Cargando…
Adverse events of iron and/or erythropoiesis-stimulating agent therapy in preoperatively anemic elective surgery patients: a systematic review
BACKGROUND: Iron supplementation and erythropoiesis-stimulating agent (ESA) administration represent the hallmark therapies in preoperative anemia treatment, as reflected in a set of evidence-based treatment recommendations made during the 2018 International Consensus Conference on Patient Blood Man...
Autores principales: | , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9578279/ https://www.ncbi.nlm.nih.gov/pubmed/36253838 http://dx.doi.org/10.1186/s13643-022-02081-5 |
_version_ | 1784811938760359936 |
---|---|
author | Laermans, Jorien Van Remoortel, Hans Avau, Bert Bekkering, Geertruida Georgsen, Jørgen Manzini, Paola Maria Meybohm, Patrick Ozier, Yves De Buck, Emmy Compernolle, Veerle Vandekerckhove, Philippe |
author_facet | Laermans, Jorien Van Remoortel, Hans Avau, Bert Bekkering, Geertruida Georgsen, Jørgen Manzini, Paola Maria Meybohm, Patrick Ozier, Yves De Buck, Emmy Compernolle, Veerle Vandekerckhove, Philippe |
author_sort | Laermans, Jorien |
collection | PubMed |
description | BACKGROUND: Iron supplementation and erythropoiesis-stimulating agent (ESA) administration represent the hallmark therapies in preoperative anemia treatment, as reflected in a set of evidence-based treatment recommendations made during the 2018 International Consensus Conference on Patient Blood Management. However, little is known about the safety of these therapies. This systematic review investigated the occurrence of adverse events (AEs) during or after treatment with iron and/or ESAs. METHODS: Five databases (The Cochrane Library, MEDLINE, Embase, Transfusion Evidence Library, Web of Science) and two trial registries (ClinicalTrials.gov, WHO ICTRP) were searched until 23 May 2022. Randomized controlled trials (RCTs), cohort, and case-control studies investigating any AE during or after iron and/or ESA administration in adult elective surgery patients with preoperative anemia were eligible for inclusion and judged using the Cochrane Risk of Bias tools. The GRADE approach was used to assess the overall certainty of evidence. RESULTS: Data from 26 RCTs and 16 cohort studies involving a total of 6062 patients were extracted, on 6 treatment comparisons: (1) intravenous (IV) versus oral iron, (2) IV iron versus usual care/no iron, (3) IV ferric carboxymaltose versus IV iron sucrose, (4) ESA+iron versus control (placebo and/or iron, no treatment), (5) ESA+IV iron versus ESA+oral iron, and (6) ESA+IV iron versus ESA+IV iron (different ESA dosing regimens). Most AE data concerned mortality/survival (n=24 studies), thromboembolic (n=22), infectious (n=20), cardiovascular (n=19) and gastrointestinal (n=14) AEs. Very low certainty evidence was assigned to all but one outcome category. This uncertainty results from both the low quantity and quality of AE data due to the high risk of bias caused by limitations in the study design, data collection, and reporting. CONCLUSIONS: It remains unclear if ESA and/or iron therapy is associated with AEs in preoperatively anemic elective surgery patients. Future trial investigators should pay more attention to the systematic collection, measurement, documentation, and reporting of AE data. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13643-022-02081-5. |
format | Online Article Text |
id | pubmed-9578279 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-95782792022-10-19 Adverse events of iron and/or erythropoiesis-stimulating agent therapy in preoperatively anemic elective surgery patients: a systematic review Laermans, Jorien Van Remoortel, Hans Avau, Bert Bekkering, Geertruida Georgsen, Jørgen Manzini, Paola Maria Meybohm, Patrick Ozier, Yves De Buck, Emmy Compernolle, Veerle Vandekerckhove, Philippe Syst Rev Research BACKGROUND: Iron supplementation and erythropoiesis-stimulating agent (ESA) administration represent the hallmark therapies in preoperative anemia treatment, as reflected in a set of evidence-based treatment recommendations made during the 2018 International Consensus Conference on Patient Blood Management. However, little is known about the safety of these therapies. This systematic review investigated the occurrence of adverse events (AEs) during or after treatment with iron and/or ESAs. METHODS: Five databases (The Cochrane Library, MEDLINE, Embase, Transfusion Evidence Library, Web of Science) and two trial registries (ClinicalTrials.gov, WHO ICTRP) were searched until 23 May 2022. Randomized controlled trials (RCTs), cohort, and case-control studies investigating