New antiobesity agents in type 2 diabetes: Overview of clinical trials with sibutramine and orlistat

Diabetes and Metabolism

Volumn 28, Issue 6 I, 2002, Pages 437-445

  Scheen, A J ^a   Ernest, Ph ^a  

^a UNIVERSITY OF LIÈGE   (Belgium)

Author keywords

Insulin sensitivity; Obesity; Orlistat; Sibutramine; Type 2 diabetes; Weight loss

Indexed keywords

ANTIOBESITY AGENT; DEXFENFLURAMINE; FLUOXETINE; GLUCOSE; HEMOGLOBIN A1C; INSULIN; METFORMIN; NORADRENALIN UPTAKE INHIBITOR; ORAL ANTIDIABETIC AGENT; PLACEBO; SEROTONIN UPTAKE INHIBITOR; SIBUTRAMINE; SULFONYLUREA DERIVATIVE; TETRAHYDROLIPSTATIN; TRIACYLGLYCEROL LIPASE;

BODY WEIGHT; CENTRAL NERVOUS SYSTEM; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES MELLITUS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MECHANISM; HUMAN; HYPERTENSION; IMPAIRED GLUCOSE TOLERANCE; INSULIN SENSITIVITY; MAJOR CLINICAL STUDY; META ANALYSIS; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OBESITY; RANDOMIZED CONTROLLED TRIAL; REVIEW; STEATORRHEA; TACHYCARDIA; TARGET ORGAN; TREATMENT OUTCOME; VITAMIN DEFICIENCY; WEIGHT REDUCTION;

ANTI-OBESITY AGENTS; APPETITE DEPRESSANTS; BLOOD GLUCOSE; CLINICAL TRIALS; CONTROLLED CLINICAL TRIALS; CYCLOBUTANES; DIABETES MELLITUS; DIABETES MELLITUS, TYPE 2; HUMANS; LACTONES; OBESITY; WEIGHT LOSS;

EID: 0036943785     PISSN: 12623636     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (91)

