Two-Year Statin Therapy Does Not Alter the Progression of Intima-Media Thickness in Patients with Type 2 Diabetes Without Manifest Cardiovascular Disease

Beishuizen ED, van de Ree MA, Jukema JW, Tamsma JT, van der Vijver JC, Meinders AE, Putter H, Huisman MV. Diabetes Care. 2004;27:2887-2892.

Statin therapy in patients with type 2 diabetes and no history of cardiovascular disease had no effect on carotid intima-media thickness (IMT) after 2 years, as demonstrated in this randomized, placebo-controlled, double-blind study. This is the first prospective study to report the effect of statin therapy on carotid and femoral IMT in type 2 diabetes.

In total, 250 patients with type 2 diabetes were randomized to treatment with cerivastatin 0.4 mg/day or placebo for 2 years. Cerivastatin was replaced with 20 mg simvastatin for 1 month until study end upon the withdrawal of cerivastatin from the market in August 2001, and the study remained blinded.

At 2 years, there was no significant change from baseline in common carotid artery IMT in the statin or placebo group (0.763 and 0.780 mm at baseline, respectively). Further, there were no significant between-group differences in change in IMT in any carotid segment. Low-density lipoprotein cholesterol decreased by 25% in the statin group and 8% in the placebo group (P<.001). Two patients in the statin group and 12 in the placebo group experienced a cardiovascular event (P = .006).

Statins have been shown to significantly slow the progression of carotid IMT in patients with established coronary artery disease and in patients with familial hypercholesterolemia; however, in this study statin therapy had no effect on carotid IMT in patients with type 2 diabetes. The authors postulate that in type 2 diabetes, the reduction of cardiovascular disease events with statin therapy, as observed in this study, is not related to regression in IMT, and that vessel walls may be resistant to general regression by alterations to local intravascular cholesterol metabolism.