Kidney Week

Abstract: FR-PO332

High Incidence of Adverse Drug Reactions in Patients with Advanced CKD

Session Information

• CKD: Clinical, Outcomes, Trials - II
  November 08, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

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

Authors

• Laville, Solene M., CESP, Inserm U1018, Kidney and Heart Team, Villejuif, France

Solene M. Laville,

• Metzger, Marie, CESP, Inserm U1018, Kidney and Heart Team, Villejuif, France

Marie Metzger,

• Stengel, Benedicte, CESP, Inserm U1018, Kidney and Heart Team, Villejuif, France

Benedicte Stengel,

• Jacquelinet, Christian, Agence de la biomedecine, Saint-Denis La Plaine, France

Christian Jacquelinet,

• Laville, Maurice, University Claude Bernard, Pierre Benite, France

Maurice Laville,

• Frimat, Luc, Nancy University Hospital, Vandoeuvre les Nancy, France

Luc Frimat,

• Fouque, Denis, University Claude Bernard, Pierre Benite, France

Denis Fouque,

• Combe, Christian, CHU de Bordeaux , Bordeaux, France

Christian Combe,

• Gras, Valérie, Amiens University Hospital, Amiens, France

Valérie Gras,

• Moragny, Julien, Amiens University Hospital, Amiens, France

Julien Moragny,

• Massy, Ziad, Ambroise Pare University Hospital, Boulogne Billancourt/ Paris cedex, France

Ziad Massy,

• Liabeuf, Sophie, Amiens University Hospital, Amiens, France

Sophie Liabeuf,

Background

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.

Methods

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.

Results

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]).

Conclusion

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.

Funding

• Commercial Support –