title: Rosiglitazone and carotid IMT progression rate in a mixed cohort of patients with type 2 diabetes and the insulin resistance syndrome: main results from the Rosiglitazone Atherosclerosis Study.
abstract: OBJECTIVE
  Insulin resistance is associated with progression of atherosclerosis. We assessed the effect of 12 months of treatment with rosiglitazone (RSG) on the progression of carotid intima-media thickness (IMT) in people with type 2 diabetes mellitus (T2DM) or the insulin resistance syndrome (IRS).
  
  
  METHODS
  Randomized, double-blind, placebo-controlled trial.
  
  
  METHODS
  Malmö University Hospital, Malmö, Sweden.
  
  
  METHODS
  555 subjects (200 with T2DM and 355 nondiabetics with IRS according to EGIR criteria), aged 35-80 years. 447 subjects (165 T2DM and 282 IRS) completed the study.
  
  
  METHODS
  Participants were allocated to placebo or RSG 4 mg for 2 months and then 8 mg daily.
  
  
  METHODS
  Change in composite IMT [mean IMT in the common carotid artery (CCA) and maximal IMT in the bulb] was the primary and various other IMT measures were secondary outcome variables.
  
  
  RESULTS
  There was no effect of RSG treatment in the mixed population. In T2DM patients there was a reduced progression of the composite IMT (mean change: 0.041 vs. 0.070 mm, P = 0.07), and of the mean IMT CCA (mean change: -0.005 mm vs. 0.021 mm, P = 0.007). RSG treatment led to significant reductions of HOMA-IR, fasting plasma glucose, HbA1c, PAI-1 activity, fibrinogen, C-reactive protein and matrix metalloproteinase-9.
  
  
  CONCLUSIONS
  In a mixed study population of patients with T2DM and IRS RSG treatment was not associated with a statistically significant reduction of carotid IMT progression rate. Separate analyses of these two patient groups indicated, however, a significant beneficial effect on CCA IMT in T2DM patients but no similar effect in subjects with IRS.
authors.affiliation: Department of Clinical Sciences in Malmö, Lund University, Malmö, Sweden. bo.hedblad@med.lu.se
authors.forename: B
authors.initials: B
authors.lastname: Hedblad
authors.forename: A
authors.initials: A
authors.lastname: Zambanini
authors.forename: P
authors.initials: P
authors.lastname: Nilsson
authors.forename: L
authors.initials: L
authors.lastname: Janzon
authors.forename: G
authors.initials: G
authors.lastname: Berglund
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D050197:Atherosclerosis / Q000188:drug therapy*; D002340:Carotid Artery Diseases / Q000188:drug therapy* / Q000473:pathology; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000473:pathology; D003925:Diabetic Angiopathies / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D000077154:Rosiglitazone; D013548:Sweden; D045162:Thiazolidinediones / Q000627:therapeutic use*; D017539:Tunica Intima / Q000473:pathology
chemical_list: D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone