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Original ArticlesChronic Kidney Disease
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Adverse Drug Reactions in Patients with CKD

Solène M. Laville, Valérie Gras-Champel, Julien Moragny, Marie Metzger, Christian Jacquelinet, Christian Combe, Denis Fouque, Maurice Laville, Luc Frimat, Bruce M. Robinson, Bénédicte Stengel, Ziad A. Massy, Sophie Liabeuf and on behalf of the Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) Study Group
CJASN August 2020, 15 (8) 1090-1102; DOI: https://doi.org/10.2215/CJN.01030120
Solène M. Laville
1Paris-Saclay University, Versailles Saint-Quentin-en-Yvelines University, National Institute of Health and Medical Research, Center for research in Epidemiology and Population Health (CESP), Clinical Epidemiology Team, Villejuif, France
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Valérie Gras-Champel
2Department of Clinical Pharmacology, Amiens University Hospital, Amiens, France
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Julien Moragny
2Department of Clinical Pharmacology, Amiens University Hospital, Amiens, France
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Marie Metzger
1Paris-Saclay University, Versailles Saint-Quentin-en-Yvelines University, National Institute of Health and Medical Research, Center for research in Epidemiology and Population Health (CESP), Clinical Epidemiology Team, Villejuif, France
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Christian Jacquelinet
1Paris-Saclay University, Versailles Saint-Quentin-en-Yvelines University, National Institute of Health and Medical Research, Center for research in Epidemiology and Population Health (CESP), Clinical Epidemiology Team, Villejuif, France
3Renal Epidemiology and Information Network Registry, Biomedicine Agency, Saint Denis, France
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Christian Combe
4Department of Nephrology Transplantation Dialysis, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France
5Inserm Unit 1026, University of Bordeaux Segalen, Bordeaux, France
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Denis Fouque
6Nephrology Department, Centre Hospitalier Lyon Sud, Université de Lyon, Carmen, Pierre-Bénite, France
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Maurice Laville
6Nephrology Department, Centre Hospitalier Lyon Sud, Université de Lyon, Carmen, Pierre-Bénite, France
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Luc Frimat
7Nephrology Department, Centre Hospitalier Régional Universitaire de Nancy, Vandoeuvre-lès-Nancy, France
8Lorraine University, APEMAC, Vandoeuvre-lès-Nancy, France
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Bruce M. Robinson
9Arbor Research Collaborative for Health, Ann Arbor, Michigan
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Bénédicte Stengel
1Paris-Saclay University, Versailles Saint-Quentin-en-Yvelines University, National Institute of Health and Medical Research, Center for research in Epidemiology and Population Health (CESP), Clinical Epidemiology Team, Villejuif, France
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Ziad A. Massy
1Paris-Saclay University, Versailles Saint-Quentin-en-Yvelines University, National Institute of Health and Medical Research, Center for research in Epidemiology and Population Health (CESP), Clinical Epidemiology Team, Villejuif, France
10Division of Nephrology, Ambroise Paré University Hospital, Assistance publique – Hôpitaux de Paris, Boulogne-Billancourt/Paris, France
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Sophie Liabeuf
2Department of Clinical Pharmacology, Amiens University Hospital, Amiens, France
11MP3CV Laboratory, EA7517, University of Picardie Jules Verne, Amiens, France
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Abstract

Background and objectives Little is known about the burden of adverse drug reactions in CKD. We estimated the incidence of overall and serious adverse drug reactions and assessed the probability of causation, preventability, and factors associated with adverse drug reactions in patients seen by nephrologists.

Design, setting, participants, & measurements The Chronic Kidney Disease-Renal Epidemiology and Information Network cohort included 3033 outpatients (65% men) with CKD and eGFR<60 ml/min per 1.73 m2, with follow-up for 2 years. Adverse drug reactions were identified from hospitalization reports, medical records, and participant interviews and finally assessed for causality, preventability, and immediate therapeutic management by experts in pharmacology.

Results Median (interquartile range) age was 69 (60–76) years old; 55% had eGFR≥30 ml/min per 1.73 m2, and 45% had eGFR<30 ml/min per 1.73 m2. Participants were prescribed a median (range) of eight (five to ten) drugs. Over 2 years, 536 patients had 751 adverse drug reactions, 150 (in 125 participants) classified as serious, for rates of 14.4 (95% confidence interval, 12.6 to 16.5) and 2.7 (95% confidence interval, 1.7 to 4.3) per 100 person-years, respectively. Among the serious adverse drug reactions, 32% were considered preventable or potentially preventable; 16 caused death, directly or indirectly. Renin-angiotensin system inhibitors (15%), antithrombotic agents (14%), and diuretics (10%) were the drugs to which the most adverse drug reactions were imputed, but antithrombotic agents caused 34% of serious adverse drug reactions. The drug was discontinued in 71% of cases, at least temporarily. Adjusted hazard ratios for serious adverse drug reaction were significantly higher in patients with eGFR<30 versus ≥30 ml/min per 1.73 m2 (1.8; 95% confidence interval, 1.3 to 2.6), in those prescribed more than ten versus less than five medications (2.4; 95% confidence interval, 1.1 to 5.2), or in those with poor versus good adherence (1.6; 95% confidence interval, 1.4 to 2.4).

Conclusions Adverse drug reactions are common and sometimes serious in patients with CKD. Many serious adverse drug reactions may be preventable. Some specific pharmacologic classes, particularly antithrombotic agents, are at risk of serious adverse drug reactions.

Clinical Trial registry name and registration number Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN), NCT03381950

  • chronic kidney disease
  • pharmacoepidemiology
  • antithrombotic agents
  • adverse drug reactions
  • risk factors
  • diuretics
  • Renin-Angiotensin System
  • glomerular filtration rate
  • Cohort Studies
  • Renal Insufficiency
  • Chronic
  • Drug-Related Side Effects and Adverse Reactions
  • hospitalization
  • Medical Records
  • Received January 24, 2019.
  • Accepted May 13, 2020.
  • Copyright © 2020 by the American Society of Nephrology
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Clinical Journal of the American Society of Nephrology: 15 (8)
Clinical Journal of the American Society of Nephrology
Vol. 15, Issue 8
August 07, 2020
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Adverse Drug Reactions in Patients with CKD
Solène M. Laville, Valérie Gras-Champel, Julien Moragny, Marie Metzger, Christian Jacquelinet, Christian Combe, Denis Fouque, Maurice Laville, Luc Frimat, Bruce M. Robinson, Bénédicte Stengel, Ziad A. Massy, Sophie Liabeuf, on behalf of the Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) Study Group
CJASN Aug 2020, 15 (8) 1090-1102; DOI: 10.2215/CJN.01030120

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Adverse Drug Reactions in Patients with CKD
Solène M. Laville, Valérie Gras-Champel, Julien Moragny, Marie Metzger, Christian Jacquelinet, Christian Combe, Denis Fouque, Maurice Laville, Luc Frimat, Bruce M. Robinson, Bénédicte Stengel, Ziad A. Massy, Sophie Liabeuf, on behalf of the Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) Study Group
CJASN Aug 2020, 15 (8) 1090-1102; DOI: 10.2215/CJN.01030120
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Keywords

  • chronic kidney disease
  • pharmacoepidemiology
  • antithrombotic agents
  • adverse drug reactions
  • risk factors
  • diuretics
  • Renin-Angiotensin System
  • glomerular filtration rate
  • Cohort Studies
  • Renal Insufficiency
  • Chronic
  • Drug-Related Side Effects and Adverse Reactions
  • hospitalization
  • Medical Records

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