometabolic risk improved by weight-loss drugs? Lancet. 2010;376(9741):567-568.
36. Greenway FL, Fujioka K, Plodkowski RA, et al; COR-I Study Group. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2010;376(9741):595-605.
37. New obesity pill: new hopes, old fears. Lancet. 2010; 376(9758):2042.
38. Mercer SL. ACS chemical neuroscience molecule spotlight on contrave. ACS Chem Neurosci. 2011;2(9):484-486.
39. Katsiki N, Hatzitolios AI, Mikhailidis DP. Naltrexone sustained-release (SR) + bupropion SR combination therapy for the treatment of obesity: 'a new kid on the block'? Ann Med. 2011;43(4):249-258.
40. Ornellas T, Chavez B. Naltrexone SR/Bupropion SR (Contrave): A New Approach to Weight Loss in Obese Adults. P T. 2011;36(5):255-262.
41. Halpern B, Faria AM, Halpern A. Bupropion/naltrexone fixed-dose combination for the treatment of obesity. Drugs Today (Barc). 2011;47(8):575-581.
42. Billes SK, Greenway FL. Combination therapy with naltrexone and bupropion for obesity. Expert Opin Pharmacother. 2011;12(11): 1813-1826.
43. Plutzky J, Chilton R, Still C, Burns C, Kim D, Dunayevich E. Weight loss, blood pressure, pulse and circadian patterns with naltrexone sustained-release/Bupropion sustained-release combination therapy for obesity. J Am Coll Cardiol. 2011;57(14s1):E517.
44. Reece AS. Hypothalamic opioid-melanocortin appetitive balance and addictive craving. Med Hypotheses. 2011;76(1):132-137.
45. Makowski CT, Gwinn KM, Hurren KM. Naltrexone/bupropion: an investigational combination for weight loss and maintenance. Obes Facts. 2011;4(6):489-494.
46. Wadden TA, Foreyt JP, Foster GD, et al. Weight loss with naltrexone SR/bupropion SR combination therapy as an adjunct to behavior modification: the COR-BMOD trial. Obesity (Silver Spring). 2011;19(1):110-120.
47. Smith SR, Fujioka K, Gupta AK, et al. Combination therapy with naltrexone and bupropion for obesity reduces total and visceral adiposity. Diabetes Obes Metab. 2013;15(9):863-866.
48. Apovian CM, Aronne L, Rubino D, et al; COR-II Study Group. A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II). Obesity (Silver Spring). 2013;21(5):935-943.
49. McElroy SL, Guerdjikova AI, Kim DD, et al. Naltrexone/Bupropion combination therapy in overweight or obese patients with major depressive disorder: results of a pilot study. Prim Care Companion CNS Disord. 2013;15(3):pii:PCC.12m01494.
50. Wang GJ, Tomasi D, Volkow ND, et al. Effect of combined naltrexone and bupropion therapy on the brain's reactivity to food cues. Int J Obes (Lond). 2014;38(5):682-688.
51. Woods SC, D'Alessio DA. Central control of body weight and appetite. J Clin Endocrinol Metab. 2008;93(11 Suppl 1):S37-S50.
52. Gadde KM, Parker CB, Maner LG, et al. Bupropion for weight loss: an investigation of efficacy and tolerability in overweight and obese women. Obes Res. 2001;9(9):544-551.
53. Anderson JW, Greenway FL, Fujioka K, Gadde KM, McKenney J, O'Neil PM. Bupropion SR enhances weight loss: a 48-week double-blind, placebo-controlled trial. Obes Res. 2002;10(7):633-642.
54. Lobmaier PP, Kunøe N, Gossop M, Waal H. Naltrexone depot formulations for opioid and alcohol dependence: a systematic review. CNS Neurosci Ther. 2011;17(6):629-636.
55. Naltrexone hydrochloride tablets USP 50 mg [prescribing information]. St Louis, MO: Mallinckrodt. Available from: http://www.mallinckrodt.com/WorkArea/DownloadAsset.aspx?id=1943. Accessed August 1, 2014.
56. Holtzman SG. Suppression of appetitive behavior in the rat by naloxone: lack of effect of prior morphine dependence. Life Sci. 1979;24(3):219-226.
57. Yeomans MR, Gray RW. Opioid peptides and the control of human ingestive behaviour. Neurosci Biobehav Rev. 2002;26(6):713-728.
58. Fantino M, Hosotte J, Apfelbaum M. An opioid antagonist, naltrexone, reduces preference for sucrose in humans. Am J Physiol. 1986;251(1 Pt 2):R91-R96.
59. Spiegel TA, Stunkard AJ, Shrager EE, O'Brien CP, Morrison MF, Stellar E. Effect of naltrexone on food intake, hunger, and satiety in obese men. Physiol Behav. 1987;40(2):135-141.
60. Atkinson RL, Berke LK, Drake CR, Bibbs ML, Williams FL, Kaiser DL. Effects of long-term therapy with naltrexone on body weight in obesity. Clin Pharmacol Ther. 1985;38(4):419-422.
61. Maggio CA, Presta E, Bracco EF, et al. Naltrexone and human eating behavior: a dose-ranging inpatient trial in moderately obese men. Brain Res Bull. 1985;14(6):657-661.
62. Malcolm R, O'Neil PM, Sexauer JD, Riddle FE, Currey HS, Counts C. A controlled trial of naltrexone in obese humans. Int J Obes. 1985;9(5):347-353.
63. de Zwaan M, Mitchell JE. Opiate antagonists and eating behavior in humans: a review. J Clin Pharmacol. 1992;32(12):1060-1072.
64. Mitchell JE, Morley JE, Levine AS, Hatsukami D, Gannon M, Pfohl D. High-dose naltrexone therapy and dietary counseling for obesity. Biol Psychiatry. 1987;22(1):35-42.
65. Korner J, Leibel RL. To eat or not to eat - how the gut talks to the brain. N Engl J Med. 2003;349(10):926-928.
66. Orexigen Therapeutics, Inc. Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study) In: ClinicalTrials.gov [website on the Internet]. Bethseda, MD: US National Library of Medicine; 2012 [updated May 20, 2014]. Available from: http://clinicaltrials.gov/show/NCT01601704. NLM identifier: NCT01601704. Accessed June 6, 2014.