Rehabilitation of pioglitazone

Hillaire-Buys D, Faillie JL. Pioglitazone and the risk of bladder cancer. BMJ 2012;344:e3500. http://dx.doi.org/10.1136/bmj.e3500

Takeda Pharmaceutical Company Limited. Takeda Announces Completion of the Post-Marketing Commitment to Submit Data to the FDA, the EMA and the PMDA for Pioglitazone Containing Medicines Including ACTOS. http://www.takeda.us/newsroom/press_release_detail.aspx? year=2014&id=314 (accessed 27 March 2015)

European Medicines Agency. Assessment report for Actos, Glustin, Competact, Glubrava, Tandemact (INN: Pioglitazone, pioglitazone+ glimepiride, pioglitazone+metformin) 22, December 2011 (EMA,CHMP/940059/2011). Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000285/WC500126656.pdf. (accessed 24 February 2015).

Sato K, Awasaki Y, Kandori H, et al. 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. http://dx.doi.org/10.1016/j.taap.2011.01.006

Lewis JD, Ferrara A, Peng T, et al. Risk of bladder cancer among diabetic patients treated with pioglitazone: interim report of a longitudinal cohort study. Diabetes Care 2011;34:916-22. http://dx.doi.org/10.2337/dc10-1068

Lewis JD, Ferrara A, Strom BL, et al. Cohort Study of Pioglitazone and Bladder Cancer in Patients with Diabetes: Fourth Interim Analysis (8-Year) Report with Data from January 1, 1997 to December 31, 2010. May 30, 2012. http://general.takedapharm.com/Trial-Disclosure/01-03-TL-OPI524-8-year-Interim-Report.pdf . (accessed 23 December 2014).

Ryder REJ. Pioglitazone has a dubious bladder cancer risk but an undoubted cardiovascular benefit. Diabet Med 2015;32:305-13. http://dx.doi.org/10.1111/dme.12627

Levin D, Bell S, Sund R, et al. Pioglitazone and bladder cancer risk: a multipopulation pooled, cumulative exposure analysis. Diabetologia 2015; 58:493-504. http://dx.doi.org/10.1007/s00125-014-3456-9

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;366:1279-89. http://dx.doi.org/10.1016/S0140-6736(05)67528-9

Ryder REJ. Neither evidence from the PROactive study nor the KPNC supports pioglitazone as a tumour promoter. Diabet Med 2015;32:438-9. http://dx.doi.org/10.1111/dme.12703

Ryder REJ. Pioglitazone – reports of its death are greatly exaggerated* – it is alive and ready to resume saving lives. Diabet Med 2015;32:e9-e15. http://dx.doi.org/10.1111/dme.12736

Gale EAM. Pioglitazone: Are rumours of its death exaggerated? Diabet Med 2015;32:431-7. http://dx.doi.org/10.1111/dme.12708

Erdmann E, Song E, Spanheimer R, van Troostenburg de Bruyn AR, Perez A: Observational follow-up of the PROactive study: a 6-year update. Diabetes Obes Metab 2014;16:63-74. http://dx.doi.org/10.1111/dom.12180

Ryder REJ. Pioglitazone: an agent which reduces stroke, myocardial infarction and death and is also a key component of the modern paradigm for the optimum management of type 2 diabetes. Br J Diabetes Vasc Dis 2011;11:113-20. http://dx.doi.org/10.1177/1474651411412658

Erdmann E, Dormandy JA, Charbonnel B, Massi-Benedetti M, Moules IK, Skene AM, Investigators PR: 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. http://dx.doi.org/10.1016/j.jacc.2006.12.048

Wilcox R, Bousser MG, Betteridge DJ, et al, Investigators PR: 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. http://dx.doi.org/10.1161/01.STR.0000257974.06317.49

Schneider CA, Ferrannini E, Defronzo R, Schernthaner G, Yates J, Erdmann E. Effect of pioglitazone on cardiovascular outcome in diabetes and chronic kidney disease. J Am Soc Nephrol 2008;19:182-7. http://dx.doi.org/10.1681/ASN.2007060678

