阿托伐他汀10毫克/天对胰岛素抵抗的影响：一项针对高脂血症患者的为期12周的开放标签研究。

Effects of atorvastatin 10 mg/d on insulin resistance: A 12-week, open-label study in hyperlipidemic patients.

作者信息

Ozerkan Filiz, Ozdogan Oner, Zoghi Mehdi, Nalbantgil Sanem, Yavuzgil Oğuz, Remzi Önder M

机构信息

Cardiology Department, Ege University Medical School, Bornova-Izmir, Turkey.

出版信息

Curr Ther Res Clin Exp. 2006 Jan;67(1):44-54. doi: 10.1016/j.curtheres.2006.02.002.

DOI:10.1016/j.curtheres.2006.02.002

PMID:24678082

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3966010/

Abstract

BACKGROUND

In addition to their cholesterol-lowering effects, hydroxymethylglutaryl coenzyme A reductase inhibitors ("statins") might have pleiotropic, nonlipid effects. Insulin resistance syndrome is known to increase the risk for cardiovascular disease. However, the effects of statins on insulin resistance are a subject of controversy.

OBJECTIVE

We aimed to investigate the effects of atorvastatin on insulin resistance in hyperlipidemic patients.

METHODS

This 12-week, prospective, nonrandomized, open-label study was conducted at the outpatient cardiology clinic, Ege University Medical School, Bornova-Izmir, Turkey. Hyperlipidemic patients aged ≥18 years with insulin resistance and no other components of the metabolic syndrome were included in the study. Atorvastatin 10 mg QD (after the evening meal) was administered by mouth (tablet) over a 12-week period. At baseline and after 12 weeks of treatment, insulin sensitivity was assessed using homeostasis model assessment (HOMA) index methodology. Serum lipid parameters and fasting levels of plasma glucose and insulin (FPG and FPI, respectively) were measured at the same 2 time points. The tolerability of atorvastatin was assessed using laboratory analysis and physical examination, including vital sign measurements.

RESULTS

Fifteen white patients (9 women, 6 men; mean [SD] age, 52 [8] years) participated in the study. No significant changes in HOMA index were found (mean [SD], 3.1 [1.5] vs 3.2 [1.9]). The lipid profile was improved significantly at 12 weeks compared with baseline (mean [SD] low-density lipoprotein cholesterol, 173.2 [21.3] vs 110.8 [43.6] mg/dL; total cholesterol, 270.9 [21.5] vs 201.2 [46.7] mg/dL; and triglycerides, 269.5 [46.3] vs 205.5 [49.3] mg/dL; all, P < 0.001). No significant change in mean (SD) plasma high-density lipoprotein cholesterol level (45.5 [6.6] vs 43.7 [8.1] mg/dL) was found. In addition, no significant changes in FPG (85.3 [12.71 vs 84.8 [10.4] mg/dL), or FPI (13.5 [9.7] vs 13.9 [10.1] μU/mL) were found. None of the patients required withdrawal of medication due to an adverse event.

CONCLUSION

In this pilot study in hyperlipidemic patients with insulin resistance, 12 weeks of treatment with atorvastatin 10 mg QD was effective in controlling hyperlipidemia but did not reduce the severity of insulin resistance.

摘要

背景

除降低胆固醇的作用外，羟甲基戊二酰辅酶A还原酶抑制剂（“他汀类药物”）可能具有多效性的非脂质效应。胰岛素抵抗综合征已知会增加心血管疾病风险。然而，他汀类药物对胰岛素抵抗的影响存在争议。

目的

我们旨在研究阿托伐他汀对高脂血症患者胰岛素抵抗的影响。

方法

这项为期12周的前瞻性、非随机、开放标签研究在土耳其伊兹密尔博尔诺瓦的埃杰大学医学院门诊心脏病科进行。纳入年龄≥18岁、有胰岛素抵抗且无代谢综合征其他组分的高脂血症患者。在12周期间口服（片剂）阿托伐他汀10毫克，每日一次（晚餐后）。在基线和治疗12周后，使用稳态模型评估（HOMA）指数方法评估胰岛素敏感性。在相同的两个时间点测量血脂参数以及空腹血糖和胰岛素水平（分别为FPG和FPI）。使用实验室分析和体格检查（包括生命体征测量）评估阿托伐他汀的耐受性。

结果

15名白人患者（9名女性，6名男性；平均[标准差]年龄，52[8]岁）参与了该研究。未发现HOMA指数有显著变化（平均[标准差]，3.1[1.5]对3.2[1.9]）。与基线相比，12周时血脂谱有显著改善（平均[标准差]低密度脂蛋白胆固醇，173.2[21.3]对110.8[43.6]毫克/分升；总胆固醇，270.9[21.5]对201.2[46.7]毫克/分升；甘油三酯，269.5[46.3]对205.5[49.3]毫克/分升；均P<0.001）。未发现平均（标准差）血浆高密度脂蛋白胆固醇水平有显著变化（45.5[6.6]对43.7[8.1]毫克/分升）。此外，未发现FPG（85.3[12.7]对84.8[10.4]毫克/分升）或FPI（13.5[9.7]对13.9[10.1]微单位/毫升）有显著变化。没有患者因不良事件需要停药。