Department of Clinical Pharmacy, University of Colorado-Denver, 12631 East 17th Ave, PO Box 6511, Aurora, CO 80045, USA.
J Clin Lipidol. 2007 Dec;1(6):626-33. doi: 10.1016/j.jacl.2007.10.004. Epub 2007 Oct 18.
The purpose of this study was to evaluate the effects on LDL-cholesterol (LDL-C) from addition of plant sterol treatment to patients with dyslipidemia already taking a statin and colesevelam hydrochloride (HCl). Current cholesterol treatment guidelines recommend use of plant stanols/sterols to help reach LDL-C goals in patients taking other lipid-lowering therapies. Previous data demonstrate LDL-C lowering by adding stanols/sterols to statins. However, data are conflicting regarding the benefit from combination stanols/sterols with bile acid sequestrants.
Fifty-five subjects on a stable dose of statin completed a 10-week, double-blind, randomized study of colesevelam HCl 3.75 g/day alone for 4 weeks, then 6 weeks of additional 2 g/day plant sterol-fortified orange juice (S-OJ) or placebo orange juice (P-OJ). Serum total cholesterol (TC), LDL-C, HDL-cholesterol (HDL-C), triglycerides (TG), apolipoprotein B (ApoB), and high-sensitivity C-reactive protein (hs-CRP) were measured at baseline, 4 weeks, and 10 weeks.
Baseline LDL-C measurements (mean ± SD) were similar between S-OJ and P-OJ groups (122 ± 20 vs 126 ± 24 mg/dL, respectively). Four weeks of colesevelam HCl in combination with a statin significantly reduced TC, LDL-C, and ApoB (9.6%, P < 0.001; 21.9%, P < 0.001; and 8.5%, P = 0.001, respectively), and significantly increased HDL-C (6.2%, P = 0.002) and TG (18.8%, P = 0.002). However, compared to P-OJ, 10 weeks of S-OJ produced no effect on any outcome parameter beyond that of colesevelam HCl.
Plant S-OJ appears to be ineffective at further reducing LDL-C when added to statin and colesevelam HCl combination therapy in patients with dyslipidemia.
本研究旨在评估在服用他汀类药物和考来烯胺盐酸盐（HCl）的血脂异常患者中添加植物固醇治疗对 LDL-胆固醇（LDL-C）的影响。目前的胆固醇治疗指南建议使用植物甾醇/固醇来帮助服用其他降脂疗法的患者达到 LDL-C 目标。先前的数据表明，添加甾醇/固醇可降低 LDL-C。然而，关于组合使用甾醇/固醇与胆汁酸螯合剂的益处，数据存在矛盾。
55 名服用稳定剂量他汀类药物的受试者完成了一项为期 10 周、双盲、随机研究，在第 4 周单独服用考来烯胺 HCl 3.75g/天，然后在第 6 周服用 2g/天强化植物固醇的橙汁（S-OJ）或安慰剂橙汁（P-OJ）。在基线、4 周和 10 周时测量血清总胆固醇（TC）、LDL-C、高密度脂蛋白胆固醇（HDL-C）、甘油三酯（TG）、载脂蛋白 B（ApoB）和高敏 C 反应蛋白（hs-CRP）。
S-OJ 和 P-OJ 组的基线 LDL-C 测量值（平均值±标准差）相似（分别为 122±20 和 126±24mg/dL）。他汀类药物联合考来烯胺 HCl 治疗 4 周可显著降低 TC、LDL-C 和 ApoB（分别降低 9.6%，P<0.001；降低 21.9%，P<0.001；降低 8.5%，P=0.001），并显著升高 HDL-C（升高 6.2%，P=0.002）和 TG（升高 18.8%，P=0.002）。然而，与 P-OJ 相比，S-OJ 在 10 周时的添加对除考来烯胺 HCl 以外的任何结果参数均无影响。
当添加到他汀类药物和考来烯胺 HCl 联合治疗血脂异常患者时，植物 S-OJ 似乎无法进一步降低 LDL-C。
