American Heart Journal
Volume 151, Issue 3 , Pages 633-642 , March 2006

Clinical trial issues in weight-loss therapy

  • Manesh R. Patel, MD

      Affiliations

    • Duke University Medical Center, Durham, NC
    • Corresponding Author InformationReprint requests: Manesh R Patel, MD, 111 VA Medical Center, Box 31152 DUMC, Durham, NC 27708.
    • ,
  • Mark Donahue, MD

      Affiliations

    • Duke University Medical Center, Durham, NC
    • ,
  • Peter W.F. Wilson, MD

      Affiliations

    • Medical University of South Carolina, Charleston, SC
    • ,
  • Robert M. Califf, MD

      Affiliations

    • Duke University Medical Center, Durham, NC

Received 8 March 2005 ,Accepted 8 March 2005.

References 

  1. Flegal KM, Carroll MD, Kuczmarksi RJ, et al. Overweight and obesity in the United States: prevalence and trends, 1960-1994. Int J Obes Relat Metab Disord. 1998;22:39–47
  2. U.S. Food and Drug Administration, Division of Metabolic and Endocrine Drug Products. Draft guidance for the clinical evaluation of weight-control drugs. Rockville (Md): U.S. Food and Drug Administration; 1996;Available at http://www.fda.gov/cder/guidance/obesity.pdf[accessed March 18, 2004]
  3. Spake A. Natural hazards. Tonic or toxic? Americans are gobbling up nature's remedies for everything from obesity to depression. US News World Rep. 2001;12:42–49
  4. Reimer KA, Califf RM. Good news for experimental concept but bad news for clinically effective therapy. Circulation. 1999;99:198–200
  5. Smalley W, Shatin D, Wysowski DK, et al. Contraindicated use of cisapride: impact of food and drug administration regulatory action. JAMA. 2000;284:3036–3039
  6. Lauer M, Anderson KM, Kannel WB, et al. The impact of obesity on left ventricular mass and geometry. The Framingham Heart Study. JAMA. 1991;266:231–236
  7. Hubert HB, Feinleib M, McNamara PM, et al. Obesity as an independent risk factor for cardiovascular disease: a 26-year follow-up of participants in the Framingham Heart Study. Circulation. 1983;67:968–977
  8. Sniderman AD, Cianflone K. Metabolic disruptions in the adipocyte-hepatocyte fatty acid axis as causes of hyperapo-B. Int J Obes Relat Metab Disord. 1995;19:S27–S33
  9. Colditz GA, Willet WC, Stampfer MJ, et al. Weight as a risk for clinical diabetes in women. Am J Epidemiol. 1990;132:501–513
  10. Landin K, Stigendal L, Eriksson E, et al. Abdominal obesity is associated with an impaired fibrinolytic activity and elevated plasminogen activator inhibitor-1. Metabolism. 1990;39:1044–1048
  11. Must A, Spadano J, Coakley EH, et al. The disease burden associated with overweight and obesity. JAMA. 1999;282:1523–1529
  12. Manson JE, Colditz GA, Stampfer MJ, et al. A prospective study of obesity and risk of coronary heart disease in women. N Engl J Med. 1990;322:882–889
  13. Calle EE, Thun MJ, Petrelli JM, et al. Body-mass index and mortality in a prospective cohort of U.S. adults. N Engl J Med. 1999;341:1097–1105
  14. Woosley RL. Drug labeling revisions—guaranteed to fail?. JAMA. 2000;284:3047–3049
  15. Skinner BF. The operant side of behavior therapy. J Behav Ther Exp Psychiatry. 1988;19:171–179
  16. Foreyt JP, Goodrick GK, Gotto AM. Limitations of behavioral treatment of obesity: review and analysis. J Behav Med. 1981;4:159–174
  17. Perri MG, McAdoo WG, Spevak PA, et al. Effect of a multicomponent maintenance program on long-term weight loss. J Consult Clin Psychol. 1984;52:480–481
  18. Foreyt JP, Goodrick GK. Evidence for success of behavior modification in weight loss and control. Ann Intern Med. 1993;119:698–701
