Risk Factors for Thromboembolic Events in Patients With Dialysis-Dependent CKD: Pooled Analysis of Four Global Roxadustat Phase 3 Trials
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| Titel: | Risk Factors for Thromboembolic Events in Patients With Dialysis-Dependent CKD: Pooled Analysis of Four Global Roxadustat Phase 3 Trials |
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| Autoren: | Takayuki Hamano, Yusuke Yamaguchi, Kashia Goto, Shaka Martin, Alina Jiletcovici, Frank Dellanna, Tadao Akizawa, Jonathan Barratt |
| Quelle: | Adv Ther |
| Verlagsinformationen: | Springer Science and Business Media LLC, 2024. |
| Publikationsjahr: | 2024 |
| Schlagwörter: | Hemoglobins, Renal Dialysis, Risk Factors, Thromboembolism, Glycine, Humans, Anemia, Renal Insufficiency, Chronic, Isoquinolines, Glycine/adverse effects [MeSH], Thromboembolism/etiology [MeSH], Aged [MeSH], Humans [MeSH], Hemoglobins/analysis [MeSH], Roxadustat, Risk Factors [MeSH], Renal Insufficiency, Chronic/complications [MeSH], Anemia/etiology [MeSH], Thromboembolism/chemically induced [MeSH], Isoquinolines/adverse effects [MeSH], Chronic kidney disease, Renal Insufficiency, Chronic/therapy [MeSH], Original Research, Renal Dialysis/adverse effects [MeSH], Aged |
| Beschreibung: | Risk factors for thromboembolic events in patients with dialysis-dependent chronic kidney disease (CKD) receiving roxadustat are unknown. Iron deficiency has been reported as a risk factor for thrombosis in the general population.Thromboembolic events with onset before and after week 12 in patients receiving roxadustat were evaluated in this pooled analysis of four global phase 3 trials, PYRENEES, SIERRAS, HIMALAYAS, and ROCKIES. Baseline risk factors for thromboembolic events were investigated by Cox regression analyses. Nested case-control analyses with matched pairs of case-control data explored the relationship between thromboembolic events and last known laboratory parameters before event onset.Of 2354 patients, 1026 thromboembolic events were observed in 568 patients. Baseline risk factors found included hemodialysis (vs peritoneal dialysis), advanced age (≥ 65 years), Black race, high high-sensitivity C-reactive protein, and history of thromboembolism, cardiovascular disease, or diabetes. Univariate case-control analyses revealed that high hemoglobin rate of rise (≥ 0.5 g/dL/week; odds ratio [OR] 2.09; 95% confidence interval [CI] 0.98-4.46) showed a trend towards increased risk of thromboembolic events before week 12, and high rate of hemoglobin decline was associated with events after week 12 ( |
| Publikationsart: | Article Other literature type |
| Sprache: | English |
| ISSN: | 1865-8652 0741-238X |
| DOI: | 10.1007/s12325-023-02728-2 |
| Zugangs-URL: | https://pubmed.ncbi.nlm.nih.gov/38363466 https://repository.publisso.de/resource/frl:6523572 |
| Rights: | CC BY NC URL: http://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial 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-nc/4.0/ (http://creativecommons.org/licenses/by-nc/4.0/) . |
| Dokumentencode: | edsair.doi.dedup.....c9fe6eeef3561b17da2aefa8afb9e872 |
| Datenbank: | OpenAIRE |
Nájsť tento článok vo Web of Science | Abstract: | Risk factors for thromboembolic events in patients with dialysis-dependent chronic kidney disease (CKD) receiving roxadustat are unknown. Iron deficiency has been reported as a risk factor for thrombosis in the general population.Thromboembolic events with onset before and after week 12 in patients receiving roxadustat were evaluated in this pooled analysis of four global phase 3 trials, PYRENEES, SIERRAS, HIMALAYAS, and ROCKIES. Baseline risk factors for thromboembolic events were investigated by Cox regression analyses. Nested case-control analyses with matched pairs of case-control data explored the relationship between thromboembolic events and last known laboratory parameters before event onset.Of 2354 patients, 1026 thromboembolic events were observed in 568 patients. Baseline risk factors found included hemodialysis (vs peritoneal dialysis), advanced age (≥ 65 years), Black race, high high-sensitivity C-reactive protein, and history of thromboembolism, cardiovascular disease, or diabetes. Univariate case-control analyses revealed that high hemoglobin rate of rise (≥ 0.5 g/dL/week; odds ratio [OR] 2.09; 95% confidence interval [CI] 0.98-4.46) showed a trend towards increased risk of thromboembolic events before week 12, and high rate of hemoglobin decline was associated with events after week 12 ( |
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| ISSN: | 18658652 0741238X |
| DOI: | 10.1007/s12325-023-02728-2 |