Safety and efficacy of rosiglitazone in the elderly diabetic patient

Vascular Health and Risk Management

Volumn 5, Issue , 2009, Pages 389-395

  Viljoen, Adie ^a   Sinclair, Alan ^b  

^a LISTER HOSPITAL   (United Kingdom)

^b UNIVERSITY OF BEDFORDSHIRE   (United Kingdom)

Author keywords

Cardiovascular disease; Elderly; Rosiglitazone; Thiazolidinedione; Type 2 diabetes

Indexed keywords

GLIBENCLAMIDE; METFORMIN; PEROXISOME PROLIFERATOR ACTIVATED RECEPTOR; PIOGLITAZONE; PLACEBO; RAMIPRIL; ROSIGLITAZONE; SULFONYLUREA DERIVATIVE; 2,4 THIAZOLIDINEDIONE DERIVATIVE; ANTIDIABETIC AGENT;

ADD ON THERAPY; ADIPOSE TISSUE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CLINICAL TRIAL; DIABETIC PATIENT; DRUG CONTRAINDICATION; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; FRACTURE; HEART FAILURE; HEART INFARCTION; HUMAN; INSULIN SENSITIVITY; ISCHEMIC HEART DISEASE; MORTALITY; NON INSULIN DEPENDENT DIABETES MELLITUS; REVIEW; SIDE EFFECT; TREATMENT OUTCOME; AGE; AGED; CHEMICALLY INDUCED DISORDER; DRUG POTENTIATION; EVIDENCE BASED MEDICINE; HEART MUSCLE ISCHEMIA; RISK ASSESSMENT; RISK FACTOR;

AGE FACTORS; AGED; CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS, TYPE 2; EVIDENCE-BASED MEDICINE; FRACTURES, BONE; HEART FAILURE; HUMANS; HYPOGLYCEMIC AGENTS; MYOCARDIAL ISCHEMIA; PEROXISOME PROLIFERATOR-ACTIVATED RECEPTORS; RISK ASSESSMENT; RISK FACTORS; THIAZOLIDINEDIONES; TREATMENT OUTCOME;

EID: 67449089733     PISSN: 11766344     EISSN: 11782048     Source Type: Journal    
DOI: 10.2147/vhrm.s4053     Document Type: Review

References (58)

