Abstract
BACKGROUND: This study aimed to investigate the efficacy and safety of simvastatin plus hirudin in preventing atherosclerosis in the patients with early type 2 diabetes mellitus (T2DM). METHODS: This was a 24-week, randomized, open-label and controlled study in which 150 outpatients initially diagnosed with T2DM were randomly assigned into either simvastatin (40 mg daily at night) plus hirudin (3 g thrice daily) group [combined group (CG) n=75] or simvastatin (40 mg once daily) group [monotherapy group (MG) n=75]. The therapeutic efficacy was evaluated by the score of carotid artery atherosclerosis, plaque size, peak systolic velocity (PSV) and end-diastolic velocity (EDV) on carotid ultrasonography at three and six months after treatment. Logistic regression analysis was used to investigate the correlation between treatment and carotid atherosclerosis. RESULTS: One hundred and thirty-one patients completed this study, and there were no significant differences in the dropout rate in the CG (14.67%) and the MG (10.67%). Significant difference was found in the incidence of adverse events in the CG compared with the MG (37.50% vs. 17.91%, P<0.05) due to the higher risk of hemorrhage (12.50% vs. 1.49%, P<0.05), which did not affect the treatment compliance. The efficacy of combined treatment was better than monotherapy in the enhancement of carotid artery atherosclerosis scores (P<0.01), the plaque thickness (P<0.05) and the change of PSV (P<0.05) and EDV (P<0.05) since three months after treatment, which maintained to the end of observation. In addition, hirudin treatment was able to independently predict the carotid artery atherosclerosis scores (β=2.37, P<0.05), the plaque thickening (β=3.51, P<0.01) and the change of PSV (β=1.69, P<0.05) and EDV (β=1.79, P<0.05). CONCLUSIONS: Combined use of simvastatin and hirudin is well tolerated and possesses better anti-atherosclerotic effects than simvastatin alone in patients with early T2DM.