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Volumn 31, Issue 10, 2008, Pages 839-850

Monitoring the safety of pioglitazone: Results of a prescription-event monitoring study of 12 772 patients in England

Author keywords

Adverse drug reactions incidence; Pioglitazone, adverse reactions; Prescription event monitoring; Thiazolidinediones, adverse reactions; Type 2 diabetes mellitus

Indexed keywords

GLITAZONE DERIVATIVE; INSULIN; METFORMIN; PEROXISOME PROLIFERATOR ACTIVATED RECEPTOR GAMMA; PIOGLITAZONE; ROSIGLITAZONE; SULFONYLUREA; TROGLITAZONE;

EID: 50649121372     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200831100-00003     Document Type: Article
Times cited : (18)

References (31)
  • 1
    • 0034925848 scopus 로고    scopus 로고
    • PPAR gamma/RXR as a molecular target for diabetes
    • Lenhard JM. PPAR gamma/RXR as a molecular target for diabetes. Receptors Channels 2001; 7 (4): 249-58
    • (2001) Receptors Channels , vol.7 , Issue.4 , pp. 249-258
    • Lenhard, J.M.1
  • 2
    • 0031566772 scopus 로고    scopus 로고
    • Diabetes drug withdrawn after reports of hepatic events [letter]
    • Dec 13;
    • Wise J. Diabetes drug withdrawn after reports of hepatic events [letter]. BMJ 1997 Dec 13; 315 (7122): 1564
    • (1997) BMJ , vol.315 , Issue.7122 , pp. 1564
    • Wise, J.1
  • 3
    • 0035169430 scopus 로고    scopus 로고
    • Hepatotoxicity with thiazolidinediones: Is it a class effect?
    • Scheen AJ. Hepatotoxicity with thiazolidinediones: is it a class effect? Drug Saf 2001; 24 (12): 873-88
    • (2001) Drug Saf , vol.24 , Issue.12 , pp. 873-888
    • Scheen, A.J.1
  • 4
    • 0033645002 scopus 로고    scopus 로고
    • Thiazolidinedione hepatotoxicity: A class effect?
    • Oct;
    • Tolman KG. Thiazolidinedione hepatotoxicity: a class effect? Int J Clin Pract Suppl 2000 Oct; (113): 29-34
    • (2000) Int J Clin Pract Suppl , vol.113 , pp. 29-34
    • Tolman, K.G.1
  • 6
    • 0037133507 scopus 로고    scopus 로고
    • Mixed hepatocellular-cholestatic liver injury after pioglitazone therapy
    • Mar 19;
    • May LD, Lefkowitch JH, Kram MT, et al. Mixed hepatocellular-cholestatic liver injury after pioglitazone therapy. Ann Intern Med 2002 Mar 19; 136 (6): 449-52
    • (2002) Ann Intern Med , vol.136 , Issue.6 , pp. 449-452
    • May, L.D.1    Lefkowitch, J.H.2    Kram, M.T.3
  • 7
    • 0037137174 scopus 로고    scopus 로고
    • Severe but reversible cholestatic liver injury after pioglitazone therapy [letter]
    • Nov 19;
    • Pinto AG, Cummings OW, Chalasani N. Severe but reversible cholestatic liver injury after pioglitazone therapy [letter]. Ann Intern Med 2002 Nov 19; 137 (10): 857
    • (2002) Ann Intern Med , vol.137 , Issue.10 , pp. 857
    • Pinto, A.G.1    Cummings, O.W.2    Chalasani, N.3
  • 8
    • 0035928644 scopus 로고    scopus 로고
    • Hepatocellular injury in a patient receiving pioglitazone [letter]
    • Aug 21;
    • Maeda K. Hepatocellular injury in a patient receiving pioglitazone [letter]. Ann Intern Med 2001 Aug 21; 135 (4): 306
    • (2001) Ann Intern Med , vol.135 , Issue.4 , pp. 306
    • Maeda, K.1
  • 9
    • 0036174783 scopus 로고    scopus 로고
    • Pioglitazone-associated fulminant hepatic failure
    • Feb;
    • Chase MP, Yarze JC. Pioglitazone-associated fulminant hepatic failure. Am J Gastroenterol 2002 Feb; 97 (2): 502-3
    • (2002) Am J Gastroenterol , vol.97 , Issue.2 , pp. 502-503
    • Chase, M.P.1    Yarze, J.C.2
  • 10
    • 0036272050 scopus 로고    scopus 로고
    • Pioglitazone-induced hepatic injury in a patient previously receiving troglitazone with success
    • Apr;
    • Nagasaka S, Abe T, Kawakami A, et al. Pioglitazone-induced hepatic injury in a patient previously receiving troglitazone with success. Diabet Med 2002 Apr; 19 (4): 347-8
    • (2002) Diabet Med , vol.19 , Issue.4 , pp. 347-348
    • Nagasaka, S.1    Abe, T.2    Kawakami, A.3
  • 11
    • 4344572776 scopus 로고    scopus 로고
    • Fatal liver failure associated with pioglitazone [letter]
    • Aug 21;
    • Farley-Hills E, Sivasankar R, Martin M. Fatal liver failure associated with pioglitazone [letter]. BMJ 2004 Aug 21; 329 (7463): 429
