UOC Cure Subacute, IRCCS, Istituti Clinici Scientifici Maugeri, via Camaldoli 64, 20138, Milan, Italy.
Internal Medicine, Vimercate Hospital, A.S.S.T. di Vimercate, via Santi Cosma e Damiano 10, 20871, Vimercate, MB, Italy.
Clin Drug Investig. 2019 Apr;39(4):355-362. doi: 10.1007/s40261-018-0742-1.
Warfarin-related nephropathy is an unexplained acute kidney injury, and may occur in patients with supratherapeutic INR, in the absence of overt bleeding. Similar findings have been observed in rats treated with dabigatran etexilate. We conducted a prospective study in dabigatran etexilate-treated patients to assess the incidence of dabigatran-related nephropathy and to investigate the possible correlation between dabigatran plasma concentration (DPC) and worsening renal function.
One hundred and seven patients treated long term with dabigatran etexilate for non-valvular atrial fibrillation (NVAF) were followed up for 90 days. DPC, serum creatinine (SCr) and serum cystatin C were prospectively measured. Ninety five patients had complete follow-up data and were evaluable for primary endpoint.
Eleven patients had supratherapeutic DPC, defined as DPC higher than 200 ng/ml at study enrolment, but at the end of follow-up no patient showed a persistent increase in SCr. No patients experienced acute kidney injury.
Our study shows that no persistent renal detrimental effect is associated with dabigatran treatment. An increase in SCr during dabigatran treatment is reversible and it seems to be unrelated to dabigatran itself.
华法林相关性肾病是一种不明原因的急性肾损伤，可能发生在 INR 高于治疗范围但无明显出血的患者中。在接受达比加群酯治疗的大鼠中也观察到了类似的发现。我们进行了一项前瞻性研究，以评估达比加群酯治疗患者中达比加群相关性肾病的发生率，并探讨达比加群血浆浓度（DPC）与肾功能恶化之间的可能相关性。
107 例非瓣膜性心房颤动（NVAF）患者长期接受达比加群酯治疗，随访 90 天。前瞻性测量达比加群酯血浆浓度（DPC）、血清肌酐（SCr）和血清胱抑素 C。95 例患者有完整的随访数据，可用于评估主要终点。
11 例患者的达比加群酯 DPC 高于 200ng/ml，定义为研究入组时 DPC 高于 200ng/ml，但在随访结束时，没有患者的 SCr 持续升高。没有患者发生急性肾损伤。
我们的研究表明，达比加群酯治疗与持续性肾损害无关。达比加群酯治疗期间 SCr 的升高是可逆的，似乎与达比加群酯本身无关。
Zotero 插件