The Efficacy and Safety of Sibutramine for Weight Loss: A Systematic Review

Archives of Internal Medicine

Volumn 164, Issue 9, 2004, Pages 994-1003

  Arterburn, David E ^a,d,e   Crane, Paul K ^b   Veenstra, David L ^c  

^a DEPARTMENT OF VETERANS AFFAIRS   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

^d UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^e VETERANS AFFAIRS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHOLESTEROL; GLUCOSE; GLYCOSYLATED HEMOGLOBIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; SIBUTRAMINE; TRIACYLGLYCEROL;

ADULT; BEHAVIOR MODIFICATION; BLOOD PRESSURE; BODY MASS; BODY WEIGHT; CHOLESTEROL BLOOD LEVEL; COMORBIDITY; CONTROLLED STUDY; DIABETES CONTROL; DIABETES MELLITUS; DRUG EFFICACY; DRUG SAFETY; EXERCISE; FEMALE; GLUCOSE BLOOD LEVEL; HEART RATE; HUMAN; HYPERLIPIDEMIA; HYPERTENSION; LOW CALORY DIET; MAJOR CLINICAL STUDY; MALE; METABOLIC PARAMETERS; OBESITY; PRIORITY JOURNAL; REVIEW; TREATMENT OUTCOME; TRIACYLGLYCEROL BLOOD LEVEL; WEIGHT REDUCTION;

APPETITE DEPRESSANTS; BLOOD PRESSURE; CYCLOBUTANES; HEART RATE; HUMANS; OBESITY; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; WEIGHT LOSS;

EID: 2342453289     PISSN: 00039926     EISSN: None     Source Type: Journal    
DOI: 10.1001/archinte.164.9.994     Document Type: Review

References (61)

1. Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002;288:1723-1727.
2. Pi Sunyer FX, Becker DM, Bouchard C, et al. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: executive summary. Am J Clin Nutr. 1998;68:899-917.
3. Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and obesity. JAMA. 1999;282:1523-1529.
4. ASHP therapeutic position statement on the safe use of pharmacotherapy for obesity management in adults: developed by the ASHP Commission on Therapeutics and approved by the ASHP Board of Directors on April 23, 2001. Am J Health Syst Pharm. 2001;58:1645-1655.
5. Arterburn D. Obesity. Clin Evid. June 2002:538-547.
6. Scheen AJ, Lefebvre PJ. Pharmacological treatment of obesity: present status. Int J Obes Relat Metab Disord. 1999;23(suppl 1):47-53.
7. Center for Drug Evaluation and Research, Food and Drug Administration. Phenlypropanolamine (PPA) information. Available at: http://www.fda.gov/cder/drug /infopage/ppa/. Accessed May 15, 2003.
8. Committee on Safety in Medicines, Medicines Control Agency. Important safety message: European withdrawal of anorectic agents/appetite suppressants: new legal developments, no new safety issues: licences for phentermine and amfepramone being withdrawn May 2001. Available at: http:/www.mca.gov.uk/ ourwork /monitorsafequalmed/safetymessages/anorectic.htm. Accessed May 15, 2003.
9. IMS Health. The ballooning obesity market: tough to burst. Available at: http: //www.ims-global.com/insight/news_story/0210/news_story_021022.htm. Accessed May 15, 2003.
10. Clapham JC, Arch JR, Tadayyon M. Anti-obesity drugs: a critical review of current therapies and future opportunities. Pharmacol Ther. 2001;89:81-121.
11. Centre for Pharmaceutical Administration, Health Sciences Authority. Drug alerts: updates report on sibutramine. Available at: http://www.hsa.gov.sg/hsa/CPA /CPA_pharma_drugalerts.htm#12. Accessed May 15, 2003.
12. Public Citizen Health Research Group. Petition to FDA to ban the diet drug sibutramine (MERIDIA) [HRG publication 1613]. Available at: http://www.citizen.org /publications/print_release.ctm?ID = 7160. Accessed May 15, 2003.
13. O'Meara S, Riemsma R, Shirran L, Mather L, ter Riet G. The clinical effectiveness and cost-effectiveness of sibutramine in the management of obesity: a technology assessment. Health Technol Assess. 2002;6:1-97.
14. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement: Quality of Reporting of Meta-analyses. Lancet. 1999;354:1896-1900.
15. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1-12.
16. Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses. Ann Intern Med. 2001;135:982-989.
17. Pettiti DB. Meta-analysis, Decision Analysis, and Cost-effectiveness Analysis Methods for Quantitative Synthesis in Medicine. New York, NY: Oxford University Press Inc; 1999.
18. Stata Reference Manual Release 7. Vol 2. College Station, Tex: State Press; 2001.
19. Egger M, Smith GD, Phillips AN. Meta-analysis: principles and procedures. BMJ. 1997;315:1533-1537.
20. Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997;315:629-634.
21. Finer N, Bloom SR, Frost GS, Banks LM, Griffiths J. Sibutramine is effective for weight loss and diabetic control in obesity with type 2 diabetes: a randomised, double-blind, placebo-controlled study. Diabetes Obes Metab. 2000;2:105-112.
22. Hanotin C, Thomas F, Jones SP, Leutenegger E, Drouin P. Efficacy and tolerability of sibutramine in obese patients: a dose-ranging study. Int J Obes Relat Metab Disord. 1998;22:32-38.
23. Hansen DL, Toubro S, Stock MJ, Macdonald IA, Astrup A. The effect of sibutramine on energy expenditure and appetite during chronic treatment without dietary restriction. Int J Obes Relat Metab Disord. 1999;23:1016-1024.
24. Hazenberg BP. Randomized, double-blind, placebo-controlled, multicenter study of sibutramine in obese hypertensive patients. Cardiology. 2000;94:152-158.
25. Kim SM, Kim YS, Park HS, Nam SY, Lee J. Efficacy of sibutramine in preobese and obese class I [abstract]. Int J Obes Relat Metab Disord. 2001;25(suppl 2):S117.
26. Seagle HM, Bessesen DH, Hill JO. Effects of sibutramine on resting metabolic rate and weight loss in overweight women. Obes Res. 1998;6:115-121.
27. Walsh KM, Leen E, Lean ME. The effect of sibutramine on resting energy expenditure and adrenaline-induced thermogenesis in obese females. Int J Obes Relat Metab Disord. 1999;23:1009-1015.
28. Zannad F, Gille B, Grentzinger A, et al. Effects of sibutramine on ventricular dimensions and heart valves in obese patients during weight reduction. Am Heart J. 2002;144:508-515.
29. Zhao Y, Wang X, Yan Z. A randomized, double-blind, placebo-controlled, multicenter study on sibutramine in over-weighted and obese subjects [in Chinese]. Zhonghua Yu Fang Yi Xue Za Zhi. 2001;35:329-332.
30. Tambascia MA, Geloneze B, Repetto EM, Rodovalho GS. The impact of sibutramine on insulin resistance and metabolic parameters [abstract]. Int J Obes Relat Metab Disord. 2001;25(suppl 2):S110.
31. Serrano-Rios M, Melchionda N, Moreno-Carretero E. Role of sibutramine in the treatment of obese type 2 diabetic patients receiving sulphonylurea therapy. Diabet Med. 2002;19:119-124.
32. Hainer V. Czech trial of sibutramine in the treatment of obesity: multicentric randomized study [abstract]. Int J Obes Relat Metab Disord. 2001;25(suppl 2): S107.