  19. Whelton PK, Appel LJ, Espeland MA, et al. Sodium restriction and weight loss in the treatment of hypertension in older persons: a randomized controlled Trial Of Nonpharmacologic interventions in the Elderly (TONE). TONE Collaborative Research Group. JAMA. 1998;279:839–846
  20. MacMahon S, Cutler J, Brittain E, et al. Obesity and hypertension: epidemiological and clinical issues. Eur Heart J. 1987;8:57–70
  21. Hellenius ML, de Faire U, Berglund B, et al. Diet and exercise are equally effective in reducing risk for cardiovascular disease. Results of a randomized controlled study in men with slightly to moderately raised cardiovascular risk factors. Atherosclerosis. 1993;103:81–91
  22. Karvetti RL, Hakala P. A seven-year follow-up of a weight reduction programme in Finnish primary health care. Eur J Clin Nutr. 1992;46:743–752
  23. Agurs-Collins TD, Kumanyika SK, Ten Have TR, et al. A randomized controlled trial of weight reduction and exercise for diabetes management in older African-American subjects. Diabetes Care. 1997;20:1503–1511
  24. Connolly HM, Crary JL, McGoon MD, et al. Valvular heart disease associated with fenfluramine-phentermine. N Engl J Med. 1997;337:581–588
  25. Mason EE, Tang S, Renquist KE, et al. A decade of change in obesity surgery. National Bariatric Surgery Registry (NBSR) Contributors. Obes Surg. 1997;7:189–197
  26. Anonymous . NIH conference. Gastrointestinal surgery for severe obesity. Consensus Development Conference Panel. Ann Intern Med. 1991;115:956–961
  27. Forsell P, Hallerback B, Glise H, et al. Complications following Swedish adjustable gastric banding: a long-term follow-up. Obes Surg. 1999;9:11–16
  28. Pories WJ, Swanson MS, MacDonald KG, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995;222:339–350
  29. F. Hoffman-LaRoche, Ltd. Xenica (orlistat) new drug application. Nutley (NJ): F. Hoffman-LaRoche, Ltd; 1998;
  30. Yanovski SZ, Bain RP, Williamson DF. Report of a National Institutes of Health–Centers for Disease Control and Prevention workshop on the feasibility of conducting a randomized clinical trial to estimate the long-term health effects of intentional weight loss in obese persons. Am J Clin Nutr. 1999;69:366–372
  31. National Institutes of Health. RFA KD 98-019. Study of Health Outcomes of Weight-loss (SHOW). Release date: November 18, 1998. Available at http://grants2.nih.gov/grants/guide/rfa-files/RFA-DK-98-019.html. [accessed March 18, 2004].
  32. Califf RM, DeMets DL. Principles from clinical trials relevant to clinical practice: part I. Circulation. 2002;106:1015–1021
  33. Centers for Disease Control and Prevention. Update: prevalence of overweight among children, adolescents, and adults—United States, 1988-1994. JAMA. 1997;277:1111
  34. Yusuf S, Sleight P, Pogue J, et al. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. N Engl J Med. 2000;342:145–153
  35. Flegal KM. The obesity epidemic in children and adults: current evidence and research issues. Med Sci Sports Exerc. 1999;31:509–514
  36. Lissner L, Odell PM, D'Agostino RB, et al. Variability of body weight and health outcomes in the Framingham population. N Engl J Med. 1991;324:1839–1844
  37. Blair SN, Shaten J, Brownell K, et al. Body weight change, all-cause mortality, and cause-specific mortality in the Multiple Risk Factor Intervention Trial. Ann Intern Med. 1993;119:749–757
  38. Bennett CL, Weinberg PD, Rozenberg-Ben-Dror K, et al. Thrombotic thrombocytopenic purpura associated with ticlopidine. A review of 60 cases. Ann Intern Med. 1998;128:541–544
  39. Bennett CL, Davidson CJ, Raisch DW, et al. Thrombotic thrombocytopenic purpura associated with ticlopidine in the setting of coronary artery stents and stroke prevention. Arch Intern Med. 1999;159:2524–2528
