title: Cardiac safety profile of rosiglitazone: a comprehensive meta-analysis of randomized clinical trials.
abstract: BACKGROUND
  Some meta-analyses of randomized clinical trials suggested that rosiglitazone could be associated with increased risk for myocardial infarction (MI). Available meta-analyses, based on studies sponsored by GlaxoSmithKline (GSK), failed to include all trials performed with rosiglitazone. Aim of this analysis is the assessment of the cardiovascular risk with rosiglitazone, using a comprehensive data set.
  
  
  METHODS
  Results of 164 trials with duration >4 weeks were retrieved from http://ctr.gsk.co.uk/welcome.asp and from Medline, while unpublished studies were identified from www.clinicaltrials.gov. A total of 164 trials (42,922 and 45,483 patient years for rosiglitazone and comparators, respectively) were included in the analysis.
  
  
  RESULTS
  The OR for all-cause and cardiovascular mortality with rosiglitazone was 0.93[0.76;1.14] and 0.94[0.68;1.29], respectively; rosiglitazone-associated risk for nonfatal MI and heart failure was 1.14[0.90;1.45] and 1.69[1.21;2.36], respectively. The risk of heart failure was higher (2.20[1.28;3.78]) when rosiglitazone was administered as add-on therapy to insulin.
  
  
  CONCLUSIONS
  Figures for rosiglitazone-associated risk for myocardial infarction could be lower than those previously reported on the basis of a smaller number of clinical trials. No increase of all-cause or cardiovascular mortality were observed with rosiglitazone. Conversely, treatment with rosiglitazone is associated with a relevant increase in the risk of heart failure, particularly in insulin-treated patients.
authors.affiliation: Sections of Geriatric Cardiology, Department of Cardiovascular Medicine, University of Florence and AOU Careggi, Florence.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Mannucci
authors.forename: Matteo
authors.initials: M
authors.lastname: Monami
authors.forename: Mauro
authors.initials: M
authors.lastname: Di Bari
authors.forename: Caterina
authors.initials: C
authors.lastname: Lamanna
authors.forename: Francesca
authors.initials: F
authors.lastname: Gori
authors.forename: Gian Franco
authors.initials: GF
authors.lastname: Gensini
authors.forename: Niccolò
authors.initials: N
authors.lastname: Marchionni