Drug safety evaluation of naltrexone/bupropion for the treatment of obesity

Bibliography

• Lankford T, Hardman D, Dankmeyer C, et al. Analysis of state obesity legislation from 2001 to 2010. J Public Health Manag Pract 2013;19(3 Suppl 1):S114-18
   PubMedGoogle Scholar
• Barker LE, Kirtland KA, Gregg EW, et al. Geographic distribution of diagnosed diabetes in the U.S.: a diabetes belt. Am J Prev Med 2011;40(4):434-9
   PubMed Web of Science ®Google Scholar
• UN-FAO. Food and Agriculture Organizations of the United Nations. The state of food and agriculture. FAO, Rome, Italy; 2013. p. 114
   Google Scholar
• Ford ES, Mokdad AH, Giles WH, et al. Geographic variation in the prevalence of obesity, diabetes, and obesity-related behaviors. Obes Res 2005;13(1):118-22
   PubMedGoogle Scholar
• Hursting SD, Berger NA. Energy balance, host-related factors, and cancer progression. J Clin Oncol 2010;28(26):4058-65
   PubMed Web of Science ®Google Scholar
• Li F, Fisher KJ, Harmer P. Prevalence of overweight and obesity in older U.S. adults: estimates from the 2003 Behavioral Risk Factor Surveillance System survey. J Am Geriatr Soc 2005;53(4):737-9
   PubMed Web of Science ®Google Scholar
• Danielsen KK, Sundgot-Borgen J, Maehlum S, et al. Beyond weight reduction: Improvements in quality of life after an intensive lifestyle intervention in subjects with severe obesity. Ann Med 2014. [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• NHLBI Obesity Education Initiative. The practical guide identification, evaluation, and treatment of overweight and obesity in adults. NIH Publication, NIH, Bethesda, MD; 2000
   Google Scholar
• Picot J, Jones J, Colquitt JL, et al. The clinical effectiveness and cost-effectiveness of bariatric (weight loss) surgery for obesity: a systematic review and economic evaluation. Health Technol Assess 2009;13(41):1-190; 215-357, iii-iv
   Web of Science ®Google Scholar
• Jensen C, Flum DR. The costs of nonsurgical and surgical weight loss interventions: is an ounce of prevention really worth a pound of cure? Surg Obes Relat Dis 2005;1(3):353-7
   PubMedGoogle Scholar
• Salem L, Jensen CC, Flum DR. Are bariatric surgical outcomes worth their cost? A systematic review. J Am Coll Surg 2005;200(2):270-8
   PubMed Web of Science ®Google Scholar
• Basu A. Forecasting distribution of body mass index in the United States: is there more room for growth? Med Decis Making 2010;30(3):E1-E11
   PubMed Web of Science ®Google Scholar
• FDA. Guidance for industry developing products for weight management. FDA, Rockville, MD; 2007. 7533dft (01/31/2007) p. 1-16
   Google Scholar
• Garcia Diaz E, Martin Folgueras T. Systematic review of the clinical efficacy of sibutramine and orlistat in weight loss, quality of life and its adverse effects in obese adolescents. Nutr Hosp 2011;26(3):451-7
   PubMed Web of Science ®Google Scholar
• Acharya NV, Wilton LV, Shakir SA. Safety profile of orlistat: results of a prescription-event monitoring study. Int J Obes (Lond) 2006;30(11):1645-52
   PubMed Web of Science ®Google Scholar
• Rucker D, Padwal R, Li SK, et al. Long term pharmacotherapy for obesity and overweight: updated meta-analysis. BMJ 2007;335(7631):1194-9
   PubMed Web of Science ®Google Scholar
• Filippatos TD, Derdemezis CS, Gazi IF, et al. Orlistat-associated adverse effects and drug interactions: a critical review. Drug Saf 2008;31(1):53-65
   PubMed Web of Science ®Google Scholar
• McClendon KS, Riche DM, Uwaifo GI. Orlistat: current status in clinical therapeutics. Expert Opin Drug Saf 2009;8(6):727-44
   PubMed Web of Science ®Google Scholar
• Connery TP. Orlistat over the counter: is it worth it? BMJ 2008;336(7634):7
   PubMed Web of Science ®Google Scholar
• FDA. NDA 22580 VI-0521 (Qnexa) Briefing Document, 2012 (22-Feb-2012 )
   Google Scholar
• Derosa G, Maffioli P. Anti-obesity drugs: a review about their effects and their safety. Expert Opin Drug Saf 2012;11(3):459-71
   PubMed Web of Science ®Google Scholar
• Rothman RB, Hendricks EJ. Phentermine cardiovascular safety. Am J Emerg Med 2009;27(8):1010-13
   PubMed Web of Science ®Google Scholar
• FDA. Risk of oral clefts in children born to mothers taking Topamax (topiramate)[03-04-2011] Drug Safety Communication, 2011 (07-March-2011).
