Bibliography
- Lalloyer F, Staels B. Fibrates, glitazones, and peroxisome proliferator-activated receptors. Arterioscler Thromb Vasc Biol 2010;30:894-9
- Lee SS, Pineau T, Drago J, Targeted disruption of the alpha isoform of the peroxisome proliferator-activated receptor gene in mice results in abolishment of the pleiotropic effects of peroxisome proliferators. Mol Cell Biol 1995;15:3012-22
- Mazzone T, Chait A, Plutzky J. Cardiovascular disease risk in type 2 diabetes mellitus: insights from mechanistic studies. Lancet 2008;371:1800-9
- Knopp RH. Drug treatment of lipid disorders. N Engl J Med 1999;341:498-511
- Keech A, Simes RJ, Barter P, 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
- The ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010;362:1563-74
- Rubins HB, Robins SJ, Collins D, Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group. N Engl J Med 1999;341:410-18
- Frick MH, Elo O, Haapa K, Helsinki heart study: primary-prevention trial with gemfibrozil in middle-aged men with dyslipidemia. Safety of treatment, changes in risk factors, and incidence of coronary heart disease. N Engl J Med 1987;317:1237-45
- Jun M, Foote C, Lv J, Effects of fibrates on cardiovascular outcomes: a systematic review and meta-analysis. Lancet 2010;375:1875-84
- Dormandy JA, Charbonnel B, Eckland DJ, 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;366:1279-89
- Sarafidis PA, Stafylas PC, Georgianos PI, Effect of thiazolidinediones on albuminuria and proteinuria in diabetes: a meta-analysis. Am J Kidney Dis 2010;55:835-47
- Shen LQ, Child A, Weber GM, Rosiglitazone and delayed onset of proliferative diabetic retinopathy. Arch Ophthalmol 2008;126:793-9
- GlaxoSmithKline. AVANDIA. 2011. Available from: http://us.gsk.com/products/assets/us_avandia.pdf [Accessed 8 October 2012]
- Takeda Pharmaceuticals. Actos. 2012. Available from: http://www.actos.com/ImportantSafetyInformation.aspx [Accessed 8 October 2012]
- Carey DG, Jenkins AB, Campbell LV, Abdominal fat and insulin resistance in normal and overweight women: direct measurements reveal a strong relationship in subjects at both low and high risk of NIDDM. Diabetes 1996;45:633-8
- Kissebah AH, Krakower GR. Regional adiposity and morbidity. Physiol Rev 1994;74:761-811
- Nguyen-Duy TB, Nichaman MZ, Church TS, Visceral fat and liver fat are independent predictors of metabolic risk factors in men. Am J Physiol Endocrinol Metab 2003;284:E1065-71
- Seppala-Lindroos A, Vehkavaara S, Hakkinen AM, Fat accumulation in the liver is associated with defects in insulin suppression of glucose production and serum free fatty acids independent of obesity in normal men. J Clin Endocrinol Metab 2002;87:3023-8
- Shah PK, Mudaliar S, Chang AR, Effects of intensive insulin therapy alone and in combination with pioglitazone on body weight, composition, distribution and liver fat content in patients with type 2 diabetes. Diabetes Obes Metab 2011;13:505-10
- Martens FM, Visseren FL, Lemay J, Metabolic and additional vascular effects of thiazolidinediones. Drugs 2002;62:1463-80
- Fonseca V. Effect of thiazolidinediones on body weight in patients with diabetes mellitus. Am J Med 2003;115(Suppl 8A):42S-8S
- Derosa G, Maffioli P. Thiazolidinediones plus metformin association on body weight in patients with type 2 diabetes. Diabetes Res Clin Pract 2011;91:265-70
- Balas B, Belfort R, Harrison SA, Pioglitazone treatment increases whole body fat but not total body water in patients with non-alcoholic steatohepatitis. J Hepatol 2007;47:565-70
- Karalliedde J, Buckingham RE. Thiazolidinediones and their fluid-related adverse effects: facts, fiction and putative management strategies. Drug Saf 2007;30:741-53
