Intravenous ferric carboxymaltose for iron repletion following acute heart failure in patients with and without diabetes: a subgroup analysis of the randomized AFFIRM-AHF trial.
AFFIRM-AHF
Acute heart failure
Diabetes
Ferric carboxymaltose
Iron deficiency
Journal
Cardiovascular diabetology
ISSN: 1475-2840
Titre abrégé: Cardiovasc Diabetol
Pays: England
ID NLM: 101147637
Informations de publication
Date de publication:
17 08 2023
17 08 2023
Historique:
received:
27
02
2023
accepted:
27
07
2023
medline:
21
8
2023
pubmed:
18
8
2023
entrez:
17
8
2023
Statut:
epublish
Résumé
In AFFIRM-AHF, treatment of iron deficiency with intravenous ferric carboxymaltose (FCM) reduced the risk of heart failure (HF) hospitalization and improved quality of life (QoL) vs placebo in patients stabilized following an acute HF (AHF) episode, with no effect on cardiovascular (CV) death. Diabetes and iron deficiency frequently accompany AHF. This post hoc analysis explored the effects of diabetes on outcomes in AFFIRM-AHF patients. Patients were stratified by diabetes yes/no at baseline. The effects of FCM vs placebo on primary (total HF hospitalizations and CV death) and secondary (total CV hospitalizations and CV death; CV death; total HF hospitalizations; time to first HF hospitalization or CV death; and days lost due to HF hospitalizations or CV death) endpoints at Week 52 and change vs baseline in disease-specific QoL (12-item Kansas City Cardiomyopathy Questionnaire [KCCQ-12]) at Week 24 were assessed by subgroup. For each endpoint, the interaction between diabetes status and treatment outcome was explored. Of 1108 AFFIRM-AHF patients, 475 (FCM: 231; placebo: 244) had diabetes and 633 (FCM: 327; placebo: 306) did not have diabetes. Patients with diabetes were more commonly male (61.5% vs 50.9%), with a higher frequency of ischemic HF etiology (57.9% vs 39.0%), prior HF history (77.7% vs 66.5%), and comorbidities (including previous myocardial infarction [49.3% vs 32.9%] and chronic kidney disease [51.4% vs 32.4%]) than those without diabetes. The annualized event rate/100 patient-years with FCM vs placebo for the primary endpoint was 66.9 vs 80.9 in patients with diabetes (rate ratio [RR]: 0.83, 95% CI 0.58-1.81) and 51.3 vs 66.9 in patients without diabetes (RR: 0.77, 95% CI 0.55-1.07), with no significant interaction between diabetes status and treatment effect (p The clinical and QoL benefits observed with intravenous FCM in patients with iron deficiency following stabilization from an AHF episode are independent of diabetes status. Trial registration Clinicaltrials.gov, NCT02937454 (registered 10.18.2016).
Sections du résumé
BACKGROUND
In AFFIRM-AHF, treatment of iron deficiency with intravenous ferric carboxymaltose (FCM) reduced the risk of heart failure (HF) hospitalization and improved quality of life (QoL) vs placebo in patients stabilized following an acute HF (AHF) episode, with no effect on cardiovascular (CV) death. Diabetes and iron deficiency frequently accompany AHF. This post hoc analysis explored the effects of diabetes on outcomes in AFFIRM-AHF patients.
METHODS
Patients were stratified by diabetes yes/no at baseline. The effects of FCM vs placebo on primary (total HF hospitalizations and CV death) and secondary (total CV hospitalizations and CV death; CV death; total HF hospitalizations; time to first HF hospitalization or CV death; and days lost due to HF hospitalizations or CV death) endpoints at Week 52 and change vs baseline in disease-specific QoL (12-item Kansas City Cardiomyopathy Questionnaire [KCCQ-12]) at Week 24 were assessed by subgroup. For each endpoint, the interaction between diabetes status and treatment outcome was explored.
