Rosiglitazone: Trials, tribulations and termination

Drugs

Volumn 71, Issue 2, 2011, Pages 123-130

  Krentz, Andrew J ^a  

^a UNIVERSITY OF BEDFORDSHIRE   (United Kingdom)

Author keywords

Rosiglitazone; Type 2 diabetes mellitus.

Indexed keywords

GLITAZONE DERIVATIVE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; INSULIN; LOOP DIURETIC AGENT; METFORMIN; METFORMIN PLUS PIOGLITAZONE; METFORMIN PLUS ROSIGLITAZONE; PIOGLITAZONE; PLACEBO; ROSIGLITAZONE; SULFONYLUREA; TROGLITAZONE;

CARDIOVASCULAR RISK; CLINICAL TRIAL (TOPIC); CONGESTIVE HEART FAILURE; DIABETES MELLITUS; DRUG CONTRAINDICATION; DRUG EFFECT; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG WITHDRAWAL; EDEMA; FLUID RETENTION; GLYCEMIC CONTROL; HEART FAILURE; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HIGH RISK PATIENT; HUMAN; ISCHEMIC HEART DISEASE; LIPID METABOLISM; LIVER FAILURE; META ANALYSIS (TOPIC); MORTALITY; NON INSULIN DEPENDENT DIABETES MELLITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIDE EFFECT; STROKE; WEIGHT GAIN;

CONTROLLED CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; EUROPE; HISTORY, 21ST CENTURY; HUMANS; HYPOGLYCEMIC AGENTS; MYOCARDIAL INFARCTION; SAFETY-BASED DRUG WITHDRAWALS; THIAZOLIDINEDIONES; UNITED STATES;

EID: 79551540182     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/11585300-000000000-00000     Document Type: Review

References (40)