- Nesto RW, Bell D, Bonow RO, Thiazolidinedione use, fluid retention, and congestive heart failure: a consensus statement from the American Heart Association and American Diabetes Association. October 7, 2003. Circulation 2003;108:2941-8
- Actos Summary of Product Characteristics European Label. 2012. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/07/WC500109185.pdf [Accessed 10 October 2012]
- Guan Y, Hao C, Cha DR, Thiazolidinediones expand body fluid volume through PPARgamma stimulation of ENaC-mediated renal salt absorption. Nat Med 2005;11:861-6
- Zhang H, Zhang A, Kohan DE, Collecting duct-specific deletion of peroxisome proliferator-activated receptor gamma blocks thiazolidinedione-induced fluid retention. Proc Natl Acad Sci USA 2005;102:9406-11
- Karalliedde J, Buckingham R, Starkie M, Effect of various diuretic treatments on rosiglitazone-induced fluid retention. J Am Soc Nephrol 2006;17:3482-90
- Hansen L, Ekstrom CT, Tabanera YP, The Pro12Ala variant of the PPARG gene is a risk factor for peroxisome proliferator-activated receptor-gamma/alpha agonist-induced edema in type 2 diabetic patients. J Clin Endocrinol Metab 2006;91:3446-50
- Hernandez AV, Usmani A, Rajamanickam A, Thiazolidinediones and risk of heart failure in patients with or at high risk of type 2 diabetes mellitus: a meta-analysis and meta-regression analysis of placebo-controlled randomized clinical trials. Am J Cardiovasc Drugs 2011;11:115-28
- Graham DJ, Ouellet-Hellstrom R, MaCurdy TE, Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA 2010;304:411-18
- Masoudi FA, Inzucchi SE, Wang Y, Thiazolidinediones, metformin, and outcomes in older patients with diabetes and heart failure: an observational study. Circulation 2005;111:583-90
- Lago RM, Singh PP, Nesto RW. Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: a meta-analysis of randomised clinical trials. Lancet 2007;370:1129-36
- Erdmann E, Charbonnel B, Wilcox RG, Pioglitazone use and heart failure in patients with type 2 diabetes and preexisting cardiovascular disease: data from the PROactive study (PROactive 08). Diabetes Care 2007;30:2773-8
- Giles TD, Miller AB, Elkayam U, Pioglitazone and heart failure: results from a controlled study in patients with type 2 diabetes mellitus and systolic dysfunction. J Card Fail 2008;14:445-52
- Dargie HJ, Hildebrandt PR, Riegger GA, A randomized, placebo-controlled trial assessing the effects of rosiglitazone on echocardiographic function and cardiac status in type 2 diabetic patients with New York Heart Association Functional Class I or II Heart Failure. J Am Coll Cardiol 2007;49:1696-704
- Kasiske B, Cosio FG, Beto J, Clinical practice guidelines for managing dyslipidemias in kidney transplant patients: a report from the managing dyslipidemias in chronic kidney disease work group of the national kidney foundation kidney disease outcomes quality initiative. Am J Transplant 2004;4(Suppl 7):13-53
- Davidson MH, Armani A, McKenney JM, Safety considerations with fibrate therapy. Am J Cardiol 2007;99:3C-18C
- KDOQI. KDOQI clinical practice guidelines and clinical practice recommendations for diabetes and chronic kidney disease. Am J Kidney Dis 2007;49:S12-S154
- Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults.Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) (Adult Treatment Panel III). JAMA 2001;285:2486-97
- Tsimihodimos V, Miltiadous G, Bairaktari E, Possible mechanisms of the fibrate-induced increase in serum creatinine. Clin Nephrol 2002;57:407-8
- Hottelart C, El Esper N, Rose F, Fenofibrate increases creatininemia by increasing metabolic production of creatinine. Nephron 2002;92:536-41
- Ansquer JC, Dalton RN, Causse E, Effect of fenofibrate on kidney function: a 6-week randomized crossover trial in healthy people. Am J Kidney Dis 2008;51:904-13
