Pioglitazone has a dubious bladder cancer risk but an undoubted cardiovascular benefit

Diabetic Medicine

Volumn 32, Issue 3, 2015, Pages 305-313

  Ryder, R E J ^a  

^a CITY HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

PIOGLITAZONE; 2,4 THIAZOLIDINEDIONE DERIVATIVE; ANTIDIABETIC AGENT;

ARTICLE; BLADDER CANCER; BREAST CANCER; CANCER RISK; CARDIOVASCULAR DISEASE; CARDIOVASCULAR EFFECT; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; CORONARY ARTERY RECANALIZATION; DISEASE EXACERBATION; FLUID RETENTION; FRACTURE; GLYCEMIC CONTROL; HEART FAILURE; HEART INFARCTION; HUMAN; LEG REVASCULARIZATION; META ANALYSIS (TOPIC); MORBIDITY; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; OBSERVATIONAL STUDY; PREMATURE MORTALITY; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIDE EFFECT; ANIMAL; BIOASSAY; CARDIOVASCULAR SYSTEM; DIABETES MELLITUS, TYPE 2; DISEASE MODEL; DRUG EFFECTS; FEMALE; KAPLAN MEIER METHOD; LONGITUDINAL STUDY; MALE; RAT; RETROSPECTIVE STUDY; RISK FACTOR; URINARY BLADDER NEOPLASMS;

ANIMALS; CARDIOVASCULAR SYSTEM; DIABETES MELLITUS, TYPE 2; DISEASE MODELS, ANIMAL; ENDPOINT DETERMINATION; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; KAPLAN-MEIER ESTIMATE; LONGITUDINAL STUDIES; MALE; RATS; RETROSPECTIVE STUDIES; RISK FACTORS; THIAZOLIDINEDIONES; URINARY BLADDER NEOPLASMS;

EID: 84922674097     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/dme.12627     Document Type: Article

References (51)

