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Hemostatic challenges in patients with chronic immune thrombocytopenia treated with eltrombopag

机译：Eltrombopag治疗的慢性免疫性血小板减少症患者的止血挑战

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Chronic immune thrombocytopenia (ITP) is an autoimmune disease that results in chronically low platelet counts. Treatment guidelines recommend a platelet count of at least 50 000/μl before minor surgery and at least 80 000/μl before major surgery. This retrospective analysis explored invasive non-dental procedures associated with the risk of bleeding (hemostatic challenges) among patients with chronic ITP in five phase 2/phase 3 studies of the thrombopoietin-receptor agonist, eltrombopag. Data collection for patients who underwent hemostatic challenges included demographics, study medication, timing of the procedure, platelet counts at last assessment before and first assessment after the procedure, supplemental ITP treatment, and bleeding events. Among 494 patients who participated in the studies, 87 hemostatic challenges were recorded. Median platelet counts before 44 major procedures in 32 patients were 100 000/μl and 18 500/μl among patients who received eltrombopag and placebo, respectively; before 43 minor procedures in 38 patients, median platelet counts were 82 000/μl and 20 000/μl among patients who received eltrombopag and placebo, respectively. A minority of patients required supplemental ITP treatment. Only 2 of 87 hemostatic challenges were associated with bleeding events; both patients received eltrombopag and pre-procedural platelet counts were 83 000/μl and 2000/μl. Although the number of patients who did not undergo procedures due to thrombocytopenia was not captured, these data suggest a majority of patients with chronic ITP who receive eltrombopag and experience increases in platelet counts meet current pre-procedural platelet count recommendations. The potential role of eltrombopag in supporting preparation of chronic ITP patients for surgical procedures still needs to be clinically established.
机译：慢性免疫性血小板减少症（ITP）是一种自身免疫性疾病，可导致血小板计数长期降低。治疗指南建议小手术前血小板计数至少为50,000 /μl，大手术前血小板计数至少为80000 /μl。这项回顾性分析在血小板生成素受体激动剂Eltrombopag的5期2期/ 3期研究中探索了与慢性ITP患者出血风险（止血挑战）相关的侵入性非牙科程序。接受止血挑战的患者的数据收集包括人口统计学，研究药物，手术时机，手术前最后评估和手术后首次评估的血小板计数，补充ITP治疗以及出血事件。在参加该研究的494位患者中，记录了87次止血挑战。在接受Eltrombopag和安慰剂治疗的32位患者中，进行44次大手术之前的血小板中位计数分别为100 000 /μl和18500 /μl。在38位患者进行43次小手术之前，接受Eltrombopag和安慰剂治疗的患者的血小板中位数分别为82 000 /μl和20000 /μl。少数患者需要补充ITP治疗。 87个止血挑战中只有2个与出血事件相关;两名患者均接受了厄波莫帕格治疗，术前血小板计数分别为83 000 /μl和2000 /μl。尽管未捕获因血小板减少症而未接受手术的患者人数，但这些数据表明接受Eltrombopag治疗且血小板计数增加的大多数慢性ITP患者符合当前的术前血小板计数建议。 Eltrombopag在支持准备手术治疗的ITP慢性患者中的潜在作用仍然需要临床确定。

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