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Drug Evaluations

Pharmacokinetics, efficacy and safety of aleglitazar for the treatment of type 2 diabetes with high cardiovascular risk

, BS (Clinical Research Assistant) , , NP (Nurse Coordinator) & , MBBS FRCP FACP
Pages 753-763 | Published online: 27 Apr 2011

Bibliography

  • National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2007. Centers for Disease Control and Prevention. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2008. Available from: www.cdc.gov/diabetes/pubs/estimates07.htm. [Last accessed 9 December 2010]
  • National diabetes surveillance system. Centers for Disease Control and Prevention. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Available at: apps.nccd.cdc.gov/DDTSTRS/NationalSurvData.aspx. [Last accessed 9 December 2010]
  • UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998;352:854-65
  • Gerstein HC, Miller ME, Byington RP, Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008;358:2545-59
  • Patel A, MacMahon S, Chalmers J, ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008;358:2560-72
  • Skyler JS, Bergenstal R, Bonow RO, Intensive glycemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA diabetes trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association. Diabetes Care 2009;32:187-92
  • Kelly TN, Bazzano LA, Fonseca VA, Glucose control and cardiovascular disease in type 2 diabetes. Ann Intern Med 2009;151:1-13
  • Ray KK, Seshasai SR, Wijesuriya S, Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus: a meta-analysis of randomized controlled trials. Lancet 2009;373:1765-72
  • American Diabetes Association. Standards of medical care in diabetes – 2010. Diabetes Care 2010;33:S11-61
  • Rodbard HW, Blonde L, Braithwaite SS, AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract 2007;13:1-68
  • Diabetes Atherosclerosis Intervention Study Investigators. Effect of fenofibrate on progression of coronary-artery disease in type 2 diabetes: the Diabetes Atherosclerosis Intervention Study, a randomized study. Lancet 2001;357:905-10
  • Robins SJ, Rubins HB, Faas FH, on behalf of the VA-HIT Study Group. Insulin resistance and cardiovascular events with low HDL cholesterol: the Veterans Affairs HDL Intervention Trial (VA-HIT). Diabetes Care 2003;26:1513-17
  • Rubins HB, Robins SJ, Collins D, Diabetes, plasma insulin, and cardiovascular disease: subgroup analysis from the Department of Veterans Affairs High-Density Lipoprotein Intervention Trial (VA-HIT). Arch Intern Med 2002;162:2597-604
  • Keech A, Simes RJ, Barter P, FIELD study investigators. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet 2005;366:1849-61
  • Ginsberg HN, Elam MB, Lovato LC, ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010;362:1563-74
  • Nissen SE, Nicholls SJ, Wolski K, PERISCOPE Investigators. Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: the PERISCOPE randomized controlled trial. JAMA 2008;299:1561-73
  • Dormandy JA, Charbonnel B, Eckland DJA, on behalf of the PROactive investigators. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial in macroVascular Events): a ransomised controlled trial. Lancet 2005;366:1279-89
  • Home PD, Pocock SJ, Beck-Nielsen H, RECORD Study Team. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multcentre, randomized, open-label trial. Lancet 2009;373:2125-35
  • Davidson MH, Armani A, McKenney JM, Jacobson TA. Safety considerations with fibrate therapy. Am J Cardiol 2007;99:3C-18C
  • Krishnaswami A, Ravi-Kumar S, Lewis JM. Thiazolidinediones: a 2010 perspective. Perm J 2010;14:64-72
  • Sanwald-Ducray P, D'ardhuy XL, Jamois C, Banken L. Pharmacokinetics, pharmacodynamics, and tolerability of aleglitazar in patients with type 2 diabetes: results from a randomized, placebo-controlled clinical study. Clin Pharmacol Ther 2010;88:197-203
  • Henry RR, Lincoff AM, Mudaliar S, Effects of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on risk of cardiovascular disease in patients with type 2 diabetes (SYNCHRONY): a phase II, randomised, dose-ranging study. Lancet 2009;374:126-35
  • Herz M, Gaspari F, Perico N, Effects of high dose aleglitazar on renal function in patients with type 2 diabetes. Int J Cardiol 2010; published online 15 September 2010 doi: 10.1016/j.ijcard.2010.08.037
  • Steiner G. Fibrates and coronary risk reduction. Atherosclerosis 2005;182:199-207
  • Keating GM, Ormrod D. Micronised fenofibrate: an updated review of its clinical efficacy in the management of dyslipidemia. Drugs 2002;62:1909-44
  • Lalloyer F, Staels B. Fibrates, glitazones, and peroxisome proliferator-activated receptors. Arterioscler Thromb Vasc Biol 2010;30:894-9
  • Christodoulides C, Vidal-Puig A. PPARs and adipocyte function. Mol Cell Endocrinol 2010;318:61-8