Gastaldelli A, Ferrannini E, Miyazaki Y, Matsuda M Mari A, DeFronzo RA. Thiazolidinediones improve beta-cell function in type 2 diabetic patients. Am J Phyisol Endocrinol Metab 2007;292:E871-83. http://dx.doi.org/10.1152/ajpendo.00551.2006

Miyazaki Y, Mahankali A, Matsuda M, et al. Effect of pioglitazone on abdominal fat distribution and insulin sensitivity in type 2 diabetic patients. J Clin Endocrinol Metab 2002;87:2784-91. http://dx.doi.org/10.1210/jcem.87.6.8567

Miyazaki M, De Filippis E, Bajaj M, et al. Predictors of improved glycaemic control with rosiglitazone therapy in type 2 diabetic patients: a practical approach for the primary care physician. Br J Diabetes Vasc Dis 2005;5: 28-35. http://dx.doi.org/10.1177/14746514050050010601

Guan Y, Hao C, Cha DR, et al. Thiazolidinediones expand body fluid volume through PPARgamma stimulation of EnaC-mediated renal salt absorption. Nat Med 2005;11:86-6. http://dx.doi.org/10.1038/nm1278

Singh S, Loke YK, Furberg CD. Thiazolidinediones and heart failure – a teleo-analysis. Diabetes Care 2007;30:2148-53. http://dx.doi.org/10.2337/dc07-0141

Molina-Wilkins M, Clarke GD, Martinez S, et al. Impaired left ventricular diastolic function (LVDF) is associated with myocardial insulin resistance in patients with type 2 diabetes mellitus (T2DM). Diabetes 2014; 63(suppl 1):A298.

Molina-Wilkins M, Clarke GD, Dong F, et al. Pioglitazone improves myocardial glucose uptake and myocardial blood flow in type 2 diabetic subjects. Diabetes 63 (suppl 1):A237, 2014.

DeFronzo RA: Insulin resistance, lipotoxicity, type 2 diabetes and atherosclerosis: the missing links. The Claude Bernard Lecture 2009. Diabetologia 2010;53:1270-87. http://dx.doi.org/10.1007/s00125-010-1684-1

Erdmann E, Charbonnel B, Wilcox RG, et al, Investigators PR: 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;30:2773-28. http://dx.doi.org/10.2337/dc07-0717

Betteridge DJ. Thiazolidinediones and fracture risk in patients with type 2 diabetes. Diabet Med 2011;28:759-71. http://dx.doi.org/10.1111/j.1464-5491.2010.03187.x

Bodmer M, Meier C, Kraenzlin ME, Meier CR. Risk of fractures with glitazones: a critical review of the evidence to date. Drug Saf 2009; 32:539-47. http://dx.doi.org/10.2165/00002018-200932070-00001

Abdul-Ghani MA, Puckett C, Triplitt C, et al. Initial combination therapy with metformin/pioglitazone/exenatide is more effective than sequential add-on therapy in subjects with new onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT): A randomized trial. Diabetes Obes Metab 2015;17: 268-75. http://dx.doi.org/10.1111/dom.12417

DeFronzo RA, Eldor R, Abdul-Ghani M. Pathophysiologic approach to therapy in patients with newly diagnosed type 2 diabetes mellitus. Diabetes Care 2013;36(suppl 2):S127-38. http://dx.doi.org/10.2337/dcS13-2011

DeFronzo RA. Banting Lecture: from the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes 2009;58:773-95. http://dx.doi.org/10.2337/db09-9028

DeFronzo RA, Tripathy D, Schwenke DC, et al. Prevention of diabetes with pioglitazone in ACT NOW: Physiologic correlates. Diabetes 2013; 62:3920-6. http://dx.doi.org/10.2337/db13-0265

Abdul-Ghani MA, Jenkinson CP, Richardson DK, Tripathy D, DeFronzo RA: Insulin secretion and action in subjects with impaired fasting glucose and impaired glucose tolerance: results from the Veterans Administration Genetic Epidemiology Study. Diabetes 2006;55:1430-5. http://dx.doi.org/10.2337/db05-1200

DeFronzo RA, Tripathy D, Schwenke DC, et al. for the ACT NOW Study. Pioglitazone for diabetes prevention in impaired glucose tolerance. NEJM 2011;364:1104-15. http://dx.doi.org/10.1056/NEJMoa1010949