Phentermine and topiramate for the management of obesity: A review

Drug Design, Development and Therapy

Volumn 7, Issue , 2013, Pages 267-278

  Cosentino, Gina ^a   Conrad, Ariane O ^b   Uwaifo, Gabriel I ^a  

^a LOUISIANA STATE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b XAVIER UNIVERSITY OF LOUISIANA   (United States)

Author keywords

Anorexiants; Cardiovascular risk factors; Dysmetabolic syndrome; Obesity; Obesity complications; Obesity pharmacotherapy

Indexed keywords

PHENTERMINE; PHENTERMINE RESIN; PLACEBO; TOPIRAMATE; ANTIOBESITY AGENT; FRUCTOSE;

ABDOMINAL PAIN; AGITATION; ANHIDROSIS; ANOREXIA; ANXIETY; ATAXIA; BIPOLAR DISORDER; BIPOLAR I DISORDER; BLURRED VISION; CENTRAL NERVOUS SYSTEM DISEASE; CLOSED ANGLE GLAUCOMA; COGNITIVE DEFECT; CONSTIPATION; DEPRESSION; DIPLOPIA; DISEASE ASSOCIATION; DIZZINESS; DOSE RESPONSE; DRUG ABUSE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG RESEARCH; DRUG SAFETY; DRUG STRUCTURE; DRUG WITHDRAWAL; DYSGEUSIA; EVENING DOSAGE; GASTROINTESTINAL SYMPTOM; HEADACHE; HEART DISEASE; HUMAN; INSOMNIA; IRRITABILITY; KIDNEY TUBULE ACIDOSIS; MEMORY DISORDER; METABOLIC ACIDOSIS; MIGRAINE; MOOD DISORDER; MYOPIA; NEPHROLITHIASIS; NERVOUSNESS; NONHUMAN; OBESITY; PARESTHESIA; PRACTICE GUIDELINE; RECOMMENDED DRUG DOSE; REVIEW; RISK FACTOR; SCHIZOAFFECTIVE PSYCHOSIS; SEIZURE; SIDE EFFECT; TREATMENT INDICATION; TREMOR; VISUAL DISORDER; WEIGHT CONTROL; WEIGHT REDUCTION; WITHDRAWAL SYNDROME; XEROSTOMIA; ANALOGS AND DERIVATIVES; CLINICAL TRIAL (TOPIC); DRUG COMBINATION;

ANTI-OBESITY AGENTS; CLINICAL TRIALS AS TOPIC; DRUG THERAPY, COMBINATION; FRUCTOSE; HUMANS; OBESITY; PHENTERMINE;

EID: 84876041829     PISSN: 11778881     EISSN: None     Source Type: Journal    
DOI: 10.2147/DDDT.S31443     Document Type: Review

References (86)

