Safety Profile of Roxadustat in Anemic Patients: A Meta-Analysis of 21 RCTs

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dc.contributor.authorTanriverdi, Lokman Hekim
dc.contributor.authorSarici, Ahmet
dc.contributor.authorErkurt, Mehmet Ali
dc.contributor.authorBerktas, Haci Bayram
dc.date.accessioned2026-04-04T13:30:50Z
dc.date.available2026-04-04T13:30:50Z
dc.date.issued2025
dc.departmentİnönü Üniversitesi
dc.description.abstractObjective: Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor used to treat anemia in patients with chronic kidney disease. We aimed to assess its safety and tolerability profile through a meta-analysis of randomized controlled trials (RCTs). Methods: A systematic search of the Cochrane CENTRAL, Ovid Medline R, PubMed, and Web of Science databases was conducted up to January1, 2025 was conducted. RCTs comparing roxadustat with control groups were included. Inverse-variance-weighted random-effects models were used. The primary outcome was the risk of any serious treatment-emergent adverse event (TEAE). Subgroup analyses were based on etiology, comparator, and prior erythropoiesis-stimulating agent (ESA) use. Results: Twenty-one RCTs involving 11.686 patients were included. Roxadustat was not associated with a higher risk of any serious TEAE compared with placebo [risk ratio (RR) =1.37, 95% confidence interval (CI): 0.79-2.371 or with ESA (RR=1.05, 95% CI: 0.99-1.10). Similarly, cardiac serious adverse events (SAEs) did not differ significantly when compared with ESA (RR=1.11, 95% CI: 0.75-1.12) or placebo (RR=1.11, 95% CI: 0.92-1.35). Hyperkalemia incidence was significantly higher compared with placebo (RR=1.25, 95% CI: 1.02-1.53) but not compared with ESA (RR=1.03, 95% CI: 0.77-1.36). There were also no significant differences in the incidence of serious infections (RR=0.74, 95% CI: 0.21-2.59), azotemia (RR=0.96, 95% CI: 0.46-2.00), hypertension (RR=1.06, 95% CI: 0.93-1.21), or pneumonia (RR=0.96, 95% CI: 0.81-1.14) compared with ESA. Notably, withdrawal due to adverse events (RR=2.11, 95% CI: 1.59-2.79) was significantly higher compared with ESA. TEAEs leading to death were similar compared with ESA (RR=0.98, 95% CI: 0.85-1.13) but were increased compared with placebo (RR=1.21, 95% CI: 1.04-1.42). All-cause mortality was significantly lower than with placebo (RR=0.40, 95% CI: 0.28-0.57) but was similar to ESA (RR=0.89, 95% CI: 0.57-1.37). Subgroup analyses for the primary outcome by etiology and prior ESA use were not consistent with the main findings. Conclusions: Roxadustat demonstrated a SAE profile generally comparable to that of ESA, with no significant differences in cardiac SAEs, serious infections, azotemia, hypertension, or pneumonia. Hyperkalemia was more frequent compared with placebo, and withdrawals due to adverse events were more frequent compared with ESA. TEAEs leading
dc.identifier.doi10.4274/MMJ.galenos.2025.44045
dc.identifier.endpage261
dc.identifier.issn2149-2042
dc.identifier.issn2149-4606
dc.identifier.issue4
dc.identifier.pmid41479171
dc.identifier.scopus2-s2.0-105026254047
dc.identifier.scopusqualityQ2
dc.identifier.startpage250
dc.identifier.trdizinid1371376
dc.identifier.urihttps://doi.org/10.4274/MMJ.galenos.2025.44045
dc.identifier.urihttps://search.trdizin.gov.tr/tr/yayin/detay/1371376
dc.identifier.urihttps://hdl.handle.net/11616/108393
dc.identifier.volume40
dc.identifier.wosWOS:001656942000001
dc.identifier.wosqualityQ2
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakTR-Dizin
dc.indekslendigikaynakPubMed
dc.language.isoen
dc.publisherGalenos Publ House
dc.relation.ispartofMedeniyet Medical Journal
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.snmzKA_WOS_20250329
dc.subjectChronic Kidney-Disease
dc.subjectActive-Comparator
dc.subjectEpoetin Alpha
dc.subjectTreat Anemia
dc.subjectPhase-3
dc.subjectHemodialysis
dc.subjectFg-4592
dc.titleSafety Profile of Roxadustat in Anemic Patients: A Meta-Analysis of 21 RCTs
dc.typeArticle

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