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首页> 外文期刊>Journal of Clinical Pharmacy and Therapeutics >Lack of clinically significant pharmacological interactions between ticagrelor and enoxaparin or unfractionated heparin in healthy subjects
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Lack of clinically significant pharmacological interactions between ticagrelor and enoxaparin or unfractionated heparin in healthy subjects

机译：替卡格雷与依诺肝素或普通肝素之间缺乏临床上重要的药理相互作用

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What is known and Objective: Patients with acute coronary syndromes (ACS) receive several pharmacological therapies concomitantly, including antiplatelet and anticoagulant agents. As unfractionated heparin (UFH) activates platelets in vitro and in vivo, co-administration with an antiplatelet agent may lead to decreased clinical effectiveness of the latter. The aim was therefore to determine any potential drug-drug interactions between the new oral antiplatelet agent ticagrelor, and UFH or enoxaparin. Methods: In two open-label, three-period, crossover trials, healthy subjects were randomized to receive ticagrelor alone or with enoxaparin (study 1) or UFH (study 2), or enoxaparin or UFH alone. Ticagrelor plasma concentrations, inhibition of platelet aggregation (IPA), anti-factor Xa levels, activated partial thromboplastin time (aPTT) and activated coagulation time (ACT) were measured. Results: Thirty and 28 subjects completed studies 1 and 2, respectively. Study drugs were generally well tolerated, with no significant bleeding or serious adverse events. Co-administration with enoxaparin or UFH had no significant effect on ticagrelor pharmacokinetics. The effect of ticagrelor on IPA was unimpaired by co-administration of enoxaparin, except for a marginal (-2·9%; 908·7%.h, 881·9%.h) reduction in final extent area under the effect curve (AUEC) 2-12 (95% CI: -51·6%.h, -2·0%.h). Co-administering UFH with ticagrelor caused small decreases in IPA max (-3·8%; 94·6%, 91·0%) and AUEC 2-12 (-6·8%; 888·6%.h, 828·3%.h) vs. ticagrelor alone (95% CI: final extent IPA max-5·7%, -1·6%; AUEC 2-12-109·8%.h, -10·8%.h). Ticagrelor had no clinically significant effects on enoxaparin as assessed by anti-factor Xa (study 1), or UFH as assessed by aPTT or ACT (study 2). What is new and conclusions: Enoxaparin and UFH had no effect on the pharmacokinetics and no clinically significant effect on the pharmacodynamics of ticagrelor. Ticagrelor had no clinically significant effects on the pharmacodynamics of enoxaparin or UFH.
机译：已知和目的：急性冠脉综合征（ACS）患者会同时接受多种药物治疗，包括抗血小板药和抗凝药。由于普通肝素（UFH）在体外和体内均能激活血小板，因此与抗血小板药共同给药可能导致后者的临床有效性降低。因此，目的是确定新的口服抗血小板药替卡格雷或UFH或依诺肝素之间的任何潜在药物相互作用。方法：在两项开放式，三期，交叉试验中，健康受试者被随机分配接受替卡格雷或单独使用依格帕洛或依诺肝素（研究1）或UFH（研究2），或单独接受依诺肝素或UFH。测量了替卡格雷的血浆浓度，对血小板聚集的抑制（IPA），抗因子Xa水平，活化的部分凝血活酶时间（aPTT）和活化的凝血时间（ACT）。结果：30名和28名受试者分别完成了研究1和2。研究药物通常耐受良好，没有明显的出血或严重不良事件。与依诺肝素或UFH共同给药对替卡格雷的药代动力学没有明显影响。替加格雷对IPA的作用不受依诺肝素共同给药的影响，但作用曲线下最终范围面积减少了（-2·9％; 908·7％.h，881·9％.h）（ AUEC）2-12（95％CI：-51·6％.h，-2·0％.h）。 UFH与替卡格雷联用会导致IPA max（-3·8％; 94·6％，91·0％）和AUEC 2-12（-6·8％; 888·6％.h，828· 3％.h）与单独使用替卡瑞洛（95％CI：最终程度IPA max-5·7％，-1·6％; AUEC 2-12-109·8％.h，-10·8％.h） 。如通过抗Xa因子评估（研究1）或通过aPTT或ACT评估UFH（研究2），替卡格雷对依诺肝素没有临床意义。新发现和结论：依诺肝素和UFH对替卡格雷的药代动力学没有影响，对替卡格雷的药效学也没有临床意义。替卡格雷对依诺肝素或UFH的药效学无临床意义的影响。

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