1. National Task Force on the Prevention and Treatment of Obesity. Overweight, obesity and health risk. Arch Intern Med, 2000, 160, 898-904.
2. Scheen AJ. From obesity to diabetes. Why, when and who? Acta Clin Belg, 2000, 55, 9-15.
3. Scheen AJ. Obesity and diabetes. In: Kopelman PG, editor. The management of obesity and related disorders. London, UK: Martin Dunitz Ltd, 2001, 11-44.
4. Willett WC, Dietz WH, Colditz GA. Guidelines for healthy weight. N Engl J Med, 1999, 341, 427-434.
5. Scheen AJ, Lefebvre PJ. Pathophysiology of Type 2 diabetes. In: Kuhlmann J, Puls W, editors. Handbook of Experimental Pharmacology, Oral Antidiabetics. Berlin: Springer Verlag, 1996, 7-42.
6. Scheen AJ, Paquot N, Letiexhe MR et al. Glucose metabolism in obese subjects: lessons from OGTT, IVGTT and clamp studies. Int J Obesity, 1995, 19. S14-S20.
7. Kissebah AH, Krakower GR. Regional adiposity and morbidity. Physiol Rev, 1994, 7, 761-811.
8. Wajchenberg BJ. Subcutaneous and visceral adipose tissue: their relation to the metabolic syndrome. Endocr Rev, 2000, 21, 697-738.
9. DeFronzo RA, Ferrannini E. Insulin resistance: a multifaceted syndrome responsible for NIDDM, obesity, hypertension, dyslipidemia, and atherosclerotic cardiovascular disease. Diabetes Care, 1991, 14, 173-194.
10. Haffner SM, D'Agostino R Jr, Mykkänen L et al. Insulin sensitivity in subjects with type 2 diabetes. Relationship to cardiovascular risk factors: the Insulin Resistance Atherosclerosis Study. Diabetes Care, 1999, 22, 562-568.
11. Long SD, O'Brien K, MacDonald KG et al. Weight loss in severely obese subjects prevents the progression of impaired glucose tolerance to type II diabetes. A longitudinal intervention study. Diabetes Care, 1993, 17, 372-375.
12. Sjöström CD, Lissner L, Wedel H, Sjöström L. Reduction in incidence of diabetes, hypertension and lipid disturbances after intentional weight loss induced by bariatric surgery: the SOS Intervention Study. Obes Res, 1999, 7, 477-484.
13. Kelley DE. Effects of weight loss on glucose homeostasis in NIDDM. Diabetes Rev, 1995, 3, 366-377.
14. Brown SA, Upchurch S, Anding R et al. Promoting weight loss in type II diabetes. Diabetes Care, 1996, 19, 613-624.
15. Maggio CA, Pi-Sunyer FX. The prevention and treatment of obesity. Application to type 2 diabetes. Diabetes Care, 1997, 20, 1744-1766.
16. Campbell L, Rössner S. Management of obesity in patients with Type 2 diabetes. Diabetic Med, 2001, 18, 345-354.
17. Williams KV, Kelley DE. Metabolic consequences of weight loss on glucose metabolism and insulin action in type 2 diabetes. Diabetes Obes Metab, 2000, 2, 121-129.
18. Goldstein DJ. Beneficial health effects of modest weight loss. Int J Obes, 1992, 16, 397-415.
19. Bosello O, Armellini F, Zamboni M, Fitchet M. The benefits of modest weight loss in type 11 diabetes. Int J Obesity, 1997, 21, S10-S13.
20. Pi-Sunyer FX. A review of long-term studies evaluating the efficacy of weight loss in ameliorating disorders associated with obesity. Clin Ther, 1996, 18, 1006-1035.
21. Williamson DF, Thompson TJ, Thun M et al. Intentional weight loss and mortality among overweight individuals with diabetes. Diabetes Care, 2000, 23, 1499-1504.
22. Scheen AJ, Lefebvre PJ. Management of the obese diabetic patient. Diabetes Rev, 1999, 7, 77-93.
23. Scheen AJ. Current management strategies for coexisting diabetes mellitus and obesity. Drugs, 2002, 62, in press.
24. Basdevant A, Laville M, Ziegler O et al. Guide pratique pour le diagnostic, la prévention, le traitement des obésités en France. Diab Metab, 1998, 24, 10-42.
25. Scheen AJ. Drug treatment of non-insulin-dependent diabetes mellitus in the 1990s: achievements and future developments. Drugs, 1997, 54, 355-368.
26. Scheen AJ, Lefebvre PJ. Oral antidiabetic agents: a guide to selection. Drugs, 1998, 55, 225-236.
27. DeFronzo RA. Pharmacologic therapy for type 2 diabetes mellitus. Ann Intern Med, 1999, 131, 281-303.
28. Bray GA, Ryan DH. Drugs used in the treatment of obesity. Diabetes Rev, 1997, 5, 83-103.
29. Scheen AJ, Lefebvre PJ. Pharmacological treatment of obesity: present status. Int J Obes, 1999, 23, 47-53.
30. Scheen AJ, Lefebvre PJ. Pharmacological treatment of the obese diabetic patient. Diab Metab, 1993, 19, 547-559.
31. Kosmiski L, Eckel RH. Anorectic agents in non-insulin dependent diabetes mellitus. Curr Opin Endocrinol Diab, 1997, 4, 36-39.
32. Scheen AJ, Lefebvre PJ. Antiobesity pharmacotherapy in the management of type 2 diabetes. Diabetes/Metab Res Rev, 2000, 16, 114-124.