    • (2004) BMJ , vol.329 , Issue.7463 , pp. 429
    • Farley-Hills, E.1    Sivasankar, R.2    Martin, M.3
  • 12
    • 33751010734 scopus 로고    scopus 로고
    • Thiazolidinediones in patients with diabetes mellitus and heart failure: Implications of emerging data
    • Macfarlane DP, Fisher M. Thiazolidinediones in patients with diabetes mellitus and heart failure: implications of emerging data. Am J Cardiovasc Drugs 2006; 6 (5): 297-304
    • (2006) Am J Cardiovasc Drugs , vol.6 , Issue.5 , pp. 297-304
    • Macfarlane, D.P.1    Fisher, M.2
  • 13
    • 26244453309 scopus 로고    scopus 로고
    • 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
    • Oct 8;
    • 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 Oct 8; 366 (9493): 1279-89
    • (2005) Lancet , vol.366 , Issue.9493 , pp. 1279-1289
    • Dormandy, J.A.1    Charbonnel, B.2    Eckland, D.J.3
  • 14
    • 12144288524 scopus 로고    scopus 로고
    • Thiazolidinedione-associated congestive heart failure and pulmonary edema
    • Apr;
    • Jamieson A, Abousleiman Y. Thiazolidinedione-associated congestive heart failure and pulmonary edema. Mayo Clin Proc 2004 Apr; 79 (4): 571-7
    • (2004) Mayo Clin Proc , vol.79 , Issue.4 , pp. 571-577
    • Jamieson, A.1    Abousleiman, Y.2
  • 15
    • 0041778253 scopus 로고    scopus 로고
    • Thiazolidinedione-associated congestive heart failure and pulmonary edema
    • Sep;
    • Kermani A, Garg A. Thiazolidinedione-associated congestive heart failure and pulmonary edema. Mayo Clin Proc 2003 Sep; 78 (9): 1088-91
    • (2003) Mayo Clin Proc , vol.78 , Issue.9 , pp. 1088-1091
    • Kermani, A.1    Garg, A.2
  • 16
    • 34250212715 scopus 로고    scopus 로고
    • Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes
    • Jun 14;
    • Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007 Jun 14; 356 (24): 2457-71
    • (2007) N Engl J Med , vol.356 , Issue.24 , pp. 2457-2471
    • Nissen, S.E.1    Wolski, K.2
  • 17
    • 34548590934 scopus 로고    scopus 로고
    • Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: A meta-analysis of randomized trials
    • Sep 12;
    • Lincoff AM, Wolski K, Nicholls SJ, et al. Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. JAMA 2007 Sep 12; 298 (10): 1180-8
    • (2007) JAMA , vol.298 , Issue.10 , pp. 1180-1188
    • Lincoff, A.M.1    Wolski, K.2    Nicholls, S.J.3
  • 18
    • 0031752685 scopus 로고    scopus 로고
    • Global burden of diabetes, 1995-2025: Prevalence, numerical estimates, and projections
    • Sep;
    • King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care 1998 Sep; 21 (9): 1414-31
    • (1998) Diabetes Care , vol.21 , Issue.9 , pp. 1414-1431
    • King, H.1    Aubert, R.E.2    Herman, W.H.3
  • 19
    • 84889411524 scopus 로고    scopus 로고
    • Prescription-event monitoring
    • Strom BL, editor, 4th ed. Chichester: John Wiley & Sons Ltd
    • Shakir S. Prescription-event monitoring. In: Strom BL, editor. Pharmacoepidemiology. 4th ed. Chichester: John Wiley & Sons Ltd, 2005: 203-16
    • (2005) Pharmacoepidemiology , pp. 203-216
    • Shakir, S.1
  • 20
    • 0002601104 scopus 로고
    • Sample size considerations for pharmaco-epidemiology studies
    • Strom B, editor, 2nd ed. Chichester: John Wiley & Sons
    • Strom B. Sample size considerations for pharmaco-epidemiology studies. In: Strom B, editor. Pharmaco-epidemiology. 2nd ed. Chichester: John Wiley & Sons, 1994
    • (1994) Pharmaco-epidemiology
    • Strom, B.1
  • 21
    • 0003718175 scopus 로고    scopus 로고
    • . Post marketing surveillance. Table 7.1. Sample sizes required to observe a single adverse reaction with a given probability and anticipated incidence
    • Machin D, editor, 2nd ed. Oxford: Blackwell Science Ltd
    • Machin D, Campbell M, Fayers P, et al. Chapter 7. Post marketing surveillance. Table 7.1. Sample sizes required to observe a single adverse reaction with a given probability and anticipated incidence. In: Machin D, editor. Sample size tables for clinical studies. 2nd ed. Oxford: Blackwell Science Ltd, 1997: 150
    • (1997) Sample size tables for clinical studies , pp. 150
    • Machin, D.1    Campbell, M.2    Fayers, P.3
