Key result
Two years of statin therapy did not significantly alter carotid IMT progression compared to placebo, but significantly reduced cardiovascular events (2 vs 12 events; P=0.006).
Why the study?
Does statin therapy reduce the progression of carotid intima-media thickness in patients with type 2 diabetes without manifest cardiovascular disease?
RCT (n=250)
Double-blind
randomized
Does statin therapy reduce the progression of carotid intima-media thickness in patients with type 2 diabetes without manifest cardiovascular disease?
Two years of statin therapy did not alter carotid IMT progression in type 2 diabetes patients without CVD, despite significantly reducing actual cardiovascular events, suggesting IMT may be a poor surrogate marker in this population.
Statin therapy reduces events in T2DM without manifest CVD despite no IMT effect; challenges carotid IMT as a surrogate endpoint.
OBJECTIVE: Cardiovascular disease (CVD) is the most important cause of mortality in patients with type 2 diabetes. We aimed to determine the effect of statin therapy versus placebo on the progression of carotid intima-media thickness (IMT) in type 2 diabetic patients without manifest CVD. RESEARCH DESIGN AND METHODS: A randomized, placebo-controlled, double-blind clinical trial was performed in 250 patients with type 2 diabetes. Patients were given either 0.4 mg cerivastatin or placebo daily. In August 2001, when cerivastatin was withdrawn from the market, 0.4 mg cerivastatin was replaced by 20 mg simvastatin without deblinding the study. The primary end point was the change of mean common carotid IMT, as measured by B-mode ultrasound, over 2 years. RESULTS: Common carotid IMT at baseline was 0.780 mm in the placebo group and 0.763 mm in the statin group and did not change significantly after 2 years. There was no significant difference in IMT change in any carotid segment between the groups. LDL cholesterol was reduced by 25% in the statin group and increased by 8% in the placebo group (P <0.001). Cardiovascular events occurred in 12 patients in the placebo group and two patients in the statin group (P=0.006). CONCLUSIONS: There was no effect of 2 years' statin therapy on carotid IMT in type 2 diabetic subjects. The natural history of IMT in our patients was milder than anticipated. In contrast, we observed a significantly lower cardiovascular event rate on statin therapy. Prognostic tools other than IMT should be explored in this patient group.
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Beishuizen et al. (2004) conducted an RCT in Type 2 diabetes without manifest cardiovascular disease (n=250). Statin therapy (cerivastatin/simvastatin) vs. Placebo was evaluated on Change of mean common carotid IMT over 2 years. Two years of statin therapy did not significantly alter carotid IMT progression compared to placebo, but significantly reduced cardiovascular events (2 vs 12 events; P=0.006).
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