Exposure to inhibitors of the renin–angiotensin system is a major independent risk factor for acute renal failure induced by sucrose-containing intravenous immunoglobulins: a case–control study

Authors

  • Guillaume Moulis,

    Corresponding author
    • U1027 INSERM Pharmacoepidemiology Unit, Department of Clinical Pharmacology Centre Régional Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur les Médicaments, Toulouse University Hospital, University of Toulouse, Toulouse, France
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  • Laurent Sailler,

    1. U1027 INSERM Pharmacoepidemiology Unit, Department of Clinical Pharmacology Centre Régional Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur les Médicaments, Toulouse University Hospital, University of Toulouse, Toulouse, France
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  • Agnès Sommet,

    1. U1027 INSERM Pharmacoepidemiology Unit, Department of Clinical Pharmacology Centre Régional Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur les Médicaments, Toulouse University Hospital, University of Toulouse, Toulouse, France
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  • Maryse Lapeyre-Mestre,

    1. U1027 INSERM Pharmacoepidemiology Unit, Department of Clinical Pharmacology Centre Régional Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur les Médicaments, Toulouse University Hospital, University of Toulouse, Toulouse, France
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  • Jean-Louis Montastruc,

    1. U1027 INSERM Pharmacoepidemiology Unit, Department of Clinical Pharmacology Centre Régional Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur les Médicaments, Toulouse University Hospital, University of Toulouse, Toulouse, France
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  • the French Association of Regional Pharmacovigilance Centers

    1. U1027 INSERM Pharmacoepidemiology Unit, Department of Clinical Pharmacology Centre Régional Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur les Médicaments, Toulouse University Hospital, University of Toulouse, Toulouse, France
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G. Moulis, Service de Pharmacologie Clinique, Faculté de Médecine, 37 Allées Jules-Guesde, 31000 Toulouse, France.

E-mail: gmoulis@hotmail.com

ABSTRACT

Purpose

Risk factors for intravenous immunoglobulin-induced renal failure (IVIg-RF) were suspected from case series studies. This study was aimed at quantifying the risk of IVIg-RF associated with exposure to drugs that modify intrarenal hemodynamics.

Methods

We conducted a case–control study in the French Pharmacovigilance Database (FPVD). Adult IVIg-RF cases registered in the FPVD from 1996 to 2009 were reviewed. Controls were patients included in the FPVD for another IVIg adverse effect. Controls were matched for sucrose content of the preparation, year of adverse event and age. The predictors of IVIg-RF were exposure to angiotensin-converting enzyme inhibitors (ACE-I), angiotensin receptor antagonists (ARA), diuretics, age, gender and weight, IVIg delivered dose and infusion duration, chronic kidney disease, hypertension and diabetes mellitus. Acute IVIg-RF was defined as a calculated creatinine clearance less than 60 mL/min and, in the event of chronic kidney disease, (i) a more than 50% increase of serum creatinine, (ii) an indication of oligo-anuria or (iii) a requirement for dialysis.

Results

We selected 71 cases and 71 controls. Forty-nine percent of the cases required transient hemodialysis. In the final multivariate model, exposure to ACE-I and/or ARA was the sole independent predictor associated with IVIg-RF (OR = 7.9, 95%CI = 1.3–49.2). There was an interaction between ‘diabetes mellitus’ (OR = 7.7, 95%CI = 2.3–25.5) and ‘chronic kidney disease’ (OR = 13.0, 95%CI = 3.1–54.7), both being strong risk factors in univariate models (p < 0.001). Chronic hypertension was a risk factor for hemodialysis.

Conclusions

Temporary interruption of ACE-I and ARA may be considered at the time of IVIg infusion. Copyright © 2011 John Wiley & Sons, Ltd.

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