  • 24
    • 0003161322 scopus 로고    scopus 로고
    • November, Multi-centre research in the NHS the process of ethical review when there is no local researcher [online, Available from URL:, Accessed 2008 Jul 26
    • Department of Health. Supplementary operational guidelines for NHS Research Ethics Committees - November 2000. Multi-centre research in the NHS the process of ethical review when there is no local researcher [online]. Available from URL: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/ PublicationsPolicyAndGuidance/DH_4006696. [Accessed 2008 Jul 26]
    • (2000) Supplementary operational guidelines for NHS Research Ethics Committees
  • 25
    • 4043100289 scopus 로고    scopus 로고
    • Effect of the insulin sensitizer pioglitazone on insulin resistance, hyperandrogenism, and ovulatory dysfunction in women with polycystic ovary syndrome
    • Aug;
    • Brettenthaler N, De GC, Huber PR, et al. Effect of the insulin sensitizer pioglitazone on insulin resistance, hyperandrogenism, and ovulatory dysfunction in women with polycystic ovary syndrome. J Clin Endocrinol Metab 2004 Aug; 89 (8): 3835-40
    • (2004) J Clin Endocrinol Metab , vol.89 , Issue.8 , pp. 3835-3840
    • Brettenthaler, N.1    De, G.C.2    Huber, P.R.3
  • 26
    • 1842660808 scopus 로고    scopus 로고
    • Improvement of fat redistribution, insulin resistance and hepatic fatty infiltration in HIV-associated lipodystrophy syndrome by pioglitazone: A case report
    • Feb;
    • Prasithsirikul W, Bunnag P. Improvement of fat redistribution, insulin resistance and hepatic fatty infiltration in HIV-associated lipodystrophy syndrome by pioglitazone: a case report. J Med Assoc Thai 2004 Feb; 87 (2): 166-72
    • (2004) J Med Assoc Thai , vol.87 , Issue.2 , pp. 166-172
    • Prasithsirikul, W.1    Bunnag, P.2
  • 27
    • 50649114859 scopus 로고    scopus 로고
    • Takeda UK Limited, Aug [online, Available from URL:, Accessed 2008 Aug 19
    • Takeda UK Limited. Summary of Product Characteristics for Actos (pioglitazone hydrochloride), 2007 Aug [online]. Available from URL: http://emc.medicines.org.uk/industry/default.asp [Accessed 2008 Aug 19]
    • (2007) Summary of Product Characteristics for Actos (pioglitazone hydrochloride)
  • 28
    • 33847675510 scopus 로고    scopus 로고
    • The effect of pioglitazone on recurrent myocardial infarction in 2,445 pa-tients with type 2 diabetes and previous myocardial infarction: Results from the PROactive (PROactive 05) Study
    • May 1;
    • Erdmann E, Dormandy JA, Charbonnel B, et al. The effect of pioglitazone on recurrent myocardial infarction in 2,445 pa-tients with type 2 diabetes and previous myocardial infarction: results from the PROactive (PROactive 05) Study. J Am Coll Cardiol 2007 May 1; 49 (17): 1772-80
    • (2007) J Am Coll Cardiol , vol.49 , Issue.17 , pp. 1772-1780
    • Erdmann, E.1    Dormandy, J.A.2    Charbonnel, B.3
  • 29
    • 35649003900 scopus 로고    scopus 로고
    • A comparison of pioglitazone and rosiglitazone for hospitalization for acute myocardial infarction in type 2 diabetes
    • Oct;
    • Gerrits CM, Bhattacharya M, Manthena S, et al. A comparison of pioglitazone and rosiglitazone for hospitalization for acute myocardial infarction in type 2 diabetes. Pharmacoepidemiol Drug Saf 2007 Oct; 16 (10): 1065-71
    • (2007) Pharmacoepidemiol Drug Saf , vol.16 , Issue.10 , pp. 1065-1071
    • Gerrits, C.M.1    Bhattacharya, M.2    Manthena, S.3
  • 30
    • 0004293174 scopus 로고    scopus 로고
    • 2nd ed. New York: Churchill Livingstone Inc
    • Larsen WJ. Human embryology. 2nd ed. New York: Churchill Livingstone Inc., 1997: 62-3
    • (1997) Human embryology , pp. 62-63
    • Larsen, W.J.1
  • 31
    • 0022922048 scopus 로고
    • Diabetic embryopathy: Pathogenesis, prenatal diagnosis and prevention
    • Jun;
    • Reece EA, Hobbins JC. Diabetic embryopathy: pathogenesis, prenatal diagnosis and prevention. Obstet Gynecol Surv 1986 Jun; 41 (6): 325-35
    • (1986) Obstet Gynecol Surv , vol.41 , Issue.6 , pp. 325-335
    • Reece, E.A.1    Hobbins, J.C.2


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