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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
Author(s) -
Moulis Guillaume,
Sailler Laurent,
Sommet Agnès,
LapeyreMestre Maryse,
Montastruc JeanLouis
Publication year - 2012
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.2253
Subject(s) - medicine , kidney disease , diabetes mellitus , renal function , dialysis , adverse effect , creatinine , hemodialysis , ace inhibitor , univariate analysis , angiotensin converting enzyme , gastroenterology , endocrinology , multivariate analysis , blood pressure
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.