Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia
Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia
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DOI：
10.1053/j.gastro.2018.05.025
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发表时间：
2018-09-01
期刊：
影响因子：
29.4
通讯作者：
Hassanein, Tarek
中科院分区：
文献类型：
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作者：
Terrault, Norah;Chen, Yi-Cheng;Hassanein, Tarek
背景与目的：患有血小板减少症和慢性肝病 (CLD) 的患者可能需要在预定手术前输注血小板，以降低出血风险。我们对接受预定手术的血小板减少症和慢性肺病患者进行了 2 项随机、安慰剂对照的 3 期试验，以评估 avatrombopag 在增加该患者群体血小板计数方面的安全性和有效性。方法：在 ADAPT-1 和 ADAPT-2 研究中，患有血小板减少症和 CLD 的成人（分别为 n = 231 和 n = 204）根据其基线血小板计数（低于 40 x 10(9)/L 或 40 至低于 50 x 10(9)/L）被分入 2 个队列中的 1 个，并且在每个队列中被随机 (2:1) 接受 5 剂每日剂量的avatrombopag（如果基线血小板计数低于 40 x 10(9)/L，则为 60 mg；如果基线血小板计数低于 40 至低于 50 x 10(9)/L，则为 40 mg）或安慰剂。 ADAPT-1 于 2014 年 2 月至 2017 年 1 月在 20 个国家的 75 个研究中心进行，ADAPT-2 于 2013 年 12 月至 2017 年 1 月在 16 个国家的 74 个研究中心进行。主要终点是在预定手术后 7 天内不需要血小板输注或出血抢救手术的患者比例。结果：在 ADAPT-1 研究中，接受 60 mg avatrombopag 治疗的患者和接受 40 mg avatrombopag 治疗的患者中有 65.6% 和 88.1% 的患者达到主要终点，而接受安慰剂的患者分别为 22.9% 和 38.2%（P
BACKGROUND & AIMS: Patients with thrombocytopenia and chronic liver disease (CLD) may require platelet transfusions before scheduled procedures to decrease risk of bleeding. We performed 2 randomized, placebo-controlled, phase 3 trials in patients with thrombocytopenia and CLD undergoing scheduled procedures to evaluate the safety and efficacy of avatrombopag in increasing platelet counts in this patient population. METHODS: In the ADAPT-1 and ADAPT-2 studies, adults with thrombocytopenia and CLD (n = 231 and n = 204, respectively) were in 1 of 2 cohorts according to their baseline platelet count (below 40 x 10(9)/L or 40 to below 50 x 10(9)/L) and within each cohort were randomized (2:1) to receive 5 daily doses of avatrombopag (60 mg if baseline platelet count below 40 x 10(9)/L or 40 mg if 40 to below 50 x 10(9)/L) or placebo. ADAPT-1 was conducted at 75 study sites in 20 countries, from February 2014 through January 2017, and ADAPT-2 was conducted at 74 sites in 16 countries, from December 2013 through January 2017. The primary endpoint was the proportion of patients not requiring platelet transfusions or rescue procedures for bleeding up to 7 days after a scheduled procedure. RESULTS: In the ADAPT-1 study, 65.6% of patients who received 60 mg avatrombopag and 88.1% of patients who received 40 mg avatrombopag met the primary endpoint compared with 22.9% and 38.2% of patients receiving placebo, respectively (P