   Google Scholar
• VIVUS. Qysmia- Package Insert 2013
   Google Scholar
• Davidson MH, Tonstad S, Oparil S, et al. Changes in cardiovascular risk associated with phentermine and topiramate extended-release in participants with comorbidities and a body mass index ≥ 27 kg/m(2). Am J Cardiol 2013;111(8):1131-8
   PubMed Web of Science ®Google Scholar
• James WP, Caterson ID, Coutinho W, et al. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med 2010;363(10):905-17
   PubMed Web of Science ®Google Scholar
• Padwal R. Contrave, a bupropion and naltrexone combination therapy for the potential treatment of obesity. Curr Opin Investig Drugs 2009;10(10):1117-25
   PubMed Web of Science ®Google Scholar
• Ginzburg HM, Glass WJ. The role of the National Institute on Drug Abuse in the development of naltrexone. J Clin Psychiatry 1984;45(9 Pt 2):4-6
   PubMed Web of Science ®Google Scholar
• Lobmaier P, Kornor H, Kunoe N, et al. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev 2008(2):CD006140
   PubMed Web of Science ®Google Scholar
• Mannelli P, Gottheil E, Peoples JF, et al. Chronic very low dose naltrexone administration attenuates opioid withdrawal expression. Biol Psychiatry 2004;56(4):261-8
   PubMed Web of Science ®Google Scholar
• Lee MC, Wagner HN Jr, Tanada S, et al. Duration of occupancy of opiate receptors by naltrexone. J Nucl Med 1988;29(7):1207-11
   PubMed Web of Science ®Google Scholar
• Hyman SM, Fox H, Hong KI, et al. Stress and drug-cue-induced craving in opioid-dependent individuals in naltrexone treatment. Exp Clin Psychopharmacol 2007;15(2):134-43
   PubMed Web of Science ®Google Scholar
• Pettinati HM, O'Brien CP, Rabinowitz AR, et al. The status of naltrexone in the treatment of alcohol dependence: specific effects on heavy drinking. J Clin Psychopharmacol 2006;26(6):610-25
   PubMed Web of Science ®Google Scholar
• Chamorro AJ, Marcos M, Miron-Canelo JA, et al. Association of micro-opioid receptor (OPRM1) gene polymorphism with response to naltrexone in alcohol dependence: a systematic review and meta-analysis. Addict Biol 2012;17(3):505-12
   PubMed Web of Science ®Google Scholar
• Greenstein RA, Arndt IC, McLellan AT, et al. Naltrexone: a clinical perspective. J Clin Psychiatry 1984;45(9 Pt 2):25-8
   PubMed Web of Science ®Google Scholar
• Sullivan MA, Vosburg SK, Comer SD. Depot naltrexone: antagonism of the reinforcing, subjective, and physiological effects of heroin. Psychopharmacology (Berl) 2006;189(1):37-46
   PubMed Web of Science ®Google Scholar
• Leri F, Burns LH. Ultra-low-dose naltrexone reduces the rewarding potency of oxycodone and relapse vulnerability in rats. Pharmacol Biochem Behav 2005;82(2):252-62
   PubMed Web of Science ®Google Scholar
• Richardson DK, Reynolds SM, Cooper SJ, et al. Endogenous opioids are necessary for benzodiazepine palatability enhancement: naltrexone blocks diazepam-induced increase of sucrose-‘liking'. Pharmacol Biochem Behav 2005;81(3):657-63
   PubMed Web of Science ®Google Scholar
• Taha SA, Norsted E, Lee LS, et al. Endogenous opioids encode relative taste preference. Eur J Neurosci 2006;24(4):1220-6
   PubMed Web of Science ®Google Scholar
• Grimm JW, Manaois M, Osincup D, et al. Naloxone attenuates incubated sucrose craving in rats. Psychopharmacology (Berl) 2007;194(4):537-44
   PubMed Web of Science ®Google Scholar
• Benjamin D, Grant ER, Pohorecky LA. Naltrexone reverses ethanol-induced dopamine release in the nucleus accumbens in awake, freely moving rats. Brain Res 1993;621(1):137-40
   PubMed Web of Science ®Google Scholar
• Valenta JP, Job MO, Mangieri RA, et al. Mu-opioid receptors in the stimulation of mesolimbic dopamine activity by ethanol and morphine in Long-Evans rats: a delayed effect of ethanol. Psychopharmacology (Berl) 2013;228(3):389-400
   PubMed Web of Science ®Google Scholar
• Kelley AE, Berridge KC. The neuroscience of natural rewards: relevance to addictive drugs. J Neurosci 2002;22(9):3306-11
