在基于烟酸的治疗方案中加用依折麦布治疗原发性高脂血症的有效性和耐受性。

Effectiveness and tolerability of adding ezetimibe to niacin-based regimens for treatment of primary hyperlipidemia.

作者信息

Jelesoff Nicole E, Ballantyne Christie M, Xydakis Antonios M, Chiou Philip, Jones Peter H, Guyton John R

机构信息

Department of Medicine, Division of Endocrinology, Nutrition, and Metabolism, Duke University Medical Center, Durham, North Carolina 27710, USA.

出版信息

Endocr Pract. 2006 Mar-Apr;12(2):159-64. doi: 10.4158/EP.12.2.159.

DOI:10.4158/EP.12.2.159

PMID:16690463

Abstract

OBJECTIVE

To determine the effectiveness and tolerability of adding ezetimibe, 10 mg daily, to niacin-based regimens for dyslipidemia.

METHODS

We conducted a retrospective review of medical records of 53 patients in 2 lipid clinics who received ezetimibe as add-on therapy to stable doses of niacin and other lipid medications. Mean percentage changes of lipoprotein cholesterol and triglyceride levels were determined. Safety and tolerability measures included adverse events, serum hepatic transaminases, and hemoglobin A1c (in patients with diabetes).

RESULTS

Most study subjects (81%) had established atherosclerotic disease. The niacin formulation was extended-release in 31 patients (58%), immediate-release in 17 (32%), and slow-release in 5 (9%). Most patients (75%) were also taking a statin. Add-on ezetimibe therapy yielded mean reductions of 18% for total cholesterol (P<0.001), 25% for low-density lipoprotein (LDL) cholesterol (P<0.001), and 17% for triglycerides (P<0.001). High-density lipoprotein (HDL) cholesterol did not change significantly (+2%). Only 7 patients (13%) met Adult Treatment Panel III (ATP III) LDL cholesterol goals before the addition of ezetimibe, but 24 (45%; P<0.001 compared with baseline) attained these goals after addition of ezetimibe to the therapeutic regimen. Ezetimibe effectiveness did not correlate with the baseline dose of niacin or the dose/efficacy of the statin used. The addition of ezetimibe to niacin-based therapy for dyslipidemia was well tolerated. No patient had clinically significant elevations in hepatic enzyme or hemoglobin A1c levels or discontinued the ezetimibe therapy permanently.

CONCLUSION

In our study, the addition of ezetimibe to niacin-based regimens lowered the LDL cholesterol level by 25% and did not change the level of HDL cholesterol. This combination can be useful in multidrug regimens for high-risk patients with dyslipidemia who are not achieving ATP III treatment goals.

摘要

目的

确定每日添加10毫克依折麦布至基于烟酸的血脂异常治疗方案中的有效性和耐受性。

方法

我们对2家血脂门诊的53例患者的病历进行了回顾性研究，这些患者接受依折麦布作为稳定剂量烟酸和其他降脂药物的附加治疗。测定了脂蛋白胆固醇和甘油三酯水平的平均百分比变化。安全性和耐受性指标包括不良事件、血清肝转氨酶和糖化血红蛋白A1c（糖尿病患者）。

结果

大多数研究对象（81%）患有已确诊的动脉粥样硬化疾病。31例患者（58%）使用的烟酸制剂为缓释型，17例（32%）为速释型，5例（9%）为缓释型。大多数患者（75%）也在服用他汀类药物。添加依折麦布治疗后，总胆固醇平均降低18%（P<0.001），低密度脂蛋白（LDL）胆固醇降低25%（P<0.001），甘油三酯降低17%（P<0.001）。高密度脂蛋白（HDL）胆固醇无显著变化（升高2%）。添加依折麦布前，只有7例患者（13%）达到成人治疗小组第三次报告（ATP III）的LDL胆固醇目标，但在治疗方案中添加依折麦布后，24例患者（45%；与基线相比P<0.001）达到了这些目标。依折麦布的有效性与烟酸的基线剂量或所用他汀类药物的剂量/疗效无关。在基于烟酸的血脂异常治疗中添加依折麦布耐受性良好。没有患者出现肝酶或糖化血红蛋白A1c水平的临床显著升高，也没有患者永久停用依折麦布治疗。