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.
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。