1. Ahluwalia IB, Mack KA, Mokdad A. Report from the CDC. Changes in selected chronic disease-related risks and health conditions for nonpregnant women 18-44 years old BRFSS. J Womens Health (Larchmt). Jun 2005;14(5):382-386.
2. Ford ES, Mokdad AH, Giles WH, Galuska DA, Serdula MK. Geographic variation in the prevalence of obesity, diabetes, and obesity-related behaviors. Obes Res. Jan 2005;13(1):118-122.
3. Ford ES, Mokdad AH. Epidemiology of obesity in the Western Hemisphere. J Clin Endocrinol Metab. Nov 2008;93(11 Suppl 1):S1-S8.
4. Ford ES, Zhao G, Li C, Pearson WS, Mokdad AH. Trends in obesity and abdominal obesity among hypertensive and nonhypertensive adults in the United States. Am J Hypertens. Oct 2008;21(10):1124-1128.
5. Thorpe KE, Philyaw M. The medicalization of chronic disease and costs. Annu Rev Public Health. Apr 2012;33:409-423.
6. Khan A, Raza S, Khan Y, et al. Current updates in the medical management of obesity. Recent Pat Endocr Metab Immune Drug Discov. May 2012;6(2):117-128.
7. Plourde G, Prud'homme D. Managing obesity in adults in primary care. Cmaj. June 12, 2012;184(9):1039-1044.
8. Robinson GA, Geier M, Rizzolo D, Sedrak M. Childhood obesity: complications, prevention strategies, treatment. Jaapa. Dec 2011; 24(12):58-63.
9. Lakshman R, Elks CE, Ong KK. Childhood obesity. Circulation. October 2, 2012;126(14):1770-1779.
10. Holterman MJ, Le Holterman AX, Browne AF. Pediatric obesity. Surg Clin North Am. Jun 2012;92(3):559-582, viii.
11. Li Z, Heber D. Sarcopenic obesity in the elderly and strategies for weight management. Nutr Rev. Jan 2012;70(1):57-64.
12. Donini LM, Savina C, Gennaro E, et al. A systematic review of the literature concerning the relationship between obesity and mortality in the elderly. J Nutr Health Aging. Jan 2012;16(1):89-98.
13. Mathus-Vliegen EM. Prevalence, pathophysiology, health consequences and treatment options of obesity in the elderly: a guideline. Obes Facts. 2012;5(3):460-483.
14. Witkamp RF. Current and future drug targets in weight management. Pharm Res. Aug 2011;28(8):1792-1818.
15. Shekelle PG, Morton SC, Maglione M, et al. Pharmacological and surgical treatment of obesity. Evid Rep Technol Assess (Summ). Jul 2004;103:1-6.
16. Norris SL, Zhang X, Avenell A, Gregg E, Schmid CH, Lau J. Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2005;1:CD004096.
17. Chugh PK, Sharma S. Recent advances in the pathophysiology and pharmacological treatment of obesity. J Clin Pharm Ther. Oct 2012;37(5):525-535.
18. Ioannides-Demos LL, Piccenna L, McNeil JJ. Pharmacotherapies for obesity: past, current, and future therapies. J Obes. 2011;2011: 179674.
19. Derosa G, Maffioli P. Anti-obesity drugs: a review about their effects and their safety. Expert Opin Drug Saf. May 2012;11(3): 459-471.
20. Kushner RF, Manzano H. Obesity pharmacology: past, present, and future. Curr Opin Gastroenterol. Mar 2002;18(2):213-220.
21. Ioannides-Demos LL, Proietto J, McNeil JJ. Pharmacotherapy for obesity. Drugs. 2005;65(10):1391-1418.
22. Li Z, Maglione M, Tu W, et al. Meta-analysis: pharmacologic treatment of obesity. Ann Intern Med. April 5, 2005;142(7):532-546.
23. Halford JC, Boyland EJ, Blundell JE, Kirkham TC, Harrold JA. Pharmacological management of appetite expression in obesity. Nat Rev Endocrinol. May 2010;6(5):255-269.
24. Greenway FL, Bray GA. Combination drugs for treating obesity. Curr Diab Rep. Apr 2010;10(2):108-115.
25. Johnson AM. Two new drugs approved for obesity. S D Med. Sep 2012;65(9):356-357.
26. Taylor AA, Ragbir S. Three in one: safety, efficacy, and patient acceptability of triple fixed-dose combination medicine in the management of hypertension. Patient Prefer Adherence. 2012;6:555-563.
27. Taddei S. Fixed-dose combination therapy in hypertension: pros. High Blood Press Cardiovasc Prev. June 1, 2012;19(2):55-57.
28. Han S, Iglay K, Davies MJ, Zhang Q, Radican L. Glycemic effectiveness and medication adherence with fixed-dose combination or coadministered dual therapy of antihyperglycemic regimens: a meta-analysis. Curr Med Res Opin. Jun 2012;28(6):969-977.
29. Garcia-Donaire JA, Ruilope LM. 'Multiple action fixed combination. Present or future?' Fundam Clin Pharmacol. Feb 24(1):37-42.
30. Gerbino PP, Shoheiber O. Adherence patterns among patients treated with fixed-dose combination versus separate antihypertensive agents. Am J Health Syst Pharm. Jun 2007;64(12):1279-1283.
31. Bangalore S, Shahane A, Parkar S, Messerli FH. Compliance and fixed-dose combination therapy. Curr Hypertens Rep. Jun 2007;9(3): 184-189.