1. Dennis M. US jury orders Takeda, Eli Lilly to pay $9 billion in damages over Actos. FirstWord Pharma, 8, April 2014. Available at http://www.firstwordpharma.com/node/1201482. Last accessed 22 August 2014.
2. Completion of the Post-Marketing Commitment to Submit Data to the FDA. FirstWord Pharma, 28, August 2014. Available at http://www.firstwordpharma.com/node/1232261#axzz3BlGF2JfP. Last accessed 30 August 2014.
3. Lewis JD, Ferrara A, Peng T, Hedderson M, Bilker WB, Quesenberry CP Jr. et al. Risk of bladder cancer among diabetic patients treated with pioglitazone: interim report of a longitudinal cohort study. Diabetes Care 2011; 34: 916-922.
4. Azoulay L, Yin H, Filion KB, Assayag J, Majdan A, Pollak MN et al. The use of pioglitazone and the risk of bladder cancer in people with type 2 diabetes: nested case-control study. BMJ 2012; 344: e3645.
5. Hillaire-Buys D, Faillie JL. Pioglitazone and the risk of bladder cancer. BMJ 2012; 344: e3500.
6. 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. Last accessed 23 August 2014.
7. Suzuki S, Arnold LL, Pennington KL, Kakiuchi-Kiyota S, Wei M, Wanibuchi H et al. Effects of pioglitazone, a peroxisome proliferator-activated receptor gamma agonist, on the urine and urothelium of the rat. Toxicol Sci 2010; 113: 349-357.
8. Sato K, Awasaki Y, Kandori H, Tanakamaru ZY, Nagai H, Baron D 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: 234-244.
9. Fukushima S, Shibata MA, Shirai T, Tamano S, Ito N. Roles of urinary sodium ion concentration and pH in promotion by ascorbic acid of urinary bladder carcinogenesis in rats. Cancer Res 1986; 46: 1623-1626.
10. Dormandy JA, Charbonnel B, Eckland DJ, Erdmann E, Massi-Benedetti M, Moules IK et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspectivepioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet 2005; 366: 1279-1289.
11. Hillaire-Buys D, Faillie JL, Montastruc JL. Pioglitazone and bladder cancer. Lancet 2011; 378:1543-1544; author reply 4-5.
12. Erdmann E, Dormandy JA, Massi-Bendetti M, Spanheimer R. Pioglitazone and bladder cancer. Lancet 2011; 378: 1544-1545.
13. 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.
14. National Institute for Health and Clinical Excellence. Guidance on the use of pioglitazone for the treatment of type 2 diabetes. London. Technology Appraisal 63. August 2003
15. National Institute for Health and Clinical Excellence. The management of type 2 diabetes. Quick reference guide. May 2009. Available at http://www.nice.org.uk/nicemedia/pdf/CG87QuickRefGuide.pdf. Last accessed 20 July 20 2012.
16. Yeung NG, Husain I, Waterfall N. Diabetes mellitus and bladder cancer - an epidemiological relationship? Pathol Oncol Res 2003; 91: 30-31.
17. Coughlin SS, Calle EE, Teras LR, Petrelli J, Thun MJ. Diabetes mellitus as a predictor of cancer mortality in a large cohort of US adults. Am J Epidemiol 2004; 159: 1160-1167.
18. MacKenzie T, Zens MS, Ferrara A, Schned A, Karagas MR. Diabetes and risk of bladder cancer: evidence from a case-control study in New England. Cancer 2011; 117: 1552-1556.
19. Holman RR, Turner RC. A practical guide to basal and prandial insulin therapy. Diabet Med 1985; 2: 45-53.
20. Koebnick C, Michaud D, Moore SC, Park Y, Hollenbeck A, Ballard-Barbash R et al. Body mass index, physical activity, and bladder cancer in a large prospective study. Cancer Epidemiol Biomarkers Prev 2008; 17: 1214-1221.
21. Freedman ND, Silverman DT, Hollenbeck AR, Schatzkin A, Abnet CC. Association between smoking and risk of bladder cancer among men and women. JAMA 2011; 306: 737-745.
22. Berhanu P, Perez A, Yu S. Effect of pioglitazone in combination with insulin therapy on glycaemic control, insulin dose requirement and lipid profile in patients with type 2 diabetes previously poorly controlled with combination therapy. Diabetes Obes Metab 2007; 9: 512-520.
23. Smith U, Gale EA. Does diabetes therapy influence the risk of cancer? Diabetologia 2009; 52: 1699-1708.
24. ORIGIN Trial Investigators, Gerstein HC, Bosch J, Dagenais GR, Díaz R, Jung H et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 2012; 367: 319-328.
25. Andrew AS, Schned AR, Heaney JA, Karagas MR. Bladder cancer risk and personal hair dye use. Int J Cancer 2004; 109: 581-586.
26. Koutros S, Silverman DT, Baris D, Zahm SH, Morton LM, Colt JS et al. Hair dye use and risk of bladder cancer in the New England bladder cancer study. Int J Cancer 2011; 129: 2894-2904.
27. Nissen SE, Wolski K. Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes. N Engl J Med 2007; 356: 2457-2471.
28. 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: 113-120.
