The effect of intravenous ferric carboxymaltose on health-related quality of life in iron-deficient patients with acute heart failure: the results of the AFFIRM-AHF study
Ewa A Jankowska
(1)
,
Bridget-Anne Kirwan
(2, 3)
,
Mikhail Kosiborod
(4, 5)
,
Javed Butler
(6)
,
Stefan D Anker
(7)
,
Theresa Mcdonagh
(8)
,
Maria Dorobantu
(9)
,
Jarosław Drozdz
(10)
,
Gerasimos Filippatos
(11, 12)
,
Andre Keren
(13)
,
Irakli Khintibidze
(14)
,
Hans Kragten
(15)
,
Felipe A Martinez
(16)
,
Marco Metra
(17, 18)
,
Davor Milicic
(19)
,
Marcus Ohlsson
(20)
,
Alexander Parkhomenko
(21)
,
Domingo A Pascual-Figal
(22)
,
Frank Ruschitzka
(23)
,
David Sim
(24)
,
Hadi Skouri
(25)
,
Peter van der Meer
(26)
,
Basil S Lewis
(27, 28)
,
Josep Comin-Colet
(29, 30)
,
Stephan von Haehling
(31, 32)
,
Alain Cohen-Solal
(33)
,
Nicolas Danchin
(34, 35)
,
Wolfram Doehner
(36, 7, 32)
,
Henry J Dargie
(37)
,
Michael Motro
(38, 39)
,
Tim Friede
(31, 32)
,
Vincent Fabien
(40)
,
Fabio Dorigotti
(40)
,
Stuart Pocock
(3, 41)
,
Piotr Ponikowski
(1)
1
Wrocław Medical University
2 SR - Socar Research S.A. [Nyon, Switzerland]
3 LSHTM - London School of Hygiene and Tropical Medicine
4 Saint Luke's Mid America Heart Institute
5 UMKC - University of Missouri [Kansas City]
6 UMMC - University of Mississippi Medical Center
7 Charité - UniversitätsMedizin = Charité - University Hospital [Berlin]
8 King‘s College London
9 UB - Universitatea din Bucuresti
10 MUL - Medical University of Łódź
11 NKUA - National and Kapodistrian University of Athens
12 UOA - Université d'Athènes
13 AHRH - Assuta Hospital in Ramat HaHayal [Tel Aviv-Yafo, Israel]
14 Tbilisi State University
15 MUMC - Maastricht University Medical Centre
16 Prague University of Economics and Business
17 UniBs - Università degli Studi di Brescia = University of Brescia
18 Civic Hospital of Brescia
19 University of Zagreb
20 Skane University Hospital [Malmo]
21 NSC/MDSIC - National Scientific Center "M.D. Strazhesko Institute of Cardiology" [Kyiv, Ukraine]
22 Universidad de Murcia
23 University hospital of Zurich [Zurich]
24 NHCS - National Heart Centre Singapore
25 AUB - American University of Beirut Faculty of Medicine and Medical Center
26 UMCG - University Medical Center Groningen [Groningen]
27 Rappaport faculty of Medicine
28 Technion - Israel Institute of Technology [Haifa]
29 L’Hospitalet de Llobregat [Barcelona, Spain]
30 IDIBELL - Institut d'Investigació Biomèdica de Bellvitge [Barcelone]
31 UMG - University Medical Center Göttingen
32 DZHK - German Center for Cardiovascular Research
33 MASCOT (UMR_S_942 / U942) - Marqueurs cardiovasculaires en situation de stress
34 AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)
35 HEGP - Hôpital Européen Georges Pompidou [APHP]
36 BIH - Berlin Institute of Health
37 University of Glasgow
38 TAU - Tel Aviv University
39 Kfar Saba and Sackler School of Medicine
40 Vifor Pharma Ltd [Glattbrugg, Switzerland]
41 UCL - University College of London [London]
2 SR - Socar Research S.A. [Nyon, Switzerland]
3 LSHTM - London School of Hygiene and Tropical Medicine
4 Saint Luke's Mid America Heart Institute
5 UMKC - University of Missouri [Kansas City]
6 UMMC - University of Mississippi Medical Center
7 Charité - UniversitätsMedizin = Charité - University Hospital [Berlin]
8 King‘s College London
9 UB - Universitatea din Bucuresti
10 MUL - Medical University of Łódź
11 NKUA - National and Kapodistrian University of Athens
12 UOA - Université d'Athènes
13 AHRH - Assuta Hospital in Ramat HaHayal [Tel Aviv-Yafo, Israel]
14 Tbilisi State University
15 MUMC - Maastricht University Medical Centre
16 Prague University of Economics and Business
17 UniBs - Università degli Studi di Brescia = University of Brescia
18 Civic Hospital of Brescia
19 University of Zagreb
20 Skane University Hospital [Malmo]
21 NSC/MDSIC - National Scientific Center "M.D. Strazhesko Institute of Cardiology" [Kyiv, Ukraine]
22 Universidad de Murcia
23 University hospital of Zurich [Zurich]
24 NHCS - National Heart Centre Singapore
25 AUB - American University of Beirut Faculty of Medicine and Medical Center
