Troglitazone

Current Opinion in Endocrinology and Diabetes

Volumn 5, Issue 2, 1998, Pages 90-96

  Kelley, David E ^a   Killian, Diane ^a  

^a UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA TOCOPHEROL; INSULIN; SULFONYLUREA DERIVATIVE; TROGLITAZONE;

DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; IMPAIRED GLUCOSE TOLERANCE; INSULIN RESISTANCE; JAPAN; NON INSULIN DEPENDENT DIABETES MELLITUS; REVIEW; UNITED KINGDOM; UNITED STATES;

EID: 0031747514     PISSN: 10683097     EISSN: None     Source Type: Journal    
DOI: 10.1097/00060793-199804000-00004     Document Type: Review

References (50)

1. Saltiel A, Olefsky J: Thiazolidinediones in the treatment of insulin resistance and type II diabetes. Diabetes 1996, 45:1661-1669. An excellent review of the mechanism of action of thiazolidinediones and of the metabolic effects on insulin resistance and hyperglycemia.
2. Auboeuf D, Rieusset J, Fajas L, Valuer P, Freering V, Riou J, Staels B, Auwerx J, Laville M, Vidal H: Tissue distribution and quantification of the expression of mRNAs of perixosome proliferator-activated receptors and liver X receptor-α in humans: no alteration in adipose tissue of obese and NIDDM patients. Diabetes 1997, 46:1319-1327.
3. Peraldi P, Xu M, Spiegelman B: Thiazolidinediones block tumor necrosis factor-α-induced inhibition of insulin signaling. J Clin Invest 1997, 100:1863-1869. An important set of in vitro studies of the effect of thiazolidinediones to modulate expression of TNF-α in adipocytes and the impact of insulin signaling.
4. Miles P, Romeo O, Higo K, Cohen A, Rafaat K, Olefsky J: TNF-α induced insulin resistance in vivo and its prevention by troglitazone. Diabetes 1997, 46:1678-1683.
5. Nolan J, Olefsky J, Nyce M, Considine R, Caro J: Effect of troglitazone on leptin production: studies in vitro and in human subjects. Diabetes 1997, 45:1276-1278.
6. Muoio D, Dohm L, Fiedorek F, Tapscott E, Coleman R: Leptin directly alters lipid partitioning in skeletal muscle. Diabetes 1997, 46:1360-1363.
7. Shimabukuro M, Koyama K, Chen G, Wang M-Y, Trieu F, Lee Y, Newgard C, Unger R: Direct antidiabetic effect of leptin through triglyceride depletion of tissues. Proc Natl Acad Sci U S A 1997, 94:4637-4641.
8. Park K, Abrams L, Nikoulina S, Mudaliar S, Ciardaldi T, Henry R: Effect of troglitazone on glucose transport and glycogen synthase activity in human skeletal muscle cultures from obese non-diabetic and NIDDM subjects. Diabetes 1996, 45(suppl 2):93A.
9. Hoffman C, Lerenz K, Colca JR: Glucose transport deficiency in diabetic animals is corrected by treatment with the oral antihyperglycemic agent pioglitazone. Endocrinology 1991, 129:1915-1925.
10. Burant C, Sreenan S, Hirano K-I, Tai T-A, Lohmiller J, Lukens J, Davidson N, Ross S, Graves R: Troglitazone action is independent of adipose tissue. J Clin Invest 1997, 100:2900-2908. Using an interesting animal model with greatly depleted adipose tissue mass, this study helps to delineate the direct effects of troglitazone on skeletal muscle lipid and glucose metabolism.
11. Fulgencio J-P, Kohl C, Girard J, Pegorier J-P: Troglitazone inhibits fatty acid oxidation and esterification, and gluconeogenesis in isolated hepatocytes from starved rats. Diabetes 1996, 46:1556-1562. A thorough examination of the in vitro effects of thiazolidinediones on pathways of fatty acid metabolism in hepatocytes.
12. Kurebayashi S, Hirose T, Miyashita Y, Kasayama S, Kishimoto T: Thiazolidinediones downregulate stearoyl-CoA desaturase 1 gene expression in 3T3-L1 adipocytes. Diabetes 1997, 46:2115-2118.