  40. Bennett CL, Connors JM, Carwile JM, et al. Thrombotic thrombocytopenic purpura associated with clopidogrel. N Engl J Med. 2000;342:1773–1777
  41. Parisi AF. Diet-drug debacle. Ann Intern Med. 1998;129:903–905
  42. Wellman PJ, Maher TJ. Synergistic interactions between fenfluramine and phentermine. Int J Obes Relat Metab Disord. 1999;23:723–732
  43. Giese SY, Neborsky R. Serotonin syndrome: potential consequences of Meridia combined with Demerol or fentanyl. Plast Reconstr Surg. 2001;107:293–294
  44. Kernan WN, Viscoli CM, Brass LM, et al. Phenylpropanolamine and the risk of hemorrhagic stroke. N Engl J Med. 2000;343:1826–1832
  45. Khurana V, de la Fuente M, Bradley TP, et al. Hypertensive crisis secondary to phenylpropanolamine interacting with triple-drug therapy for HIV prophylaxis. Am J Med. 1999;106:118–119
  46. Lee KY, Beilin LJ, Vandongen R. Severe hypertension after ingestion of an appetite suppressant (phenylpropanolamine) with indomethacin. Lancet. 1979;1:1110–1111
  47. Mersfelder TL. Phenylpropanolamine and stroke: the study, the FDA ruling, the implications. Cleve Clin J Med 2001;68:208–9, 213–9, 223.
  48. Furberg CD, Herrington DM, Psaty BM. Are drugs within a class interchangeable?. Lancet. 1999;354:1202–1204
  49. Knoll Pharmaceuticals, Inc.. Meridia (sibutramine hydrochloride monohydrate) new drug application 20-632. Mt. Olive (NJ): Knoll Pharmaceuticals, Inc.; 1996;
  50. Davidson MH, Hauptman J, DiGirolamo M, et al. Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized control trial. JAMA. 1999;281:235–242
  51. McMahon FG, Fujioka K, Singh BN, et al. Efficacy and safety of sibutramine in obese white and African American patients with hypertension: a 1-year, double-blind, placebo-controlled, multicenter trial. Arch Intern Med. 2000;160:2185–2191
  52. Dujovne CA, Zavoral JH, Rowe E, et al. Effects of sibutramine on body weight and serum lipids: a double blind, randomized, placebo-controlled study in 322 overweight and obese patients with dyslipidemia. Am Heart J. 2001;142:489–497
  53. Patel MR, McGuire DK. Pounds of prevention: obesity therapy. Am Heart J. 2001;142:388–390
  54. Ziegler O, Quilliot D. Drug treatment of obesity and type 2 diabetes. Diabetes Metab. 2000;26:34–41
  55. Manson JE, Willett WC, Stampfer MJ, et al. Body weight and mortality among women. N Engl J Med. 1995;333:677–685
  56. Rezulin to be withdrawn from the market. [Press release] Rockville (Md): U.S. Food and Drug Administration; 2000;Available at http://www.fda.gov/bbs/topics/NEWS/NEW00721.html
  57. Roche announces voluntary withdrawal of Posicor. [Press release] Nutley (NJ): Hoffman-LaRoche, Inc; 1998;Available at http://www.fda.gov/medwatch/safety/1998/mibefr.htm[accessed March 18, 2004]
  58. Manson JE, Faich GA. Pharmacotherapy for obesity—do the benefits outweigh the risks?. N Engl J Med. 1996;335:659–660
  59. CenterWatch Clinical Trials Listing Service. Available at http://www.centerwatch.com2004;[accessed March 18, 2004]
  60. Wierenga DE, Eaton CR. Phases of product development. Washington (DC): Pharmaceutical Research and Manufacturers of America; 2001;
  61. Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346:393–403
  62. National Task Force on Prevention and Treatment of Obesity. Towards prevention of obesity: research directions. Obes Res. 1994;2:571–584

PII: S0002-8703(05)00252-8

doi: 10.1016/j.ahj.2005.03.006

American Heart Journal
Volume 151, Issue 3 , Pages 633-642 , March 2006

Article Tools

* Image Usage & Resolution