33. Gonzalez BJ, Lopez AJC, Bravo GAL, Uriostegui TY. Sibutramine reduces the carbohydrate craving in obese patients [abstract]. Int J Obes Relat Metab Disord. 2000;24(suppl 1):S177.
34. Gokcel A, Karakose H, Ertorer EM, Tanaci N, Tutuncu NB, Guvener N. Effects of sibutramine in obese female subjects with type 2 diabetes and poor blood glucose control. Diabetes Care. 2001;24:1957-1960.
35. Fanghanel G, Cortmas L, Sanchez-Reyes L, Berber A. Safety and efficacy of sibutramine in overweight Hispanic patients with hypertension [abstract]. Obes Res. 2001;9(suppl 3):202S.
36. Fanghanel G, Cortinas L, Sanchez-Reyes L, Berber A. A clinical trial of the use of sibutramine for the treatment of patients suffering essential obesity. Int J Obes Relat Metab Disord. 2000;24:144-150.
37. Faria AN, Ribeiro Filho FF, Lerario DD, Kohlmann N, Ferreira SR, Zanella MT. Effects of sibutramine on the treatment of obesity in patients with arterial hypertension. Arq Bras Cardiol. 2002;78:172-180.
38. Cuellar GEM, Ruiz AM, Monsalve MCR, Berber A. Six-month treatment of obesity with sibutramine 15 mg: a double-blind, placebo-controlled monocenter clinical trial in a Hispanic population. Obes Res. 2000;8:71-82.
39. Ballard RD, Shreve PE, Dextradeur TC, Sanders KK. Efficacy of sibutramine for promoting weight loss in the treatment of obstructive sleep apnea [abstract]. Int J Obes Relat Metab Disord. 2001;25(suppl 2):S109.
40. Apfelbaum M, Vague P, Ziegler O, Hanotin C, Thomas F, Leutenegger E. Long-term maintenance of weight loss after a very-low-calorie diet: a randomized blinded trial of the efficacy and tolerability of sibutramine. Am J Med. 1999;106:179-184.
41. Hauner H, Meier M, Wendland G, Kurscheid T, Lauterbach KW. Weight reduction by sibutramine in obese subjects in primary care medicine: the S.A.T. study [abstract]. Int J Obes Relat Metab Disord. 2000;24(suppl 1):S100.
42. McNulty SJ, Ur E, Williams G. A randomized trial of sibutramine in the management of obese type 2 diabetic patients treated with metformin. Diabetes Care. 2003;26:125-131.
43. Smith IG. Randomized placebo-controlled trial of long-term treatment with sibutramine in mild to moderate obesity. J Fam Pract. 2001;50:505-512.
44. Wirth A, Krause J. Long-term weight loss with sibutramine: a randomized controlled trial. JAMA. 2001;286:1331-1339.
45. Dujovne CA, Zavoral JH, Rowe E, Mendel CM. 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.
46. Fujioka K, Seaton TB, Rowe E, et al. Weight loss with sibutramine improves glycaemic control and other metabolic parameters in obese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2000;2:175-187.
47. Sramek JJ, Leibowitz MT, Weinstein SP, et al. Efficacy and safety of sibutramine for weight loss in obese patients with hypertension well controlled by β-adrenergic blocking agents: a placebo-controlled, double-blind, randomised trial. J Hum Hypertens. 2002;16:13-19.
48. Weintraub M, Rubio A, Golik A, Byrne L, Scheinbaum ML. Sibutramine in weight control: a dose-ranging, efficacy study. Clin Pharmacol Ther. 1991;50:330-337.
49. James WPT, Astrup A, Finer N, et al. Effect of sibutramine on weight maintenance after weight loss: a randomised trial. Lancet. 2000;356:2119-2125.
50. Fanghanel G, Cortinas L, Sanchez-Reyes L, Berber A. Second phase of a double-blind study clinical trial on sibutramine for the treatment of patients suffering essential obesity: 6 months after treatment cross-over. Int J Obes Relat Metab Disord. 2001;25:741-747.
51. Hansen D, Astrup A, Toubro S, et al. Predictors of weight loss and maintenance during 2 years of treatment by sibutramine in obesity: results from the European multi-centre STORM trial: Sibutramine Trial of Obesity Reduction and Maintenance. Int J Obes Relat Metab Disord. 2001;25:496-501.
52. Bach DS, Rissanen AM, Mendel CM, et al. Absence of cardiac valve dysfunction in obese patients treated with sibutramine. Obes Res. 1999;7:363-369.
53. Obesity: Preventing and Managing the Global Epidemic: Report of a WHO Consultation. Geneva, Switzerland: World Health Organization; 2000. WHO Technical Report Series, No. 894. WHO Technical Series.
54. Douketis JD, Feightner JW, Attia J, Feldman WF, Canadian Task Force on Preventive Health Care. Periodic health examination, 1999 update, 1: detection, prevention and treatment of obesity. CMAJ. 1999;160:513-525.
55. The Surgeon General's Call to Action to Prevent and Decrease Overweight and Obesity. Rockville, Md: Office of the Surgeon General, Public Health Service, US Dept of Health and Human Services; 2001.
56. Committee for Proprietary Medicinal Products Opinion Following an Article 31 Referral: Sibutramine. London, England: European Agency for the Evaluation of Medicinal Products; 2002. Report 4514.
57. Meisler JG. Toward optimal health: the experts discuss weight control drugs. J Womens Health Gend Based Med. 2001;10:101-107.
58. Williamson DF. Pharmacotherapy for obesity. JAMA. 1999;281:278-280.
59. Allison DB, Faith MS, Gorman BS. Publication bias in obesity treatment trials? Int J Obes Relat Metab Disord. 1996;20:931-937.
60. Sterne JA, Egger M, Smith GD. Systematic reviews in health care: investigating and dealing with publication and other biases in meta-analysis. BMJ. 2001;323: 101-105.
61. Thompson SG. Why sources of heterogeneity in meta-analysis should be investigated. BMJ. 1994;309:1351-1355.