29. Piccinni C, Motola D, Marchesini G, Poluzzi E. Assessing the association of pioglitazone use and bladder cancer through drug adverse event reporting. Diabetes Care 2011; 34: 1369-1371.
30. Lewis JD, Ferrara A, Strom BL, Quesenberry CP Jr, Bilker WB, Peng T 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. Available at http://general.takedapharm.com/Trial-Disclosure/01-03-TL-OPI-524-8-year-Interim-Report.pdf. Last accessed 23 August 2014.
31. Neumann A, Weill A, Ricordeau P, Fagot JP, Alla F, Allemand H. Pioglitazone and risk of bladder cancer among diabetic patients in France: a population-based cohort study. Diabetologia 2012; 55: 1953-1962.
32. Update on ongoing European review of pioglitazone-containing medicines - Suspension of use of these medicines in France while Europe-wide review continues. European Medicines Agency, Press release, 9 June 2011. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/06/news_detail_001275.jsp&mid=WC0b01ac058004d5c1. Last accessed 23 August 2014.
33. Oliveria SA, Koro CE, Yood MU, Sowell M. Cancer incidence among patientstreated with antidiabetic pharmacotherapy. Diabetes Metabolic Syndr Clin Res Rev 2008; 2: 47-57.
34. Tseng CH. Pioglitazone and bladder cancer: a population-based study of Taiwanese. Diabetes Care 2012; 35: 278-280.
35. Chang CH, Lin JW, Wu LC, Lai MS, Chuang LM. Arnold Chan K. Association of thiazolidinediones with liver cancer and colorectal cancer in type 2 diabetes mellitus. Hepatology 2012; 55: 1462-1472.
36. Wei L, Macdonald TM, Mackenzie IS. Pioglitazone and bladder cancer: A propensity score matched cohort study. Br J Clin Pharmacol 2013; 75: 254-259.
37. van Staa TP, Patel D, Gallagher AM, de Bruin ML. Glucose-lowering agents and the patterns of risk for cancer: a study with the General Practice Research Database and secondary care data. Diabetologia 2012; 55: 654-665.
38. Robson J. Incretins and pancreatitis-what happens next? A personal viewpoint. Diabet Med 2013; 30: 1156-1159.
39. Butler PC, Elashoff M, Elashoff R, Gale EAM. A critical analysis of the clinical use of incretin-based therapies: are the GLP-1 therapies safe? Diabetes Care 2013; 36: 2118-2125.
40. Erdmann E, Dormandy JA, Charbonnel B, Massi-Benedetti M, Moules IK, Skene AM et al. 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: 1772-1780.
41. Wilcox R, Bousser MG, Betteridge DJ, Schernthaner G, Pirags V, Kupfer S et al. Effects of pioglitazone in patients with type 2 diabetes with or without previous stroke: results from PROactive (PROspectivepioglitAzone Clinical Trial In macroVascular Events 04). Stroke 2007; 38: 865-873.
42. Mazzone T, Meyer PM, Feinstein SB, Davidson MH, Kondos GT, D'Agostino RB Sr et al. Effect of pioglitazone compared with glimepiride on carotid intima-media thickness in type 2 diabetes: a randomized trial. JAMA 2006; 296: 2572-2581.
43. Nissen SE, Nicholls SJ, Wolski K, Nesto R, Kupfer S, Perez A et al. Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: the PERISCOPE randomized controlled trial. JAMA 2008; 299: 1561-1573.
44. 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: 1180-1188.
45. Tzoulaki I, Molokhia M, Curcin V, Little MP, Millett CJ, Ng A et al. Risk of cardiovascular disease and all cause mortality among patients with type 2 diabetes prescribed oral antidiabetes drugs: retrospective cohort study using UK general practice research database. BMJ 2009; 339: b4731.
46. Ryder REJ. Pioglitazone and bladder cancer. Lancet 2011; 378: 1544.
47. Pioglitazone and bladder cancer. A letter from the Association of British Clinical Diabetologists (ABCD) to the Medicines and Healthcare Products Regulatory Agency (MHRA). 17 June 2011. Available at http://www.diabetologists-abcd.org.uk/Shared_Documents/position_papers/ABCD_pioglitazone_submission_to_MHRA.pdf. Last accessed 23 August 2014.
48. Erdmann E, Charbonnel B, Wilcox RG, Skene AM, Massi-Benedetti M, Yates J et al. Pioglitazone use and heart failure in patients with type 2 diabetes and pre-existing cardiovascular disease: data from the PROactive study (PROactive 08). Diabetes Care 2007; 30: 2773-2778.
49. Singh S, Loke YK, Furberg CD. Thiazolidinediones and heart failure - a teleo-analysis. Diabetes Care 2007; 30: 2148-2153.
50. Takeda Stock Plummets as Actos Sales Fall. Available at http://www.drugwatch.com/2012/07/09/takeda-stock-plummets-as-actos-sales-fall/. Last accessed 30 August 2014.
51. Ryder REJ. The potential risks of pancreatitis and pancreatic cancer with GLP-1-based therapies are far outweighed by the proven and potential (cardiovascular) benefits. Diabet Med 2013; 30: 1148-1155.