Obońska Karolina, Kasprzak Michał, Sikora Joanna, Obońska Ewa, Racki Krzysztof, Goździkiewicz Natalia, Krintus Magdalena, Kubica Jacek
Department of Cardiology and Internal Medicine, Nicolaus Copernicus University, Collegium Medicum, 9 Skłodowskiej-Curie Street, 85-094, Bydgoszcz, Poland.
Department of Pharmacology and Therapy, Nicolaus Copernicus University, Collegium Medicum, 9 Skłodowskiej-Curie Street, 85-094, Bydgoszcz, Poland.
Trials. 2017 Jul 11;18(1):316. doi: 10.1186/s13063-017-2047-8.
Hypercholesterolemia is one of the main risk factors for cardiovascular disease. The first line treatment for hypercholesterolemia is statin therapy. When the expected low-density lipoprotein cholesterol (LDL-C) concentration is not achieved, the pharmacotherapy may be extended by combining the statin with the cholesterol absorption inhibitor ezetimibe.
METHODS/DESIGN: The study is designed as a randomized, open-label, single-center, crossover study evaluating the effectiveness of combined therapy with rosuvastatin and ezetimibe for hypercholesterolemia. The study is planned to include 200 patients with hypercholesterolemia ineffectively treated with statins for at least 6 weeks. After enrollment participants are randomized into one of two arms receiving rosuvastatin and ezetimibe. In the first arm the study drug is administered in the morning (8:00 am) for 6 weeks and then in the evening for the next 6 weeks; in the second arm the study drug is administered at first in the evening (8:00 pm) for the first 6 weeks and then in the morning for the following 6 weeks. In order to minimize non-adherence to the treatment, all patients will receive the study drug free of charge. The primary outcome of the study is change in LDL-C at 6 and 12 weeks of the treatment, depending on the time of day of study drug administration. The secondary endpoints include change in total cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, apolipoproteins ApoB and Apo AI, non-HDL cholesterol, small, dense (sd)-LDL cholesterol, lipoprotein(a), glucose, glycated hemoglobin, high-sensitivity C-reactive protein, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, and creatine kinase at 6 and 12 weeks of the study drug treatment, as well as assessment of plasma fluorescence using stationary and time-resolved fluorescence spectroscopy at baseline and at 6 and 12 weeks of the therapy.
The RosEze trial is expected to demonstrate whether there is a significant difference in the effectiveness of the lipid-lowering therapy in reducing the concentration of cholesterol when the medications are taken in the morning compared with the evening time of day.
ClinicalTrials.gov, NCT02772640 . Registered on 28 March 2016.
高胆固醇血症是心血管疾病的主要危险因素之一。高胆固醇血症的一线治疗方法是他汀类药物治疗。当预期的低密度脂蛋白胆固醇（LDL-C）浓度未达到时，可通过将他汀类药物与胆固醇吸收抑制剂依泽替米贝联合使用来延长药物治疗。
方法/设计：本研究设计为一项随机、开放标签、单中心、交叉研究，旨在评估瑞舒伐他汀和依泽替米贝联合治疗高胆固醇血症的有效性。该研究计划纳入200例接受他汀类药物治疗至少6周但效果不佳的高胆固醇血症患者。入组后，参与者被随机分为两组，分别接受瑞舒伐他汀和依泽替米贝治疗。在第一组中，研究药物在上午（上午8:00）给药6周，然后在晚上给药6周；在第二组中，研究药物首先在晚上（晚上8:00）给药6周，然后在上午给药6周。为了尽量减少不依从治疗的情况，所有患者将免费接受研究药物。研究的主要结局是根据研究药物给药的时间，在治疗6周和12周时LDL-C的变化。次要终点包括在研究药物治疗6周和12周时总胆固醇、高密度脂蛋白（HDL）胆固醇、甘油三酯、载脂蛋白ApoB和Apo AI、非HDL胆固醇、小而密（sd）-LDL胆固醇、脂蛋白（a）、葡萄糖、糖化血红蛋白、高敏C反应蛋白、天冬氨酸转氨酶、丙氨酸转氨酶、γ-谷氨酰转移酶和肌酸激酶的变化，以及在基线以及治疗6周和12周时使用稳态和时间分辨荧光光谱法评估血浆荧光。
RosEze试验预计将证明，与晚上服药相比，早上服药时降脂治疗在降低胆固醇浓度方面的有效性是否存在显著差异。
ClinicalTrials.gov，NCT02772640。于2016年3月28日注册。
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