Contrast Media and Nephropathy: Findings From Systematic Analysis and Food and Drug Administration Reports of Adverse Effects.
Solomon, Richard MD *; DuMouchel, William PhD +
41(8):651-660, August 2006.
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Context: Recent studies suggest differences in the incidence of contrast-induced nephropathy (CIN) among contrast media (CM).
Objective: To determine whether there are significant differences among low-osmolality CM (LOCM) in the incidence of contrast-induced nephropathy (CIN), we reviewed published studies of CIN in renally impaired patients and conducted statistical data mining using databases of adverse events maintained by the U.S. Food and Drug Administration (FDA).
Data Sources: A systematic literature search was performed for prospective, controlled, English language studies published in peer-reviewed journals that reported CIN rates in renally impaired patients after a specific LOCM. Databases searched were EMBASE, MEDLINE, Biosis Previews, Derwent Drug File, Pascal, and SciScearch Cited Ref Sci. For the FDA analysis, we used the SRS and AERS databases.
Data Selection: Twenty-two studies reporting data in 3112 patients with renal impairment met the inclusion criteria. Most studies reported on the use of a pharmacologic intervention to prevent CIN. From the FDA databases, we evaluated 18 adverse event terms associated with renal injury or dysfunction after CM use.
Data Extraction: Data from 22 studies were entered into a database. A meta-regression analysis using a mixed effect model was performed. CM effect was adjusted by the following covariates: baseline patient characteristics (mean age, gender distribution) and risk factors (prevalence of diabetes mellitus, degree of renal impairment, CM volume), and the use of prophylactic drug treatments. Multiple disproportionality analyses (adjusted odds ratio, adjusted empirical Bayesian estimate, or Bayesian logistic regression) were performed on the FDA databases to estimate associations between 4 CM and 18 AE terms related to CIN.
Data Synthesis: Systematic analysis of clinical trials suggest the highest incidence of CIN occurs in patients receiving iohexol and the lowest incidence in patients receiving iopamidol, even when corrected for other CIN risk factors. Statistical data mining of FDA data also showed the highest association of CIN for iohexol and the lowest for iopamidol.
Conclusions: The risk of CIN was higher in patients receiving iohexol compared with patients receiving iopamidol. No significant differences were found comparing iohexol to other LOCMs, including iodixanol.
(C) 2006 Lippincott Williams & Wilkins, Inc.