26 UMCG - University Medical Center Groningen [Groningen]
27 Rappaport faculty of Medicine
28 Technion - Israel Institute of Technology [Haifa]
29 L’Hospitalet de Llobregat [Barcelona, Spain]
30 IDIBELL - Institut d'Investigació Biomèdica de Bellvitge [Barcelone]
31 UMG - University Medical Center Göttingen
32 DZHK - German Center for Cardiovascular Research
33 MASCOT (UMR_S_942 / U942) - Marqueurs cardiovasculaires en situation de stress
34 AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)
35 HEGP - Hôpital Européen Georges Pompidou [APHP]
36 BIH - Berlin Institute of Health
37 University of Glasgow
38 TAU - Tel Aviv University
39 Kfar Saba and Sackler School of Medicine
40 Vifor Pharma Ltd [Glattbrugg, Switzerland]
41 UCL - University College of London [London]
Ewa A Jankowska
- Function : Author
- PersonId : 1214213
- ORCID : 0000-0002-9202-432X
Mikhail Kosiborod
- Function : Author
- PersonId : 1214214
- ORCID : 0000-0002-3750-9789
Maria Dorobantu
- Function : Author
- PersonId : 794247
- ORCID : 0000-0003-1940-5262
Jarosław Drozdz
- Function : Author
- PersonId : 1214215
- ORCID : 0000-0002-0732-2104
Gerasimos Filippatos
- Function : Author
- PersonId : 762371
- ORCID : 0000-0002-5640-0332
Andre Keren
- Function : Author
- PersonId : 1214216
- ORCID : 0000-0001-6575-4901
Marcus Ohlsson
- Function : Author
- PersonId : 1214217
- ORCID : 0000-0003-0043-1727
Domingo A Pascual-Figal
- Function : Author
- PersonId : 1214218
- ORCID : 0000-0002-4993-9540
Frank Ruschitzka
- Function : Author
- PersonId : 1214219
- ORCID : 0000-0001-5972-0596
Hadi Skouri
- Function : Author
- PersonId : 1214220
- ORCID : 0000-0003-0541-4926
Basil S Lewis
- Function : Author
- PersonId : 1214221
- ORCID : 0000-0001-5604-6399
Josep Comin-Colet
- Function : Author
- PersonId : 1148956
- ORCID : 0000-0001-8780-720X
Nicolas Danchin
- Function : Author
- PersonId : 1214222
- ORCID : 0000-0001-9263-5051
Wolfram Doehner
- Function : Author
- PersonId : 1213961
- ORCID : 0000-0001-7598-708X
Tim Friede
- Function : Author
- PersonId : 1169227
- ORCID : 0000-0001-5347-7441
Vincent Fabien
- Function : Author
- PersonId : 1169228
- ORCID : 0000-0003-0654-0756
Fabio Dorigotti
- Function : Author
- PersonId : 1169232
- ORCID : 0000-0002-4388-0242
Stuart Pocock
- Function : Author
- PersonId : 803748
- ORCID : 0000-0003-2212-4007
Piotr Ponikowski
- Function : Author
- PersonId : 762615
- ORCID : 0000-0002-3391-7064
- IdRef : 159134668
Abstract
Aims: Patients with heart failure (HF) and iron deficiency experience poor health-related quality of life (HRQoL). We evaluated the impact of intravenous (IV) ferric carboxymaltose (FCM) vs. placebo on HRQoL for the AFFIRM-AHF population.
Methods and results: The baseline 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12), which was completed for 1058 (535 and 523) patients in the FCM and placebo groups, respectively, was administered prior to randomization and at Weeks 2, 4, 6, 12, 24, 36, and 52. The baseline KCCQ-12 overall summary score (OSS) mean ± standard error was 38.7 ± 0.9 (FCM group) and 37.1 ± 0.8 (placebo group); corresponding values for the clinical summary score (CSS) were 40.9 ± 0.9 and 40.1 ± 0.9. At Week 2, changes in OSS and CSS were similar for FCM and placebo. From Week 4 to Week 24, patients assigned to FCM had significantly greater improvements in OSS and CSS scores vs. placebo [adjusted mean difference (95% confidence interval, CI) at Week 4: 2.9 (0.5-5.3, P = 0.018) for OSS and 2.8 (0.3-5.3, P = 0.029) for CSS; adjusted mean difference (95% CI) at Week 24: 3.0 (0.3-5.6, P = 0.028) for OSS and 2.9 (0.2-5.6, P = 0.035) for CSS]. At Week 52, the treatment effect had attenuated but remained in favour of FCM.
Conclusion: In iron-deficient patients with HF and left ventricular ejection fraction ≤50% who had stabilized after an episode of acute HF, treatment with IV FCM, compared with placebo, results in clinically meaningful beneficial effects on HRQoL as early as 4 weeks after treatment initiation, lasting up to Week 24.
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