Mauro Molteni1, Matteo Crippa2, Annalisa Orenti3, Hernan Polo Friz2,4, Anna Menghini2, Pierluigi Tramacere5, Giuseppe Marano3, Claudio Cimminiello4, Patrizia Boracchi3. 1. UOC Cure Subacute, IRCCS, Istituti Clinici Scientifici Maugeri, via Camaldoli 64, 20138, Milan, Italy. mauro.molteni@icsmaugeri.it. 2. Internal Medicine, Vimercate Hospital, A.S.S.T. di Vimercate, via Santi Cosma e Damiano 10, 20871, Vimercate, MB, Italy. 3. Department of Clinical Sciences and Community Health, Laboratory of Medical Statistics, Epidemiology, and Biometry G. A. Maccacaro, University of Milan, via Vanzetti 5, 20133, Milan, Italy. 4. Studies and Research Office of Italian Society of Angiology and Vascular Pathology (SIAPAV), via Gorizia 22, 20144, Milan, Italy. 5. Clinical Pathology, Vimercate Hospital, A.S.S.T. di Vimercate, via Santi Cosma e Damiano 10, 20871, Vimercate, MB, Italy.
Abstract
BACKGROUND AND OBJECTIVES: 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. METHOD: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND AND OBJECTIVES: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. METHOD: 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. RESULTS: 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. CONCLUSIONS: 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.
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