PDF(Pubmed)
Abstract：
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.
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.
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.
Fixed-dose combination of rosuvastatin and ezetimibe significantly and permanently decreases LDL-C regardless of the timing of drug administration.
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.
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.
Fixed-dose combination of rosuvastatin and ezetimibe significantly and permanently decreases LDL-C regardless of the timing of drug administration.
摘要：
为了改善他汀类药物治疗无效的患者的低密度脂蛋白胆固醇（LDL-C）水平控制，我们评估了瑞舒伐他汀和依泽替米贝10mg固定剂量联合用药(FDC)的有效性及其与给药时机的关系.
随机，开放标签,单中心,交叉研究涉及83例基线LDL-C≥70mg/dL的冠心病和高胆固醇血症患者。在手臂I中，FDC药物在早上给药6周，然后在接下来的6周晚上，反之亦然。主要终点是6周和12周后LDL-C的变化。
基线时的LDL-C浓度中位数，6周和12周后分别为：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。无论药物施用时间如何，LDL-C水平都相似（早上62.50mg/dL[50.70;76.00]vs.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）vs.63.40mg/dL（50.60；74.00），p=0.775；12周：62.00mg/dL（50.20；74.40）vs.59.05mg/dL（47.65；66.05），p=0.362。早晨LDL-C浓度的绝对变化与晚上给药-6周：-34.6mg/dL（-56.55;-19.85）（-34.87％）与-31.10mg/dL(-44.20;-16.00)(-35.87%)(p不显著);12.周：-34.20mg/dL（-47.8；-19.0）（-37.12%）与-37.20mg/dL(-65.55;-23.85)(-40.06%)(p不显著)。该疗法安全且耐受性良好。
无论给药时机如何，瑞舒伐他汀和依泽替米贝的固定剂量组合均可显著且永久地降低LDL-C。
随机，开放标签,单中心,交叉研究涉及83例基线LDL-C≥70mg/dL的冠心病和高胆固醇血症患者。在手臂I中，FDC药物在早上给药6周，然后在接下来的6周晚上，反之亦然。主要终点是6周和12周后LDL-C的变化。
基线时的LDL-C浓度中位数，6周和12周后分别为：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。无论药物施用时间如何，LDL-C水平都相似（早上62.50mg/dL[50.70;76.00]vs.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）vs.63.40mg/dL（50.60；74.00），p=0.775；12周：62.00mg/dL（50.20；74.40）vs.59.05mg/dL（47.65；66.05），p=0.362。早晨LDL-C浓度的绝对变化与晚上给药-6周：-34.6mg/dL（-56.55;-19.85）（-34.87％）与-31.10mg/dL(-44.20;-16.00)(-35.87%)(p不显著);12.周：-34.20mg/dL（-47.8；-19.0）（-37.12%）与-37.20mg/dL(-65.55;-23.85)(-40.06%)(p不显著)。该疗法安全且耐受性良好。
无论给药时机如何，瑞舒伐他汀和依泽替米贝的固定剂量组合均可显著且永久地降低LDL-C。
