Marchesini Francesca, Ossato Andrea, Zendrini Alberto, Arginelli Federica, Zuppini Teresa, Realdon Nicola, Zamperini Massimo, Tessari Roberto
IRCCS Ospedale Sacro Cuore Don Calabria, Negrar di Valpolicella, Italy.
University of Padova, Padova, Italy.
Hosp Pharm. 2022 Apr;57(2):241-245. doi: 10.1177/00185787211016335. Epub 2021 May 22.
Recently, the atrial fibrillation treatment guidelines have been updated to now recommend Non-vitamin K antagonist oral anticoagulants (NOACs) as the preferred alternative to warfarin for systemic embolism and stroke prevention in patients with non-valvular atrial fibrillation. NOACs have major pharmacologic advantages over warfarin, although the most common complications are gastrointestinal bleeding and NOAC-induced nephropathy within 6 weeks after starting therapy, as several recent case-reports stated. We are reporting for the first time a chronic delayed adverse reaction (regularly reported to Authorities) observed in an 82-year-old woman 27 months after starting dabigatran (110 mg twice a day), characterized by concomitant gastrointestinal bleeding and nephropathy. Idarucizumab administration immediately improved both bleeding and renal parameters. Moreover, we are going to highlight the importance of the compliance, the adherence to the therapeutic plan and the supervision of the Hospital Pharmacy on drug prescriptions. In fact in our case, dabigatran was firstly prescribed by the neurologist and delivered by the hospital pharmacy, but the patient continued the treatment for 27 months, prescribed by general practitioner without any laboratory control. This lack of supervision certainly contributed to the onset of the adverse reaction reported.
最近,房颤治疗指南已更新,现在推荐非维生素K拮抗剂口服抗凝药(NOACs)作为华法林的首选替代药物,用于预防非瓣膜性房颤患者的全身性栓塞和中风。尽管最近的几篇病例报告指出,NOACs最常见的并发症是胃肠道出血和开始治疗后6周内的NOAC引起的肾病,但与华法林相比,NOACs具有主要的药理学优势。我们首次报告了一名82岁女性在开始服用达比加群(110mg,每日两次)27个月后出现的慢性延迟不良反应(已定期向当局报告),其特征为同时出现胃肠道出血和肾病。使用艾达赛珠单抗后,出血和肾脏参数立即得到改善。此外,我们将强调依从性、坚持治疗计划以及医院药房对药物处方进行监管的重要性。事实上,在我们的病例中,达比加群最初由神经科医生开处方并由医院药房发放,但患者在没有任何实验室检查的情况下,由全科医生继续开出处方治疗了27个月。这种缺乏监管肯定促成了所报告的不良反应的发生。