   PubMed Web of Science ®Google Scholar
• Atkinson RL, Berke LK, Drake CR, et al. Effects of long-term therapy with naltrexone on body weight in obesity. Clin Pharmacol Ther 1985;38(4):419-22
   PubMed Web of Science ®Google Scholar
• Malcolm R, O'Neil PM, Sexauer JD, et al. A controlled trial of naltrexone in obese humans. Int J Obes 1985;9(5):347-53
   PubMed Web of Science ®Google Scholar
• Mitchell JE, Morley JE, Levine AS, et al. High-dose naltrexone therapy and dietary counseling for obesity. Biol Psychiatry 1987;22(1):35-42
   PubMed Web of Science ®Google Scholar
• Hatsukami DK, Mitchell JE, Morley JE, et al. Effect of naltrexone on mood and cognitive functioning among overweight men. Biol Psychiatry 1986;21(3):293-300
   PubMed Web of Science ®Google Scholar
• Hyman BT, Eslinger PJ, Damasio AR. Effect of naltrexone on senile dementia of the Alzheimer type. J Neurol Neurosurg Psychiatry 1985;48(11):1169-71
   PubMed Web of Science ®Google Scholar
• Pfohl DN, Allen JI, Atkinson RL, et al. Naltrexone hydrochloride (Trexan): a review of serum transaminase elevations at high dosage. NIDA Res Monogr 1986;67:66-72
   PubMedGoogle Scholar
• Yen MH, Ko HC, Tang FI, et al. Study of hepatotoxicity of naltrexone in the treatment of alcoholism. Alcohol 2006;38(2):117-20
   PubMed Web of Science ®Google Scholar
• Garbutt JC. Efficacy and tolerability of naltrexone in the management of alcohol dependence. Curr Pharm Des 2010;16(19):2091-7
   PubMed Web of Science ®Google Scholar
• Dhillon S, Yang LP, Curran MP. Bupropion: a review of its use in the management of major depressive disorder. Drugs 2008;68(5):653-89
   PubMed Web of Science ®Google Scholar
• Jefferson JW, Rush AJ, Nelson JC, et al. Extended-release bupropion for patients with major depressive disorder presenting with symptoms of reduced energy, pleasure, and interest: findings from a randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2006;67(6):865-73
   PubMed Web of Science ®Google Scholar
• Johnston JA, Ascher J, Leadbetter R, et al. Pharmacokinetic optimisation of sustained-release bupropion for smoking cessation. Drugs 2002;62:11-24
   PubMed Web of Science ®Google Scholar
• Ascher JA, Cole JO, Colin JN, et al. Bupropion: a review of its mechanism of antidepressant activity. J Clin Psychiatry 1995;56(9):395-401
   PubMed Web of Science ®Google Scholar
• Fava M, Rush AJ, Thase ME, et al. 15 years of clinical experience with bupropion HCl: from bupropion to bupropion SR to bupropion XL. Prim Care Companion J Clin Psychiatry 2005;7(3):106-13
   PubMedGoogle Scholar
• Demyttenaere K, Jaspers L. Review: bupropion and SSRI-induced side effects. J Psychopharmacol 2008;22(7):792-804
   PubMed Web of Science ®Google Scholar
• Menaster MJ. Weight gain, sexual dysfunction, and bupropion. J Clin Psychiatry 2005;66(10):1335-6; author reply 1336-9
   PubMed Web of Science ®Google Scholar
• Thase ME. Bipolar depression: issues in diagnosis and treatment. Harv Rev Psychiatry 2005;13(5):257-71
   PubMed Web of Science ®Google Scholar
• Fryer JD, Lukas RJ. Noncompetitive functional inhibition at diverse, human nicotinic acetylcholine receptor subtypes by bupropion, phencyclidine, and ibogaine. J Pharmacol Exp Ther 1999;288(1):88-92
   PubMed Web of Science ®Google Scholar
• Paterson NE. Behavioural and pharmacological mechanisms of bupropion's anti-smoking effects: recent preclinical and clinical insights. Eur J Pharmacol 2009;603(1-3):1-11
   PubMed Web of Science ®Google Scholar
• Fergusson D, Doucette S, Glass KC, et al. Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials. BMJ 2005;330(7488):396
   PubMed Web of Science ®Google Scholar
• Wightman DS, Foster VJ, Krishen A, et al. Meta-analysis of suicidality in placebo-controlled clinical trials of adults taking bupropion. Prim Care Companion J Clin Psychiatry 2010;12(5). pii: PCC.09m00894, doi:10.4088/PCC.09m00894blu.
