India suspends pioglitazone: Is it justified?

Diabetes and Metabolic Syndrome: Clinical Research and Reviews

Volumn 8, Issue 1, 2014, Pages 53-56

  Sadikot, S M ^a   Ghosal, Samit ^b  

^a JASLOK HOSPITAL AND RESEARCH CENTRE   (India)

^b Nightingale Hospital   (India)

Author keywords

Bladder cancer; Blood glucose; Pioglitazone; Regulatory authorities

Indexed keywords

GLUCOSE; INSULIN GLARGINE; METFORMIN; PIOGLITAZONE; ROSIGLITAZONE;

ANEMIA; BLADDER CANCER; CANCER RISK; COHORT ANALYSIS; DIABETIC PATIENT; DRUG RECALL; ETHNICITY; FAMILY HISTORY; FOLLOW UP; FRACTURE; GLUCOSE BLOOD LEVEL; GLUCOSE TRANSPORT; GOVERNMENT; HAZARD RATIO; HEART FAILURE; HUMAN; INSULIN RESISTANCE; META ANALYSIS; NON INSULIN DEPENDENT DIABETES MELLITUS; PREVALENCE; PRIORITY JOURNAL; PUBLICATION; RETINA MACULA EDEMA; REVIEW; SIDE EFFECT; SKELETAL MUSCLE;

BLADDER CANCER; BLOOD GLUCOSE; PIOGLITAZONE; REGULATORY AUTHORITIES;

DIABETES MELLITUS, TYPE 2; GOVERNMENT REGULATION; HUMANS; HYPOGLYCEMIC AGENTS; INDIA; SAFETY-BASED DRUG WITHDRAWALS; THIAZOLIDINEDIONES;

EID: 84897095553     PISSN: 18714021     EISSN: 18780334     Source Type: Journal    
DOI: 10.1016/j.dsx.2013.10.020     Document Type: Review

References (28)

1. Misbin RI. Phenformin-associated lactic acidosis: pathogenesis and treatment. Ann Intern Med 1977;87:591-5. (Pubitemid 8223612)
2. 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.
3. 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. (Pubitemid 46919772)
4. Hemkens LG, Grouven U, Bender R, Gunster C, Gutschmidt S, Selke GW, et al. Risk of malignancies in patients with diabetes treated with human insulin or insulin analogues: a cohort study. Diabetologia 2009;52:1732-44.
5. Rosenstock J, Fonseca V, McGill JB, Riddle M, Halle JP, Hramiak I, et al. Similar risk of malignancy with insulin glargine and neutral protamine Hagedorn (NPH) insulin in patients with Type 2 Diabetes: findings from a 5 year randomised, open-label study. Diabetologia 2009;52:1971-3.
6. Miller RA, Chu Q, Xie J, Foretz M, Viollet B, Birnbaum MJ. Biguanides suppress hepatic glucagon signalling by decreasing production of cyclic AMP. Nature 2013;494(14):256-60.
7. DeFronzo RA. From the triumvirate to the ominous octet: a new paradigm for the treatment of Type 2 Diabetes mellitus. Diabetes 2009;58:773-95.
8. Abdul-Ghani MA, Puckett C, Adams J, Cersosimo E, Triplitt C, Defronzo RA. Initial triple combination therapy is superior to stepwise add-on conventional therapy in newly diagnosed T2DM. In: American Diabetes Association 2013 Scientific Sessions; 2013. Abstract 72-OR.
9. Phung OJ, Scholle JM, Talwar M, Coleman CI. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in Type 2 Diabetes. JAMA 2010;303(14):1410-8.
10. Dormandy JA, Charbonnel B, Eckland DJA, Erdmann E, Massi-Benedetti M, Moules IK, 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. (Pubitemid 41416583)
11. Risoz CV, Elisaf MS, Mikhailidis DP, Liberopoulos EN. How safe is the use of thiazolidinediones in clinical practice? Expert Opin Drug Saf 2009;8(1):15-32.
12. Sinha B, Ghosal S. Pioglitazone-do we really need it to manage Type 2 Diabetes? Diab Metab Syndr: Clin Res Rev 2013;7:52-5.
13. The French targeted epidemiological study is a retrospective cohort study conducted by the French health insurance (Caisse National d'Assurance Maladie) following antidiabetic patients taking antidiabetic medicines between 2006 and 2009. [Online] Available at: http://www.afssaps.fr/var/afssaps-site/storage/ original/application/b42a6bf9a1b63c3dbec7388d3914687b.pd [accessed on: 02.07.13].
14. Lewis J, Ferrara A, Peng T, Hedderson M, Bilker WB, Quesenberry CP, 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.
15. Azoulay L, statistician HY, 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.
16. FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer; 2011 [Online]. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm [accessed on: 02.07.13].
17. Conclusions of European Medicines Authority Safety Review of Pioglitazone Welcomed by Association of British Clinical Diabetologists. [Online]. Available at: https://www.diabetologists.org.uk/Shared-Documents/position-papers/ ABCD-pioglitazone-press-release-23.7.11.pdf [accessed on: 02.07.13].
18. Ferrara and Associates. Cohort study of pioglitazone and cancer incidence in patients with diabetes. Diabetes Care 2011;34:923-9.
19. Erdmann E, Song E, Spanheimer R, Bruyn AR, Perez A. Pioglitazone and macrovascular outcomes during observational follow-up of PROactive: 6-year update. Diabetes Obesity & Metabolism 2014;16:63-74.
20. Zhang Y, Zhu C, Curado MP, Zheng T, Boyle P. Changing patterns of bladder cancer in the USA: evidence of heterogeneous disease. BJU Int 2011;109:52-6.
21. Shukla R, Karla S. Pioglitazone: Indian perspective. IJEM 2011;15(4):294-7.
22. Tseng CH. Diabetes and risk of bladder cancer: a study using the National Health Insurance database in Taiwan. Diabetologia 2011;54:2009-15.
23. National reporting system of adverse drug reactions in Taiwan. [Online]. Available at: http://adr.doh.gov.tw/default.asp [accessed on: 03.07.13].
24. Panikar V. Pioglitazone and bladder cancer: the pros and cons. JAPI 2012;60:72-73.
25. FDA approves first generic Actos to treat Type 2 Diabetes; 2011, FDA News Release. [Online]. Available at: http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm315951.htm [accessed on: 03.07.13].
26. Handelsman Y, Mechanick JI, Blonde L, Grunberger G, Bloomgarden ZT, Bray GA, et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract 2011;17(Suppl. 2):S1-53.
27. Monami M, Dicembrini I, Mannucci E. Thiazolidinediones and cancer: results of a meta-analysis of randomized clinical trials. Acta Diabetol 2013 [Online]. Available at: http//: dx.doi.org/10.1007/s00592-013-0504-8 [accessed on: 15.07.13].
28. Boyle P. DIABAMON: risk for death, CV events now lower with diabetes medication. In: Presented at: ADA Scientific Sessions; 2013.