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850. Real-world effectiveness and safety compared among isavuconazole, amphotericin B, and voriconazole in invasive mold disease patients
BACKGROUND: Isavuconazole is a brand-new triazole with broad-spectrum antifungal action. Amphotericin B and voriconazole are critical components of the antifungal arsenal. But the effectiveness and safety compared among these three drugs in invasive mold disease (IMD) are still lacking. METHODS: Rea...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10678891/ http://dx.doi.org/10.1093/ofid/ofad500.895 |
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author | Qiu, Ye Chen, Wushu Zhan, Yangqing Li, Shaoqiang Wang, Yan Chen, Zhen Li, Zhengtu Ye, Feng |
author_facet | Qiu, Ye Chen, Wushu Zhan, Yangqing Li, Shaoqiang Wang, Yan Chen, Zhen Li, Zhengtu Ye, Feng |
author_sort | Qiu, Ye |
collection | PubMed |
description | BACKGROUND: Isavuconazole is a brand-new triazole with broad-spectrum antifungal action. Amphotericin B and voriconazole are critical components of the antifungal arsenal. But the effectiveness and safety compared among these three drugs in invasive mold disease (IMD) are still lacking. METHODS: Real-world study of effectiveness and safety compared among isavuconazole, amphotericin B, and voriconazole in IMD patients was performed between October 2019 and March 2022 in the First Affiliated Hospital of Guangzhou Medical University. We included the IMD patients who were treated with isavuconazole or amphotericin B or voriconazole. We tested the non-inferiority of the primary efficacy endpoint of all-cause mortality from the first dose of the study drug to day 42 in patients who received at least one dose of the study drugs using a 10% non-inferiority margin. Meanwhile, safety was assessed in patients who received the first dose of the study drugs. RESULTS: 236 patients with IMD including 33 patients in the isavuconazole group, 24 patients in the amphotericin B group, and 179 patients in the voriconazole group were included in our study(Table 1, Figure 1). Mortality up until day 42 was 6% in the isavuconazole group, 33% in the amphotericin B group, and 16% in the voriconazole group (I: Isavuconazole, A: Amphotericin B, V: Voriconazole; I vs A: treatment difference 27.3% [95% CI 6.6 to 47.9%]; p=0·0002. I vs V: treatment difference 10.1% [95% CI –5.3 to 25.6%]; p=0·0053. V vs A: treatment difference 17.1% [95% CI 3.17 to 31.1%]; p< 0·0001) (Table 2, Figure 3). We got differences among these three groups in renal and urinary disorders(RAUD)(P=0.015), hypokalemic blood(p=0.028), and systemic events(SE)(p=0.003). Patients who received amphotericin B typically experienced a higher rate of treatment-related adverse events; however, patients who had lower adverse events rates of SE (7%) received voriconazole, and of RAUD (3%), liver disorders (3%) received isavuconazole. (Figure 2). [Figure: see text] [Figure: see text] [Figure: see text] CONCLUSION: Isavuconazole and voriconazole were superior to Amphotericin B, and Isavuconazole was non-inferior to voriconazole, for the primary efficacy endpoint in patients with IMD. The results indicated that we need to attach importance to the role of isavuconazole so that we can better use isavuconazole in clinical practice. Demographics and baseline characteristics [Figure: see text] Non-inferiority test [Figure: see text] DISCLOSURES: All Authors: No reported disclosures |
format | Online Article Text |
id | pubmed-10678891 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-106788912023-11-27 850. Real-world effectiveness and safety compared among isavuconazole, amphotericin B, and voriconazole in invasive mold disease patients Qiu, Ye Chen, Wushu Zhan, Yangqing Li, Shaoqiang Wang, Yan Chen, Zhen Li, Zhengtu Ye, Feng Open Forum Infect Dis Abstract BACKGROUND: Isavuconazole is a brand-new triazole with broad-spectrum antifungal action. Amphotericin B and voriconazole are critical components of the antifungal arsenal. But the effectiveness and safety compared among these three drugs in invasive mold disease (IMD) are still lacking. METHODS: Real-world study of effectiveness and safety compared among isavuconazole, amphotericin B, and voriconazole in IMD patients was performed between October 2019 and March 2022 in the First Affiliated Hospital of Guangzhou Medical University. We included the IMD patients who were treated with isavuconazole or amphotericin B or voriconazole. We tested the non-inferiority of the primary efficacy endpoint of all-cause mortality from the first dose of the study drug to day 42 in patients who received at least one dose of the study drugs using a 10% non-inferiority margin. Meanwhile, safety was assessed in patients who received the first dose of the study drugs. RESULTS: 236 patients with IMD including 33 patients in the isavuconazole group, 24 patients in the amphotericin B group, and 179 patients in the voriconazole group were included in our study(Table 1, Figure 1). Mortality up until day 42 was 6% in the isavuconazole group, 33% in the amphotericin B group, and 16% in the voriconazole group (I: Isavuconazole, A: Amphotericin B, V: Voriconazole; I vs A: treatment difference 27.3% [95% CI 6.6 to 47.9%]; p=0·0002. I vs V: treatment difference 10.1% [95% CI –5.3 to 25.6%]; p=0·0053. V vs A: treatment difference 17.1% [95% CI 3.17 to 31.1%]; p< 0·0001) (Table 2, Figure 3). We got differences among these three groups in renal and urinary disorders(RAUD)(P=0.015), hypokalemic blood(p=0.028), and systemic events(SE)(p=0.003). Patients who received amphotericin B typically experienced a higher rate of treatment-related adverse events; however, patients who had lower adverse events rates of SE (7%) received voriconazole, and of RAUD (3%), liver disorders (3%) received isavuconazole. (Figure 2). [Figure: see text] [Figure: see text] [Figure: see text] CONCLUSION: Isavuconazole and voriconazole were superior to Amphotericin B, and Isavuconazole was non-inferior to voriconazole, for the primary efficacy endpoint in patients with IMD. The results indicated that we need to attach importance to the role of isavuconazole so that we can better use isavuconazole in clinical practice. Demographics and baseline characteristics [Figure: see text] Non-inferiority test [Figure: see text] DISCLOSURES: All Authors: No reported disclosures Oxford University Press 2023-11-27 /pmc/articles/PMC10678891/ http://dx.doi.org/10.1093/ofid/ofad500.895 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Abstract Qiu, Ye Chen, Wushu Zhan, Yangqing Li, Shaoqiang Wang, Yan Chen, Zhen Li, Zhengtu Ye, Feng 850. Real-world effectiveness and safety compared among isavuconazole, amphotericin B, and voriconazole in invasive mold disease patients |
title | 850. Real-world effectiveness and safety compared among isavuconazole, amphotericin B, and voriconazole in invasive mold disease patients |
title_full | 850. Real-world effectiveness and safety compared among isavuconazole, amphotericin B, and voriconazole in invasive mold disease patients |
title_fullStr | 850. Real-world effectiveness and safety compared among isavuconazole, amphotericin B, and voriconazole in invasive mold disease patients |
title_full_unstemmed | 850. Real-world effectiveness and safety compared among isavuconazole, amphotericin B, and voriconazole in invasive mold disease patients |
title_short | 850. Real-world effectiveness and safety compared among isavuconazole, amphotericin B, and voriconazole in invasive mold disease patients |
title_sort | 850. real-world effectiveness and safety compared among isavuconazole, amphotericin b, and voriconazole in invasive mold disease patients |
topic | Abstract |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10678891/ http://dx.doi.org/10.1093/ofid/ofad500.895 |
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