any AE during or after iron and/or ESA administration in adult elective surgery patients with preoperative anemia were eligible for inclusion and judged using the Cochrane Risk of Bias tools. The GRADE approach was used to assess the overall certainty of evidence. RESULTS: Data from 26 RCTs and 16 cohort studies involving a total of 6062 patients were extracted, on 6 treatment comparisons: (1) intravenous (IV) versus oral iron, (2) IV iron versus usual care/no iron, (3) IV ferric carboxymaltose versus IV iron sucrose, (4) ESA+iron versus control (placebo and/or iron, no treatment), (5) ESA+IV iron versus ESA+oral iron, and (6) ESA+IV iron versus ESA+IV iron (different ESA dosing regimens). Most AE data concerned mortality/survival (n=24 studies), thromboembolic (n=22), infectious (n=20), cardiovascular (n=19) and gastrointestinal (n=14) AEs. Very low certainty evidence was assigned to all but one outcome category. This uncertainty results from both the low quantity and quality of AE data due to the high risk of bias caused by limitations in the study design, data collection, and reporting. CONCLUSIONS: It remains unclear if ESA and/or iron therapy is associated with AEs in preoperatively anemic elective surgery patients. Future trial investigators should pay more attention to the systematic collection, measurement, documentation, and reporting of AE data. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13643-022-02081-5. BioMed Central 2022-10-17 /pmc/articles/PMC9578279/ /pubmed/36253838 http://dx.doi.org/10.1186/s13643-022-02081-5 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Laermans, Jorien Van Remoortel, Hans Avau, Bert Bekkering, Geertruida Georgsen, Jørgen Manzini, Paola Maria Meybohm, Patrick Ozier, Yves De Buck, Emmy Compernolle, Veerle Vandekerckhove, Philippe Adverse events of iron and/or erythropoiesis-stimulating agent therapy in preoperatively anemic elective surgery patients: a systematic review |
title | Adverse events of iron and/or erythropoiesis-stimulating agent therapy in preoperatively anemic elective surgery patients: a systematic review |
title_full | Adverse events of iron and/or erythropoiesis-stimulating agent therapy in preoperatively anemic elective surgery patients: a systematic review |
title_fullStr | Adverse events of iron and/or erythropoiesis-stimulating agent therapy in preoperatively anemic elective surgery patients: a systematic review |
title_full_unstemmed | Adverse events of iron and/or erythropoiesis-stimulating agent therapy in preoperatively anemic elective surgery patients: a systematic review |
title_short | Adverse events of iron and/or erythropoiesis-stimulating agent therapy in preoperatively anemic elective surgery patients: a systematic review |
title_sort | adverse events of iron and/or erythropoiesis-stimulating agent therapy in preoperatively anemic elective surgery patients: a systematic review |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9578279/ https://www.ncbi.nlm.nih.gov/pubmed/36253838 http://dx.doi.org/10.1186/s13643-022-02081-5 |
work_keys_str_mv | AT laermansjorien adverseeventsofironandorerythropoiesisstimulatingagenttherapyinpreoperativelyanemicelectivesurgerypatientsasystematicreview AT vanremoortelhans adverseeventsofironandorerythropoiesisstimulatingagenttherapyinpreoperativelyanemicelectivesurgerypatientsasystematicreview AT avaubert adverseeventsofironandorerythropoiesisstimulatingagenttherapyinpreoperativelyanemicelectivesurgerypatientsasystematicreview AT bekkeringgeertruida adverseeventsofironandorerythropoiesisstimulatingagenttherapyinpreoperativelyanemicelectivesurgerypatientsasystematicreview AT georgsenjørgen adverseeventsofironandorerythropoiesisstimulatingagenttherapyinpreoperativelyanemicelectivesurgerypatientsasystematicreview AT manzinipaolamaria adverseeventsofironandorerythropoiesisstimulatingagenttherapyinpreoperativelyanemicelectivesurgerypatientsasystematicreview AT meybohmpatrick adverseeventsofironandorerythropoiesisstimulatingagenttherapyinpreoperativelyanemicelectivesurgerypatientsasystematicreview AT ozieryves adverseeventsofironandorerythropoiesisstimulatingagenttherapyinpreoperativelyanemicelectivesurgerypatientsasystematicreview AT debuckemmy adverseeventsofironandorerythropoiesisstimulatingagenttherapyinpreoperativelyanemicelectivesurgerypatientsasystematicreview AT compernolleveerle adverseeventsofironandorerythropoiesisstimulatingagenttherapyinpreoperativelyanemicelectivesurgerypatientsasystematicreview AT vandekerckhovephilippe adverseeventsofironandorerythropoiesisstimulatingagenttherapyinpreoperativelyanemicelectivesurgerypatientsasystematicreview |