- Davis TM, Ting R, Best JD, Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study. Diabetologia 2010;54:280-90
- Budde K, Neumayer HH, Fritsche L, The pharmacokinetics of pioglitazone in patients with impaired renal function. Br J Clin Pharmacol 2003;55:368-74
- Chapelsky MC, Thompson-Culkin K, Miller AK, Pharmacokinetics of rosiglitazone in patients with varying degrees of renal insufficiency. J Clin Pharmacol 2003;43:252-9
- Thomas MC, Jandeleit-Dahm KA, Tikellis C. The renoprotective actions of peroxisome proliferator-activated receptors agonists in diabetes. PPAR Res 2012;2012:ID456529
- Kim CH, Younossi ZM. Nonalcoholic fatty liver disease: a manifestation of the metabolic syndrome. Cleve Clin J Med 2008;75:721-8
- Harris EH. Elevated liver function tests in type 2 diabetes. Clin Diabetes 2005;23:115-19
- Yokoi T. Troglitazone. Handb Exp Pharmacol 2010;196:419-35
- Julie NL, Julie IM, Kende AI, Mitochondrial dysfunction and delayed hepatotoxicity: another lesson from troglitazone. Diabetologia 2008;51:2108-16
- Gale EA. Troglitazone: the lesson that nobody learned? Diabetologia 2006;49:1-6
- U.S.Department of Health and Human Services. U.S. Department of Health and Human Services. Rezulin to be withdrawn from the market.2011. Available from: http://www.fda.gov/bbs/topics/NEWS/NEW00721.html [Accessed 8 October 2012]
- Marcy TR, Britton ML, Blevins SM. Second-generation thiazolidinediones and hepatotoxicity. Ann Pharmacother 2004;38:1419-23
- Huerta C, Zhao SZ, Garcia Rodriguez LA. Risk of acute liver injury in patients with diabetes. Pharmacotherapy 2002;22:1091-6
- Tolman KG. The safety of thiazolidinediones. Expert Opin Drug Saf 2011;10:419-28
- Sanyal AJ, Campbell-Sargent C, Mirshahi F, Nonalcoholic steatohepatitis: association of insulin resistance and mitochondrial abnormalities. Gastroenterology 2001;120:1183-92
- Chitturi S, Abeygunasekera S, Farrell GC, NASH and insulin resistance: insulin hypersecretion and specific association with the insulin resistance syndrome. Hepatology 2002;35:373-9
- Belfort R, Harrison SA, Brown K, A placebo-controlled trial of pioglitazone in subjects with nonalcoholic steatohepatitis. N Engl J Med 2006;355:2297-307
- Neuschwander-Tetri BA, Brunt EM, Wehmeier KR, Improved nonalcoholic steatohepatitis after 48 weeks of treatment with the PPAR-gamma ligand rosiglitazone. Hepatology 2003;38:1008-17
- Promrat K, Lutchman G, Uwaifo GI, A pilot study of pioglitazone treatment for nonalcoholic steatohepatitis. Hepatology 2004;39:188-96
- Abbott. Trilipix. 2012. Available from: http://www.rxabbott.com/pdf/trilipix_pi.pdf [Accessed 8 October 2012]
- A co-operative trial in the primary prevention of ischaemic heart disease using clofibrate. Report from the Committee of Principal Investigators. Br Heart J 1978;40:1069-118
- FDA. LOPID® Gemfibrozil Tablets USP. 2011. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018422s048lbl.pdf [Accessed 8 October 2012]
- FDA. Antara lI (fenofibrate) Capsules. 2011.http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021695s006lbl.pdf [Accessed 8 October 2012]
- Moseley KF. Type 2 diabetes and bone fractures. Curr Opin Endocrinol Diabetes Obes 2012;19:128-35
- Rzonca SO, Suva LJ, Gaddy D, Bone is a target for the antidiabetic compound rosiglitazone. Endocrinology 2004;145:401-6
- Schwartz AV, Sellmeyer DE, Vittinghoff E, Thiazolidinedione use and bone loss in older diabetic adults. J Clin Endocrinol Metab 2006;91:3349-54
- Loke YK, Singh S, Furberg CD. Long-term use of thiazolidinediones and fractures in type 2 diabetes: a meta-analysis. CMAJ 2009;180:32-9
- Betteridge DJ. Thiazolidinediones and fracture risk in patients with Type 2 diabetes. Diabet Med 2011;28:759-71