  • Rangwala SM, Lazar MA. Peroxisome proliferator-activated receptor gamma in diabetes and metabolism. Trends Pharmacol Sci 2004;25:331-6
  • Goldberg RB, Kendall DM, Deeg MA, for the 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;28:1547-54
  • Duez H, Lefebvre B, Poulain P, Regulation of human apoA-I by gemfibrozil and fenofibrate through selective peroxisome proliferator-activated receptor alpha modulation. Arterioscler Thromb Vasc Biol 2005;25:585-91
  • Camp HS, Ou L, Wise SC, Differential activation of peroxisome proliferator-activated receptor-gamma by troglitazone and rosiglitazone. Diabetes 2000;49:539-47
  • Lecka-Czernik B, Moerman EJ, Grant DF, Divergent effects of selective peroxisome proliferator-activated receptor-gamma2 ligands on adipocyte versus osteoblast differentiation. Endocrinology 2002;143:2376-84
  • Rocchi S, Picard F, Vamecq J, A unique PPARgamma ligand with potent insulin-sensitizing yet weak adipogenic activity. Mol Cell 2001;8:737-47
  • Lehrke M, Lazar MA. The many faces of PPAR. Cell 2005;123:993-9
  • Chang F, Jaber LA, Berlie HD, O'Connell MB. Evolution of peroxisome proliferator-activated receptor agonists. Ann Pharmacother 2007;41:973-83
  • Dunn FL, Higgins LS, Fredrickson J. Depaoli AM; for the INT 131-004 study group. Selective modulation of PPARgamma activity can lower plasma glucose without typical thiazolidinedione side-effects in patients with type 2 diabetes. J Diabetes Complications 2010; doi:10.1016/j.jdiacomp.2010.06.006
  • Motani A, Wang Z, Weiszmann J, INT131: a selective modulator of PPAR gamma. J Mol Biol 2009;386:1301-11
  • Kintscher U, Goebel M. INT-131, a PPARgamma agonist for the treatment of type 2 diabetes. Curr Opin Investig Drugs 2009;10:381-7
  • Levien TL, Baker DE. New drugs in development for the treatment of diabetes. Diabetes Spectr 2009;22:92-106
  • Artis DR, Lin JJ, Zhang C, Scaffold-based discovery of indeglitazar, a PPAR pan-active anti-diabetic agent. Proc Natl Acad Sci USA 2009;106:262-7
  • Viswakarma N, Jia Y, Bai L, Coactivators in PPAR-regulated gene expression. PPAR Res 2010; published online 5 August 2010 doi: 10.1155/2010/250126
  • Schupp M, Lazar MA. Endogenous ligands for nuclear receptors: digging deeper. J Biol Chem 2010; published online 18 October 2010 doi: 10.1074/jbc.R110.182451
  • Balakumar P, Rose M, Ganti SS, PPAR dual agonists: are they opening Pandora's Box? Pharmacol Res 2007;56:91-8
  • Benardeau A, Benz J, Binggeli A, Aleglitazar, a new, potent, and balanced dual PPARalpha/gamma agonist for the treatment of type II diabetes. Bioorg Med Chem Lett 2009;19:2468-73
  • Foley-Comer AJ, Young AM, Russell-Yarde F, Jordan P. Aleglitazar, a balanced PPARalpha/gamma agonist, has no clinically relevant pharmacokinetic interaction with high-dose atorvastatin or rosuvastatin. Expert Opin Investig Drugs 2011;20:3-12
  • Nicholls SJ, Lincoff AM, Henry RR, Aleglitazar, a dual peroxisome proliferator-activated receptor (PPAR) alpha/gamma agonist, produces a shift towards a less atherogenic LDL profile in patients with type 2 diabetes [abstract]. Eur Heart J 2010;31:1020
  • Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007;356:2457-71
  • Nissen SE, Wolski K. Rosiglitazone revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med 2010;170:1191-201
  • Singh S, Loke YK, Furberg CD. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA 2007;298:1189-95
  • Seber S, Ucak S, Basat O, Altunas Y. The effect of dual PPAR alpha/gamma stimulation with combination of rosiglitazone and fenofibrate on metabolic parameters in type 2 diabetic patients. Diabetes Res Clin Pract 2006;71:52-8
  • Deeg MA, Buse JB, Goldberg RB, GLAI Study Investigators. Pioglitazone and rosiglitazone have different effects on serum lipoprotein particle concentration and sizes in patients with type 2 diabetes and dyslipidemia. Diabetes Care 2007;30:2458-64
  • Vakkilainen J, Steiner G, Ansquer J-C, ; on behalf of the DAIS Group. Relationships between low-density lipoprotein particle size, plasma lipoproteins, and progression of coronary artery disease: the Diabetes Atherosclerosis Intervention Study (DAIS). Circulation 2003;107:1733-7
  • Erdmann E, Dormandy J, Wilcox R, PROactive 07: pioglitazone in the treatment of type 2 diabetes: results of the PROactive study. Vasc Health Risk Manag 2007;3:355-70
  • Ahmed I, Furlong K, Flood J, Dual PPAR alpha/gamma agonists: promises and pitfalls in type 2 diabetes. Am J Ther 2007;14:49-62
  • Shearer BG, Billin AN. The next generation of PPAR drugs: do we have the tools to find them? Biochim Biophys Acta 2007;1771:1082-93
  • Wilding J. Thiazolidinediones, insulin resistance, and obesity: finding a balance. Int J Clin Pract 2006;60:1272-80
  • Hottelart C, El Esper N, Rose F, Fenofibrate increases creatininemia by increasing metabolic production of creatinine. Nephron 2002;92:536-41

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