Bando Yukihiro, Tohyama Hitomi, Aoki Keiko, Kanehara Hideo, Hisada Azusa, Okafuji Kazuhiro, Toya Daisyu
Department of Internal Medicine, Fukui-ken Saiseikai Hospital, Fukui, Japan.
J Clin Transl Endocrinol. 2016 Jun 16;6:1-7. doi: 10.1016/j.jcte.2016.06.001. eCollection 2016 Dec.
This preliminary randomized, parallel-group comparative study evaluated the efficacy of ipragliflozin for reduction of small dense low-density lipoprotein cholesterol (sd LDL-C) levels in Japanese patients with type 2 diabetes mellitus (T2DM).
Sixty-two patients with T2DM (age, 56 ± 8 years; hemoglobin A1c levels, 8.1 ± 0.9%; BMI, 27.5 ± 3.3 kg/m) were randomly assigned in a 2:1 ratio to receive ipragliflozin (50 mg/day) (treatment group; n = 40) or continued treatment (control group; n = 22) for 12 weeks. The primary endpoints were changes in sd LDL-C levels detected using the LipoPhor AS system; the secondary endpoints included changes in the sd LDL-C/large buoyant LDL-C (lb LDL-C) ratio, a surrogate marker for LDL particle size, and percent changes in routine lipid parameters.
The treatment group exhibited a statistically significant reduction from baseline for LDL-C levels (-0.37 mg/dL vs. 14.4 mg/dL, = 0.038), sd LDL-C levels (-1.28 mg/dL vs. 2.81 mg/dL, = 0.012), and sd LDL-C/lb LDL-C ratio (-3.20% vs. 4.58%, = 0.040) compared with the control group. Multiple regression analysis among all subjects revealed change in TG levels ( = 0.011) and LDL-C levels ( = 0.024) as well as change in body weight ( = 0.006) as independent factors contributing to the reduction in sd LDL-C.
Ipragliflozin may have a potential for lowering sd LDL-C levels associated with increasing LDL particle size in Japanese patients with T2DM.
本初步随机、平行组比较研究评估了依帕列净降低日本2型糖尿病（T2DM）患者小而密低密度脂蛋白胆固醇（sdLDL-C）水平的疗效。
62例T2DM患者（年龄56±8岁；糖化血红蛋白水平8.1±0.9%；体重指数27.5±3.3kg/m²）按2:1的比例随机分配，接受依帕列净（50mg/天）（治疗组；n=40）或继续治疗（对照组；n=22），为期12周。主要终点是使用LipoPhor AS系统检测的sdLDL-C水平变化；次要终点包括sdLDL-C/大颗粒低密度脂蛋白胆固醇（lbLDL-C）比值的变化（LDL颗粒大小的替代标志物）以及常规血脂参数的百分比变化。
与对照组相比，治疗组的LDL-C水平（-0.37mg/dL对14.4mg/dL，P=0.038）、sdLDL-C水平（-1.28mg/dL对2.81mg/dL，P=0.012）和sdLDL-C/lbLDL-C比值（-3.20%对4.58%，P=0.040）较基线有统计学意义的降低。对所有受试者进行的多元回归分析显示，甘油三酯水平变化（P=0.011）、LDL-C水平变化（P=0.024）以及体重变化（P=0.006）是导致sdLDL-C降低的独立因素。
依帕列净可能具有降低日本T2DM患者sdLDL-C水平的潜力，这与LDL颗粒大小增加有关。