33. Scheen AJ. Treatment of diabetes in patients with severe obesity. Biomed Pharmacother, 2000, 54, 74-79.
34. Fernandez-Lopez JA, Remesar X, Foz M, Alemany M. Pharmacological approaches for the treatment of obesity. Drugs, 2002, 62, 915-944.
35. Yanovski SZ, Yanovski JA. Obesity. N Engl J Med, 2002, 346, 591-602.
36. Haddock CK, Poston WSC, Dill PL et al. Pharmacotherapy for obesity: a quantitative analysis of four decades of published randomized clinical trials. Int J Obesity, 2002, 26, 262-273.
37. Scheen AJ. Results of obesity treatment. Ann Endocrinol, 2002, 63, 163-170.
38. Redmon JB, Raatz SK, Kwong CA et al. Pharmacological induction of weight loss to treat type 2 diabetes. Diabetes Care. 1999, 22, 896-903.
39. Scheen AJ, Paolisso G, Salvatore T, Lefebvre PJ. Improvement of insulin-induced glucose disposal in obese patients with NIDDM after 1-wk treatment with d-fenfluramine. Diabetes Care, 1991, 14, 325-332.
40. McNeely W, Goa KL. Sibutramine. A review of its contribution to the management of obesity. Drugs, 1998, 56, 1093-1124.
41. James WPT, Astrup A, Finer N et al. for the Storm Study Group. Effect of sibutramine on weight maintenance after weight loss: a randomised trial. Lancet, 2000, 356, 2119-2125.
42. Van Gaal LF, Pfeiffer FW. The importance of obesity in diabetes and its treatment with sibutramine. Int J Obesity, 2001, 25, S24-S28.
43. Vargars R, McMahon FG, Jain AK. Effects of sibutramine (S) vs placebo (P) in NIDDM (Abstract). Clin Pharmacol Ther, 1994, 55, 188.
44. Peirce NS, Stubbs TA, MacDonald IA, Tattersall RB. The effect of sibutramine and weight reduction on insulin sensitivity in obese type 2 diabetics (Abstract). Int J Obesity, 1998, 22, S272.
45. Heath MJ, Chong E, Weinstein SP, Seaton TB. Sibutramine enhances weight loss and improves glycemic control and plasma lipid profile in obese patients with type 2 diabetes (Abstract). Diabetes, 1999, 48, A308.
46. Shepherd G, Fitchet M, Kelly F. Sibutramine: a meta-analysis of the change in fasting plasma glucose in patients with a high baseline fasting value (≤ 5.5 mmol/1) (Abstract). Int J Obesity, 1997, 21, S54.
47. Finer N, Bloom SR, Frost GS et al. Sibutramine is effective for weight loss and diabetic control in obesity with type 2 diabetes: a randomised, double-blind, placebo-controlled study. Diabetes Obesity Metab, 2000, 2, 105-112.
48. 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 Obesity Metab, 2000, 2, 175-187.
49. Gokcel A, Karakose H. Ertorer EM et al. Effects of sibutramine in obese female subjects with type 2 diabetes and poor blood glucose control. Diabetes Care, 2001, 24, 1957-1960.
50. Serrano-Rios M, Mechionda N, Moreno Carretero E et al. Role of sibutramine in the treatment of obese type 2 diabetic patients receiving sulphonylurea therapy. Diabetic Med, 2002, 19, 119-124.
51. Rissanen A, for the Finnish Multicentre Group. Sibutramine in the treatment of obese type 11 diabetics (Abstract). Int J Obesity, 1999, 23, S63.
52. McNulty S, Williams G, for the Multicentre Sibutramine Study Group. Sibutramine in the management of obese type 2 diabetic patients treated with metformin. Submitted.
53. Gokcel A, Gumurdulu Y, Karakose H et al. Evaluation of the safety and efficacy of sibutramine, orlistat, and metformin in the treatment of obesity. Diabetes Obes Metab, 2002, 4, 49-55.
54. McNeely W, Benfield P, Orlistat. Drugs, 1998, 56, 241-249.
55. Sjöström L, Rissanen A, Andersen T et al. for the European Multicentre Orlistat Study Group. Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. Lancet, 1998, 352, 167-173.
56. 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 controlled trial. JAMA, 1999, 281, 235-242.
57. Rössner S, Sjöström L, Noack R et al. Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity. Obes Res, 2000, 8, 49-61.
58. O'Meara S, Riemsma R, Shirran L et al. A rapid and systematic review of the clinical effectiveness and cost-effectiveness of orlistat in the management of obesity. Health Technol Assess, 2001, 5, 1-8.
59. Muls E, Kolanowski J, Scheen A, Van Gaal L for the Obelhyx Study Group. The effects of orlistat on weight and on serum lipids in obese patients with hypercholesterolemia: a randomized, double-blind, placebo-controlled, multicentre study. Int J Obesity, 2001, 25, 1713-1721.
60. Rosenfalck AM, Hendel H, Rasmussen MH et al. Minor long-term changes in weight have beneficial effects on insulin sensitivity and beta-cell function in obese subjects. Diab Obesity Metab, 2002, 4, 19-28.
61. Heymsfield SB, Segal KR, Hauptman J et al. Effects of weight loss with orlistat on glucose tolerance and progression to type 2 diabetes in obese adults. Arch Intern Med, 2000, 160, 1321-1326.