- Grey A. Skeletal consequences of thiazolidinedione therapy. Osteoporos Int 2008;19:129-37
- Chan BY, Gartland A, Wilson PJ, PPAR agonists modulate human osteoclast formation and activity in vitro. Bone 2007;40:149-59
- Syversen U, Stunes AK, Gustafsson BI, Different skeletal effects of the peroxisome proliferator activated receptor (PPAR)alpha agonist fenofibrate and the PPARgamma agonist pioglitazone. BMC Endocr Disord 2009;9:10
- Stunes AK, Westbroek I, Gustafsson BI, The peroxisome proliferator-activated receptor (PPAR) alpha agonist fenofibrate maintains bone mass, while the PPAR gamma agonist pioglitazone exaggerates bone loss, in ovariectomized rats. BMC Endocr Disord 2011;11:11
- Samadfam R, Awori M, Benardeau A, Combination treatment with pioglitazone and fenofibrate attenuates pioglitazone-mediated acceleration of bone loss in ovariectomized rats. J Endocrinol 2012;212:179-86
- Jacobson TA, Zimmerman FH. Fibrates in combination with statins in the management of dyslipidemia. J Clin Hypertens (Greenwich) 2006;8:35-41
- 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
- Home PD, Pocock SJ, Beck-Nielsen H, Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 2009;373:2125-35
- Marciniak MD. Cardiovascular Events in the RECORD Trial. 2010. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218484.pdf [Accessed 8 October 2012]
- FDA. Briefing Document.2007. Available from: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4308b1-02-fda-backgrounder.pdf [Accessed 8 October 2012]
- EMA. European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim [press release]. 2010. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/09/WC500096996.pdf [Accessed 10 Oct. 2012]
- FDA. Drug Safety Communication: update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer.2011. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm [Accessed 8 October 2012]
- Yki-Jarvinen H. Thiazolidinediones. N Engl J Med 2004;351:1106-18
- Langenfeld MR, Forst T, Hohberg C, Pioglitazone decreases carotid intima-media thickness independently of glycemic control in patients with type 2 diabetes mellitus: results from a controlled randomized study. Circulation 2005;111:2525-31
- Wilcox R, Bousser MG, Betteridge DJ, Effects of pioglitazone in patients with type 2 diabetes with or without previous stroke: results from PROactive (PROspective pioglitAzone Clinical Trial In macroVascular Events 04). Stroke 2007;38:865-73
- Erdmann E, Dormandy JA, Charbonnel B, The effect of pioglitazone on recurrent myocardial infarction in 2,445 patients with type 2 diabetes and previous myocardial infarction: results from the PROactive (PROactive 05) Study. J Am Coll Cardiol 2007;49:1772-80
- Wilcox R, Kupfer S, Erdmann E. Effects of pioglitazone on major adverse cardiovascular events in high-risk patients with type 2 diabetes: results from PROspective pioglitAzone Clinical Trial In macro Vascular Events (PROactive 10). Am Heart J 2008;155:712-17
- Erdmann E, Song E, Spanheimer R, Pioglitazone and macrovascular outcomes during observational follow-up of PROactive: 6-year update [abstract 1228]. EASD; 1 – 5 October 2012; Berlin, Germany; 2012
- Erdmann E, Spanheimer R, Charbonnel B. Pioglitazone and the risk of cardiovascular events in patients with Type 2 diabetes receiving concomitant treatment with nitrates, renin-angiotensin system blockers, or insulin: results from the PROactive study (PROactive 20). J Diabetes 2010;2:212-20
- Goldberg RB, Kendall DM, Deeg MA, 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
- El Hage J. Toxicity profile of peroxisome proliferator activated receptor agonists. 2005. Available from: http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4169S2_02_02-FDA-ElHage.ppt [Accessed 11 October 2012]