   PubMedGoogle Scholar
• Beyens MN, Guy C, Mounier G, et al. Serious adverse reactions of bupropion for smoking cessation: analysis of the French Pharmacovigilance Database from 2001 to 2004. Drug Saf 2008;31(11):1017-26
   PubMed Web of Science ®Google Scholar
• James WA, Lippmann S. Bupropion: overview and prescribing guidelines in depression. South Med J 1991;84(2):222-4
   PubMed Web of Science ®Google Scholar
• Sheehan DV, Welch JB, Fishman SM. A case of bupropion-induced seizure. J Nerv Ment Dis 1986;174(8):496-8
   PubMed Web of Science ®Google Scholar
• Horne RL, Ferguson JM, Pope HG Jr, et al. Treatment of bulimia with bupropion: a multicenter controlled trial. J Clin Psychiatry 1988;49(7):262-6
   PubMed Web of Science ®Google Scholar
• Settle EC, Stahl SM, Batey SR, et al. Safety profile of sustained-release bupropion in depression: results of three clinical trials. Clin Ther 1999;21(3):454-63
   PubMed Web of Science ®Google Scholar
• Jain AK, Kaplan RA, Gadde KM, et al. Bupropion SR vs. placebo for weight loss in obese patients with depressive symptoms. Obes Res 2002;10(10):1049-56
   PubMedGoogle Scholar
• Anderson JW, Greenway FL, Fujioka K, et al. Bupropion SR enhances weight loss: a 48-week double-blind, placebo- controlled trial. Obes Res 2002;10(7):633-41
   PubMedGoogle Scholar
• 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):30-9
   PubMed Web of Science ®Google Scholar
• Kelly MJ, Loose MD, Ronnekleiv OK. Opioids hyperpolarize beta-endorphin neurons via mu-receptor activation of a potassium conductance. Neuroendocrinology 1990;52(3):268-75
   PubMed Web of Science ®Google Scholar
• Greenway FL, Fujioka K, Plodkowski RA, et al. 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
   PubMed Web of Science ®Google Scholar
• Apovian CM, Aronne L, Rubino D, et al. 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):935-43
   PubMed Web of Science ®Google Scholar
• 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):110-20
   PubMed Web of Science ®Google Scholar
• Hollander P, Gupta AK, Plodkowski R, et al. Effects of naltrexone sustained-release/bupropion sustained-release combination therapy on body weight and glycemic parameters in overweight and obese patients with type 2 diabetes. Diabetes Care 2013;36(12):4022-9
   PubMed Web of Science ®Google Scholar
• FDA. NDA 200063 Contrave (Naltrexone 4mg, 8mg/Bupropion HCL 90mg extended release tablet) Briefing Document, 2010 Advisory Committee- December 7, 2010
   Google Scholar
• FDA. Risk of oral clefts in children born to mothers taking Topamax (topiramate)[03-04-2011] Drug Safety Communication, 2011
   Google Scholar
• 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) 2013; Epub ahead of print
   Web of Science ®Google Scholar
• Hsu LK, Mulliken B, McDonagh B, et al. Binge eating disorder in extreme obesity. Int J Obes Relat Metab Disord 2002;26(10):1398-403
   PubMed Web of Science ®Google Scholar
• White MA, Grilo CM. Bupropion for overweight women with binge-eating disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 2013;74(4):400-6
   PubMed Web of Science ®Google Scholar