Hwang You Cheol, Jun Ji Eun, Jeong In Kyung, Ahn Kyu Jeung, Chung Ho Yeon
Division of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea.
Diabetes Metab J. 2019 Oct;43(5):582-589. doi: 10.4093/dmj.2018.0124. Epub 2019 Jan 16.
The apolipoprotein B/A1 (apoB/A1) ratio is a stronger predictor of future cardiovascular disease than is the level of conventional lipids. Statin and ezetimibe combination therapy have shown additional cardioprotective effects over statin monotherapy.
This was a single-center, randomized, open-label, active-controlled study in Korea. A total of 36 patients with type 2 diabetes mellitus were randomized to either rosuvastatin monotherapy (20 mg/day, =20) or rosuvastatin/ezetimibe (5 mg/10 mg/day, =16) combination therapy for 6 weeks.
After the 6-week treatment, low density lipoprotein cholesterol (LDL-C) and apoB reduction were comparable between the two groups (-94.3±15.4 and -62.0±20.9 mg/dL in the rosuvastatin group, -89.9±22.7 and -66.8±21.6 mg/dL in the rosuvastatin/ezetimibe group, =0.54 and =0.86, respectively). In addition, change in apoB/A1 ratio (-0.44±0.16 in the rosuvastatin group and -0.47±0.25 in the rosuvastatin/ezetimibe group, =0.58) did not differ between the two groups. On the other hand, triglyceride and free fatty acid (FFA) reductions were greater in the rosuvastatin/ezetimibe group than in the rosuvastatin group (-10.5 mg/dL [interquartile range (IQR), -37.5 to 29.5] and 0.0 μEq/L [IQR, -136.8 to 146.0] in the rosuvastatin group, -49.5 mg/dL [IQR, -108.5 to -27.5] and -170.5 μEq/L [IQR, -353.0 to 0.8] in the rosuvastatin/ezetimibe group, =0.010 and =0.049, respectively). Both treatments were generally well tolerated, and there were no differences in muscle or liver enzyme elevation.
A 6-week combination therapy of low-dose rosuvastatin and ezetimibe showed LDL-C, apoB, and apoB/A1 ratio reduction comparable to that of high-dose rosuvastatin monotherapy in patients with type 2 diabetes mellitus. Triglyceride and FFA reductions were greater with the combination therapy than with rosuvastatin monotherapy.
载脂蛋白B/A1（apoB/A1）比值比传统血脂水平更能预测未来心血管疾病。他汀类药物与依折麦布联合治疗已显示出比他汀类药物单药治疗具有额外的心脏保护作用。
这是一项在韩国进行的单中心、随机、开放标签、活性对照研究。总共36例2型糖尿病患者被随机分为瑞舒伐他汀单药治疗组（20毫克/天，n = 20）或瑞舒伐他汀/依折麦布联合治疗组（5毫克/10毫克/天，n = 16），治疗6周。
6周治疗后，两组的低密度脂蛋白胆固醇（LDL-C）和apoB降低情况相当（瑞舒伐他汀组分别为-94.3±15.4和-62.0±20.9毫克/分升，瑞舒伐他汀/依折麦布组分别为-89.9±22.7和-66.8±21.6毫克/分升，p分别为0.54和0.86）。此外，两组之间apoB/A1比值的变化（瑞舒伐他汀组为-0.44±0.16，瑞舒伐他汀/依折麦布组为-0.47±0.25，p = 0.58）没有差异。另一方面，瑞舒伐他汀/依折麦布组的甘油三酯和游离脂肪酸（FFA）降低幅度大于瑞舒伐他汀组（瑞舒伐他汀组分别为-10.5毫克/分升[四分位间距（IQR），-37.5至29.5]和0.0微当量/升[IQR，-136.8至146.0]，瑞舒伐他汀/依折麦布组分别为-49.5毫克/分升[IQR，-108.5至-27.5]和-170.5微当量/升[IQR，-353.0至0.8]，p分别为0.010和0.049）。两种治疗总体耐受性良好，肌肉或肝酶升高方面没有差异。
低剂量瑞舒伐他汀和依折麦布的6周联合治疗在2型糖尿病患者中显示出与高剂量瑞舒伐他汀单药治疗相当的LDL-C、apoB和apoB/A1比值降低效果。联合治疗比瑞舒伐他汀单药治疗在降低甘油三酯和FFA方面效果更佳。
