Department of Medicine, Division of Cardiology, Health Sciences Center #T16 - 080, State University of New York, Stony Brook, NY 11794 USA.
J Clin Lipidol. 2009 Apr;3(2):119-24. doi: 10.1016/j.jacl.2009.02.008. Epub 2009 Feb 11.
Both colesevelam hydrochloride (colesevelam) and ezetimibe monotherapy have been reported to lower low-density lipoprotein cholesterol (LDL-C) approximately 15-17% in patients with hypercholesterolemia. When statin therapy is inadequate to reach desired LDL-C goals, the choice of add-on therapy, while multifactorial, must consider efficacy of additional LDL-C reduction.
To provide pilot study data in assessing the relative potential of ezetimibe or colesevelam to further reduce LDL-C in statin-treated patients.
Fourteen patients with hypercholesterolemia, who at baseline were on treatment with a stable regimen of low- to moderate-dose statin therapy, were randomized to receive colesevelam HCl 3.75 g/day or ezetimibe 10 mg/day as add-on therapy (AOT). At the end of 6 weeks, each patient was crossed over to the alternative AOT.
LDL cholesterol fell an additional 21.0% on colesevelam (P < .001) and 28.3% on ezetimibe (P <.001) with a 7.3% difference between AOTs (P <.02). Non-high-density lipoprotein cholesterol (non-HDL-C) fell an additional 15.1% on colesevelam (P <.001) and 25.6% on ezetimibe (P <.001) with a 10.5% difference between AOTs (P <.001). The non-HDL-C/HDL-C ratio fell an additional 15.3% on colesevelam (P <.01) and 22.8% on ezetimibe (P <.001) with a 7.5% difference between AOTs (P <.02). Zero of 10 and six of 10 secondary prevention patients reached an LDL-C level of <70 mg/dl on colesevelam and ezetimibe respectively (P <.005).
Colesevelam HCl and ezetimibe are both effective AOTs in patients on statin therapy. The superior further improvement in the lipid panel with ezetimibe compared to colesevelam was demonstrated in this placebo uncorrected crossover pilot study.
已有研究报道，盐酸考来维仑（考来维仑）和依折麦布单药治疗可使高胆固醇血症患者的低密度脂蛋白胆固醇（LDL-C）降低约 15-17%。当他汀类药物治疗不足以达到理想的 LDL-C 目标时，附加治疗的选择虽然是多因素的，但必须考虑额外降低 LDL-C 的疗效。
提供评估依折麦布或考来维仑在他汀类药物治疗患者中进一步降低 LDL-C 的相对潜力的初步研究数据。
14 名高胆固醇血症患者，基线时正在接受低至中剂量他汀类药物稳定治疗方案，随机接受考来维仑 HCl 3.75 g/天或依折麦布 10 mg/天作为附加治疗（AOT）。在 6 周结束时，每位患者交叉接受另一种 AOT。
考来维仑使 LDL 胆固醇进一步降低 21.0%（P<.001），依折麦布降低 28.3%（P<.001），两种 AOT 之间的差异为 7.3%（P<.02）。非高密度脂蛋白胆固醇（non-HDL-C）在考来维仑组进一步降低 15.1%（P<.001），依折麦布组降低 25.6%（P<.001），两种 AOT 之间的差异为 10.5%（P<.001）。非-HDL-C/HDL-C 比值在考来维仑组进一步降低 15.3%（P<.01），依折麦布组降低 22.8%（P<.001），两种 AOT 之间的差异为 7.5%（P<.02）。在考来维仑和依折麦布组中，分别有 0/10 和 6/10 的二级预防患者达到 LDL-C<70mg/dl 的水平（P<.005）。
盐酸考来维仑和依折麦布均为他汀类药物治疗患者的有效 AOT。与考来维仑相比，依折麦布在脂质谱方面的进一步改善更为显著，这在本未经安慰剂校正的交叉初步研究中得到了证明。