1. Intensive blood-glucose control with sulphonylureas or in-sulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33): UK Prospective Diabetes Study (UKPDS) Group [published erratum appears in Lancet 1999; 354 (9178): 602]. Lancet 1998; 352 (9131): 837-53
2. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34): UK Prospective Diabetes Study (UKPDS) Group [published erratum appears in Lancet 1998; 352 (9139): 1558]. Lancet 1998; 352 (9131): 854-65
3. DeFronzo RA, Ferrannini E. Insulin resistance: a multi-faceted syndrome responsible for NIDDM, obesity, hypertension, dyslipidemia, and atherosclerotic cardiovascular disease. Diabetes Care 1991; 14 (3): 173-94
4. Yki-Jarvinen H. Thiazolidinediones. N Engl J Med 2004;351 (11): 1106-18
5. Krentz AJ, Bailey CJ. Oral antidiabetic agents: current role in type 2 diabetes mellitus. Drugs 2005; 65 (3): 385-411
6. Bailey CJ, Turner RC. Metformin. N Engl J Med 1996; 334 (9): 574-9
7. Stout RW. Hyperinsulinemia and atherosclerosis. Diabetes 1996; 45 Suppl. 3: S45-6
8. Hemmingsen B, Lund SS, Wetterslev J, et al. Oral hypogly-caemic agents, insulin resistance and cardiovascular disease in patients with type 2 diabetes. Eur J Endocrinol 2009 Jul; 161 (1): 1-9
9. Krentz AJ, Bailey CJ, Melander A. Thiazolidinediones for type 2 diabetes: new agents reduce insulin resistance but need long term clinical trials. BMJ 2000; 321 (7256): 252-3
10. Nattrass M, Alberti KG. Biguanides. Diabetologia 1978; 14 (2): 71-4
11. Krentz AJ, Ferner RE, Bailey CJ. Comparative tolerability profiles of oral antidiabetic agents. Drug Saf 1994; 11 (4): 223-41
12. Krentz AJ. Sulfonylureas in the prevention of vascular complications: from UKPDS to the ADVANCE study, in the metabolic syndrome: diabetes, obesity, hyperlipidemia and hypertension. In: Crepaldi GT, Avogaro AA, editors. Amsterdam: Excerpta Medica International Conference Series, 2002: 261-77
13. Johnsen SP, Monster TB, Olsen ML, et al. Risk and short-term prognosis of myocardial infarction among users of antidiabetic drugs. Am J Ther 2006; 13 (2): 134-40
14. Goldberg RB, Kendall DM, Deeg MA, et al. A comparison of lipid and glycemic effects of pioglitazone and rosiglita-zone in patients with type 2 diabetes and dyslipidemia. Diabetes Care 2005; 28 (7): 1547-54
15. Gale EA. Diabetes in the UK: time for a reality check? Diabet Med 2010; 27 (9): 973-6
16. Dormandy JA, Charbonnel B, Eckland DJ, et al., PROac-tive investigators. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macro-Vascular Events): a randomised controlled trial. Lancet 2005; 366 (9493): 1279-89
17. DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators, Gerstein HC, Yusuf S, 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(9541):1096-105
18. Kahn SE, Haffner SM, Heise MA, et al., ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006; 355 (23): 2427-43
19. Lincoff AM, Wolski K, Nicholls SJ, et al. Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. JAMA 2007; 298 (10): 1180-8
20. Nissen SE, Nicholls SJ, Wolski K, et al., PERISCOPE In-estigators. Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: the PERISCOPE randomized controlled trial. JAMA 2008; 299 (13): 1561-73
21. Krentz A. Thiazolidinediones: effects on the development and progression of type 2 diabetes and associated vascular complications. Diabetes Metab Res Rev 2009; 25 (2): 112-26
22. Nathan DM, Buse JB, Davidson MB, et al., American Diabetes Association; European Association for the Study of Diabetes. Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 2009; 52 (1): 17-30
23. Rodbard HW, Jellinger PS, Davidson JA, et al. Statement by an American Association of Clinical Endocrinologists/ American College of Endocrinology consensus panel on type 2 diabetes mellitus: an algorithm for glycemic control [published erratum appears in Endocr Pract 2009; 15 (7): 768-70]. Endocr Pract 2009; 15 (6): 540-59
24. National Institute for Health and Clinical Excellence. Type 2 diabetes: newer agents (partial update of CG66) [online]. Available from URL: http://www.nice.org.uk/CG87 [Accessed 2010 Nov 22]
25. Diamond GA, Bax L, Kaul S. Uncertain effects of rosigli-tazone on the risk for myocardial infarction and cardiovascular death. Ann Intern Med 2007; 147 (8): 578-81
26. Schernthaner G, Chilton RJ. Cardiovascular risk and thiazolidinediones: what do meta-analyses really tell us? Diabetes Obes Metab 2010; 12: 1023-35
27. Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes: an interim analysis. N Engl J Med 2007; 357 (1): 28-38
28. Home PD, Pocock SJ, Beck-Nielsen H, et al., RECORD Study Team. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 2009; 373 (9681): 2125-35
29. BARI 2D Study Group, Frye RL, August P, et al. A ran-domized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med 2009;360(24):2503-15
30. US FDA. Avandia (rosiglitazone): REMS - risk of cardio-vascular events [online]. Available from URL: http://www. fda.gov/Safety/MedWatch/ SafetyInformation/SafetyAlerts forHumanMedicalProducts/ucm226994.htm [Accessed 2010 Dec 6]
31. European Medicines Agency. European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim [online]. Available from URL: http://www.ema. europa.eu/ema/index.jsp?curl=pages/news-and-events/news/ 2010/09/news-detail-001119.jsp&murl=menus/news-and-events/news-and-events. jsp&mid=WC0b01ac058004d5c1 &jsenabled=true [Accessed 2010 Dec 6]
32. Graham DJ, Ouellet-Hellstrom R, MaCurdy TE, et al. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglita-zone or pioglitazone. JAMA 2010; 304 (4): 411-8
33. Nissen SE, Wolski K. Rosiglitazone revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med. Epub 2010 Jun 28
34. Woodcock J, Sharfstein JM, Hamburg M. Regulatory ac-tion on rosiglitazone by the U.S. Food and Drug Administration. N Engl J Med 2010; 363 (16): 1489-91
35. Blind E, Dunder K, de Graeff PA, et al. Rosiglitazone: a European regulatory perspective. Diabetologia. Epub 2010 Dec 14
36. Shah ND, Montori VM, Krumholz HM, et al. Responding to an FDA warning: geographic variation in the use of rosiglitazone. N Engl J Med 2010; 363: 2081-4
37. Nissen SE, Wolski K, Topol EJ. Effect of muraglitazar on death and major adverse cardiovascular events in patients with type 2 diabetes mellitus. JAMA 2005; 294 (20): 2581-6
38. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry: diabetes melli-tus - evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. 2008, Dec [online]. Available from URL: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulator [Accessed 2010 Nov 12]
39. EMA (2008). Concept paper on the need for revision of the note for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus [online]. Available from URL: http://www.ema.europa.eu/docs/ en-GB/document-library/Scientific-guideline/2009/09/WC50 0003182.pdf [Accessed 2010 Dec 16]
40. Cohen D. Rosiglitazone: what went wrong? BMJ 2010 Sep 6; 341: c4848