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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.

Hedblad, Bo LU ; Zambanini, A; Nilsson, P; Janzon, Lars LU and Berglund, Göran LU (2007) In Journal of Internal Medicine 261(3). p.293-305
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). Design. Randomized, double-blind, placebo-controlled trial. Setting. Malmo University Hospital, Malmo, Sweden. Subjects. 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. Intervention. Participants were allocated to placebo or RSG 4 mg for 2 months and then 8 mg daily. Main outcome measure. Change in composite IMT [mean IMT in the... (More)
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). Design. Randomized, double-blind, placebo-controlled trial. Setting. Malmo University Hospital, Malmo, Sweden. Subjects. 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. Intervention. Participants were allocated to placebo or RSG 4 mg for 2 months and then 8 mg daily. Main outcome measure. 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. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Journal of Internal Medicine
volume
261
issue
3
pages
293 - 305
publisher
Wiley-Blackwell Publishing Ltd
external identifiers
  • wos:000244244400010
  • scopus:33846987115
ISSN
1365-2796
DOI
10.1111/j.1365-2796.2007.01767.x
language
English
LU publication?
yes
id
6890b033-6de7-4528-9f36-495f766c037d (old id 165669)
alternative location
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=17305652&dopt=Abstract
date added to LUP
2007-07-23 14:04:40
date last changed
2017-01-01 07:05:48
@article{6890b033-6de7-4528-9f36-495f766c037d,
  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). Design. Randomized, double-blind, placebo-controlled trial. Setting. Malmo University Hospital, Malmo, Sweden. Subjects. 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. Intervention. Participants were allocated to placebo or RSG 4 mg for 2 months and then 8 mg daily. Main outcome measure. 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.},
  author       = {Hedblad, Bo and Zambanini, A and Nilsson, P and Janzon, Lars and Berglund, Göran},
  issn         = {1365-2796},
  language     = {eng},
  number       = {3},
  pages        = {293--305},
  publisher    = {Wiley-Blackwell Publishing Ltd},
  series       = {Journal of Internal Medicine},
  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.},
  url          = {http://dx.doi.org/10.1111/j.1365-2796.2007.01767.x},
  volume       = {261},
  year         = {2007},
}