PMID- 31475172 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220410 IS - 2305-5839 (Print) IS - 2305-5847 (Electronic) IS - 2305-5839 (Linking) VI - 7 IP - 14 DP - 2019 Jul TI - Anti-atherosclerotic effects between a combined treatment with simvastatin plus hirudin and single simvastatin therapy in patients with early type 2 diabetes mellitus. PG - 302 LID - 10.21037/atm.2019.05.69 [doi] LID - 302 AB - 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 (beta=2.37, P<0.05), the plaque thickening (beta=3.51, P<0.01) and the change of PSV (beta=1.69, P<0.05) and EDV (beta=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. FAU - Li, De-Qiang AU - Li DQ AD - Department of Integrated Internal Medicine, The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China. FAU - Lv, Fei-Fei AU - Lv FF AD - Department of Integrated Internal Medicine, The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China. FAU - Li, Zhong-Chun AU - Li ZC AD - Department of Neurology, Tongde Hospital of Zhejiang Province, Hangzhou 310012, China. FAU - Dai, Zhi-Yuan AU - Dai ZY AD - Department of Preventive Medicine, Xiaoying Street Community Health Center, Hangzhou 310002, China. FAU - Wang, Hong-Xia AU - Wang HX AD - Department of Ultrasound Medicine, The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China. FAU - Han, Yang AU - Han Y AD - Department of Integrated Internal Medicine, The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China. LA - eng PT - Journal Article PL - China TA - Ann Transl Med JT - Annals of translational medicine JID - 101617978 PMC - PMC6694273 OTO - NOTNLM OT - Type 2 diabetes mellitus (T2DM) OT - atherosclerosis OT - hirudin OT - simvastatin COIS- Conflict of Interests: The authors have no conflicts of interest to declare. EDAT- 2019/09/03 06:00 MHDA- 2019/09/03 06:01 PMCR- 2019/07/01 CRDT- 2019/09/03 06:00 PHST- 2019/09/03 06:00 [entrez] PHST- 2019/09/03 06:00 [pubmed] PHST- 2019/09/03 06:01 [medline] PHST- 2019/07/01 00:00 [pmc-release] AID - atm-07-14-302 [pii] AID - 10.21037/atm.2019.05.69 [doi] PST - ppublish SO - Ann Transl Med. 2019 Jul;7(14):302. doi: 10.21037/atm.2019.05.69.