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Investigation on Dabigatran Etexilate and Worsening of Renal Function in Patients with Atrial fibrillation: The IDEA Study

  • Mauro MolteniEmail author
  • Matteo Crippa
  • Annalisa Orenti
  • Hernan Polo Friz
  • Anna Menghini
  • Pierluigi Tramacere
  • Giuseppe Marano
  • Claudio Cimminiello
  • Patrizia Boracchi
Original Research Article
  • 64 Downloads

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.

Notes

Acknowledgements

We are grateful to Dr. Maria Cristina Straface and Giuseppina Caiazzo for laboratory measurements, and to the nurses of the medical ward “Tulipano Rosso” of Vimercate Hospital, for harvesting blood samples.

Author Contributions

CC, MM, HPF and MC drafted the design of the trial and the planning of the analyses. PB, GM and AO performed the statistical analyses. PT and MC performed the laboratory analysis. All the other authors enrolled patients and led the clinical follow-up. CC, MM and MC wrote the first draft of the manuscript, and all the authors participated in subsequent revisions and approved the final version of the manuscript.

Compliance with Ethical Standards

Funding

This research did not receive any specific grants from funding agencies in the public, commercial or not-for-profit sectors.

Conflict of interest

Dr. Mauro Molteni has received consultancy, lectures and research fees from Bayer, BMS/Pfizer, Boehringer Ingelheim, Daiichi Sankyo, Novartis, Portola and Sanofi. Dr. Matteo Crippa has no conflicts of interest to disclose. Dr. Annalisa Orenti has no conflicts of interest to disclose. Dr. Polo Friz has received personal fees for collaborations as a medical writer, consultant, sponsored conferences and lectures by Sanofi, Bayer, Daiichi Sankyo, Pfizer, Boehringer Ingelheim, Health and Life, Clinical Forum, Xcape Srl, McCann Complete Medical Srl, IMSHealth London. Dr. Anna Menghini has no conflicts of interest to disclose. Dr. Pierluigi Tramacere has no conflicts of interest to disclose. Dr. Giuseppe Marano has no conflicts of interest to disclose. Dr. Patrizia Boracchi has no conflicts of interest to disclose. Dr. Claudio Cimminiello has received consultancy/lectures fees from Bayer, BMS/Pfizer, Boehringer Ingelheim, Sanofi, and MSD.

Ethical approval

The local Ethics Committee approved the study.

Informed consent

All patients provided written informed consent.

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Mauro Molteni
    • 1
    Email author
  • Matteo Crippa
    • 2
  • Annalisa Orenti
    • 3
  • Hernan Polo Friz
    • 2
    • 5
  • Anna Menghini
    • 2
  • Pierluigi Tramacere
    • 4
  • Giuseppe Marano
    • 3
  • Claudio Cimminiello
    • 5
  • Patrizia Boracchi
    • 3
  1. 1.UOC Cure SubacuteIRCCS, Istituti Clinici Scientifici MaugeriMilanItaly
  2. 2.Internal MedicineVimercate Hospital, A.S.S.T. di VimercateVimercateItaly
  3. 3.Department of Clinical Sciences and Community Health, Laboratory of Medical Statistics, Epidemiology, and Biometry G. A. MaccacaroUniversity of MilanMilanItaly
  4. 4.Clinical PathologyVimercate Hospital, A.S.S.T. di VimercateVimercateItaly
  5. 5.Studies and Research Office of Italian Society of Angiology and Vascular Pathology (SIAPAV)MilanItaly

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