Department of Clinical Pharmacy, Firoozgar Clinical Research Development Center (FCRDC), Iran University of Medical Sciences, Tehran, Iran.
School of Pharmacy-International Campus, Iran University of Medical Sciences, Tehran, Iran.
J Clin Pharmacol. 2022 Nov;62(11):1379-1384. doi: 10.1002/jcph.2096. Epub 2022 Jun 25.
Heparin-induced thrombocytopenia (HIT) is a serious adverse drug reaction due to its related risk of life- and limb-threatening thrombosis. Apixaban is a direct factor Xa inhibitor that may be intended as an ideal alternative for the management of HIT. In this open-label, single-arm, pilot intervention study, the efficacy and safety of apixaban were evaluated in 30 patients aged >18 years with clinically suspected HIT (4Ts score ≥4 points). Patients with mechanical heart valves, chronic kidney disease, hepatic impairment, and active bleeding were excluded. In all patients with inclusion criteria, heparin or enoxaparin was discontinued and apixaban was started. The dose of apixaban for HIT suspected patients was defined on the basis of the reason for anticoagulant therapy. End points included confirmed thrombosis, mortality, and adverse treatment-related events. After apixaban therapy, platelet counts normalized in all patients; none of the 30 subjects developed new, progressive, or recurrent thrombosis; and only 1 of 30 patients developed a hemorrhagic event. Five patients (16.7%) died, but the reason for death was not linked to thrombosis, hemorrhage, or adverse effects of apixaban. Along with the available emerging data, our results propose that apixaban could be a safe and effective drug for the management of suspected HIT in clinically stable patients.
肝素诱导的血小板减少症(HIT)是一种严重的药物不良反应,因为它有导致生命和肢体受到威胁的血栓形成风险。阿哌沙班是一种直接的 Xa 因子抑制剂,可能是治疗 HIT 的理想替代药物。在这项开放性、单臂、初步干预研究中,对 30 名年龄>18 岁、有临床疑似 HIT(4Ts 评分≥4 分)的患者评估了阿哌沙班的疗效和安全性。患有机械性心脏瓣膜病、慢性肾脏病、肝损伤和有活动性出血的患者被排除在外。在所有符合纳入标准的患者中,停止使用肝素或依诺肝素,并开始使用阿哌沙班。疑似 HIT 患者的阿哌沙班剂量是根据抗凝治疗的原因来确定的。终点包括确诊的血栓形成、死亡率和不良治疗相关事件。在阿哌沙班治疗后,所有患者的血小板计数均恢复正常;30 名受试者中无一例发生新的、进行性或复发性血栓形成;仅有 1 例发生出血事件。5 名患者(16.7%)死亡,但死亡原因与血栓形成、出血或阿哌沙班的不良反应无关。结合现有的新出现的数据,我们的结果表明,阿哌沙班可能是一种安全有效的药物,可用于治疗临床稳定的疑似 HIT 患者。