Key result
Rosiglitazone did not significantly affect the development of carotid atheroma compared to placebo in patients with type 2 diabetes over one year (mean difference in total wall volume 15.7 mm³, p=0.57).
Why the study?
Does rosiglitazone reduce carotid atherosclerosis in patients with type 2 diabetes mellitus?
RCT (n=48)
Double-blind
Randomized
No
Does rosiglitazone reduce carotid atherosclerosis in patients with type 2 diabetes mellitus?
Mean Difference: 15.7 (95% CI -39.5–70.9)
Absolute Event Rate: 12.7% vs -2.9%
p-value: p=0.57
Rosiglitazone does not significantly affect the progression of carotid atherosclerotic burden over one year in patients with type 2 diabetes.
Clinicians should not pursue rosiglitazone for carotid atherosclerosis in T2DM; confirms neutral effect on plaque progression in RCT.
There has been much interest in carotid artery wall thickening as a marker of atherosclerosis, both by ultrasound and more recently by magnetic resonance (MR). Ultrasound measurements are limited by the presumption that the vessel is uniform. MR does not have this limitation. Rosiglitazone (RSG) is a nuclear PPAR-gamma agonist and has important effects in diabetes control which has led to its widespread use as a complement to existing diabetes drugs. It is known to lead to minor fluid retention in some patients, and recent reports suggest that it may be associated with an increased risk of ischemic cardiovascular events. However, this effect is controversial and may not be seen with all glitazones.
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Varghese et al. (2008) conducted an RCT in Type 2 diabetes mellitus with carotid atheroma (n=48). Rosiglitazone vs. Placebo was evaluated on Change in total carotid wall volume (mm³) (MD 15.7, 95% CI -39.5, 70.9, p=0.57). Rosiglitazone did not significantly affect the development of carotid atheroma compared to placebo in patients with type 2 diabetes over one year (mean difference in total wall volume 15.7 mm³, p=0.57).
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