瑞舒伐他汀/依折麦布联合治疗与瑞舒伐他汀单药治疗对2型糖尿病患者脂蛋白的疗效及安全性比较：多中心随机对照研究
Comparison of the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy and Rosuvastatin Monotherapy on Lipoprotein in Patients With Type 2 Diabetes: Multicenter Randomized Controlled Study.
作者信息
Lee Jiwoo, Hwang You-Cheol, Lee Woo Je, Won Jong Chul, Song Kee-Ho, Park Cheol-Young, Ahn Kyu Jeung, Park Joong-Yeol
机构信息
Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea.
Division of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Korea.
出版信息
Diabetes Ther. 2020 Apr;11(4):859-871. doi: 10.1007/s13300-020-00778-1. Epub 2020 Feb 17.
INTRODUCTION
Ezetimibe/statin combination therapy has been reported to provide additional cardioprotective effects compared to statin monotherapy. The apolipoprotein B/A1 (apoB/A1) ratio is an effective predictor of cardiovascular diseases. The aim of this study was to compare the efficacy and safety of rosuvastatin/ezetimibe combination therapy versus rosuvastatin monotherapy using the apoB/A1 ratio in patients with diabetes and hypercholesterolemia.
METHODS
In this randomized, multicenter, open-label, parallel-group study, patients were randomly assigned to receive the combination therapy of rosuvastatin 5 mg/ezetimibe 10 mg once daily (n = 68) or monotherapy with rosuvastatin 10 mg once daily (n = 68), for 8 weeks.
RESULTS
After the 8-week treatment, percentage change (least-square means ± standard error) in the apoB/A1 ratio in the rosuvastatin/ezetimibe group was significantly decreased compared to the rosuvastatin group (- 46.14 ± 1.58% vs. - 41.30 ± 1.58%, respectively; P = 0.03). In addition, the proportion of patients achieving > 50% reduction in low-density lipoprotein-cholesterol (LDL-C) and in the comprehensive lipid target (LDL-C < 70 mg/dL, non-HDL-cholesterol [non-HDL-C] < 100 mg/dL, and apoB < 80 mg/dL) was significantly different between the two groups (76.5 and 73.5% in the rosuvastatin/ezetimibe group and 47.1 and 45.6% in the rosuvastatin group, respectively; P < 0.001). The reduction in total cholesterol, non-HDL-C, LDL-C, and apoB were greater in the rosuvastatin/ezetimibe group than in the rosuvastatin group. Both treatments were well tolerated, and no between-group differences in drug-related adverse events were observed.
CONCLUSION
The apoB/A1 ratio was significantly reduced in patients receiving combination therapy with ezetimibe and rosuvastatin compared to those receiving rosuvastatin monotherapy. Both treatments were well tolerated in patients with type 2 diabetes and hypercholesterolemia.
TRIAL REGISTRATION
NCT03446261.
引言
据报道，依折麦布/他汀类药物联合治疗与他汀类药物单药治疗相比，具有额外的心脏保护作用。载脂蛋白B/A1（apoB/A1）比值是心血管疾病的有效预测指标。本研究的目的是比较瑞舒伐他汀/依折麦布联合治疗与瑞舒伐他汀单药治疗对糖尿病和高胆固醇血症患者apoB/A1比值的疗效和安全性。
方法
在这项随机、多中心、开放标签、平行组研究中，患者被随机分配接受瑞舒伐他汀5毫克/依折麦布10毫克每日一次的联合治疗（n = 68）或瑞舒伐他汀10毫克每日一次的单药治疗（n = 68），为期8周。
结果
经过8周治疗后，瑞舒伐他汀/依折麦布组apoB/A1比值的百分比变化（最小二乘均值±标准误差）与瑞舒伐他汀组相比显著降低（分别为-46.14±1.58%和-41.30±1.58%；P = 0.03）。此外，两组患者实现低密度脂蛋白胆固醇（LDL-C）降低>50%以及达到综合血脂目标（LDL-C<70毫克/分升、非高密度脂蛋白胆固醇[非HDL-C]<100毫克/分升和apoB<80毫克/分升）的比例存在显著差异（瑞舒伐他汀/依折麦布组分别为76.5%和73.5%，瑞舒伐他汀组分别为47.1%和45.6%；P<0.001）。瑞舒伐他汀/依折麦布组总胆固醇、非HDL-C、LDL-C和apoB的降低幅度大于瑞舒伐他汀组。两种治疗耐受性均良好，未观察到组间药物相关不良事件的差异。
结论
与接受瑞舒伐他汀单药治疗的患者相比，接受依折麦布和瑞舒伐他汀联合治疗的患者apoB/A1比值显著降低。两种治疗在2型糖尿病和高胆固醇血症患者中耐受性均良好。
试验注册
NCT03446261。
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