Department of Pharmacy Practice, Lebanese American University, Byblos, Lebanon.
Department of Pharmacy, Huntsville Hospital, Huntsville, AL, USA.
Am J Cardiovasc Drugs. 2019 Feb;19(1):59-64. doi: 10.1007/s40256-018-0300-5.
Idarucizumab is used to reverse the effects of dabigatran. Information on the use of idarucizumab in the clinical setting remains very limited.
The objective of this study was to describe clinical experience with idarucizumab in a large medical teaching center in the USA.
Patients who received idarucizumab to reverse the effects of dabigatran between 1 January 2016 and 30 June 2018 were studied. In patients with major bleeding, the efficacy of idarucizumab was assessed using criteria of the International Society of Thrombosis and Hemostasis Scientific and Standardization Subcommittee. The course of treatment and clinical outcomes in patients who received idarucizumab for emergency surgery or procedures are described.
In total, 13 patients received idarucizumab for atrial fibrillation during the study period. Their mean age was 77.5 ± 7.1 years, and 12 (92.3%) were men. Idarucizumab was used in 11 patients for major bleeding events and in two patients for emergency surgery or procedures. Intracranial hemorrhage (n = 6) and gastrointestinal bleed (n = 2) were the most common types of bleeding. Clinical hemostasis was achieved in 8 of 11 (72.7%) patients with major bleeding. One patient with acute kidney injury needed two doses of the reversal agent to achieve hemostasis. One patient underwent open heart surgery and developed postoperative hemorrhage despite receiving idarucizumab. None of the patients experienced thrombotic complications or side effects that could be attributed to idarucizumab.
Real-world experience in a US hospital with the use of idarucizumab in emergency situations requiring the reversal of the effects of dabigatran is described. Idarucizumab represents an exciting new antidote for dabigatran, but clinical efficacy and cost-effectiveness data remain lacking.
依达鲁单抗用于逆转达比加群的作用。关于依达鲁单抗在临床环境中的使用信息仍然非常有限。
本研究的目的是描述美国一家大型医学教学中心使用依达鲁单抗的临床经验。
研究对象为 2016 年 1 月 1 日至 2018 年 6 月 30 日期间接受依达鲁单抗逆转达比加群作用的患者。在大出血的患者中，使用国际血栓和止血科学与标准化分会的标准评估依达鲁单抗的疗效。描述了因急诊手术或操作而接受依达鲁单抗治疗的患者的治疗过程和临床结局。
研究期间，共有 13 例房颤患者接受了依达鲁单抗治疗。他们的平均年龄为 77.5±7.1 岁，12 例（92.3%）为男性。11 例患者因大出血事件使用依达鲁单抗，2 例患者因急诊手术或操作而使用依达鲁单抗。颅内出血（n=6）和胃肠道出血（n=2）是最常见的出血类型。11 例大出血患者中有 8 例（72.7%）达到临床止血。1 例急性肾损伤患者需要使用两种剂量的逆转剂才能止血。1 例接受心脏直视手术的患者尽管使用了依达鲁单抗，但术后仍发生出血。没有患者发生与依达鲁单抗相关的血栓并发症或副作用。
描述了美国医院在需要逆转达比加群作用的紧急情况下使用依达鲁单抗的真实世界经验。依达鲁单抗是达比加群的一种令人兴奋的新型解毒剂，但仍缺乏临床疗效和成本效益数据。
