De-Qiang Li1, Fei-Fei Lv1, Zhong-Chun Li2, Zhi-Yuan Dai3, Hong-Xia Wang4, Yang Han1. 1. Department of Integrated Internal Medicine, The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China. 2. Department of Neurology, Tongde Hospital of Zhejiang Province, Hangzhou 310012, China. 3. Department of Preventive Medicine, Xiaoying Street Community Health Center, Hangzhou 310002, China. 4. Department of Ultrasound Medicine, The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China.
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.
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.
Entities:
Keywords:
Type 2 diabetes mellitus (T2DM); atherosclerosis; hirudin; simvastatin
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