title: Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database.
abstract: BACKGROUND
  Thiazolidinediones (TZDs), rosiglitazone (RGZ) and pioglitazone (PGZ) are widely used as hypoglycemic drugs in patients with type 2 diabetes mellitus. The aim of our study was to investigate the profile of adverse drug reactions (ADRs) related to TZDs and to investigate potential risk factors of these ADRs.
  
  
  METHODS
  Type 2 diabetic patients were identified from the French Database of PharmacoVigilance (FPVD) between 2002 and 2006. We investigated ADR related to TZD, focusing on 4 ADR: edema, heart failure, myocardial infarction and hepatitis corresponding to specific WHO-ART terms.
  
  
  RESULTS
  Among a total of 99,284 adult patients in the FPVD, 2295 reports concerned type 2 diabetic patients (2.3% of the whole database), with 161 (7%) exposed to TZDs. The frequency of edema and cardiac failure was significantly higher with TZDs than in other patients (18% and 7.4% versus 0.8% and 0.1% respectively, p < 0.001) whereas the frequency of hepatitis was similar (5.9% versus 4%, NS). A multiple logistic regression model taking into account potential confounding factors (age, gender, drug exposure and co-morbidities) found that TZD exposure remained associated with heart failure and edema, but not with hepatitis or myocardial infarction.
  
  
  CONCLUSIONS
  Thiazolidinediones exposure is associated with an increased risk of edema and heart failure in patients with type 2 diabetes even when recommendations for use are respected. In contrast, the risk of hepatic reactions and myocardial infarction with this class of drugs seems to be similar to other hypoglycemic agents.
authors: Unité INSERM 1027, Equipe de Pharmacoépidémiologie, Université de Toulouse, Toulouse, France.
authors: Stephanie
authors: S
authors: Berthet
authors: Pascale
authors: P
authors: Olivier
authors: Jean-Louis
authors: JL
authors: Montastruc
authors: Maryse
authors: M
authors: Lapeyre-Mestre
references: CMAJ. 2009 Jan 6;180(1):32-9
references: 19073651
references: Diabetes Care. 2007 Aug;30(8):2148-53
references: 17536074
references: Therapie. 1985 Mar-Apr;40(2):111-8
references: 4002188
references: Therapie. 2007 Nov-Dec;62(6):483-8
references: 18316014
references: Am J Epidemiol. 1982 Jan;115(1):92-106
references: 7055134
references: JAMA. 2007 Sep 12;298(10):1180-8
references: 17848652
references: Expert Opin Drug Saf. 2009 Jan;8(1):15-32
references: 19236215
references: Drug Saf. 2001;24(12):873-88
references: 11735645
references: Diabetes Care. 2003 Nov;26(11):2983-9
references: 14578227
references: JAMA. 2010 Jul 28;304(4):411-8
references: 20584880
references: Pharmacoepidemiol Drug Saf. 2009 Dec;18(12):1238-43
references: 19623674
references: JAMA. 2007 Sep 12;298(10):1189-95
references: 17848653
references: Drug Saf. 2005;28(8):731-40
references: 16048358
references: Diabetes Care. 2001 Jul;24(7):1226-32
references: 11423507
references: JAMA. 2007 Dec 12;298(22):2634-43
references: 18073359
references: Arch Intern Med. 2010 Jul 26;170(14):1191-1201
references: 20656674
references: BMJ. 2007 Sep 8;335(7618):497
references: 17761999
references: N Engl J Med. 2007 Jun 14;356(24):2457-71
references: 17517853
references: Pharmacotherapy. 2002 Jul;22(7):924-9
references: 12126225
references: Eur J Clin Pharmacol. 1997;52(6):423-7
references: 9342576
references: Clin Neuropharmacol. 2003 May-Jun;26(3):142-5
references: 12782916
references: Lancet. 2009 Jun 20;373(9681):2125-35
references: 19501900
references: Diabetes Obes Metab. 2005 Mar;7(2):161-9
references: 15715889
references: Lancet. 2000 Oct 7;356(9237):1255-9
references: 11072960
references: Fundam Clin Pharmacol. 2006 Aug;20(4):391-5
references: 16867024
references: JAMA. 2002 Oct 2;288(13):1588
references: 12350188
references: Diabetes Metab. 2008 Feb;34(1):38-45
references: 18068386