62. Lindgarde F. The effect of orlistat on body weight and coronary heart disease risk profile in obese patients: the Swedish Multimorbidity Study. J Intern Med, 2000, 248, 245-254.
63. Zavoral JH. Treatment with orlistat reduces cardiovascular risk in obese patients. J Hypertens, 1998, 16, 2013-2017.
64. Tong PC, Lee ZS, Sea MS et al. Effects of orlistat on cardiovascular risk factor and insulin sensitivity in young obese Chinese subjects with or without type 2 diabetes (Abstract). Diabetes, 2002, 51, A411.
65. Wilding J. Orlistat-induced weight loss improves insulin resistance in obese patients (Abstract). Diabetologia, 1999, 42, A215.
66. Després JP. The impact of orlistat on the multifactorial risk profile of abdominally obese patients (Abstract). Diabetes, 1999, 48, A307.
67. Keating GM, Jarvis B. Orlistat. In the prevention and treatment of type 2 diabetes mellitus. Drugs, 2001, 61, 2107-2119.
68. Kelley DE, Jneidi M. Orlistat in the treatment of Type 2 diabetes mellitus. Expert Opin Pharmacother, 2002, 3, 599-605.
69. Hollander PA, Elbein SC, Hirsch IB et al. Role of orlistat in the treatment of obese patients with type 2 diabetes. A 1-year randomized double-blind study. Diabetes Care, 1998, 21, 1288-1294.
70. Miles JM, Leiter L, Hollander P et al. Effect of orlistat in overweight and obese patients with type 2 diabetes treated with metformin. Diabetes Care, 2002, 25, 1123-1128.
71. Halpern A. Latino-American multicentre study with orlistat in overweight or obese patients with type 2 diabetes (Abstract). Diabetes, 2001, 50, A437.
72. Deerochanawong C. Effect of treatment with orlistat in overweight or obese Thai patients with type 2 diabetes (Abstract). Diabetes, 2001, 50, A433.
73. Bonnici F. Effect of orlistat on glycemic control and body weight in overweight or obese South African patients with type 2 diabetes (Abstract). Diabetes, 2002, 51, A412-413.
74. Kelley DE, Bray GA, Pi-Sunyer FX et al. Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes. A 1-year randomized controlled trial. Diabetes Care, 2002, 25, 1033-1041.
75. Hollander P, Lucas C, Hauptman J et al. Orlistat reduces body weight and cardiovascular disease risk factors in obese men and women with type 2 diabetes (Abstract). Diabetes, 1999, 48, A310.
76. Lamotte M, Annemans L, Lefever A et al. A health economic model to assess the long-term effects and cost-effectiveness of orlistat in obese type 2 diabetic patients. Diabetes Care, 2002, 25, 303-308.
77. Maetzel A, Ruof J, Covington MT, Wolf A. Cost-effectiveness of treatment of overweight and obese diabetic patient with orlistat (Abstract). Diabetes, 2002, 51, A276.
78. lc levels (Abstract). Diabetes, 2002, 51, A412.
79. lc levels ≥8% (Abstract). Diabetes, 2002, 51, A95.
80. Jacob S, Gomis R, Miles JM. Effect of orlistat on glycemic control in patients on or near maximal doses of oral anti-diabetic (OAD) medications (Abstract). Diabetes, 2002, 51, A413.
81. lc levels ≥8% (Abstract). Diabetes, 2002, 51, A413.
82. Vessby B. Dietary fat and insulin action in humans. Br J Nutr, 2000, 83, S91-S96.
83. Hu FB, van Dam RM, Liu S. Diet and risk of type 2 diabetes: the role of types of fat and carbohydrate. Diabetologia, 2001, 44, 805-817.
84. Unger RH. Lipotoxicity in the pathogenesis of obesity-dependent NIDDM. Genetic and clinical implications. Diabetes, 1995, 44, 863-870.
85. McGarry, JD, Dobbins RL. Fatty acids, lipotoxicity and insulin secretion. Diabetologia, 1999, 42, 128-138.
86. Robertson RP, Porte D Jr. Adrenergic modulation of basal insulin secretion in man. Diabetes, 1973, 22, 1-8.
87. Rizza RA, Cryer PE, Haymond MW, Gerich JE. Adrenergic mechanisms for the effects of epinephrine on glucose production and clearance in man. J Clin Invest, 1980, 65, 682-689.
88. Wadden TA, Berkovitz RI, Womble LG et al. Effects of sibutramine plus orlistat in obese women following 1 year of treatment by sibutramine alone: a placebo-controlled trial. Obesity Res, 2000, 8, 431-437.
89. Torgerson JS, Arlinger K, Käppi M, Sjöström L. Principles for enhancement recruitment of subjects in a large clinical trial: the XENDOS study experience. Control Clin Trials, 2000, 22, 515-525.
90. Scheen AJ, Paquot N, Letiexhe MR, Jandrain BJ. Approches pharmacologiques de prévention du diabète de type 2. Med Hyg, 2002, 60. 1480-1484.
91. Scheen AJ. Prévention du diabète de type 2 chez le sujet obèse: premiers résultats avec l'orlistat dans l'étude XENDOS. Rev Med Liège. 2002, 57, 617-621.