The comparative safety of various intravenous iron preparations in chronic kidney disease patients.
The relative safety of parenteral iron preparations is a controversial issue in the management of anemia in chronic kidney disease (CKD), as direct head-to-head comparative trials are lacking. In this study, patients of CKD were randomized to receive intravenous low molecular weight iron dextran (ID), sodium ferrigluconate complex (SFGC), and iron sucrose (IS) at doses and infusion rates recommended by the product manufacturer. One time test dose was used only for ID and SFGC. A total of 2,980 injections (n = 339) of i.v. iron was given, and 49 patients (14.45% per patient) and a total of 56 adverse events (1.88% per infusion) were noted. Odds ratios (OR) of serious adverse drug events (ADE; i.e., death, anaphylaxis, or suspected immuno-allergic events) per patient was not significant between ID vs. SFGC (3.566) and SFGC vs. IS (2.129), whereas that between ID vs. IS (7.594) was highly significant (p = 0.034). OR of serious ADE exposure was significantly higher in ID vs. SFGC (OR = 5.670, p = 0.0147) and ID vs. IS (OR = 7.799, p < 0.001). No significant difference was seen between the three groups in terms of non-serious ADEs. Drug discontinuation occurred significantly more often with ID. One patient who developed anaphylactoid reaction with SFGC and ID tolerated iron sucrose well.
Anirban
Ganguli
G
Department of Nephrology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Kohli
H S
HS
Jha
Vivekanand
V
Gupta
K L
KL
Sakhuja
Vinay
V
D000328:Adult; D000367:Age Factors; D000704:Analysis of Variance; D018798:Anemia, Iron-Deficiency / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage / Q000009:adverse effects*; D000077605:Ferric Oxide, Saccharated; D005500:Follow-Up Studies; D005937:Glucaric Acid; D006801:Humans; D007262:Infusions, Intravenous; D007505:Iron-Dextran Complex / Q000008:administration & dosage / Q000009:adverse effects*; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011336:Probability; D006435:Renal Dialysis / Q000009:adverse effects / Q000379:methods; D018570:Risk Assessment; D012720:Severity of Illness Index; D012737:Sex Factors; D016896:Treatment Outcome
D005290:Ferric Compounds; D007505:Iron-Dextran Complex; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid; C035552:ferric gluconate