RESULTS
Of 1108 AFFIRM-AHF patients, 475 (FCM: 231; placebo: 244) had diabetes and 633 (FCM: 327; placebo: 306) did not have diabetes. Patients with diabetes were more commonly male (61.5% vs 50.9%), with a higher frequency of ischemic HF etiology (57.9% vs 39.0%), prior HF history (77.7% vs 66.5%), and comorbidities (including previous myocardial infarction [49.3% vs 32.9%] and chronic kidney disease [51.4% vs 32.4%]) than those without diabetes. The annualized event rate/100 patient-years with FCM vs placebo for the primary endpoint was 66.9 vs 80.9 in patients with diabetes (rate ratio [RR]: 0.83, 95% CI 0.58-1.81) and 51.3 vs 66.9 in patients without diabetes (RR: 0.77, 95% CI 0.55-1.07), with no significant interaction between diabetes status and treatment effect (p
CONCLUSIONS
The clinical and QoL benefits observed with intravenous FCM in patients with iron deficiency following stabilization from an AHF episode are independent of diabetes status. Trial registration Clinicaltrials.gov, NCT02937454 (registered 10.18.2016).
Identifiants
pubmed: 37592272
doi: 10.1186/s12933-023-01943-z
pii: 10.1186/s12933-023-01943-z
pmc: PMC10436432
doi:
Substances chimiques
ferric carboxymaltose
6897GXD6OE
Iron
E1UOL152H7
Banques de données
ClinicalTrials.gov
['NCT02937454']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
215Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
Références
J Am Coll Cardiol. 2006 Jan 3;47(1):76-84
pubmed: 16386668
Eur Heart J. 2020 Jan 7;41(2):255-323
pubmed: 31497854
Diabetes Ther. 2018 Feb;9(1):37-47
pubmed: 29134606
Circulation. 2003 Jan 21;107(2):223-5
pubmed: 12538418
Acta Haematol. 2004;112(3):126-8
pubmed: 15345893
Circulation. 2017 Feb 21;135(8):724-735
pubmed: 28052977
Eur J Heart Fail. 2018 May;20(5):853-872
pubmed: 29520964
N Engl J Med. 2009 Dec 17;361(25):2436-48
pubmed: 19920054
Diabetes Care. 2017 May;40(5):671-678
pubmed: 28255009
Lancet. 2020 Dec 12;396(10266):1895-1904
pubmed: 33197395
Eur Heart J. 2015 Mar 14;36(11):657-68
pubmed: 25176939
Eur J Heart Fail. 2022 Sep;24(9):1519-1528
pubmed: 35748124
Eur J Heart Fail. 2019 Dec;21(12):1651-1658
pubmed: 31883356
Eur Heart J. 2008 Jun;29(11):1377-85
pubmed: 18413309
Am Heart J. 2013 Apr;165(4):575-582.e3
pubmed: 23537975
Acta Biomed. 2017 Apr 28;88(1):112-118
pubmed: 28467345
J Am Coll Cardiol. 2019 Feb 12;73(5):602-611
pubmed: 30732715
Diabetes Care. 2013 Dec;36(12):4147-56
pubmed: 24130349
Am J Cardiol. 2010 Feb 1;105(3):373-7
pubmed: 20102951
Diabetes Care. 2010 Apr;33(4):780-5
pubmed: 20067959
Eur J Heart Fail. 2022 May;24(5):833-842
pubmed: 35334136
Eur J Prev Cardiol. 2019 Jan;26(1):72-82
pubmed: 30335505
Eur J Heart Fail. 2017 Jan;19(1):54-65
pubmed: 27790816
Eur Heart J. 2021 Aug 17;42(31):3011-3020
pubmed: 34080008
Eur J Heart Fail. 2021 Mar;23(3):420-431
pubmed: 33443295
Eur Heart J. 2010 Aug;31(15):1872-80
pubmed: 20570952
Eur J Heart Fail. 2020 Oct;22(10):1777-1785
pubmed: 32227556
Eur J Prev Cardiol. 2020 Dec;27(2_suppl):27-34
pubmed: 33238738