- El-Hage J. Preclinical and clinical safety assessments for PPAR agonists. FDA: Metabolic and Endocrine Drug Products Center for Drug Evaluation and Research, 2011
- El-Hage J. Peroxisome proliferator-activated receptor agonists: carcinogenicity findings and regulatory recommendations. International Atherosclerosis Society Symposium on PPAR; 19 March 2005; Monte Carlo, Monaco
- Spanheimer R, Erdmann E, Song E, Pioglitazone and bladder malignancy during observational follow-up of PROactive: 6-year update [abstract 787]. EASD; 1 – 5 October 2012; Berlin, Germany; 2012
- EMA. European medicines agency recommends new contra-indications and warnings for pioglitazone to reduce small increased risk of bladder cancer. 2011. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/public_health_alerts/2011/07/human_pha_detail_000033.jsp&mid=&source=homeMedSearch&category=human&jsenabled=true [Accessed 8 October 2012]
- Lewis JD, Ferrara A, Peng T, Risk of bladder cancer among diabetic patients treated with pioglitazone: interim report of a longitudinal cohort study. Diabetes Care 2011;34:916-22
- Neumann A, Weill A, Ricordeau P, Pioglitazone and risk of bladder cancer among diabetic patients in France: a population-based cohort study. Diabetologia 2012;55:1953-62
- Azoulay L, Yin H, Filion KB, The use of pioglitazone and the risk of bladder cancer in people with type 2 diabetes: nested case-control study. BMJ 2012;344:e3645
- Assessment report for Actos, Glustin, Competact, Glubrava, Tandemact. 2011. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000285/WC500126656.pdf [Accessed 8 October 2012]
- Colmers IN, Bowker SL, Majumdar SR, Use of thiazolidinediones and the risk of bladder cancer among people with type 2 diabetes: a meta-analysis. CMAJ 2012;184:E675-83
- Lubet RA, Fischer SM, Steele VE, Rosiglitazone, a PPAR gamma agonist: potent promoter of hydroxybutyl(butyl)nitrosamine-induced urinary bladder cancers. Int J Cancer 2008;123:2254-9
- Drug: Pargluva® (muraglitazar, BMS-298,585 Preclinical Pharmacology and Toxicology Summary. 2011. Available from: http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B2_02_01-FDA-Preclin-Pharm-Tox.pdf [Accessed 8 October 2012]
- Tannehill-Gregg SH, Sanderson TP, Minnema D, Rodent carcinogenicity profile of the antidiabetic dual PPAR alpha and gamma agonist muraglitazar. Toxicol Sci 2007;98:258-70
- Dominick MA, White MR, Sanderson TP, Urothelial carcinogenesis in the urinary bladder of male rats treated with muraglitazar, a PPAR alpha/gamma agonist: evidence for urolithiasis as the inciting event in the mode of action. Toxicol Pathol 2006;34:903-20
- Suzuki S, Arnold LL, Pennington KL, Effects of pioglitazone, a peroxisome proliferator-activated receptor gamma agonist, on the urine and urothelium of the rat. Toxicol Sci 2010;113:349-57
- Cohen SM. Effects of PPARgamma and combined agonists on the urinary tract of rats and other species. Toxicol Sci 2005;87:322-7
- Varley CL, Southgate J. Effects of PPAR agonists on proliferation and differentiation in human urothelium. Exp Toxicol Pathol 2008;60:435-41
- Varley CL, Stahlschmidt J, Lee WC, Role of PPARgamma and EGFR signalling in the urothelial terminal differentiation programme. J Cell Sci 2004;117:2029-36
- Cohen SM. Urinary bladder carcinogenesis. Toxicol Pathol 1998;26:121-7
- Sato K, Awasaki Y, Kandori H, Suppressive effects of acid-forming diet against the tumorigenic potential of pioglitazone hydrochloride in the urinary bladder of male rats. Toxicol Appl Pharmacol 2011;251:234-44
- Van Vleet TR, White MR, Sanderson TP, Subchronic urinary bladder effects of muraglitazar in male rats. Toxicol Sci 2007;96:58-71