1. UK Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352(9131):837-853.
2. Colhoun HM, Betteridge DJ, Durrington PN, et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet. 2004;364(9435):685-696.
3. Collins R, Armitage J, Parish S, Sleigh P, Peto R. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet. 2003;361(9374):2005-2016.
4. Cholesterol Treatment Trialists' (CTT) Collaborators, Kearney PM, Blackwell L, et al. Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet. 2008;371(9607):117-125.
5. Gaede P, Vedel P, Larsen N, et al. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003;348(5):383-393.
6. Kannel WB. Lipids, diabetes, and coronary heart disease: insights from the Framingham Study. Am Heart J. 1985;110:1100-1107.
7. Sinclair AJ, Finucane P, editors. Diabetes in Old Age, 3rd Ed. Hoboken, NJ: Wiley; 1995.
8. Nathan DM, Buse JB, Davidson MB, et al; American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009;32(1):193-203.
9. Yki-Järvinen H. Thiazolidinediones. N Engl J Med. 2004;351(11):1106-1118.
10. Chawla A, Repa JJ, Evans RM, et al. Nuclear receptors and lipid physiology: opening the X-files. Science. 2001;294(5548):1866-1870.
11. Aronoff S, Rosenblatt S, Braithwaite S, Egan JW, Mathisen AL, Schneider RL. Pioglitazone hydrochloride monotherapy improves glycemic control in the treatment of patients with type 2 diabetes: a 6-month randomized placebo-controlled dose-response study. Diabetes Care. 2000;23:1605-1611.
12. Kipnes MS, Krosnick A, Rendell MS, Egan JW, Mathisen AL, Schneider RL. Pioglitazone hydrochloride in combination with sulfonylurea therapy improves glycaemic control in patients with type 2 diabetes mellitus: a randomized, placebo-controlled study. Am J Med. 2001;111:10-17.
13. Raskin P, Rendell M, Riddle MC, Dole JF, Freed MI, Rosenstock J. A randomized trial of rosiglitazone therapy in patients with inadequately controlled insulin-treated type2 diabetes. Diabetes Care. 2001;24:1226-1232.
14. Fonseca V, Rosenstock J, Patwardhan R, Salzman A. Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus: a randomized controlled trial. JAMA. 2000;283:1695-1702.
15. Iwamoto Y, Kosaka K, Kuzuya T, Akanuma Y, Shigeta Y, Kaneko T. Effects of troglitazone: a new hypoglycemic agent in patients with NIDDM poorly controlled by diet therapy. Diabetes Care. 1996;19(2):151-156.
16. Kumar S, Boulton AJ, Beck-Nielsen H, et al. Troglitazone, an insulin action enhancer, improves metabolic control in NIDDM patients. Troglitazone Study Group. Diabetologia. 1996;39(6):701-709. Erratum in: Diabetologia. 1996;39(10):1245.
17. Rosen CJ. The rosiglitazone story-lessons from an FDA Advisory Committee meeting. N Engl J Med. 2007;357(9):844-846.
18. Issemann I, Green S. Activation of a member of the steroid hormone receptor superfamily by peroxisome proliferators. Nature. 1990;347(6294):645-650.
19. Badr M. A forum for a highly important and ever-expanding field of study. PPAR Res. 2006;2006:61385.
20. van Raalte DH, Li M, Pritchard PH, Wasan KM. Peroxisome proliferator-activated receptor (PPAR)-alpha: a pharmacological target with a promising future. Pharm Res. 2004 Sep;21(9):1531-1538.
21. Walczak R, Tontonoz P. PPARadigms and PPARadoxes: expanding roles for PPARgamma in the control of lipid metabolism. J Lipid Res. 2002;43(2):177-186.
22. Rosen ED, Walkey CJ, Puigserver P, Spiegelman BM. Transcriptional regulation of adipogenesis. Genes Dev. 2000;14(11):1293-1307.
23. Nolan JJ, 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.
24. Miyazaki Y, Glass L, Triplitt C, et al. Effect of rosiglitazone on glucose and nonesterified fatty acid metabolism in Type 2 diabetic patients. Diabetologia. 2001;44:2210-2219.
25. Kadowaki T, Yamauchi T, Kubota N, Hara K, Ueki K, Tobe K. Adiponectin and adiponectin receptors in insulin resistance, diabetes, and the metabolic syndrome. J Clin Invest. 2006;116(7):1784-1792.
26. Han SJ, Kang ES, Hur KY, et al. Rosiglitazone inhibits early stage of glucolipotoxicity-induced beta-cell apoptosis. Horm Res. 2008;70:165-173.
27. The Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358:2545-2559.
28. FDA Briefing Document: Joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. 30 July 2007. Philadelphia, PA: GlaxoSmithKline; 2007. Accessed Jan 11, 2009. Available from: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007- 4308b1-02-fda-backgrounder.pdf.
29. McAfee AT, Koro C, Landon J, Ziyadeh N, Walker AM. Coronary heart disease outcomes in patients receiving antidiabetic agents. Pharmacoepidemiol Drug Saf. 2007;16:711-725.
30. Gerstein HC, Yusuf S, Bosch J, et al. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial. Lancet. 2006;368:1096-1105.
31. Kahn SE, Haffner SM, Heise MA, et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006;355:2427-2443.
32. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356(24):2457-2471.
