ROSuvastatin 低剂量联合依折麦布可有效且永久性地降低低密度脂蛋白胆固醇浓度，与给药时间无关（ROSEZE）：一项随机、交叉研究——初步结果。

Low dose of ROSuvastatin in combination with EZEtimibe effectively and permanently reduce low density lipoprotein cholesterol concentration independently of timing of administration (ROSEZE): A randomized, crossover study - preliminary results.

机构信息

Department of Cardiology and Internal Medicine, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Poland.

Department of Laboratory Medicine, Nicolaus Copernicus University, Collegium Medicum, 9 Sklodowskiej-Curie Street, 85-094 Bydgoszcz, Poland.

出版信息

Cardiol J. 2021;28(1):58-66. doi: 10.5603/CJ.a2020.0166. Epub 2020 Nov 17.

DOI:10.5603/CJ.a2020.0166

PMID:33200812

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8105047/

Abstract

BACKGROUND

In an attempt to improve low density lipoprotein-cholesterol (LDL-C) level control in patients ineffectively treated with statins, we evaluated the effectiveness of a fixed-dose combination (FDC) of 10 mg rosuvastatin and ezetimibe and its relation to the timing of drug administration.

METHODS

A randomized, open label, single center, crossover study involving 83 patients with coronary artery disease and hypercholesterolemia with baseline LDL-C ≥ 70 mg/dL. In arm I the FDC drug was administered in the morning for 6 weeks, then in the evening for the following 6 weeks and vice versa in arm II. The primary endpoint was the change in LDL-C after 6 and 12 weeks.

RESULTS

The median LDL-C concentration at baseline, after 6 and 12 weeks respectively was: 98.10 mg/dL (Q1;Q3: 85.10;116.80), 63.14 mg/dL (50.70;77.10) and 59.40 mg/dL (49.00;73.30); p < 0.001. LDL-C levels were similar regardless of the timing of drug administration (morning 62.50 mg/dL [50.70;76.00] vs. evening 59.70 mg/dL [48.20;73.80]; p = 0.259], in both time points: 6 week: 63.15 mg/dL (50.75;80.65) vs. 63.40 mg/dL (50.60;74.00), p = 0.775; and 12 week: 62.00 mg/dL (50.20;74.40) vs. 59.05 mg/dL (47.65;66.05), p = 0.362. The absolute change in LDL-C concentration for the morning vs. evening drug administration was - 6 week: -34.6 mg/dL (-56.55; -19.85) (-34.87%) vs. -31.10 mg/dL (-44.20; -16.00) (-35.87%) (p not significant); 12. week: -34.20 mg/dL (-47.8; -19.0) (-37.12%) vs. -37.20 mg/dL (-65.55; -23.85) (-40.06%) (p not significant). The therapy was safe and well tolerated.

CONCLUSIONS

Fixed-dose combination of rosuvastatin and ezetimibe significantly and permanently decreases LDL-C regardless of the timing of drug administration.

摘要

背景

为了提高他汀类药物治疗效果不佳的患者的低密度脂蛋白胆固醇（LDL-C）水平控制，我们评估了 10 毫克瑞舒伐他汀和依折麦布固定剂量组合（FDC）的有效性及其与给药时间的关系。

方法

一项随机、开放标签、单中心、交叉研究，共纳入 83 例患有冠状动脉疾病和高胆固醇血症且基线 LDL-C≥70mg/dL 的患者。在臂 I 中，FDC 药物在早上给药 6 周，然后在晚上给药 6 周，然后在臂 II 中相反。主要终点是 6 周和 12 周时 LDL-C 的变化。

结果

基线、6 周和 12 周时 LDL-C 浓度的中位数分别为：98.10mg/dL（Q1；Q3：85.10；116.80）、63.14mg/dL（50.70；77.10）和 59.40mg/dL（49.00；73.30）；p<0.001。无论给药时间如何，LDL-C 水平均相似（早上 62.50mg/dL[50.70；76.00]与晚上 59.70mg/dL[48.20；73.80]；p=0.259]，在两个时间点：6 周：63.15mg/dL（50.75；80.65）与 63.40mg/dL（50.60；74.00），p=0.775；12 周：62.00mg/dL（50.20；74.40）与 59.05mg/dL（47.65；66.05），p=0.362。早上与晚上给药的 LDL-C 浓度绝对变化为：-6 周：-34.6mg/dL（-56.55；-19.85）（-34.87%）与-31.10mg/dL（-44.20；-16.00）（-35.87%）（p 无显著差异）；12 周：-34.20mg/dL（-47.80；-19.00）（-37.12%）与-37.20mg/dL（-65.55；-23.85）（-40.06%）（p 无显著差异）。该治疗安全且耐受良好。