阿托伐他汀/非诺贝特固定剂量复方制剂与阿托伐他汀对2型糖尿病合并血脂异常患者血脂谱的疗效和安全性比较

Efficacy and Safety of the Fixed-Dose Combination of Atorvastatin/Fenofibrate Versus Atorvastatin on the Lipid Profile of Patients with Type 2 Diabetes and Dyslipidemia.

作者信息

Padilla-Padilla Francisco G, Ruiz-Bernes Lina N, Román-Pintos Luis M, Peraza-Zaldívar Juan A, Sander-Padilla José G, Lugo-Sánchez Laura A, Rios-Brito Kevin F, Arguedas-Núñez María M, Flores-Huanosta Diana, González-Canudas Jorge

机构信息

Clinical and Interventional Cardiology, Tarascos, No. Ext. 3469, Int. 507, Monraz, 44670, Guadalajara, Jalisco, Mexico.

Hospital Hispano, S.A. de C.V., Pedro Moreno No. 934, Centro, Guadalajara, Jalisco, Mexico.

出版信息

Cardiol Ther. 2025 Jun;14(2):297-314. doi: 10.1007/s40119-025-00410-y. Epub 2025 May 5.

DOI:10.1007/s40119-025-00410-y

PMID:40323331

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12084457/

Abstract

INTRODUCTION

In dyslipidemia associated with type 2 diabetes (T2DM), elevated triglycerides (TG), increased low-density lipoprotein cholesterol (LDL-C), and decreased high-density lipoprotein cholesterol (HDL-C) levels are commonly found, resulting in a high prevalence of mixed dyslipidemia among patients with T2DM. Therefore, the combination therapy of atorvastatin/fenofibrate may be useful for simplifying pharmacological regimens, enhancing adherence, and requiring fewer doses of each drug to achieve the target, which decreases the number of adverse events.

METHODS

We conducted a randomized multicenter, double-blind clinical trial of patients with T2DM and mixed dyslipidemia to evaluate the magnitude of change in lipid profile with a fixed-dose combination (FDC) therapy group of atorvastatin 20 mg/fenofibrate 160 mg (G_FDC) versus atorvastatin 20 mg monotherapy group (G_M), both oral route, one tablet every 24 h. The magnitude of change in the lipid profile at 2 and 4 months was compared within each group and between groups using the analysis of variance (ANOVA) test. A p value ≤ 0.05 was considered statistically significant.

RESULTS

A total of 76 patients were included (38 per group), with an age of 56.7 ± 10.2 years, and 56.6% were women. The values at 4 months for G_FDC vs. G_M were as follow: TG mg/dL (-144.3 vs. -64.0, p = 0.004), TG percentage change (%C) (-47.9 vs. -33.1, p = 0.007); LDL-C mg/dL (-50.5 vs. -51.7, p = 0.784), LDL-C %C (-42.5 vs. -45.6, p = 0.899). The percentage of patients who achieved the targets for triglycerides (TG) was 56.7% compared to 43.8% (p = 0.309), while for LDL-C, it was 73.3% compared to 78.1% (p = 0.660). Finally, the predictive cardiovascular risk indices (∆ of change) showed a TG/HDL index of -3.9 ± 4.6 vs. -1.5 ± 2.9 (p = 0.015) and a Tg/glucose index of -0.7 ± 0.5 vs. -0.3 ± 0.4 (p = 0.003).

CONCLUSION

The FDC therapy of atorvastatin 20 mg/fenofibrate 160 mg achieved a greater percentage reduction in lipid profile than atorvastatin alone. No differences in adverse events were observed between the groups.

CLINICAL TRIALS REGISTRATION

ClinicalTrials.gov No. NCT04882293, registration date: February 28, 2022.

摘要

引言

在2型糖尿病（T2DM）相关的血脂异常中，常见甘油三酯（TG）升高、低密度脂蛋白胆固醇（LDL-C）增加和高密度脂蛋白胆固醇（HDL-C）水平降低，导致T2DM患者中混合性血脂异常的患病率较高。因此，阿托伐他汀/非诺贝特联合治疗可能有助于简化药物治疗方案、提高依从性，并减少每种药物达到目标所需的剂量，从而减少不良事件的发生。

方法

我们对T2DM和混合性血脂异常患者进行了一项随机多中心、双盲临床试验，以评估阿托伐他汀20mg/非诺贝特160mg固定剂量复方（FDC）治疗组（G_FDC）与阿托伐他汀20mg单药治疗组（G_M）口服给药，每24小时一片，血脂谱变化的幅度。使用方差分析（ANOVA）检验比较每组内和组间2个月和4个月时血脂谱的变化幅度。p值≤0.05被认为具有统计学意义。

结果

共纳入76例患者（每组38例），年龄56.7±10.2岁，女性占56.6%。G_FDC与G_M在4个月时的值如下：TG（mg/dL）（-144.3对-64.0，p=0.004），TG变化百分比（%C）（-47.9对-33.1，p=0.007）；LDL-C（mg/dL）（-50.5对-51.7，p=0.784），LDL-C %C（-42.5对-45.6，p=0.899）。达到甘油三酯（TG）目标的患者百分比为56.7%，而单药组为43.8%（p=0.309），而LDL-C的达标率分别为73.3%和78.1%（p=0.660）。最后，预测心血管风险指数（变化量）显示TG/HDL指数为-3.9±4.6对-1.5±2.9（p=0.015），Tg/血糖指数为-0.7±0.5对-0.3±0.4（p=0.003）。