33. Home PD, Pocock SJ, Beck-Nielsen H, et al; RECORD Study Group. Rosiglitazone evaluated for cardiovascular outcomes - an interim analysis. N Engl J Med. 2007;357(1):28-38.
34. Singh S, Loke YK, Furberg CD. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA. 2007;298:1189-1195.
35. GlaxoSmithKline Study Nos. ZM2005/00181/01 and HM2006/00497/00/ WEUSRTP866: Avandia Cardiovascular Event Modeling Project and Coronary Heart Disease Outcomes in Patients Receiving Antidiabetic Agents. Accessed Jan 11, 2007. Available from: http://ctr.gsk.co.uk/Summary/Rosiglitazone/III-CVmodeling. pdf.
36. Richter B, Bandeira-Echtler E, Bergerhoff K, Clar C, Ebrahim S. Rosiglitazone for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2007;3:CD006063.
37. Wierzbicki AS. Surrogate markers, atherosclerosis and cardiovascular disease prevention. Int J Clin Pract. 2008;62(7):981-987.
38. Mulrow CD, Cornell J, Localio AR. Rosiglitazone: a thunderstorm from scarce and fragile data. Ann Intern Med. 2007;147(8):585-587.
39. Lipscombe LL, Gomes T, Lévesque LE, Hux JE, Juurlink DN, Alter DA. Thiazolidinediones and cardiovascular outcomes in older patients with diabetes. JAMA. 2007;298(22):2634-2643.
40. Winkelmayer WC, Setoguchi S, Levin R, Solomon DH. Comparison of cardiovascular outcomes in elderly patients with diabetes who initiated rosiglitazone vs pioglitazone therapy. Arch Intern Med. 2008;168(21):2368-2375.
41. Dormandy JA, Charbonnel B, Eckland DJ, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005;366(9493):1279-1289.
42. Lincoff AM, Wolski K, Nicholls SJ, Nissen SE. Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. JAMA. 2007;298(10):1180-1188.
43. Mannucci E, Monami M, Lamanna C, Gensini GF, Marchionni N. Pioglitazone and cardiovascular risk. A comprehensive meta-analysis of randomized clinical trials Diabetes Obes Metab. 2008;10(12):1221-1238.
44. Goldberg RB, Kendall DM, Deeg MA, et al; GLAI Study Investigators. A comparison of lipid and glycemic effects of pioglitazone and rosiglitazone in patients with type 2 diabetes and dyslipidemia. Diabetes Care. 2005;28(7):1547-1554.
45. Deeg MA, Buse JB, Goldberg RB, et al; GLAI Study Investigators. Pioglitazone and rosiglitazone have different effects on serum lipoprotein particle concentrations and sizes in patients with type 2 diabetes and dyslipidemia. Diabetes Care. 2007;30(10):2458-2464.
46. Deeg MA, Tan MH. Pioglitazone versus rosiglitazone: Effects on lipids, lipoproteins, and apolipoproteins in head-to-head randomized clinical studies. PPAR Res. 2008;2008:520465.
47. Hsiao A, Worrall DS, Olefsky JM, Subramaniam S. Variance-modeled posterior inference of microarrray data: detecting gene-expression changes in 3T3-L1 adipocytes. Bioinformatics. 2004;20(17):3108-3127.
48. European Agency for the Evaluation of Medicinal Products (EMEA). EPARS for authorised medicinal products for human use. London, UK: Avandia; 2007. Accessed Jan 11, 2009. Available from: http://www. emea.europa.eu/humandocs/ Humans/EPAR/avandia/avandia.htm.
49. Nesto RW, Bell D, Bonow RO, et al. Thiazolidinedione use, fluid retention, and congestive heart failure: a consensus statement from the American Heart Association and American Diabetes Association. Diabetes Care. 2004;27:256-263.
50. Singh S, Loke YK, Furberg CD. Thiazolidinediones and heart failure: a teleo-analysis. Diabetes Care. 2007;30:2148-2153.
51. Singh S, Loke YK, Furberg CD. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA. 2007;298(10):1189-1195.
52. Schwartz AV, Sellmeyer DE, Vittinghoff E, et al. Thiazolidinedione use and bone loss in older diabetic adults. J Clin Endocrinol Metab. 2006;91(9):3349-3354.
53. Takeda Pharmaceuticals. Observation of an increased incidence of fractures in female patients who received long-term treatment with ACTOS® (pioglitazone HCl) tablets for type 2 diabetes mellitus. March 2007. Accessed on Jan 11, 2009. Available from: http://www. fda.gov/medwatch/safety/2007/ Actosmar0807.pdf.
54. Loke YK, Singh S, Furberg C. Long-term use of thiazolidinediones and fractures in type 2 diabetes: a meta-analysis. CMAJ. 2009;180(1):32-39.
55. Grey A, Bolland M, Gamble G, et al. The peroxisome proliferatoractivated receptor-gamma agonist rosiglitazone decreases bone formation and bone mineral density in healthy postmenopausal women: a randomized, controlled trial. Clin Endocrinol Metab. 2007;92(4):1305-1310.
56. Glintborg D, Andersen M, Hagen C, Heickendorff L, Hermann AP. Association of pioglitazone treatment with decreased bone mineral density in obese premenopausal patients with polycystic ovary syndrome: a randomized, placebo-controlled trial. J Clin Endocrinol Metab. 2008;93(5):1696-1701.
57. Ali AA, Weinstein RS, Stewart SA, Parfitt AM, Manolagas SC, Jilka RL. Rosiglitazone causes bone loss in mice by suppressing osteoblast differentiation and bone formation. Endocrinology. 2005;146:1226-1235.
58. Lipscombe LL. Thiazolidinediones: Do harms outweigh benefits? CMAJ. 2009;180:16-17.