- DeSesso JM. Anatomical relationships of urinary bladders compared: their potential role in the development of bladder tumours in humans and rats. Food Chem Toxicol 1995;33:705-14
- European Medicines Agency. Actos. 2012. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/07/WC500109185.pdf [Accessed 10 October 2012]
- Burns KA, Vanden Heuvel JP. Modulation of PPAR activity via phosphorylation. Biochim Biophys Acta 2007;1771:952-60
- Diradourian C, Girard J, Pegorier JP. Phosphorylation of PPARs: from molecular characterization to physiological relevance. Biochimie 2005;87:33-8
- Kodera Y, Takeyama K, Murayama A, Ligand type-specific interactions of peroxisome proliferator-activated receptor gamma with transcriptional coactivators. J Biol Chem 2000;275:33201-4
- Rocchi S, Auwerx J. Peroxisome proliferator-activated receptor gamma, the ultimate liaison between fat and transcription. Br J Nutr 2000;84(Suppl 2):S223-7
- Picard F, Auwerx J. PPAR(gamma) and glucose homeostasis. Annu Rev Nutr 2002;22:167-97
- Yamauchi T, Oike Y, Kamon J, Increased insulin sensitivity despite lipodystrophy in Crebbp heterozygous mice. Nat Genet 2002;30:221-6
- Staels B, Maes M, Zambon A. Fibrates and future PPARalpha agonists in the treatment of cardiovascular disease. Nat Clin Pract Cardiovasc Med 2008;5:542-53
- Dunn FL, Higgins LS, Fredrickson J, Selective modulation of PPARgamma activity can lower plasma glucose without typical thiazolidinedione side-effects in patients with Type 2 diabetes. J Diabetes Complications 2011;25:151-8
- Rogue A, Lambert C, Josse R, Comparative gene expression profiles induced by PPARgamma and PPARalpha/gamma agonists in human hepatocytes. PLoS One 2011;6:e18816
- FDA. Advisory Committees. 2012. Available from: http://www.fda.gov/ohrms/dockets/ac/cder05.html [Accessed 8 October 2012]
- Dietz M, Mohr P, Kuhn B, Comparative molecular profiling of the novel PPAR-a/g activator aleglitazar: PPAR selectivity, activity and interaction with cofactors. Chem Med Chem 2012;7:1101-11
- Kendall DM, Rubin CJ, Mohideen P, Improvement of glycemic control, triglycerides, and HDL cholesterol levels with muraglitazar, a dual (alpha/gamma) peroxisome proliferator-activated receptor activator, in patients with type 2 diabetes inadequately controlled with metformin monotherapy: A double-blind, randomized, pioglitazone-comparative study. Diabetes Care 2006;29:1016-23
- Davies P. FDA seeks more data on diabetes drug. Wall Street J 2005;D7
- 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;294:2581-6
- Kamber N, Davis TM. Tesaglitazar. IDrugs 2005;8:927-35
- Fagerberg B, Edwards S, Halmos T, Tesaglitazar, a novel dual peroxisome proliferator-activated receptor alpha/gamma agonist, dose-dependently improves the metabolic abnormalities associated with insulin resistance in a non-diabetic population. Diabetologia 2005;48:1716-25
- Bays H, McElhattan J, Bryzinski BS. A double-blind, randomised trial of tesaglitazar versus pioglitazone in patients with type 2 diabetes mellitus. Diab Vasc Dis Res 2007;4:181-93
- AstraZeneca Discontinues Development of GALIDA TM (tesaglitazar). 2012. Available from: http://www.astrazeneca.com/Media/Press-releases/Article/20060504–AstraZeneca-Discontinues-Development-of-GALIDA-TM-te [Accessed 8 October 2012]
- Ericsson H, Hamren B, Bergstrand S, Pharmacokinetics and metabolism of tesaglitazar, a novel dual-acting peroxisome proliferator-activated receptor alpha/gamma agonist, after a single oral and intravenous dose in humans. Drug Metab Dispos 2004;32:923-9
- Hamren B, Ericsson H, Samuelsson O, Mechanistic modelling of tesaglitazar pharmacokinetic data in subjects with various degrees of renal function–evidence of interconversion. Br J Clin Pharmacol 2008;65:855-63