13. Kumar S, Boulton A, Beck-Nielsen H, Berthezene F, Muggeo M, Persson B, Spinas G, Donoghue S, Lettis S, Stewart-Long P, the Troglitazone Study Group: Troglitazone, an insulin action enhancer, improves metabolic control in NIDDm patients. Diabetologia 1996, 39:701-709. A large, multicenter, placebo-controlled study of the metabolic effects of troglitazone in patients with type 2 diabetes mellitus.
14. Valiquett T, Huang S, Whitcomb R: Effects of troglitazone monotherapy in patients with NIDDM: a 6-month multicenter study. Diabetes 1996, 47(suppl 1):43A.
15. Iwamoto Y, Kosaka K, Kuzuya T, Akanuma Y, Shigeta Y, KaneOOko T: Effects of troglitazone. A new hypoglycemic agent in patients with NIDDM poorly controlled by diet therapy. Diabetes Care 1996, 19:151-156.
16. Kaneko T: Troglitazone (CS-045): a new antidiabetic agent. Horm Metab Res 1997, 29:203-213. An excellent review of the pharmacology of troglitazone.
17. Kuzuya T, Iwamoto Y, Kosaka K, et al.: An early phase II clinical trial of a new oral hypoglycemic drug, CS-045, in patients with non-insulin dependent diabetes mellitus [in Japanese]. Rinsho Iyaku 1993, 2(suppl9):3-18.
18. Suter SL, Nolan JJ, Wallace P, Gumbiner B, Olefsky JM: Metabolic effects of new oral hypoglycemie agent CS-045 in NIDDM subjects. Diabetes Care 1992, 15:193-203.
19. Troglitazone Study Group: The metabolic effects of troglitazone in non-insulin dependent diabetes. Diabetes 1997, 46:149A.
20. Balcom J, Sindelar D, Neal D, Cherrington A: Troglitazone does not sensitize the liver to insulin in the normal dog. Diabetes Res 1997, 32:115-132.
21. Kawai K, Tokui T, Muramatsu S, Okada T, Ishigama M, Komai T: Enterohepatic circulation of sulfate and glucuronide conjugate of CS-045, an antidiabetic drug. Xenobio Metabol Dispos 1991, 6(suppl):109.
22. Spencer CM, Markham A: Troglitazone. Drugs 1997, 54:90-102. Another excellent review of the pharmacodynamic, pharmacokinetics, clinical trials, and toxicity of troglitazone.
23. Shibata H, Nii S, Kobayashi M, et al.: Phase I study of a new hypoglycemic agent CS-045 in healthy volunteers. Safety and pharmacokinetics in single administration [in Japanese]. Rinsho Iyaku 1993, 9:1503-1518.
24. Young MA, Robinson CE, Devoy MAB, et al.: The influence of food on the pharmacokinetics of GR92132X, a thiazolidinedione, in healthy subjects [abstract]. Br J Clin Pharmacol 1994, 37:482P.
25. Rezulin (Troglitazone) [package insert]. Morris Plains, NJ: Warner-Lambert Company, 1997.
26. Abramowicz M: Troglitazone for non-insulin-dependent diabetes mellitus. Med Lett Drugs Ther 1997, 39:49-51.
27. Shibukawa A, Sawada T, Nakao C, et al.: High-performance frontal analysis for the study of protein binding of troglitazone (CS-045) in albumin solution and in human plasma. J Chromatogr A 1995, 697:337-343.
28. Noguchi N, Sakai H, Kato Y, Tsuchiya J, Yamamoto Y, Niki E, Honkoshi H, Kodama T: Inhibition of oxidation of low density lipoprotein by troglita-zone. Atherosclerosis 1996, 123:227-234.
29. Ogihara T, Rakugi H, Ikegama H, et al.: Enhancement of insulin sensitivity by troglitazone lowers blood pressure in diabetic hypertensives. Am J Hypertens 1995, 8:316-320.
30. Kotchen T: Attenuation of hypertension by insulin-sensitizing agents. Hypertension 1996, 28:219-223.
31. Ghazzi M, Perez J, Antonucci T, Driscoll J, Huang S, Faja B, Whitcomb R, Troglitazone Study Group: Cardiac and glycemic benefits of troglita-zone treatment in NIDDM. Diabetes 1997, 46:433-439. A large open-label study that demonstrates cardiac safety of troglitazone and contains comparative metabolic effects of sulfonylurea and troglitazone monotherapy.
32. Nolan J, Ludvik B, Beerdsen P, Joyce M, Olefsky J: Improvement in glucose tolerance and insulin resistance in obese subjects treated with troglitazone. N Engl J Med 1994, 331:1188-1193.
