Center for Diabetes, Metabolism and Endocrinology, Toho University Sakura Medical Center, Chiba 285-8741, Japan.
J Clin Lipidol. 2013 Nov-Dec;7(6):615-25. doi: 10.1016/j.jacl.2013.09.002. Epub 2013 Sep 18.
TAK-085 is an omega-3 preparation that contains eicosapentaenoic acid ethyl-ester (EPA-E) and docosahexaenoic acid-ethyl ester used in the management of hypertriglyceridemia.
The aim of the study was to evaluate the long-term safety (adverse events [AEs], laboratory parameters, vital signs, weight, and electrocardiograms) and effects on lipid profiles, especially triglyceride levels, of TAK-085 in Japanese patients with hypertriglyceridemia (triglyceride levels ≥150 mg/dL and <750 mg/dL).
In this multicenter, open-label, randomized study, adults with hypertriglyceridemia undergoing lifestyle modification received TAK-085 2 g (2 g once daily; n = 165) or 4 g (2 g twice daily; n = 171), or EPA-E 1.8 g (0.6 g three times daily; n = 167) for 52 weeks. Patients were stratified for co-administration of a statin.
TAK-085 was well tolerated throughout the 52-week study. Overall, no substantial differences were found in the tolerability of TAK-085 2 g, TAK-085 4 g, and EPA-E 1.8 g with incidence rates for AEs of 83.6%, 86.0%, and 89.2%, respectively. Most AEs were mild or moderate in severity. Triglyceride levels decreased from baseline in all groups by week 4, and the decreases were maintained throughout the study. At week 52 the reduction in triglycerides with TAK-085 2 g (-13.9%) was similar to that with EPA-E 1.8 g (-12.1%), whereas the reduction seen with TAK-085 4 g (-25.5%) was greater than that with EPA-E 1.8 g, as assessed by point estimates and 95% confidence intervals.
TAK-085 was safe and well tolerated for up to 52 weeks of treatment in Japanese patients with hypertriglyceridemia undergoing lifestyle modification. Reductions in triglyceride levels achieved after 4 weeks were maintained at 52 weeks.
TAK-085 是一种含有二十碳五烯酸乙酯（EPA-E）和二十二碳六烯酸乙酯的 omega-3 制剂，用于治疗高甘油三酯血症。
本研究旨在评估 TAK-085 在日本高甘油三酯血症（甘油三酯水平≥150mg/dL 且＜750mg/dL）患者中的长期安全性（不良事件[AE]、实验室参数、生命体征、体重和心电图）和对血脂谱的影响，尤其是甘油三酯水平。
在这项多中心、开放标签、随机研究中，正在进行生活方式改变的高甘油三酯血症成年患者接受 TAK-085 2g（2g 每日 1 次；n=165）或 4g（2g 每日 2 次；n=171），或 EPA-E 1.8g（0.6g 每日 3 次；n=167）治疗 52 周。患者根据他汀类药物的联合使用情况进行分层。
在整个 52 周的研究中，TAK-085 均具有良好的耐受性。总体而言，TAK-085 2g、TAK-085 4g 和 EPA-E 1.8g 的耐受性无实质性差异，AE 发生率分别为 83.6%、86.0%和 89.2%。大多数 AE 为轻度或中度。所有组的甘油三酯水平从基线开始在第 4 周下降，并且在整个研究过程中保持下降。在第 52 周时，与 EPA-E 1.8g（-12.1%）相比，TAK-085 2g（-13.9%）降低甘油三酯的效果相似，而 TAK-085 4g（-25.5%）的降低幅度大于 EPA-E 1.8g，这可以通过点估计值和 95%置信区间评估。
在接受生活方式改变的日本高甘油三酯血症患者中，TAK-085 治疗长达 52 周是安全且耐受良好的。治疗 4 周后达到的甘油三酯水平在 52 周时得以维持。
