添加植物固醇的联合他汀类药物和考来维仑盐酸盐治疗未能降低低密度脂蛋白胆固醇浓度。

Plant sterols added to combination statin and colesevelam hydrochloride therapy failed to lower low-density lipoprotein cholesterol concentrations.

机构信息

Department of Clinical Pharmacy, University of Colorado-Denver, 12631 East 17th Ave, PO Box 6511, Aurora, CO 80045, USA.

出版信息

J Clin Lipidol. 2007 Dec;1(6):626-33. doi: 10.1016/j.jacl.2007.10.004. Epub 2007 Oct 18.

DOI:10.1016/j.jacl.2007.10.004

PMID:21291705

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

摘要

背景

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。

方法

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）。

结果

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。