33. Berkowitz K, Peters R, Kjos S, Goico J, Marroquin A, Dunn M, Xiang A, Azen S, Buchanan T: Effect of troglitazone on insulin sensitivity and pancreatic β-cell function in women at high risk for NIDDM. Diabetes 1996, 45:1572-1579. A prospective study of the efficacy of troglitazone in treating insulin resistance and preventing type 2 diabetes mellitus.
34. Antonucci T, McLain R, Whitcomb R, Lockwood D: Impaired glucose tolerance is normalized by treatment with the thiazolidinedione troglitazone. Diabetes Care 1997, 20:188-193. A prospective study of the efficacy of troglitazone in preventing type 2 diabetes mellitus.
35. Cavaghan M, Ehrmann D, Byrne M, Polonsky K: Treatment with the oral antidiabetic agent troglitazone improves β cell responses to glucose in subjects with impaired glucose tolerance. J Clin Invest 1997, 100:530-537. A detailed in vivo examination of the effects of troglitazone on β-cell function in individuals with IGT.
36. Iwamoto Y, Kosaka K, Kuzuya T, Akanuma Y, Shigeta Y, Kaneko T: Effects of combination therapy of troglitazone and sulfonylureas in patients with type 2 diabetes who were poorly controlled by sulfonylurea therapy alone. Diabetic Med 1996, 13:365-370.
37. Ghazzi M, Radke-Mitchell L, Venable T, Whitcomb R, the Troglitazone Study Group: Troglitazone improves glycemic control in patients with Type II diabetes who are not optimally controlled on sulfonylurea. Diabetes 1997, 46(suppl 1):44A.
38. Raskin P, Graveline J: Efficacy of troglitazone in combination with insulin in NIDDM. Diabetes 1997, 46(suppl 1):44A.
39. Akanuma Y, Kosaka K, Kuzuya T, et al.: Clinical evaluation of a new oral hypoglycemic agent CS-045 in patients with NIDDM poorly controlled by sulphonylureas. A dose-finding study by dose increase method [in Japanese]. Rinsho Iyaku 1993, 3(suppl 9):39-60.
40. Akanuma Y, Kosaka K, Kuzuya T, et al.: Long-term study of a new oral hypoglycemic agent, CS-045, in patients with non-insulin dependent diabetes mellitus [in Japanese]. Rinsho Iyaku 1993, 3(suppl 9):127-149.
41. Kuzuya T, Iwamoto Y, Kosaka K, et al.: An early phase II clinical trial of a new oral hypoglycemic drug, CS-045, in patients with non-insulin dependent diabetes mellitus [in Japanese]. Rinsho Iyaku 1993, 3(suppl 9):3-18.
42. Kosaka K, Kuzuya T, Akanuma Y, et al.: Clinical evaluation of a new oral hypoglycemic drug CS-045 in patients with NIDDM poorly controlled by sulphonylureas. A double-blind, placebo-controlled study [in Japanese]. Rinsho Iyaku 1993, 3(suppl 9):95-126.
43. Fukuda T, Nakano O, Amano M, et al.: A clinical study of a new hypoglycemic agent, troglitazone, in type 2 diabetes patients who are unsatisfactorily-controlled with insulin [in Japanese]. Rinsho Iyaku 1995, 11:2055-2062.
44. Kosaka K, Toyota T, Kuzuya T, et al.: Clinical evaluation of a new hypoglycemic agent CS-045 in combination with insulin. Igaku Ayumi 1996, 179:951-979.
45. Kuzuya T, Iwamoto Y, Kosaka K, et al.: An early phase II clinical trial of a new oral hypoglycemic drug, CS-045, in patients with non-insulin dependent diabetes mellitus [in Japanese]. Rinsho Iyaku 1993, 3(suppl 9):3-18.
46. Kuzuya T, Iwamoto Y, Kosaka K, et al.: A pilot clinical trial of a new oral hypoglycemic agent, CS-045, in patients with NIDDM. Diabetes Res Clin Pract 1991, 11:147-154.
47. Sigmund W: Parke-Davis letter to healthcare professionals. Morris Plains, NJ: Parke-Davis, October 31, 1997.
48. Parke-Davis announces new label changes for its type 2 diabetic drug, Rezulin. Warner-Lambert News, Morris Plains, NJ, December 1, 1997.
49. Updated statement from the American Diabetes Association about Rezulin (troglitazone) and new prescribing information/warnings. http://www.diabetes.org/ada/PRECRIBINGINFORMATION.HTML. December 1, 1997.
50. Segal M: Patient testing and labeling strengthened for Rezulin. FDA Talk Paper. http://www.fda.gov/bbs/topics/ANSWERS/ANS00837.htm. December 1, 1997.