32. Sanz G, Fuster V. Polypill and global cardiovascular health strategies. Semin Thorac Cardiovasc Surg. Spring 2011;23(1):24-29.
33. Garcia-Donaire JA, Ruilope LM. 'Multiple action fixed combination. Present or future?' Fundam Clin Pharmacol. Feb 2010;24(1):37-42.
34. Klonoff DC, Greenway F. Drugs in the pipeline for the obesity market. J Diabetes Sci Technol. Sep 2008;2(5):913-918.
35. Atkinson RL, Blank RC, Schumacher D, Dhurandhar NV, Ritch DL. Long-term drug treatment of obesity in a private practice setting. Obes Res. Nov 1997;5(6):578-586.
36. Spitz AF, Schumacher D, Blank RC, Dhurandhar NV, Atkinson RL. Long-term pharmacologic treatment of morbid obesity in a community practice. Endocr Pract. Sep-Oct 1997;3(5):269-275.
37. Astrup A, Breum L, Toubro S, Hein P, Quaade F. The effect and safety of an ephedrine/caffeine compound compared to ephedrine, caffeine and placebo in obese subjects on an energy restricted diet. A double blind trial. Int J Obes Relat Metab Disord. Apr 1992;16(4): 269-277.
38. Weintraub M, Sundaresan PR, Schuster B, et al. Long-term weight control study. II (weeks 34 to 104). An open-label study of continuous fenfluramine plus phentermine versus targeted intermittent medication as adjuncts to behavior modification, caloric restriction, and exercise. Clin Pharmacol Ther. May 1992;51(5):595-601.
39. Weintraub M, Sundaresan PR, Madan M, et al. Long-term weight control study. I (weeks 0 to 34). The enhancement of behavior modification, caloric restriction, and exercise by fenfluramine plus phentermine versus placebo. Clin Pharmacol Ther. May 1992;51(5):586-594.
40. Astrup A, Toubro S, Cannon S, Hein P, Madsen J. Thermogenic synergism between ephedrine and caffeine in healthy volunteers: a double-blind, placebo-controlled study. Metabolism. Mar 1991;40(3): 323-329.
41. Mercer SL. ACS Chemical Neuroscience Molecule Spotlight on Contrave. ACS Chem Neurosci. September 21, 2011;2(9):484-486.
42. Ornellas T, Chavez B. Naltrexone SR/bupropion SR (contrave): a new approach to weight loss in obese adults. P T. May 2011;36(5): 255-262.
43. Greenway FL, Dunayevich E, Tollefson G, et al. Comparison of combined bupropion and naltrexone therapy for obesity with monotherapy and placebo. J Clin Endocrinol Metab. Dec 2009;94(12):4898-4906.
44. Greenway FL, Whitehouse MJ, Guttadauria M, et al. Rational design of a combination medication for the treatment of obesity. Obesity (Silver Spring). Jan 2009;17(1):30-39.
45. Gadde KM, Allison DB, Ryan DH, et al. Effects of low-dose, controlledrelease, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. Lancet. April 16, 2011;377(9774):1341-1352.
46. Garvey WT, Ryan DH, Look M, et al. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebocontrolled, phase 3 extension study. Am J Clin Nutr. Feb 2012;95(2): 297-308.
47. Allison DB, Gadde KM, Garvey WT, et al. Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP). Obesity (Silver Spring). Feb 2012;20(2):330-342.
48. Colman E. Anorectics on trial: a half century of federal regulation of prescription appetite suppressants. Ann Intern Med. September 6, 2005;143(5):380-385.
49. Colman E, Golden J, Roberts M, Egan A, Weaver J, Rosebraugh C. The FDA's assessment of two drugs for chronic weight management. N Engl J Med. October 25, 2012;367(17):1577-1579.
50. Hendricks EJ, Greenway FL. A study of abrupt phentermine cessation in patients in a weight management program. Am J Ther. Jul 2011; 18(4):292-299.
51. Hendricks EJ, Rothman RB, Greenway FL. How physician obesity specialists use drugs to treat obesity. Obesity (Silver Spring). Sep 2009;17(9):1730-1735.
52. Hendricks EJ, Greenway FL, Westman EC, Gupta AK. Blood pressure and heart rate effects, weight loss and maintenance during long-term phentermine pharmacotherapy for obesity. Obesity (Silver Spring). Dec 2011;19(12):2351-2360.
53. Lexicomp. http://online.lexi.com.ezproxy.xula.edu/lco/action/home. Lexicomp Online Web Site. Accessed Nov 2012.
54. Bray GA. Drug insight: appetite suppressants. Nat Clin Pract Gastroenterol Hepatol. Feb 2005;2(2):89-95.
55. Adipex-P [package insert]. Sellersville, PA: Teva Pharmaceuticals, USA; 2012.
56. Phentermine: an appetite-suppressant amphetamine classified as a narcotic in France. Is a combination with topiramate on the horizon? Prescrire Int. Sep 21(130):209.
57. Munro JF, MacCuish AC, Wilson EM, Duncan LJ. Comparison of continuous and intermittent anorectic therapy in obesity. Br Med J. February 10, 1968;1(5588):352-354.
