Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, 167 Beilishi Road, Xi Cheng District, Beijing, China.
Zhengzhou People Hospital, Zhengzhou, China.
Cardiovasc Drugs Ther. 2018 Feb;32(1):47-56. doi: 10.1007/s10557-018-6772-3.
Ticagrelor is an orally administered, reversibly binding, direct-acting P2Y receptor antagonist previously evaluated in several phase III trials. This phase IV, multicenter, single-arm trial assessed the safety and incidence of cardiovascular (CV) events with ticagrelor in Chinese patients experiencing an acute coronary syndrome (ACS).
Patients hospitalized with an ACS received ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) plus low-dose aspirin (75-100 mg/day) for up to 12 months. Safety was evaluated via PLATO-defined bleeding events, adverse events (AEs), serious AEs, and laboratory measurements. The incidence of major CV events was also evaluated.
The safety population included 2001 patients. During ticagrelor treatment, 426 (21.3%) patients had at least one PLATO-defined bleeding AE, mainly minimal bleedings (n = 333). Major bleeding events occurred in 27 (1.3%) patients, including fatal/life-threatening bleeding in 17 (0.8%) patients and other major bleeding in 11 (0.5%) patients, with a Kaplan-Meier estimate of patients with the event (95% CI) of 1.6% (1.1-2.3%). In total, 784 (39.2%) patients had at least one non-bleeding AE, the majority of which were mild in severity. The composite endpoint of CV death, myocardial infarction, and stroke occurred in 83 (4.1%) patients.
Ticagrelor plus low-dose aspirin for up to 1 year was associated with a low rate of major bleeding events and a low incidence of major CV events (CV death, myocardial infarction, stroke) in Chinese patients with ACS. The overall safety profile of ticagrelor in this population was in line with current prescribing information.
替格瑞洛是一种口服、可逆结合、直接作用的 P2Y 受体拮抗剂，先前已在多项 III 期临床试验中进行了评估。这项 IV 期、多中心、单臂试验评估了替格瑞洛在中国急性冠状动脉综合征（ACS）患者中的安全性和心血管（CV）事件发生率。
ACS 住院患者接受替格瑞洛（180mg 负荷剂量，随后每日两次 90mg）加低剂量阿司匹林（75-100mg/天）治疗，最长 12 个月。通过 PLATO 定义的出血事件、不良事件（AE）、严重 AE 和实验室检测评估安全性。还评估了主要 CV 事件的发生率。
安全性人群包括 2001 例患者。在替格瑞洛治疗期间，426 例（21.3%）患者至少发生过一次 PLATO 定义的出血 AE，主要为轻微出血（n=333）。27 例（1.3%）患者发生主要出血事件，包括致命/危及生命的出血 17 例（0.8%）和其他主要出血 11 例（0.5%），事件发生的 Kaplan-Meier 估计（95%CI）为 1.6%（1.1-2.3%）。共有 784 例（39.2%）患者至少发生过一次非出血性 AE，其中大多数为轻度。心血管死亡、心肌梗死和中风的复合终点在 83 例（4.1%）患者中发生。
替格瑞洛加低剂量阿司匹林治疗长达 1 年，与中国 ACS 患者的主要出血事件发生率低和主要 CV 事件（心血管死亡、心肌梗死、中风）发生率低相关。替格瑞洛在该人群中的总体安全性与当前的处方信息一致。
