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Kidney Week

Abstract: FR-PO332

High Incidence of Adverse Drug Reactions in Patients with Advanced CKD

Session Information

Category: CKD (Non-Dialysis)

  • 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials


  • Laville, Solene M., CESP, Inserm U1018, Kidney and Heart Team, Villejuif, France
  • Metzger, Marie, CESP, Inserm U1018, Kidney and Heart Team, Villejuif, France
  • Stengel, Benedicte, CESP, Inserm U1018, Kidney and Heart Team, Villejuif, France
  • Jacquelinet, Christian, Agence de la biomedecine, Saint-Denis La Plaine, France
  • Laville, Maurice, University Claude Bernard, Pierre Benite, 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, Amiens University Hospital, Amiens, France
  • Moragny, Julien, Amiens University Hospital, Amiens, France
  • Massy, Ziad, Ambroise Pare University Hospital, Boulogne Billancourt/ Paris cedex, France
  • Liabeuf, Sophie, Amiens University Hospital, Amiens, France

Little is known about adverse drug reactions (ADRs) in chronic kidney disease (CKD). We assessed the incidence rate and type of ADRs by CKD stage.


The CKD-REIN study includes 3033 outpatients (65% men) with CKD (eGFR<60mL/min/1.73m2). ADRs were identified from medical records, hospital discharge reports, or patient interviews and adjudicated by pharmacist experts. A serious ADR is any event that is fatal, life-threatening, permanently/significantly disabling, requires or prolongs hospitalization or medically important. Determinants of first serious ADR-events were assessed by multivariate Cox regression model.


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 years, 751 ADRs were reported in 536 patients, of which 150 were serious. The incidence rate of ADRs in patients with CKD stage 4 or 5 was 19.5[95%CI,17.6;21.4] per 100 person years (PY), against 10.9[9.7;12.1] per 100 PY in patients with CKD stage 3. We observed the same pattern for serious ADR with an incidence rate respectively of 4.0[3.2;4.8] per 100 PY in the former group and 1.8[1.3;2.2] per 100 PY for the latter one.
Antithrombotics (34%), diuretics (12%) and renin-angiotensin system inhibitors (12%) represented the most frequent pharmacological classes associated with serious ADRs. Antithrombotics-linked serious ADRs were more common in patients with a low baseline eGFR (43% in CKD stages 4-5 vs. 20% in CKD stage 3). This marked difference between stages severity was not found for serious ADR related to diuretics or RAS inhibitors.
On 10 deaths directly or indirectly related to an antithrombotic-linked serious ADRs, 8 occurred in CKD stage 4 or 5 patients, and 2 in CKD stage 3 patients.
After adjusting for relevant covariates, hazard ratios for ADRs and for serious ADRs were significantly higher in patients with baseline eGFR < 30 vs. ≥30mL/min/1.73m2 (respectively 1.6[13;1.9], 1.8[1.25-2.62]).


The burden of ADRs is high in CKD patients. A low eGFR appears as a risk factor of undergoing ADRs and serious ADRs. When taking care to CKD patients, especially advanced stages, antithrombotic agents need to be used with caution.


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