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Evaluation of pharmacokinetic pharmacodynamic efficacy and safety data of low-dose ticagrelor versus standard dose in East Asians: a systematic review

机译:低剂量替格瑞洛与标准剂量在东亚地区的药代动力学药效动力学疗效和安全性数据评估:系统评价

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摘要

East Asians are prone to higher systemic exposure and increased risk of bleeding compared to other races after administration of antiplatelet agent(s). The aim of this systematic review was to compare and evaluate the appropriateness of a lower dose versus standard dose of ticagrelor in East Asians. A systematic search was conducted in PubMed, EMBASE, and Cochrane databases for studies comparing low versus standard doses of ticagrelor in East Asian populations; a total of seven studies were included in the review. Pharmacokinetic (PK), pharmacodynamic (PD), clinical efficacy, and safety data were collected. PK data demonstrated that the Cmax and area under the curve (AUC) of ticagrelor increased dose-proportionally. PD data indicated that while the low dose of ticagrelor resulted in less antiplatelet activity in three of the five PD studies, in the other studies, there were no differences between low and standard doses. There were two clinical studies included in this review, which showed that the efficacy was similar between the low and standard doses, but both studies were limited by the number of patients included. While there were generally greater incidence of adverse events observed in the standard ticagrelor dose, the magnitude or actual difference between the two doses is difficult to determine due to lack of consistent data. In East Asians, the appropriateness of the low-dose ticagrelor cannot be determined based on the currently available evidence. Additional large-scale and longer duration studies are warranted.
机译:与其他种族相比,使用抗血小板剂后,东亚人容易出现更高的全身暴露和更高的出血风险。该系统评价的目的是比较和评估东亚替卡格雷的低剂量与标准剂量的适宜性。在PubMed,EMBASE和Cochrane数据库中进行了系统的搜索,以比较东亚人群替卡格雷的低剂量与标准剂量之间的关系。该评价共纳入七项研究。收集药代动力学(PK),药效学(PD),临床疗效和安全性数据。 PK数据表明替卡格雷的Cmax和曲线下面积(AUC)呈剂量比例增加。 PD数据表明,在五项PD研究中的三项中,低剂量替格瑞洛导致较少的抗血小板活性,而在其他研究中,低剂量和标准剂量之间没有差异。该评价包括两项临床研究,这些研究表明低剂量和标准剂量之间的疗效相似,但两项研究均受所包括患者的数量限制。尽管通常在标准替卡格雷剂量中观察到不良事件的发生率较高,但由于缺乏一致的数据,很难确定两次剂量之间的大小或实际差异。在东亚人中,不能根据目前可获得的证据确定低剂量替格瑞洛的适当性。必须进行其他大规模且持续时间较长的研究。

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