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Kidney Week

Abstract: FR-PO195

The Burden of Adverse Drug Events in Patients with Moderate or Advanced CKD: The CKD-REIN Study

Session Information

Category: CKD (Non-Dialysis)

  • 1902 CKD (Non-Dialysis): Clinical, Outcomes, and Trials


  • Laville, Solene M., CESP U1018, INSERM, Villejuif, France
  • Metzger, Marie, CESP U1018, INSERM, Villejuif, France
  • Stengel, Benedicte, CESP U1018, INSERM, Villejuif, France
  • Jacquelinet, Christian, Agence de la biomedecine, Saint-Denis La Plaine, France
  • Laville, Maurice, Université de Lyon, Pierre-Bénite, France
  • Frimat, Luc, Nancy University Hospital, Vandoeuvre les Nancy, France
  • Fouque, Denis, University Claude Bernard, Pierre Benite, France
  • Combe, Christian, CHU de Bordeaux, Bordeaux, France
  • Gras, Valérie, CHU Amiens, Amiens, France
  • Pisoni, Ronald L., Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
  • Massy, Ziad, Ambroise Pare University Hospital and Inserm U1018 Eq5, Boulogne Billancourt/ Paris cedex, France
  • Liabeuf, Sophie, CHU Amiens, Amiens, France

Little is known about the burden of adverse drug events (ADEs) in chronic kidney disease (CKD). We assess the incidence rate of ADEs and describe the suspected prescribed drugs associated with the main reported ADEs in the CKD-REIN cohort.


The CKD-REIN study includes 3033 outpatients (65% men) with CKD (estimated glomerular filtration rate (eGFR) <60mL/min/1.73m2). ADEs were identified from medical records, hospital discharge reports, or patient interviews. All reported ADEs were reviewed by pharmacist experts who coded the type of events and the associated suspected drugs. Incidence rates were estimated by Poisson regression, overall and by patient characteristics.


At baseline, patients' median age was 69(IQR, 60-76), median eGFR was 32(IQR, 23-41)mL/min/1.73m2 and the median number of medications was 8 per day. During a median follow-up of 2.3 years, 777 ADEs were reported in 545 patients, 27% of whom had at least two. The overall incidence rate of ADEs was 10.7[95%CI, 9.9-11.4] per 100 person years, with significantly higher rates in women than men, and in patients with diabetes, lower eGFR, cardiovascular history and with a higher number of medications at baseline; it did not differ significantly according to age. Renin-angiotensin system inhibitors (RASi) (15%), antithrombotic agents (13%) and diuretics (9%) were the drug classes most frequently associated with ADEs. As expected, main ADEs were increased serum creatinine and hypotension with RASi and diuretics, hemorrhage with antithrombotic agents, and cough with RASi. Of note, 71% of ADEs led to discontinuing treatment and 16% to modifying treatment dose.
Among the 777 evaluated ADEs, 161 (21%) were reported among inpatients, either as a cause of hospitalization or an incident event, 2.2[95%CI, 1.9-2.6] per 100 person years, four of which were linked with death. The drugs most frequently involved in ADEs associated with hospitalization or death, were vitamin K antagonists (n=39) and heparin (n=7).


The burden of ADEs is high in patients with CKD and led to discontinuing drugs prescribed to slow CKD progression and reduce cardiovascular complications. The impact of ADEs and resulting prescription changes on CKD outcomes need to be evaluated.


  • Government Support - Non-U.S.