Abstract: FR-PO221
Incidence, Characteristics, and Preventability of Adverse Drug Reactions in Patients With Moderate-to-Advanced CKD
Session Information
- Pharmacology
November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Pharmacology (PharmacoKinetics‚ -Dynamics‚ -Genomics)
- 1900 Pharmacology (PharmacoKinetics‚ -Dynamics‚ -Genomics)
Authors
- Laville, Solene M., Centre Hospitalier Universitaire Amiens-Picardie, Amiens, Hauts-de-France, France
- Gras, Valérie, Centre Hospitalier Universitaire Amiens-Picardie, Amiens, Hauts-de-France, France
- Moragny, Julien, Centre Hospitalier Universitaire Amiens-Picardie, Amiens, Hauts-de-France, France
- Jacquelinet, Christian, Agence de la biomedecine, La Plaine Saint-Denis, France
- Combe, Christian, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, Aquitaine, France
- Fouque, Denis, Claude Bernard University Lyon 1, CarMeN Inserm, Lyon, Auvergne-Rhône-Alpes , France
- Laville, Maurice, Claude Bernard University Lyon 1, CarMeN Inserm, Lyon, Auvergne-Rhône-Alpes , France
- Ayav, Carole, Clinical epidemiology, Inserm CIC-EC, Nancy University hospital, Vandoeuvre-lès-Nancy, France
- Alencar de Pinho, Natalia, Centre de Recherche en Epidemiologie et Sante des Populations, Villejuif, Île-de-France, France
- Bieber, Brian, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
- Stengel, Benedicte, Centre de Recherche en Epidemiologie et Sante des Populations, Villejuif, Île-de-France, France
- Massy, Ziad, Ambroise Paré University Hospital, APHP, Boulogne-Billancourt, Ile-De-France, France
- Liabeuf, Sophie, Centre Hospitalier Universitaire Amiens-Picardie, Amiens, Hauts-de-France, France
Group or Team Name
- CKD-REIN study Collaborators
Background
Although adverse drug reactions (ADRs) are recognized as a major problem in the CKD population, few studies have comprehensively investigated ADRs –serious or not– in this population. Our aims were to estimate the incidence of these events according to estimated glomerular filtration rate (eGFR), describe serious ADRs and determine whether they are preventable.
Methods
CKD-REIN is a prospective cohort of 3033 nephrology outpatients with a confirmed diagnosis of CKD and an eGFR < 60mL/min/1.73m2. ADRs were prospectively identified from hospitalization and medical reports and participant interviews. Experts in pharmacology assessed causality and preventability using validated tools.
Results
At baseline, patients’ median age was 69, mean eGFR was 33mL/min/1.73m2, and the median number of medications per day was 8. During a median follow-up of 4.6 years, 1672 ADRs (among which 488 were serious) occurred in 973 patients, of whom 42% had more than one ADR (incidence rate: all ADRs, 14.2[13.6-14.9] per 100 person-years (PA); serious ADRs, 4.2[3.8-4.5] per 100 PA). Among all ADRs, renal and urinary disorders (n=310), gastrointestinal disorders (n=253) and hemorrhages (n=213) were the most common.
The incidence rate of serious ADRs in patients with an eGFR <30 was twice as high as in patients with an eGFR ≥ 30mL/min/1.73m2 (6.0[5.2;6.7] vs 3.1[2.7;3.5] per 100 PA). This difference was mainly driven by bleeding events imputed to antithrombotics.
Among 488 serious ADRs, 65% were the cause of hospitalization, 31% occurred during hospitalization and 4% were serious but did not require hospitalization. More than 27% of serious ADRs were preventable or potentially preventable (n=132). The most important preventability criterion was inappropriately high dosage (n=28) and contraindications (n=35) according to the patient's kidney function. Patients were implicated in 22 preventable cases because of medication error (n=14), self-medication (n=6), and other (n=2).
Conclusion
ADRs are common in patients with CKD and are a major cause of hospitalization. Many adverse effects are preventable, suggesting the need for better dissemination of guidelines on drug management in patients with CKD.