- Hamren B, Ohman KP, Svensson MK, Pharmacokinetic-pharmacodynamic assessment of the interrelationships between tesaglitazar exposure and renal function in patients with type 2 diabetes mellitus. J Clin Pharmacol 2012;52:1317-27
- 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
- Henry RR, Lincoff AM, Mudaliar S, Effect 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 2011;151:136-42
- Sturm S, Seiberling M, Weick I, Phase I, non-randomized, open-label, single-center, single-dose study of metabolism, excretion and pharmacokinetics of 14C-radiolabeled aleglitazar in healthy male volunteers. Clin Ther 2012;34:420-9
- AstraZeneca. A 24-week, Randomised, Parallel-Group, Multi-Centre, Open-Label Study of the Renal Effects of Tesaglitazar in Patients with Type 2 Diabetes Mellitus ARMOR (Analysing Renal Mechanisms of creatinine excretion in patients On tesaglitazaR). 2011. Available from: http://www.astrazeneca.com/Media/Press-releases/Article/20060504–AstraZeneca-Discontinues-Development-of-GALIDA-TM-te [Accessed 8 October 2012]
- FDA. Clinical Perspectives on FDA Guidance for Industry: diabetes Mellitus – Evaluating CV Risk in New Anti- diabetic Therapies to Treat T2DM.2012. Available from: http://www.fda.gov/downloads/Drugs/NewsEvents/UCM209087.pdf [Accessed 8 October 2012]
- ALECARDIO study. A study with aleglitazar in patients with a recent acute coronary syndrome and type 2 diabetes mellitus. 2010. Available from: http://clinicaltrials.gov/ct2/show/NCT01042769 [ACcessed 8 October 2012]
- Plosker GL, Faulds D. Troglitazone: a review of its use in the management of type 2 diabetes mellitus. Drugs 1999;57:409-38
- Johnson MD, Campbell LK, Campbell RK. Troglitazone: review and assessment of its role in the treatment of patients with impaired glucose tolerance and diabetes mellitus. Ann Pharmacother 1998;32:337-48
- AERS data for Glucotrol. 1999. Available from: www.fda.gov/cder/adr/index.htm [Accessed 8 October 2012]
- Wilding JP, Gause-Nilsson I, Persson A. Tesaglitazar, as add-on therapy to sulphonylurea, dose-dependently improves glucose and lipid abnormalities in patients with type 2 diabetes. Diab Vasc Dis Res 2007;4:194-203
- Goke B, Gause-Nilsson I, Persson A. The effects of tesaglitazar as add-on treatment to metformin in patients with poorly controlled type 2 diabetes. Diab Vasc Dis Res 2007;4:204-13
- Golden J. Muraglitazar briefings document, safety, endocrine and metabolic drugs advisory committee meeting. FDA 2005. Available from: http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B2_02_03-FDA-MedOff-Safety.pdf
- Schwartz AV. Diabetes, TZDs, and bone: a review of the clinical evidence. PPAR Res 2006;2006:24502
- Berthet S, Olivier P, Montastruc JL, Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database. BMC Clin Pharmacol 2011;11:5
- Nafrialdi. Efficacy and safety of pioglitazone in type 2 diabetes mellitus: a postmarketing observational study. Acta Med Indones 2012;44:28-34
- Freid J, Everitt D, Boscia J. Rosiglitazone and hepatic failure. Ann Intern Med 2000;132:164
- Isley WL, Oki JC. Rosiglitazone and liver failure. Ann Intern Med 2000;133:393-4
- Lebovitz HE, Kreider M, Freed MI. Evaluation of liver function in type 2 diabetic patients during clinical trials: evidence that rosiglitazone does not cause hepatic dysfunction. Diabetes Care 2002;25:815-21
- Koro CE, Sowell MO, Stender M, The risk of myopathy associated with thiazolidinediones and statins in patients with type 2 diabetes: a nested case-control analysis. Clin Ther 2008;30:535-42
- Hellmold H, Zhang H, Andersson U, Tesaglitazar, a PPARalpha/gamma agonist, induces interstitial mesenchymal cell DNA synthesis and fibrosarcomas in subcutaneous tissues in rats. Toxicol Sci 2007;98:63-74