58. Rothman RB, Hendricks EJ. Phentermine cardiovascular safety. Am J Emerg Med. Oct 2009;27(8):1010-1013.
59. Makoundou V, Golay A. Drug control of appetite. Rev Med Suisse. January 12, 2011;7(277):57-60.
60. Uwaifo GI, Melcescu E, McDonald A, Koch CA. A case of profound weight loss secondary to use of phentermine. J Miss State Med Assoc. Dec 2009;50(12):407-415.
61. Tonstad S, Tykarski A, Weissgarten J, et al. Efficacy and safety of topiramate in the treatment of obese subjects with essential hypertension. Am J Cardiol. July 15, 2005;96(2):243-251.
62. Shank RP, Gardocki JF, Vaught JL, et al. Topiramate: preclinical evaluation of structurally novel anticonvulsant. Epilepsia. Mar-Apr 1994; 35(2):450-460.
63. Shank RP, Gardocki JF, Streeter AJ, Maryanoff BE. An overview of the preclinical aspects of topiramate: pharmacology, pharmacokinetics, and mechanism of action. Epilepsia. 2000;41 Suppl 1:S3-S9.
64. Shank RP, Maryanoff BE. Molecular pharmacodynamics, clinical therapeutics, and pharmacokinetics of topiramate. CNS Neurosci Ther. Summer 2008;14(2):120-142.
65. NCBI. Topiramate; Compound summary CID 5284627. Pub Chem compound [website]. Accessed Dec 2012.
66. NCBI. Topamax (TN)-Substance summary SID 7847603 [Website]. Accessed Dec 2012.
67. Storey JR, Calder CS, Hart DE, Potter DL. Topiramate in migraine prevention: a double-blind, placebo-controlled study. Headache. Nov-Dec 2001;41(10):968-975.
68. Chengappa KN, Rathore D, Levine J, et al. Topiramate as add-on treatment for patients with bipolar mania. Bipolar Disord. Sep 1999;1(1):42-53.
69. Bray GA, Hollander P, Klein S, et al. A 6-month randomized, placebocontrolled, dose-ranging trial of topiramate for weight loss in obesity. Obes Res. Jun 2003;11(6):722-733.
70. Lexicomp. Topiramate; Drug information. Uptodate®. Available at: http://www.uptodate.com. Accessed Dec 2012.
71. Ben-Menachem E, Axelsen M, Johanson EH, Stagge A, Smith U. Predictors of weight loss in adults with topiramate-treated epilepsy. Obes Res. Apr 2003;11(4):556-562.
72. Wilding J, Van Gaal L, Rissanen A, Vercruysse F, Fitchet M. A randomized double-blind placebo-controlled study of the long-term efficacy and safety of topiramate in the treatment of obese subjects. Int J Obes Relat Metab Disord. Nov 2004;28(11):1399-1410.
73. Astrup A, Toubro S. Topiramate: a new potential pharmacological treatment for obesity. Obes Res. Dec 2004;12 Suppl:167S-173S.
74. Bays HE, Gadde KM. Phentermine/topiramate for weight reduction and treatment of adverse metabolic consequences in obesity. Drugs Today (Barc). Dec 2011;47(12):903-914.
75. Bays H. Phentermine, topiramate and their combination for the treatment of adiposopathy ('sick fat') and metabolic disease. Expert Rev Cardiovasc Ther. Dec 8(12):1777-1801.
76. Cameron F, Whiteside G, McKeage K. Phenter mine and topiramate extended release (qsymia): first global approval. Drugs. October 22, 2012;72(15):2033-2042.
77. Malgarini RB, Pimpinella G. Phentermine plus topiramate in the treatment of obesity. Lancet. July 9, 2011;378(9786):125-126; author reply 126-127.
78. Mercer SL. ACS chemical neuroscience molecule spotlight on Qnexa. ACS Chem Neurosci. April 20, 2011;2(4):183-184.
79. Shah K, Villareal DT. Combination treatment to CONQUER obesity? Lancet. April 16, 2011;377(9774):1295-1297.
80. Qsymia [prescribing information]. Mountain view, CA: Vivus; 2012.
81. Aronne LJ, Peterson C, Troupin B, et al. Weight loss with V1-0521 (phentermine/controlled release topiramate) stops progression towards type 2 diabetes in obese non-diabetic subjects. Poster PO.22 presented at: 2010 Obesity Society meeting and the abstract included in Obesity Facts.
82. Ryan DH, Peterson C, Troupin B, et al. Weight loss at 6 months with V1-0521 (PEN/TPM combination) treatment. Paper presented at the 69th Annual Scientific Sessions of the American Diabetes Association, June 5, 2009.
83. VIVUS I. VIVUS Reports Topline Findings from FORTRESS. [media release on the Internet]. December 21, 2011. Available at http://ir.vivus.com/releasedetail.cfm?ReleaseID=634920.
84. Barter PJ, Caulfield M, Eriksson M, et al. Effects of torcetrapib in patients at high risk for coronary events. N Engl J Med. November 22, 2007;357(21):2109-2122.
85. Nissen SE, Wolski K, Topol EJ. Effect of muraglitazar on death and major adverse cardiovascular events in patients with type 2 diabetes mellitus. JAMA. November 23, 2005;294(20):2581-2586.
86. Nissen SE, Wolski K. Rosiglitazone revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med. July 26, 2010;170(14):1191-1201.