Indirect methods of comparison of the safety of ferric derisomaltose, iron sucrose and ferric carboxymaltose in the treatment of iron deficiency anemia.
Expert Rev Hematol
; 13(2): 187-195, 2020 02.
Article
de En
| MEDLINE
| ID: mdl-31928094
ABSTRACT
Objectives:
The benefits of intravenous (IV) iron greatly outweigh the risks, but IV iron formulations carry a small risk of hypersensitivity reactions (HSRs). The objective was to use standardized Medical Dictionary for Regulatory Activities queries (SMQs) to compare the safety of ferric derisomaltose/iron isomaltoside 1000 (FDI), iron sucrose (IS), and ferric carboxymaltose (FCM) using prospective trial data.Methods:
Prospective trials reporting the incidence of SMQ-coded serious or severe HSRs were identified in the literature. Four SMQs were used narrow hypersensitivity terms (A), and broad terms pertaining to potential respiratory HSRs (B), skin HSRs (C), and cardiovascular HSRs (D). Bayesian inference, naïve pooling, and adjusted indirect approaches were employed to compare HSR incidence.Results:
Twenty one prospective trials including over 8,000 patients receiving FDI, FCM or IS were retrieved. Odds ratios of any serious or severe HSR (all groups) with FDI relative to FCM were 0.41, 0.39, and 0.45 according to the Bayesian, naïve and adjusted approaches, respectively.Conclusions:
The risk of serious or severe HSRs was lower with FDI relative to FCM and IS. Using data from prospective trials including over 8,000 patients coded using a well-defined standard (SMQs) enabled a robust comparison of HSR incidence between the iron formulations.Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Composés du fer III
/
Anémie par carence en fer
/
Diholoside
/
Oxyde ferrique sucré
/
Maltose
Type d'étude:
Observational_studies
/
Risk_factors_studies
Limites:
Humans
Langue:
En
Journal:
Expert Rev Hematol
Sujet du journal:
HEMATOLOGIA
Année:
2020
Type de document:
Article
Pays d'affiliation:
Royaume-Uni