Ciric Milica Zrnic, Ostojic Miodrag, Baralic Ivana, Kotur-Stevuljevic Jelena, Djordjevic Brizita I, Markovic Stana, Zivkovic Stefan, Stankovic Ivan
Department of Bromatology, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, 11221 Belgrade, Serbia.
Faculty of Medicine, University of Belgrade, 6 Dr Subotica Street, 11000 Belgrade, Serbia.
Nutrients. 2021 Mar 10;13(3):903. doi: 10.3390/nu13030903.
Dietary supplementation with sugar cane derivates may modulate low-density lipoprotein cholesterol (LDL-C) and proprotein convertase subtilisin/kexin type 9 (PCSK9) levels. The purpose of this study was to determine if dietary supplement (DS), containing Octacosanol (20 mg) and vitamin K2 (45 µg), could restore the disrupted physiologic relation between LDL-C and serum PCSK9. Double-blind, randomized, placebo-controlled, single-center study including 87 patients on chronic atorvastatin therapy was conducted. Eighty-seven patients were randomized to receive DS ( = 42) or placebo ( = 45), and followed for 13 weeks. Serum PCSK9 levels, lipid parameters and their relationship were the main efficacy endpoints. The absolute levels of PCSK9 and LDL-C were not significantly different from baseline to 13 weeks. However, physiologic correlation between % change of PCSK9 and % change of LDL-C levels was normalized only in the group of patients treated with DS ( = 0.409, = 0.012). This study shows that DS can restore statin disrupted physiologic positive correlation between PCSK9 and LDL-C. Elevated PCSK9 level is an independent risk factor so controlling its rise by statins may be important in prevention of cardiovascular events.
补充甘蔗衍生物可能会调节低密度脂蛋白胆固醇(LDL-C)和前蛋白转化酶枯草溶菌素/kexin 9型(PCSK9)的水平。本研究的目的是确定含有二十八烷醇(20毫克)和维生素K2(45微克)的膳食补充剂(DS)是否能恢复LDL-C与血清PCSK9之间被破坏的生理关系。我们进行了一项双盲、随机、安慰剂对照、单中心研究,纳入了87例接受慢性阿托伐他汀治疗的患者。87例患者被随机分为接受DS组(n = 42)或安慰剂组(n = 45),并随访13周。血清PCSK9水平、血脂参数及其关系是主要疗效终点。从基线到13周,PCSK9和LDL-C的绝对水平与基线相比无显著差异。然而,仅在接受DS治疗的患者组中,PCSK9变化百分比与LDL-C水平变化百分比之间的生理相关性恢复正常(r = 0.409,P = 0.012)。本研究表明,DS可以恢复他汀类药物破坏的PCSK9与LDL-C之间的生理正相关。PCSK9水平升高是一个独立的危险因素,因此通过他汀类药物控制其升高可能对预防心血管事件很重要。