Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands.
Faculty of Clinical Pharmacology and Therapeutics, Academy for Postgraduate Continuous Medical Education, Moscow, Russia.
J Clin Lipidol. 2018 Mar-Apr;12(2):321-330. doi: 10.1016/j.jacl.2017.10.012. Epub 2017 Oct 27.
Adult patients with severe hypertriglyceridemia (SHTG) are at increased risk of developing acute pancreatitis and cardiovascular disease. Omega-3 carboxylic acids (OM3-CA) are approved for treatment as an adjunct to diet to reduce triglyceride (TG) concentrations in patients with SHTG.
The aim of the study was to assess efficacy and safety of the intermediate dose of OM3-CA (2 g daily), compared with olive oil 2 g daily, in reducing serum TG and lipid concentrations in patients with SHTG.
A randomized, double-blind, olive oil-controlled, parallel-group trial involving 162 adults with qualifying serum TG concentrations of at least 500 mg/dL (5.65 mmol/L) and <2500 mg/dL (28.25 mmol/L; <2000 mg/dL [22.60 mmol/L] in Canada). The treatment period after randomization was 12 weeks. Blood samples for measurement of fasting serum lipid concentrations were taken at baseline, 6, 10, and 12 weeks.
Treatment with OM3-CA 2 g daily led to a significant reduction in TG concentrations (median of differences, -14.2% [95% confidence interval: -26.2%, -2.8%; P = .017]) and non-high-density lipoprotein cholesterol concentrations (median of differences, -9.0% [95% confidence interval: -14.8%, -2.8%; adjusted P = .018]) from baseline to the Week 12 endpoint, when compared with olive oil 2 g daily. These treatment effects were more pronounced in patients with qualifying TG concentrations >885 mg/dL (10 mmol/L).
An intermediate dose of OM3-CA (2 g daily) significantly lowers TG and non-high-density lipoprotein cholesterol concentrations in patients with SHTG and may benefit individuals at risk of acute pancreatitis and cardiovascular disease.
患有严重高甘油三酯血症（SHTG）的成年患者发生急性胰腺炎和心血管疾病的风险增加。ω-3 羧酸（OM3-CA）已被批准作为饮食辅助治疗药物，用于降低 SHTG 患者的甘油三酯（TG）浓度。
本研究旨在评估中等剂量 OM3-CA（每日 2 克）与每日 2 克橄榄油相比，降低 SHTG 患者血清 TG 和血脂浓度的疗效和安全性。
这是一项随机、双盲、橄榄油对照、平行组试验，纳入了 162 名符合条件的成年患者，他们的血清 TG 浓度至少为 500mg/dL（5.65mmol/L）且<2500mg/dL（28.25mmol/L；加拿大为<2000mg/dL[22.60mmol/L]）。随机分组后治疗期为 12 周。在基线、6、10 和 12 周时采集空腹血清脂质浓度血样进行测量。
与每日 2 克橄榄油相比，每日 2 克 OM3-CA 治疗可显著降低 TG 浓度（中位数差值，-14.2%[95%置信区间：-26.2%，-2.8%；P=0.017]）和非高密度脂蛋白胆固醇浓度（中位数差值，-9.0%[95%置信区间：-14.8%，-2.8%；调整后 P=0.018]），直至第 12 周终点。在 TG 浓度>885mg/dL（10mmol/L）的患者中，这些治疗效果更为显著。
中等剂量 OM3-CA（每日 2 克）可显著降低 SHTG 患者的 TG 和非高密度脂蛋白胆固醇浓度，可能有益于发生急性胰腺炎和心血管疾病风险的个体。
